[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"axial-spondyloarthritis\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:axial-spondyloarthritis":28},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,27,0,25,[9,44,72,102,131,164,208,230,255,274,295,319,343,367,401,423,444,470,495,516,539,576,608,634,655],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":4,"eligibilityCriteria":16,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":29,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":38,"leadSponsor":40,"locationsCount":43},"100615240","phase-1-a-study-to-learn-if-bimekizumab-given-in-different-ways-is-safe-and-moves-similarly-throughout-the-body-over-time-in-adults-100615240",false,"NCT07290036","A Study to Learn if Bimekizumab Given in Different Ways is Safe and Moves Similarly Throughout the Body Over Time in Adults","An Open-label, Randomized, Parallel-group, Noninferiority Study to Evaluate the Pharmacokinetics of Bimekizumab Administered Intravenously or as a Subcutaneous Injection in Participants With Active Psoriatic Arthritis and\u002For Active Axial Spondyloarthritis","Inclusion Criteria:\n\n1. Be 18+ years old and legally able to consent\n2. Have active psoriatic arthritis (PsA) or axial spondyloarthritis (axSpA), suitable for bimekizumab treatment\n3. Weigh between 45-100 kg (females) or 50-100 kg (males).\n4. Be biologic disease-modifying anti-rheumatic drug (bDMARD)-naïve or have stopped bDMARDs ≥3 months or 5 half-lives ago\n\nExclusion Criteria:\n\n1. Serious organ system disorders (e.g., heart, liver, kidney, gastrointestinal, neuro)\n2. Severe psychiatric issues or substance abuse in the past year\n3. Recent or chronic infections, including tuberculosis (TB) or nontuberculous mycobacterium (NTMB)\n4. Other inflammatory diseases (e.g., rheumatoid arthritis (RA), lupus, inflammatory bowel disease (IBD))\n5. Recent live vaccines (within 8 weeks) or Bacillus Calmette-Guerin (BCG) (within 1 year)\n6. Recent use of glucagon-like peptide-1 (GLP-1) agonists (within 28 weeks)","ALL","18 Years",{"count":20,"type":21},392,"ESTIMATED","INTERVENTIONAL",[24],"PHASE1","To demonstrate that bimekizumab administered intravenously is noninferior to subcutaneous administration.",[27,28],"Psoriatic Arthritis","Axial Spondyloarthritis",[30],"Bimekizumab, BKZ, Phase 1B","RECRUITING","2026-06-18",{"date":34,"type":35},"2026-06-22","ACTUAL",{"date":37,"type":35},"2025-12-10",{"date":39,"type":21},"2028-09-14",{"name":41,"class":42},"UCB Biopharma SRL","INDUSTRY",62,{"id":45,"slug":46,"hasResults":12,"nctId":47,"briefTitle":48,"officialTitle":49,"acronym":4,"eligibilityCriteria":50,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":51,"targetDuration":4,"studyType":22,"phases":53,"briefSummary":55,"conditions":56,"keywords":57,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":61,"lastUpdatePostDateStruct":62,"startDateStruct":64,"completionDateStruct":66,"leadSponsor":68,"locationsCount":71},"100643527","physical-activity-through-health-technology-in-axial-spondyloarthritis-100643527","NCT07642622","Physical Activity Through Health Technology in Axial Spondyloarthritis","Expanding Access to Early Exercise Prescriptions for Underserved Patients With Axial Spondyloarthritis: A Digital Health Approach","Inclusion Criteria:\n\n* Diagnosis of axial spondyloarthritis by a rheumatologist\n* English speaking\n* Insufficiently active (less than 150 minutes of moderate intensity aerobic activity per week)\n* Willing to wear a Fitbit for the study duration\n* Willing to have or create a Google account and download the Google Health app (previously known as the Fitbit app)\n\nExclusion Criteria:\n\n* Currently pregnant\n* International travel or any circumstance causing lack of access to wi-fi\u002FInternet at any point during the study period\n* Recent or planned surgery that may affect ability to engage in physical activity\n* Unable to exercise for health reasons, or a provider has recommended against exercising for safety\u002Fhealth reasons\n* Unable to walk safely without difficulty, or is a fall risk (i.e., 3+ falls in past 6 months)\n* History of a fall resulting in a fracture or head injury in the past 6 months\n* Cardiovascular contraindicators for physical activity, or history of cardiovascular problems that may be exacerbated by physical activity, as defined by their rheumatologist\n* Diabetes causing hypoglycemia following physical activity",{"count":52,"type":21},40,[54],"NA","The purpose of this study is to find out whether a mobile app called the ExerciseRx app is a practical and helpful way for people with axial spondyloarthritis (axSpA) to receive exercise recommendations as part of their regular rheumatology care.\n\nResearchers want to learn:\n\nWhether people with axSpA find the ExerciseRx app easy to use and helpful for supporting regular exercise.\n\nWhether using the ExerciseRx app leads to improvements in symptoms, physical function, and disease activity compared with usual care.\n\nParticipants assigned to the ExerciseRx group will use the app to complete guided exercises for 20-30 minutes, four times per week. They will also receive personalized weekly step-count goals to help increase their physical activity. Researchers will compare outcomes between participants using the app and those receiving usual care.",[28],[58,59,60],"digital health","exercise","mobile app","2026-06-09",{"date":63,"type":35},"2026-06-11",{"date":65,"type":21},"2026-06",{"date":67,"type":21},"2027-06",{"name":69,"class":70},"University of Washington","OTHER",2,{"id":73,"slug":74,"hasResults":12,"nctId":75,"briefTitle":76,"officialTitle":77,"acronym":78,"eligibilityCriteria":79,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":80,"enrollmentInfo":81,"targetDuration":4,"studyType":22,"phases":83,"briefSummary":85,"conditions":86,"keywords":90,"overallStatus":92,"whyStopped":4,"lastUpdateSubmitDate":93,"lastUpdatePostDateStruct":94,"startDateStruct":96,"completionDateStruct":98,"leadSponsor":100,"locationsCount":4},"100556536","phase-2-vilamakitug-in-spondyloarthritis-placebo-controlled-investigation-for-efficacy-100556536","NCT06526377","Vilamakitug in Spondyloarthritis Placebo-controlled Investigation for Efficacy","Phase II, Double-Blind, Placebo-Controlled, Randomized Study Evaluating the Efficacy and Safety of Vilamakitug in Participants With Active Axial Spondyloarthritis","V-SPINE","Inclusion Criteria:\n\n1. Male or female aged ≥18 and ≤65 years, with body weight \\>40 kg at screening, who are willing to provide informed consent, attend all clinic visits, comply with study-related procedures and able to understand and complete study-related questionnaires.\n2. Must meet the ASAS-SPARTAN 2025 revised classification criteria for axial spondyloarthritis.\n3. Active disease at screening, defined by BASDAI ≥ 4 and ASDAS-CRP ≥ 2.1\n4. Participants should have received prior NSAIDs or have documented inadequate response to NSAIDs\n5. Participants may be biological DMARD-naïve or have documented failure of no more than 1 prior biologic DMARD (≥12 weeks)\n\nExclusion Criteria:\n\n1. History of treatment with vilamakitug\n2. Any prior exposure to \\> 1 biologic DMARD\n3. Any exposure to JAK or TYK2 inhibitors\n4. Current drug or alcohol abuse or dependence, or a history of drug or alcohol abuse or dependence within a year prior to enrollment\n5. Participation in another interventional clinical study within 30 days or 5 half-lives (whichever is longer) prior to enrollment, and during the study\n6. Female participants who are pregnant or breastfeeding at screening, or who intend to become pregnant during the study or within 8 weeks after the last dose of investigational product (IP), and male participants who intend to father a child during the study or within 8 weeks after the last dose of IP.","65 Years",{"count":82,"type":21},150,[84],"PHASE2","The goal of this clinical trial is to find out if the study drug will work as a new therapy for axSpA patients. This study is placebo-controlled, and evaluates if study drug can treat symptoms of axSpA, including global disease activity, pain, function and inflammation.",[28,87,88,89],"Ankylosing Spondylitis","r-axSpA","Nr-axSpA",[91],"axSpA","NOT_YET_RECRUITING","2026-05-11",{"date":95,"type":35},"2026-05-14",{"date":97,"type":21},"2026-09",{"date":99,"type":21},"2028-09",{"name":101,"class":42},"XBiotech, Inc.",{"id":103,"slug":104,"hasResults":12,"nctId":105,"briefTitle":106,"officialTitle":107,"acronym":108,"eligibilityCriteria":109,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":80,"enrollmentInfo":110,"targetDuration":4,"studyType":22,"phases":111,"briefSummary":113,"conditions":114,"keywords":117,"overallStatus":92,"whyStopped":4,"lastUpdateSubmitDate":121,"lastUpdatePostDateStruct":122,"startDateStruct":124,"completionDateStruct":126,"leadSponsor":128,"locationsCount":130},"100638927","phase-4-effectiveness-and-safety-of-acemetacin-in-active-axial-spondyloarthritis-a-real-world-study-100638927","NCT07582146","Effectiveness and Safety of Acemetacin in Active Axial Spondyloarthritis: A Real-world Study","Effectiveness and Safety of Acemetacin in Patients With Active Axial Spondyloarthritis: A Prospective, Multicenter, Observational Real-World Study","ARISE","Inclusion Criteria:\n\n* Subjects who fully understand the purpose and procedures of the trial and voluntarily sign the Informed Consent Form (ICF);\n* Subjects aged 18-65 years (inclusive), regardless of gender;\n* Meet the 2025 ASAS-SPARTAN Revised Classification Criteria for Axial Spondyloarthritis;\n* ASDAS score \\> 2.1.\n\nExclusion Criteria:\n\n* Subjects with known allergy to acemetacin, other NSAIDs, or any excipients;\n* Subjects with active gastrointestinal ulcer\u002Fbleeding, or a history of recurrent ulcer\u002Fbleeding;\n* Subjects with severe cardiac or renal dysfunction, or hepatic dysfunction;\n* Subjects with ulcerative colitis or Crohn's disease;\n* Subjects who received systemic glucocorticoids or intra-articular glucocorticoid injections within 3 months prior to the study start;\n* Subjects who received targeted therapy within 3 months prior to the study start;\n* Any other condition that, in the investigator's opinion, makes the subject unsuitable for participation in this study.",{"count":82,"type":21},[112],"PHASE4","The goal of this observational study is to evaluate the effectiveness and safety of acemetacin in adults (18-65 years) with active axial spondyloarthritis (axSpA) who meet the 2025 ASAS-SPARTAN revised classification criteria and have an ASDAS score greater than 2.1.\n\nThe main questions this study aims to answer are:\n\n* Does acemetacin reduce overall pain assessed by visual analog scale (VAS) after 4 weeks of treatment?\n* What proportion of patients achieve clinical remission (ASDAS ≤1.3) or low disease activity (1.3\\\u003CASDAS≤2.1) at week 4?\n* What medical problems (side effects) occur during acemetacin treatment, with particular attention to gastrointestinal and cardiovascular events?\n\nParticipants will:\n\n* Undergo screening assessments including blood tests, imaging of the sacroiliac joints (MRI, CT, X-ray), and physical examination within 7 days before starting treatment\n* Take acemetacin 90 mg by mouth once daily for 4 weeks\n* Complete a phone follow-up at week 2 and an in-clinic visit at week 4\n* Have pain scores, disease activity measures (ASDAS, BASDAI, BASFI, ASAS HI, BASMI), and laboratory tests (CRP, ESR) recorded at each visit\n* Be monitored for adverse events throughout the treatment period",[28,115,116],"Axial Spondyloarthritis, Non-Radiographic","Ankylosing Spondylitis (AS) \u002F Radiographic Axial SpA (r-axSpA)",[118,28,119,120],"Acemetacin","NSAIDs","Real-World Study","2026-05-06",{"date":123,"type":35},"2026-05-12",{"date":125,"type":21},"2026-04",{"date":127,"type":21},"2026-12",{"name":129,"class":70},"Chinese PLA General Hospital",1,{"id":132,"slug":133,"hasResults":12,"nctId":134,"briefTitle":135,"officialTitle":136,"acronym":137,"eligibilityCriteria":138,"healthyVolunteers":12,"sex":139,"minAge":18,"maxAge":4,"enrollmentInfo":140,"targetDuration":4,"studyType":22,"phases":142,"briefSummary":143,"conditions":144,"keywords":147,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":155,"lastUpdatePostDateStruct":156,"startDateStruct":158,"completionDateStruct":160,"leadSponsor":162,"locationsCount":163},"100584350","phase-1-a-study-to-assess-the-concentration-of-bimekizumab-in-mature-breast-milk-from-mothers-receiving-treatment-with-bimzelx-bimekizumab-100584350","NCT06888193","A Study to Assess the Concentration of Bimekizumab in Mature Breast Milk From Mothers Receiving Treatment With Bimzelx® (Bimekizumab)","A Multicenter Open-label, Prospective Study to Assess the Concentration of Bimekizumab in Mature Breast Milk From Mothers Receiving Treatment With Bimzelx® (Bimekizumab)","BE CARING","Inclusion Criteria:\n\n* Study participant must be at least 18 years of age at the time of signing the informed consent.\n* Study participant is being treated with commercial bimekizumab per locally approved prescribing information and in accordance with her treating physician.\n* Study participant is breastfeeding and intends to breastfeed throughout the Sampling Period.\n* The decision to treat with bimekizumab and to breastfeed is made independently from and prior to the study participant consenting to participate in the study.\n* Study participant must be on bimekizumab treatment for at least 12 weeks after delivery and since starting\u002Frestarting\u002Fcontinuing bimekizumab prior to sampling (prior to start of the Sampling Period).\n* A female study participant is eligible to participate if she is not pregnant and does not plan to become pregnant during the study.\n\nExclusion Criteria:\n\n* Study participant has any medical, obstetrical, or psychiatric condition that, in the opinion of the Investigator, could jeopardize or would compromise the study participant's ability to participate in this study.\n* The infant has any abnormality noted on physical examination or medical history that, in the opinion of the Investigator, may jeopardize or compromise study participation.\n* Study participant has a history of chronic alcohol or drug abuse within the previous last year.\n* Study participant has history of breast implants, breast augmentation, or breast reduction surgery.\n* Study participant plans a surgical intervention during the Screening Period and Sampling Period or anticipates having surgery while participating in the Sampling Period (does not apply to tubal ligation).\n* Study participant or her infant has participated in another study of an investigational medicinal product (IMP) (and\u002For an investigational device) within the previous 6 months or is currently participating in another study of an IMP (and\u002For an investigational device), unless the study is UCB PS0036 or a bimekizumab registry study.\n* Study participant or her infant has previously participated (ie, entered the sampling period) in this study.","FEMALE",{"count":141,"type":21},20,[24],"Primary purpose of the study is to assess the concentration of bimekizumab in mature human breast milk.",[145,27,28,146],"Moderate to Severe Plaque Psoriasis","Hidradenitis Suppurativa",[148,149,150,151,152,153,154],"Bimekizumab","Breastfeeding mothers","Bimzelx®","PSO","HS","AxSpa","PsA","2026-04-30",{"date":157,"type":35},"2026-05-01",{"date":159,"type":35},"2025-11-05",{"date":161,"type":21},"2027-05-03",{"name":41,"class":42},12,{"id":165,"slug":166,"hasResults":12,"nctId":167,"briefTitle":168,"officialTitle":169,"acronym":170,"eligibilityCriteria":171,"healthyVolunteers":172,"sex":17,"minAge":173,"maxAge":174,"enrollmentInfo":175,"targetDuration":4,"studyType":22,"phases":177,"briefSummary":178,"conditions":179,"keywords":191,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":199,"lastUpdatePostDateStruct":200,"startDateStruct":202,"completionDateStruct":204,"leadSponsor":206,"locationsCount":71},"100599701","phase-4-safety-and-immunogenicity-of-the-live-attenuated-tetravalent-butantan-dengue-vaccine-in-autoimmune-rheumatic-diseases-100599701","NCT07087912","Safety and Immunogenicity of the Live Attenuated Tetravalent Butantan-Dengue Vaccine in Autoimmune Rheumatic Diseases","Safety and Immunogenicity of the Live Attenuated Tetravalent Butantan-Dengue Vaccine (Butantan-DV) in Patients With Autoimmune Rheumatic Diseases Living in Dengue-Endemic Areas","BTNDV-ARD","Inclusion Criteria:\n\n* Age between 12 and 59 years\n* Male or female\n* Clinical diagnosis of an autoimmune rheumatic disease (ARD) based on internationally accepted criteria (e.g., rheumatoid arthritis, systemic lupus erythematosus, juvenile idiopathic arthritis, Sjögren's syndrome, vasculitis)\n* Healthy control matched by age and sex\n* ARD patients with clinically stable disease for at least 3 months\n* ARD patients under low-grade immunosuppression or no immunosuppression\n* Acceptable immunosuppressive treatments include:\n\nHydroxychloroquine Sulfasalazine Prednisone ≤ 20 mg\u002Fday Methotrexate ≤ 0.4 mg\u002Fkg\u002Fweek (maximum 20 mg\u002Fweek) Leflunomide 20 mg\u002Fday Azathioprine \\\u003C 3 mg\u002Fkg\u002Fday Combination therapy with low-dose prednisone (≤ 7.5 mg\u002Fday), hydroxychloroquine, or sulfasalazine\n\n* Healthy controls with no history of autoimmune or chronic infectious diseases\n* Healthy controls not taking immunosuppressive medications Willing and able to comply with study procedures and follow-up\n* Female participants of reproductive potential with negative pregnancy test at baseline\n* Female participants of reproductive potential agreeing to use effective contraception for at least 90 days after vaccination\n\nExclusion Criteria:\n\n* Prior receipt of any dengue vaccine\n* Receipt of a live attenuated vaccine within 4 weeks prior to enrollment\n* Receipt of an inactivated vaccine within 2 weeks prior to enrollment\n* Known allergy to any component of the vaccine\n* Febrile illness (≥ 37.8°C) within 72 hours prior to vaccination\n* History of immunodeficiency syndromes\n* History of asplenia\n* History of cancer\n* History of HIV infection\n* History of primary immunodeficiencies\n* Immunosuppression due to organ transplant\n* Chronic uncontrolled comorbidities (e.g., heart failure, renal failure, hepatic insufficiency, diabetes mellitus)\n* Hospitalization or acute illness at screening\n* Receipt of blood transfusion within 3 months prior to enrollment\n* Current pregnancy or breastfeeding\n* Intention to become pregnant within 90 days post-vaccination\n* Participation in another clinical trial within 30 days prior to enrollment",true,"12 Years","59 Years",{"count":176,"type":21},477,[112],"The goal of this clinical trial is to evaluate whether the live attenuated tetravalent Butantan-Dengue vaccine (Butantan-DV) is safe and capable of inducing an immune response in patients aged 12 to 59 years with autoimmune rheumatic diseases (ARDs) who are clinically stable and under low-grade or no immunosuppression, as well as in healthy volunteers matched by sex and age.\n\nThe main questions it aims to answer are:\n\nDoes the vaccine induce adequate seroconversion in patients with ARDs compared to healthy controls? What is the frequency and intensity of common adverse events after vaccination in ARDs patients? Does physical activity levels and nutritional status influence vaccine-induced immune response in patients with ARDs?\n\nResearchers will compare patients with ARDs to healthy controls to evaluate if the vaccine elicits similar immune responses and safety profiles.\n\nAll participants will:\n\n* receive a single 0.5 mL dose of the Butantan-DV vaccine via subcutaneous injection;\n* undergo blood sample collection before and after vaccination (baseline, Day 42, and Day 400) to assess antibody and cellular responses;\n* attend follow-up visits on Days 7, 14, and 42 for safety monitoring and laboratory tests;\n* report any symptoms or adverse events using a standardized diary for 42 days;\n* be followed for up to one year for long-term safety and immunogenicity assessments.\n* wear a device for 14 consecutive days to assess current and habitual physical activity levels.\n* answer three non-consecutive 24-hour dietary recalls, including at least one weekend day to assess nutritional status.\n* collect blood samples one-year after vaccination to access immunogenicity and cellular response.\n\nResearcher will also perform subgroups analysis in:\n\nA viremia subgroup (50 patients and 50 healthy controls) will provide additional samples on Days 1, 7, 14, 28, 42, and-if viremia is detected-Day 68, to evaluate post-vaccination viremia and its duration.\n\nAn immunogenicity subgroup (\\~20% of participants, n=96) will undergo cellular immune response testing via flow cytometry to evaluate T-cell responses.",[180,181,182,183,184,185,28,186,187,188,189,190],"Rheumatoid Arthritis (RA)","Juvenile Idiopathic Arthritis (JIA)","Systemic Lupus Erythematosus (SLE)","Juvenile Systemic Lupus Erythematosus","Systemic Sclerosis (SSc)","Idiopathic Inflammatory Myopathies (IIMs)","Psoriatic Arthritis (PsA)","Granulomatosis With Polyangiitis","Microscopic Polyangiitis","Antiphospholipid Syndrome","Takayasu Arteritis",[192,193,194,195,196,197,198],"Tetravalent Vaccine","Butantan-Dengue Vaccine","Autoimmune Rheumatic Diseases","Rheumatology","Pediatric Rheumatology","Infectious Disease Prevention","Vaccine","2026-04-14",{"date":201,"type":35},"2026-04-15",{"date":203,"type":21},"2026-03-16",{"date":205,"type":21},"2028-12-30",{"name":207,"class":70},"University of Sao Paulo General Hospital",{"id":209,"slug":210,"hasResults":12,"nctId":211,"briefTitle":212,"officialTitle":212,"acronym":213,"eligibilityCriteria":214,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":215,"targetDuration":4,"studyType":217,"phases":4,"briefSummary":218,"conditions":219,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":221,"lastUpdatePostDateStruct":222,"startDateStruct":224,"completionDateStruct":226,"leadSponsor":228,"locationsCount":130},"100581002","the-disease-progression-of-chinese-axial-spondyloarthritis-in-a-real-word-cohort-study-100581002","NCT06844643","The Disease Progression of Chinese Axial Spondyloarthritis in a Real-word Cohort Study","DPCASPA","Inclusion Criteria:\n\n* Patients aged 18 years or older\n* Diagnosis of axial spondyloarthritis (axSpA) according to the Assessment of Spondyloarthritis International Society (ASAS) classification criteria\n\nExclusion Criteria:\n\n* Presence of severe, unstable medical conditions that may interfere with the study assessments, including but not limited to:\n\nEnd-stage renal disease (eGFR \\\u003C 30 mL\u002Fmin\u002F1.73m²) Severe cardiovascular disease Active malignancy or malignancy requiring ongoing treatment\n\n* Current diagnosis of schizophrenia, other psychotic disorders, severe cognitive impairment, or epilepsy with recurrent uncontrolled seizures, which, in the opinion of the investigator, may impair the ability to provide informed consent or comply with follow-up visits.\n* Pregnant or lactating women",{"count":216,"type":21},2250,"OBSERVATIONAL","An observational, ambispective cohort to learn about the disease progression of axial spondyloarthritis (axSpA) according to the changes from baseline in measures of disease activity, function, and imaging.",[28,220],"Ankylosing Spondylitis (AS)","2026-04-10",{"date":223,"type":35},"2026-04-13",{"date":225,"type":35},"2025-03-01",{"date":227,"type":21},"2030-12-01",{"name":229,"class":70},"China-Japan Friendship Hospital",{"id":231,"slug":232,"hasResults":12,"nctId":233,"briefTitle":234,"officialTitle":235,"acronym":236,"eligibilityCriteria":237,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":238,"enrollmentInfo":239,"targetDuration":4,"studyType":22,"phases":241,"briefSummary":242,"conditions":243,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":245,"lastUpdatePostDateStruct":246,"startDateStruct":248,"completionDateStruct":250,"leadSponsor":252,"locationsCount":254},"100560963","inselma---a-randomised-controlled-trial-100560963","NCT06583980","INSELMA - a Randomised Controlled Trial","The Efficacy of a Complex Interdisciplinary Nurse-Coordinated SELf-MAnagement Intervention for People With Substantial Impact From Their Inflammatory Arthritis: Protocol for the Randomized Pragmatic INSELMA Trial","INSELMA-RCT","Inclusion Criteria:\n\n* Adults aged 18 years or older\n* Diagnosed with RA, PsA, or axSpA by a rheumatologist for at least 24 months. Connected to the rheumatology department of one of the participating hospitals for at least two years\n* Answer \"no\" to the Patient Acceptable Symptom State (PASS) (36), \"Think about all the ways your arthritis has affected you during the last 48 hours. If you were to remain in the next few months as you were during the last 48 hours, would this be acceptable to you?\" or\n* report ≥60 on at least one Visual Analogue Scale (VAS) (0-100) for fatigue, pain, or global assessment of the impact of the disease\n\nExclusion Criteria:\n\n* Planned change or a change during the past three months in treatment with disease modifying anti-rheumatic drugs (DMARDs) or glucocorticoids.\n* Participation in other studies of relevance for the outcomes in INSELMA (i.e. TRACE, WORK-ON, SPINCODE, COMFI, PLATE, KRAM-offer).\n* Not able to speak and understand Danish sufficiently to participate without a translator\n* Unstable psychiatric illness, cognitive impairment or other physical or mental issues that impede the ability to give informed consent to participation.\n* Current alcohol or drug use disorder documented in their medical journal\n* Pregnant or nursing a baby\n* Planned or ongoing rehabilitation at the Danish Hospital for Rheumatic Diseases or Sano, a pain or sleep clinic\n* Ongoing application for early retirement or planned surgery requiring admission\n* Did not participate in the INSELMA feasibility study or is a patient research partner in INSELMA","100 Years",{"count":240,"type":21},120,[54],"Background:\n\nPatients with inflammatory arthritis (IA) experience substantial impact of their disease despite optimal pharmacological treatment. To be able to manage these challenges effectively, patients require tailored self-management support from various professionals. We thus developed a six-month nurse-coordinated interdisciplinary self-management intervention (INSELMA), in collaboration with patients, clinicians and managers. A pilot study on the INSELMA intervention in 18 participants showed promising results. It is now relevant to test the intervention and compare it to a control group in a larger study .\n\nObjectives:\n\nThe primary objective is to compare the efficacy of the INSELMA intervention to usual care (control group), on health related quality of life measured at baseline and end of intervention (6 months after baseline).\n\nKey secondary objectives are to compare the short and longer-term effect of INSELMA on changes in mental well-being, anxiety, depression, fatigue, pain, sleep, physical activity, global impact of the disease, work ability, self-efficacy for managing chronic disease and pain and health literacy relative to usual care from baseline to 6 and 12 months after baseline and on quality of life from baseline to 12 months after baseline.\n\nMethod:\n\nA pragmatic randomised trial with a two-group parallel design.\n\nAll participants will be randomly allocated to the intervention or usual care only .\n\nBoth groups will receive usual care. The INSELMA intervention group will be assigned a coordinating rheumatology nurse who performs an initial biopsychosocial assessment. Based on the assessment, the nurse and the patient agree on which activities and goals to work towards for the following six months. The coordinating nurse can refer the patient to see a physiotherapist, an occupational therapist or social worker if needed and can help identify offers in the patients' municipality.\n\nThe primary endpoint will be change in quality of life from baseline to 6 month after baseline. Key secondary outcome measures are collected to compare the effect of INSELMA on changes in mental well-being, anxiety, depression, fatigue, pain, self-efficacy for managing pain, physical function, global impact of the disease, sleep problems and acceptable symptoms relative to usual care from baseline to 6 and 12 months after baseline.",[244,27,28],"Rheumatoid Arthritis","2025-08-14",{"date":247,"type":35},"2025-08-19",{"date":249,"type":35},"2024-09-05",{"date":251,"type":21},"2027-08-31",{"name":253,"class":70},"The Danish Center for Expertise in Rheumatology",3,{"id":256,"slug":257,"hasResults":12,"nctId":258,"briefTitle":259,"officialTitle":259,"acronym":4,"eligibilityCriteria":260,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":261,"targetDuration":4,"studyType":22,"phases":262,"briefSummary":263,"conditions":264,"keywords":4,"overallStatus":92,"whyStopped":4,"lastUpdateSubmitDate":265,"lastUpdatePostDateStruct":266,"startDateStruct":268,"completionDateStruct":270,"leadSponsor":272,"locationsCount":4},"100590412","exploring-the-feasibility-and-acceptability-of-virtual-reality-exercise-for-pain-management-fear-of-movement-mobility-and-proprioception-deficit-in-axial-spondyloarthritis-patients-during-flares-twics-design-100590412","NCT06967077","Exploring the Feasibility and Acceptability of Virtual Reality Exercise for Pain Management, Fear of Movement, Mobility, and Proprioception Deficit in Axial Spondyloarthritis Patients During Flares: Twics Design","Inclusion Criteria:\n\n1. Confirmed diagnosis of axial spondyloarthritis (axSpA).\n2. Experiencing an active flare of axSpA within the last 6 months\n3. Over 18 years of age.\n\nExclusion Criteria:\n\n1. History of major spinal surgery.\n2. Pregnancy.\n3. Severe vestibular disorders, visual, balance, neurological, or cardiovascular conditions that may affect mobility.",{"count":52,"type":21},[54],"Axial spondyloarthritis (axSpA) is an autoimmune disease that causes inflammatory arthritis of the spine, causing pain, stiffness, and mobility limitations. During flares, when symptoms worsen, people with axSpA often experience increased pain and difficulty moving, making daily activities more challenging. This study aims to explore whether virtual reality (VR) exercise can help manage pain, improve movement, and support rehabilitation for axSpA patients during flares.\n\nParticipants will use a VR system to perform gentle exercises designed to encourage movement and reduce discomfort. Their spinal mobility will be measured using motion capture technology, and their experiences with VR will be assessed through questionnaires and interviews.\n\nThis research will help determine whether VR can be a practical and beneficial tool for axSpA rehabilitation, potentially offering a new way to manage symptoms and improve quality of life. The findings will guide future studies on using VR in healthcare settings for people with chronic pain conditions.",[28],"2025-05-07",{"date":267,"type":35},"2025-05-13",{"date":269,"type":21},"2025-09-01",{"date":271,"type":21},"2027-12-10",{"name":273,"class":70},"University of Bath",{"id":275,"slug":276,"hasResults":12,"nctId":277,"briefTitle":278,"officialTitle":278,"acronym":279,"eligibilityCriteria":280,"healthyVolunteers":12,"sex":17,"minAge":281,"maxAge":4,"enrollmentInfo":282,"targetDuration":4,"studyType":22,"phases":284,"briefSummary":285,"conditions":286,"keywords":4,"overallStatus":92,"whyStopped":4,"lastUpdateSubmitDate":287,"lastUpdatePostDateStruct":288,"startDateStruct":289,"completionDateStruct":291,"leadSponsor":293,"locationsCount":130},"100590502","assessing-the-feasibility-of-the-patient-reported-outcomes-based-model-for-community-care-of-patients-with-axial-spondyloarthritis-via-a-type-1-pilot-hybrid-effectiveness-implementation-trial-using-the-re-aim-framework-100590502","NCT06968247","Assessing the Feasibility of the Patient-Reported Outcomes Based Model for Community Care of Patients With Axial Spondyloarthritis Via a Type 1 Pilot Hybrid Effectiveness-Implementation Trial Using the RE-AIM Framework","PROMise-Pilot","Inclusion Criteria:\n\n* diagnosed with axial spondyloarthritis according to the 2009 ASAS Classification Criteria of AxSpA\n* has been receiving care in Singapore General Hospital for at least 6 months\n* aged 21 years and above\n\nExclusion Criteria:\n\n* Bath Ankylosing Spondylitis Disease Activity Index score of \\>4","21 Years",{"count":283,"type":21},70,[54],"The goal of this clinical trial is to facilitate the implementation of PROMs-based care for patients with axial spondyloarthritis.\n\nThe main questions it aims to answer are:\n\n* What are the barriers, facilitators and strategies to implement PROMs-based care?\n* Can the PROMise algorithm successfully review and postpone appointments of eligible patients?\n* How feasible is PROMs-based care in patients with axial spondyloarthritis?\n\nResearchers will implement PROMs-Based care and see if PROMs-Based care is feasible and understand patient's opinions on PROMs-Based care implemented.\n\nParticipants will:\n\n* Be randomized to either receive intervention (PROM-based care) or control (usual care). Randomisation means assigning you to one of two groups by chance, like tossing a coin or rolling dice.\n* That receive PROMs-based care, will be sent PROMs questionnaires that ask them about their health conditions via SMS at a regular interval of 4 months.\n* Have their appointments postponed by 4 months, if the PROMise algorithm with specific thresholds (with overview from the rheumatology care team) assess their condition as stable through their blood test results and PROMs questionnaire.\n* Have a cap of 12 months between physician visits.",[28],"2025-05-05",{"date":267,"type":35},{"date":290,"type":21},"2025-06",{"date":292,"type":21},"2027-05",{"name":294,"class":70},"Singapore General Hospital",{"id":296,"slug":297,"hasResults":12,"nctId":298,"briefTitle":299,"officialTitle":300,"acronym":301,"eligibilityCriteria":302,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":303,"enrollmentInfo":304,"targetDuration":4,"studyType":22,"phases":305,"briefSummary":306,"conditions":307,"keywords":308,"overallStatus":92,"whyStopped":4,"lastUpdateSubmitDate":311,"lastUpdatePostDateStruct":312,"startDateStruct":314,"completionDateStruct":316,"leadSponsor":317,"locationsCount":130},"100384490","efficacy-of-non-invasive-vagus-nerve-stimulation-for-axial-spondyloarthritis-resistant-to-biotherapies-100384490","NCT04286373","Efficacy of Non-invasive Vagus Nerve Stimulation for Axial Spondyloarthritis Resistant to Biotherapies","Randomized Cross Over Study Assessing the Effectiveness of Non-invasive Vagus Nerve Stimulation in Patients With Axial Spondyloarthritis Resistant to Biotherapies","ESNV-SPA","Inclusion Criteria:\n\n* Patient from 18 to 90 years with axial SpA, meeting the ASAS classification criteria, followed for at least one year, with presence of radiological sacro-illitis (ankylosing spondylitis) or not;\n* Patient suffering active SpA, with or without treatment, having a total BASDAI score ≥ 4 (0-10) at baseline and a score of global pain ≥ 4 (0-10);\n* SpA insufficiently relieved despite optimal drug management for at least 6 months including at least 2 different NSAIDs at the maximum tolerated dose for at least 3 months (or less in case of intolerance) and at least two lines of biotherapies or discontinued SpA treatments due to intolerance, contraindication.\n\nExclusion Criteria:\n\n* Patient under guardianship;\n* Cardiac arrhythmia;\n* Patients with cochlear implant;\n* Patients with known heart disease;\n* Hypotension;\n* Asthmatic patients;\n* Refusal to participate in the study or to sign the informed consent;\n* Pregnant or breastfeed woman;\n* No affiliation to a social security scheme;\n* Previous VNS treatment;\n* Incapacity to attend the weekly appointment during the study period;\n* 12- Head trauma with fracture of rock. In case of skin lesions of the left ear, recruitment will be delayed until these lesions are healed.","90 Years",{"count":240,"type":21},[54],"The primary objective of the study is to study the change in SpA disease activity, according to ASAS20 definition (Anderson et al., 2001), after 8 weeks of VNS treatment versus placebo non-specific stimulation (control group).\n\nThe secondary objectives of the Clinical Investigation are to show differences in disease evolution between the active and placebo periods of 8 weeks treatment with active VNS versus placebo VNS of the following items:\n\n1. Change in disease activity according to \"ASAS40\" criteria\n2. Obtaining a partial remission according to the ASAS definition\n3. Change in BASFI\n4. Change in C-reactive protein (CRP)serum level and erythrocytes sedimentation rate (ESR),\n5. Change in ASDAS\\_CRP and ASDAS\\_ESR\n6. Difference in levels of circulating cytokines, IL-6, IL-23, IL-17, IL-33 and of matrix metallopeptidases (MMP3-8-9).\n7. Change in quality of life : assessment according to the following indexes: SF-36, AS Quality of Life (ASQOL)\n8. Change in Health Index of patient with SpA (ASAS HI) and of the Productivity at Work Index (WPI)\n9. Change in fatigue (BASDAI 1st question) and global pain\n10. Change in Anxiety and Depression Assessment (HAD)\n11. Change in BASMI\n12. Change in non-steroidal anti-inflammatory drugs (NSAID) intake score.",[28],[309,310],"axial spondyloarthritis","vagus nerve stimulation","2025-04-25",{"date":313,"type":35},"2025-04-27",{"date":315,"type":21},"2025-09",{"date":127,"type":21},{"name":318,"class":70},"Assistance Publique - Hôpitaux de Paris",{"id":320,"slug":321,"hasResults":12,"nctId":322,"briefTitle":323,"officialTitle":324,"acronym":4,"eligibilityCriteria":325,"healthyVolunteers":12,"sex":17,"minAge":326,"maxAge":174,"enrollmentInfo":327,"targetDuration":4,"studyType":22,"phases":329,"briefSummary":330,"conditions":331,"keywords":332,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":334,"lastUpdatePostDateStruct":335,"startDateStruct":337,"completionDateStruct":339,"leadSponsor":341,"locationsCount":130},"100579394","taekwondo-for-axial-spondyloarthritis-100579394","NCT06823726","Taekwondo for Axial Spondyloarthritis","Efficacy and Safety of a 12-Week Taekwondo Training Program in Patients With Ankylosing Spondylitis and Axial Spondyloarthritis: A Randomized Controlled Trial","Inclusion Criteria:\n\n1. Diagnosed with axial spondyloarthritis (axSpA) according to the ASAS classification criteria.\n2. Age: Between 19 and 59 years old.\n3. Stable medication or non-medication treatment:\n\n   * Patients whose medication regimen has remained stable for at least the past 3 months.\n   * Patients who have not taken medication for axSpA for at least the past 3 months.\n\nExclusion Criteria:\n\nParticipants will be excluded from the study if they meet any of the following conditions:\n\n1. History of orthopedic surgery or fractures within the past 12 months.\n2. History of cardiovascular diseases, including ischemic heart disease, cardiomyopathy, heart failure, or stroke.\n3. Advanced ankylosis in ankylosing spondylitis, as confirmed by radiographic or CT imaging:\n\n   \\- Complete ankylosis of at least two regions of the cervical, lumbar, or thoracic spine (i.e., continuous syndesmophyte formation or complete ossification between vertebral bodies).\n4. Presence of other musculoskeletal abnormalities or conditions that may limit exercise performance.\n5. Diagnosis of cancer within the past 5 years\n6. Pregnancy\n7. Regular exercise participation within the past 6 months (defined as exercising for at least 60 minutes per session, three or more times per week).\n8. Major changes in medication for axial spondyloarthritis during the study period, including:\n\n   1. Initiation or discontinuation of biologic agents or targeted therapies.\n   2. Significant changes in the continued use of NSAIDs or sulfasalazine.\n   3. Significant changes in the continued use of systemic glucocorticoids.","19 Years",{"count":328,"type":21},24,[54],"The goal of this clinical trial is to learn if Taekwondo training works to help adults with ankylosing spondylitis and axial spondyloarthritis. It will also learn about the safety of Taekwondo training for these adults.\n\nThe main questions are as follows:\n\n* Will Taekwondo training affect disease activity, functional improvement, and quality of life?\n* Will there be a difference between adults who participate in Taekwondo training and adults who continue with their usual treatment?\n* Is Taekwondo training safe for adults with ankylosing spondylitis and axial spondyloarthritis, and will it be an appropriate exercise for these adults?\n* Is there a possibility to develop a structured Taekwondo-based exercise program for adults with musculoskeletal disorders?\n\nParticipants will:\n\n* Be a part of the Taekwondo training group or the control group for 12 weeks (where the control group will later participate in the same 12 week Taekwondo for comparison)\n* Be assessed within 2 weeks before the start of the training\n* Be assessed within 1 week after completing the training",[87,28],[333,87,28],"Taekwondo","2025-03-20",{"date":336,"type":35},"2025-03-25",{"date":338,"type":21},"2025-03",{"date":340,"type":21},"2025-11",{"name":342,"class":70},"Wonju Severance Christian Hospital",{"id":344,"slug":345,"hasResults":12,"nctId":346,"briefTitle":347,"officialTitle":348,"acronym":4,"eligibilityCriteria":349,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":350,"targetDuration":4,"studyType":22,"phases":352,"briefSummary":353,"conditions":354,"keywords":355,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":357,"lastUpdatePostDateStruct":358,"startDateStruct":360,"completionDateStruct":362,"leadSponsor":364,"locationsCount":366},"100533196","phase-2-a-study-to-evaluate-608-in-patients-with-non--radiographic-axial-spondyloarthritis-nr-axspa-100533196","NCT06222671","A Study to Evaluate 608 in Patients With Non- Radiographic Axial Spondyloarthritis (Nr-axSpA)","A Multicenter, Randomized, Double-blind, Placebo-controlled, Phase II Clinical Study to Evaluate the Efficacy and Safety of 608 in Patients With Non-radiographic Axial Spondyloarthritis (Nr-axSpA)","Inclusion Criteria:\n\n1. Female and male patients at least 18 years of age at the time of screening.\n2. Diagnosis of axial spondyloarthritis according to Ankylosing Spondylo Arthritis International Society (ASAS) axial spondyloarthritis criteria\n3. Objective signs of inflammation (magnetic resonance imaging (MRI) or abnormal C-reactive protein)\n4. Total back pain as measured by NRS ≥ 4 at baseline\n\nExclusion Criteria:\n\n1. Patients with other uncontrolled active inflammatory diseases.\n2. Clinical laboratory tests and other tests that reveal abnormalities with clinical significance\n3. Patients who have active Hepatitis B, Hepatitis C or HIV infections as determined by positive results at Screening.\n4. History of cancer.\n5. Known or suspected history of immunosuppression.\n6. Known with allergic or intolerant to mometasone furoate spray or 608\u002Fplacebo.",{"count":351,"type":21},180,[84],"This study will evaluate the effect and safety of 608 in patients with nr-axSpA.",[28],[356],"non-radiographic axial spondyloarthritis","2025-03-06",{"date":359,"type":35},"2025-03-11",{"date":361,"type":35},"2024-03-22",{"date":363,"type":21},"2025-11-30",{"name":365,"class":42},"Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.",6,{"id":368,"slug":369,"hasResults":12,"nctId":370,"briefTitle":371,"officialTitle":372,"acronym":373,"eligibilityCriteria":374,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":375,"targetDuration":377,"studyType":217,"phases":4,"briefSummary":378,"conditions":379,"keywords":385,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":393,"lastUpdatePostDateStruct":394,"startDateStruct":396,"completionDateStruct":398,"leadSponsor":399,"locationsCount":130},"100578173","a-longitudinal-observational-study-to-evaluate-the-efficacy-of-movement-and-implement-concrete-movement-recommendations-with-the-help-of-mobility-tracking-with-smartwatches-in-subjects-with-axial-spondyloarthritis-100578173","NCT06807853","A LONGITUDINAL OBSERVATIONAL STUDY to EVALUATE the EFFICACY of MOVEMENT and IMPLEMENT CONCRETE MOVEMENT RECOMMENDATIONS with the HELP of MOBILITY TRACKING with SMARTWATCHES in SUBJECTS with AXIAL SPONDYLOARTHRITIS","SYMPTOM-ACCESSMENT in SUBJECTS with AXIAL SPONDYLOARTHRITIS with PATIENT-REPORTED OUTCOMES and MOBILITY TRACKING with SMARTWATCHES VIA SPECIALLY PROGRAMMED STUDY-APP to EVALUATE the EFFICACY of MOVEMENT and IMPLEMENT CONCRETE MOVEMENT RECOMMENDATIONS","SPARTAKUS","Inclusion Criteria:\n\n* Patients with Axial Spondyloarthritis\n* Patients do must have an own iPhone due to software reasons\n* do must be willing and able to wear a Smartwatch\n* do must be able to regularly fill out the PROs at home\n\nExclusion Criteria:\n\n* no iphone\n* no physical or mental Ability to wear a Smartwatch\n* no physical or mental Ability to regularly fill out the PROs at home",{"count":376,"type":21},50,"6 Months","Axial spondyloarthritis (axSpa) is a chronic inflammatoric autoimmune disease of the back with a prevalence around 1,4% (1) . In patients decreased function and decreased quality of life as well as chronic pain are strong burdens . Despite modern treatments like biological agents just 25% of the patients are at remission (2) . Besides the pharmacological treatment physical activity is known to be very important to gain disease control. A low physical activity is related to a higher disease activity and a high physical activity to better disease control. Until now there is no structured capture of the daily movements of patients with axial spondylarthritis in clinical practice. Our goal is to analyse the relationship between movement and disease activity and to implement concrete recommendations for movement in patients with axSpa.\n\nThe primary objective of the study is to investigate which type, frequency and intensity of movement are helpful in gaining and remaining disease control in patients with axSpa.\n\nMethods This monocentric longitudinal study recordes movement, sport and physical parameters like heart frequency and heart rate variability through an observational period of 6 month via smartwatch. Meanwhile we record disease activity, pain and functional outcomes with regular surveys every two weeks. Patients in every phase of disease are eligible for inclusion, but they do must have an own iPhone due to software reasons. Data is collected in a specially programmed study-app. Fifty participants will be included in this study. Until now we have 24 patients included since april 2024. Patients come to clinic every 3 month as this is our standard in outclinic patients. We than do anamnesis and a physical examination. After the study period of 6 month we transmit the mobility and disease-related data of the surveys of the patients mobile device to our system.\n\nThe primary endpoint is to find exact recommendations for concrete movement in patients with axSpa.\n\nSo this is the first study that wants to give concrete recommendations for movement in patients with axSpa with the help of mobility tracking with smartwatches. This could help to prevent flares and also to recover quicker from a flare.\n\n1. López-Medina und Moltó, \"Update on the epidemiology, risk factors, and disease outcomes of axial spondyloarthritis\".\n2. Pina Vegas u. a., \"Factors associated with remission at 5-year follow-up in recent-onset axial spondyloarthritis: results from the DESIR cohort\".",[28,380,381,382,383,115,384],"Axial Spondyloarthritis (AxSpA)","Axial Spondylarthritis (r-axSpA)","Axial Spondyloarthopathy","Axial Spondyloarthritis and Ankylosing Spondylitis","Axial and Peripheral Spondyloarthritis",[386,387,388,389,390,391,392],"Mobility Tracking","Patient-Reported Outcomes (PROs)","Disease Activity","Smartwatch","Study-App","Mobile Device","Movement Recommedations","2025-02-13",{"date":395,"type":35},"2025-02-18",{"date":397,"type":35},"2024-04-01",{"date":340,"type":21},{"name":400,"class":70},"University of Bonn",{"id":402,"slug":403,"hasResults":12,"nctId":404,"briefTitle":405,"officialTitle":406,"acronym":407,"eligibilityCriteria":408,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":409,"enrollmentInfo":410,"targetDuration":4,"studyType":22,"phases":412,"briefSummary":413,"conditions":414,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":415,"lastUpdatePostDateStruct":416,"startDateStruct":418,"completionDateStruct":420,"leadSponsor":421,"locationsCount":130},"100524740","phase-4-tofacitinib-in-early-active-axial-spondyloarthritis-100524740","NCT06112665","ToFAcitinib in Early Active Axial SpondyloarThritis:","ToFAcitinib in Early Active Axial SpondyloarThritis: a Prospective, Randomized, Double-BLind, PlAcebo-CoNtrolled MulticEntre Study","FASTLANE","Inclusion Criteria:\n\n* Clinical diagnosis of axSpA and fulfilment of the ASAS classification criteria\n* Symptom (back pain) duration for ≤ 2 years, according to the definition of early axial SpA by ASAS.\n* Active disease activity as defined by: BASDAI ≥4 and back pain score (BASDAI question 2) of ≥4 AND objective signs of inflammation evident by osteitis in MRI of SIJ AND\u002FOR elevated serum CRP levels.\n\nExclusion criteria:\n\n* active current infection, severe infections in the last 3 months\n* history of recurrent Herpes zoster or disseminated Herpes simplex\n* immunodeficiency\n* chronic Hepatitis B, C or HIV infection\n* women: pregnant or lactating (have to practice reliable method of contraception)\n* other severe diseases conflicting with a clinical study, contraindications for MRI","45 Years",{"count":411,"type":21},104,[112],"This is a phase IV, multicentre, randomized, double-blind, placebo-controlled study designed to compare the efficacy and safety of tofacitinib versus placebo (on a background of an NSAID) over 16 weeks of treatment and 4 weeks of safety follow-up in subjects with early active axSpA and inadequate response to at least one NSAID, with objective signs of inflammation.",[28],"2024-11-22",{"date":417,"type":35},"2024-11-26",{"date":419,"type":35},"2023-11-10",{"date":65,"type":21},{"name":422,"class":70},"Charite University, Berlin, Germany",{"id":424,"slug":425,"hasResults":12,"nctId":426,"briefTitle":427,"officialTitle":428,"acronym":429,"eligibilityCriteria":430,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":80,"enrollmentInfo":431,"targetDuration":4,"studyType":22,"phases":433,"briefSummary":434,"conditions":435,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":436,"lastUpdatePostDateStruct":437,"startDateStruct":439,"completionDateStruct":441,"leadSponsor":443,"locationsCount":130},"100539136","work-on-vocational-rehabilitation-for-people-with-inflammatory-arthritis-100539136","NCT06299917","WORK-ON Vocational Rehabilitation for People with Inflammatory Arthritis","WORK-ON - Vocational Rehabilitation for People with Chronic Inflammatory Arthritis - a Randomised Controlled Trial","WORK-ON","Inclusion Criteria:\n\n* Aged 18-65 years.\n* Diagnosed with RA, PsA or axSpA by a rheumatologist.\n* Undertakes paid work (full- or part-time work or studying).\n* Able to read and understand Danish.\n* Answers 'unlikely' or 'not certain' to question #6 from the WAI questionnaire: 'Do you believe, according to your present state of health, that you will be able to do your current job two years from now?' (36).\n* Willing to participate in an RCT of the modified WORK-ON VR.\n\nExclusion Criteria:\n\n* Planned or present adjustments of the pharmacological anti-rheumatic treatment (DMARDs, glucocorticoid) within the last three months.\n* Presence of morbidities other than IA that may explain reduced work ability.\n* Is under examination for comorbidities that influence work ability.\n* Major surgery was conducted within the past six months, or a surgery has been planned.\n* Is unable to understand or speak Danish at a sufficient level to participate.\n* Has cognitive or psychological impairments that may affect participation.\n* Planned or ongoing participation in another rehabilitation program (apart from physiotherapy).\n* Has participated in the WORK-ON feasibility study.\n* Retirement application process is ongoing or plans to retire within the next five years.\n* Has taken long-term sick leave (\\>4 weeks).",{"count":432,"type":21},56,[54],"People with chronic inflammatory arthritis (IA) (rheumatoid arthritis, axial spondyloarthritis, and psoriatic arthritis), often have a reduced work ability. Up to 40% lose their job in the first years after diagnosis. Consequently, they are at high risk of losing their jobs and being permanently excluded from the labour market. Therefore, a new context-specific vocational rehabilitation (VR) for people with IA was developed, based on the Medical Research Council's framework for complex interventions. The 6-months VR is called WORK-ON and consists of three parts: 1) a coordinating occupational therapist who performs an initial assessment and goalsetting process and supports cooperation between relevant partners and navigation between sectors, 2) Four group sessions with peers and if needed, 3) Individual sessions with a social worker, nurse, or physiotherapist. The objective of the WORK-ON trial is to test the overall efficacy on work ability compared to a control group who receives usual care and pamphlets for their employer and colleagues.\n\nBased on the experiences from a feasibility study, WORK-ON will be conducted as a randomised controlled trial. Patients with IA, aged 18 years or older, experiencing job insecurity will be randomised to one of two groups: the WORK-ON VR group or usual care (control group). The primary outcome; work ability measured is measured by Work Ability Index single item, at baseline, 6, 12, 18 and 30 months after baseline. Secondary outcomes are absenteeism, presenteeism, overall work impairment, activity impairment, job loss, quality of life, mental well-being, fatigue, sleep, physical activity, occupational balance and pain. Secondary outcomes are measured at baseline, 6 and 12 months after baseline. In addition, work ability, working hours per week and job loss are measured at 18 and 30 months after baseline.",[244,27,28],"2024-10-05",{"date":438,"type":35},"2024-10-09",{"date":440,"type":35},"2024-03-01",{"date":442,"type":21},"2027-09-01",{"name":253,"class":70},{"id":445,"slug":446,"hasResults":12,"nctId":447,"briefTitle":448,"officialTitle":449,"acronym":450,"eligibilityCriteria":451,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":452,"targetDuration":454,"studyType":217,"phases":4,"briefSummary":455,"conditions":456,"keywords":457,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":461,"lastUpdatePostDateStruct":462,"startDateStruct":464,"completionDateStruct":466,"leadSponsor":468,"locationsCount":71},"100561741","factors-for-the-onset-and-course-of-axial-spondylitis-100561741","NCT06594107","Factors for the Onset and Course of Axial Spondylitis","Faktorer För Uppkomst Och Förlopp Av Axial Spondylartrit","EISPA","Inclusion Criteria:\n\n* newly diagnosed patients with axial spondyloarthritis\n* treatment-naive\n* 18 years of age or older\n* Swedish-speaking\n* Able to give informed consent\n\nExclusion Criteria:\n\n* DMARD treatment,\n* ongoing infection\n* ongoing malignancy",{"count":453,"type":21},1000,"2 Years","In a research project, investigators want to study the course of the disease of axial spondylitis: the causes of disease onset, prognosis, and treatment effects. The goal is to improve treatment and in the long run also prevention of the disease. The project has a focus on the body\\'s own substance prostaglandin, and its proinflammatory role in spondylitis, but also other substances may be analyzed in blood and urine samples.\n\nThe purpose of the research project is include newly diagnosed treatment-naive patients with axial spondyloarthritis, to follow them after 1 and 2 years after treatment start, to collect clinical data, questionnaires, blood and urinsamples to find blood or urine markers that can be used for precision therapy of axial spondylitis.",[28],[458,309,459,460],"observational","prostaglandins","predictive factors","2024-09-23",{"date":463,"type":35},"2024-09-24",{"date":465,"type":35},"2022-09-01",{"date":467,"type":21},"2035-12-31",{"name":469,"class":70},"Karolinska Institutet",{"id":471,"slug":472,"hasResults":12,"nctId":473,"briefTitle":474,"officialTitle":475,"acronym":4,"eligibilityCriteria":476,"healthyVolunteers":172,"sex":17,"minAge":18,"maxAge":80,"enrollmentInfo":477,"targetDuration":4,"studyType":217,"phases":4,"briefSummary":479,"conditions":480,"keywords":484,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":486,"lastUpdatePostDateStruct":487,"startDateStruct":489,"completionDateStruct":491,"leadSponsor":493,"locationsCount":130},"100560454","osteosarcopenia-in-axial-spondyloarthritis-100560454","NCT06577350","Osteosarcopenia in Axial Spondyloarthritis","The Frequency of Osteosarcopenia and Its Relationship With Demographic and Clinical Factors in Axial Spondyloarthritis","Inclusion Criteria:\n\nPatient group:\n\n* Participants with a diagnosis of AxSpA: Participants with diagnosis of Ankylosing Spondylitis according to the modified New York criteria and participants with diagnosis of non-radiographic Spondyloarthritis (SpA) according to the Assessment of SpondyloArthritis International Society (ASAS) 2009 criteria.\n* Aged 18-65 years\n* Who gave consent to participate in the study\n\nHealthy control group:\n\n* Age- and gender-matched healthy participants (age 18-65)\n* Who gave consent to participate in the study\n\nExclusion Criteria:\n\n1. Systemic high-dose steroid use (\\>5mg\u002Fday of prednisone for more than 3 months)\n2. Possible other causes of secondary sarcopenia (uncontrolled diabetes, chronic heart failure, thyroid\u002Fparathyroid disease, chronic renal failure, chronic liver failure)\n3. Hand-related disorders\u002Fdiseases that could affect the healthy assessment of grip strength\n4. Use of any medication that could potentially affect the bone metabolism (bisphosphonates, teriparatide, anticonvulsants, heparin, and anticoagulants)\n5. Psoriasis, inflammatory bowel disease\n6. Infection in the thigh area where ultrasonographic evaluation will be performed\n7. Body weight over 100 kg (contraindication to be positioned in the BMD device)\n8. Presence of malnutrition (individuals scoring 11 or below on the Mini Nutritional Assessment-Short Form (MNA))",{"count":478,"type":21},97,"Axial spondyloarthritis is a chronic inflammatory disease affecting the spine, sacroiliac joints, entheses, and sometimes peripheral joints with a close link to HLAB27. Typical features include inflammatory back pain, limited spinal mobility, and sacroiliitis. The term axial spondyloarthritis (AxSpA) includes both Ankylosing Spondylitis (AS) where sacroiliitis is diagnosed by X-rays, and non-radiographic AxSpA, where sacroiliitis is diagnosed via magnetic resonance imaging (MRI).\n\nOsteoporosis is common in AS patients, and sarcopenia may also develop due to inflammation and immobilization. Osteosarcopenia, the co-occurrence of osteoporosis and sarcopenia, might have an impact on morbidity and mortality of AxSpA patients.\n\nThis cross-sectional study aims to determine the frequency of osteosarcopenia in AxSpA patients and to investigate its relationship with various demographic and clinical factors. A control group with similar age and gender distribution will be recruited to evaluate osteosarcopenia. Our hypothesis is that osteosarcopenia will be more frequent in the AxSpA group compared to the control group. The study will also identify the demographic and clinical factors associated with osteosarcopenia in AxSpa.",[28,87,115,481,482,483],"Osteoporosis","Sarcopenia","Osteosarcopenia",[28,87,485,481,482,483],"Non-Radiographic Axial Spondyloarthritis","2024-08-28",{"date":488,"type":35},"2024-08-29",{"date":490,"type":35},"2023-09-01",{"date":492,"type":21},"2025-04",{"name":494,"class":70},"Ankara University",{"id":496,"slug":497,"hasResults":12,"nctId":498,"briefTitle":499,"officialTitle":500,"acronym":501,"eligibilityCriteria":502,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":503,"enrollmentInfo":504,"targetDuration":4,"studyType":217,"phases":4,"briefSummary":505,"conditions":506,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":507,"lastUpdatePostDateStruct":508,"startDateStruct":510,"completionDateStruct":512,"leadSponsor":514,"locationsCount":130},"100400062","advanced-sensor-based-functional-assessments-in-axial-spondyloarthritis-100400062","NCT04489342","Advanced Sensor Based Functional ASsessmenTs in Axial Spondyloarthritis","An Investigation Into the Responsiveness of Inertial Measurement Unit (IMU) Sensor-based Tests in Measuring Changes in Spinal Mobility and Function in Axial Spondyloarthritis Patients Treated With Biologic Drug","ASFASTAS","Inclusion Criteria:\n\n1. Diagnosis of axial spondyloarthritis fulfilling ASAS classification criteria.\n2. Age ≥18 years old and \\\u003C80 years.\n3. Fulfilment of local criteria for biologic therapy for axSpA.\n4. The subjects should be able to read, write, understand and complete study questionnaires.\n5. Each subject must sign an informed consent form (ICF) indicating that he or she understands the purpose of and procedures required for the study and are willing to participate in the study.\n\nExclusion Criteria:\n\n1. Safety contra-indication for biologic drug therapy.\n2. Severely restricted hip movement (less than 20 degrees rotation in either hip).\n3. History of previous clinical (symptomatic) vertebral fracture.\n4. History of previous spinal surgery.\n5. History of previous hip replacement surgery.\n6. Major scoliosis deformity (in the opinion of the investigator).\n7. Safety contra-indication for MRI assessment.\n8. Previous biologic agent within 2 months.\n9. Pregnant or breast-feeding women.","80 Years",{"count":141,"type":21},"This is an observational study using Inertial Measurement Unit (IMU) sensors to measure the effects of biological therapy on spinal mobility and function in axial spondyloarthritis. Participants will undergo MRI scans before and after therapy in parallel to the sensor tests to establish correlation between changes in inflammatory signs and changes in spinal mobility.",[28],"2024-07-24",{"date":509,"type":35},"2024-07-25",{"date":511,"type":35},"2019-07-01",{"date":513,"type":21},"2026-02-07",{"name":515,"class":70},"Western Health and Social Care Trust",{"id":517,"slug":518,"hasResults":12,"nctId":519,"briefTitle":520,"officialTitle":521,"acronym":522,"eligibilityCriteria":523,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":238,"enrollmentInfo":524,"targetDuration":4,"studyType":217,"phases":4,"briefSummary":526,"conditions":527,"keywords":4,"overallStatus":92,"whyStopped":4,"lastUpdateSubmitDate":530,"lastUpdatePostDateStruct":531,"startDateStruct":533,"completionDateStruct":535,"leadSponsor":537,"locationsCount":4},"100555619","barriers-and-faciliators-for-physical-activity-in-people-with-rmds-100555619","NCT06514443","Barriers and Faciliators for Physical Activity in People With RMDs","Exploration of Country-specific Barriers and Facilitators for the Implementation of Physical Activity According to the EULAR Physical Activity Recommendations for People With Rheumatic Musculoskeletal Diseases in Four Different European Countries; the COPA Project","COPA","Inclusion Criteria:\n\n* adults being 18years or older\n* diagnosis of osteoarthritis, rheumatoid arthritis or axial Spondyloarthritis\n* the cognitive and linguistic competencies to answer the survey\n\nExclusion Criteria:\n\n* having a rheumatological or musculoskeletal disease other than described\n* any communication problems",{"count":525,"type":21},400,"The aim of this project is to systematically survey and explore barriers and facilitators for the implementation of physical activity according to the physical activity recommendations of the European Alliance of Associations for Rheumatology on country specific (e.g., environmental, cultural, organization and system) level. A questionnaire to explore\u002Fidentify these barriers and facilitators in the survey, will be developed through literature search, interviews with multiple stakeholders (i.e., patients with inflammatory arthritis or osteoarthritis and physical therapists) and experts in the field in four different European countries (i.e., Turkey, Switzerland, the Netherlands and France).\n\nAdditionally, in Switzerland only, the Inflammatory Arthritis Facilitators and Barriers to Physical Activity (IFAB) Questionnaire which was developed to determine the factors on personal level, will be translated into the German language. Aim is to evaluate the validity and reliability of the IFAB Questionnaire in the German-speaking population with axial Spondyloarthrits, and to perform a cultural adaptation if necessary at the same time.",[528,529,244,28],"Osteoarthritis, Knee","Osteoarthritis, Hip","2024-07-16",{"date":532,"type":35},"2024-07-23",{"date":534,"type":21},"2024-08-01",{"date":536,"type":21},"2025-03-31",{"name":538,"class":70},"Anne-Kathrin Rausch",{"id":540,"slug":541,"hasResults":12,"nctId":542,"briefTitle":543,"officialTitle":544,"acronym":545,"eligibilityCriteria":546,"healthyVolunteers":172,"sex":17,"minAge":547,"maxAge":4,"enrollmentInfo":548,"targetDuration":4,"studyType":22,"phases":549,"briefSummary":550,"conditions":551,"keywords":559,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":567,"lastUpdatePostDateStruct":568,"startDateStruct":570,"completionDateStruct":572,"leadSponsor":574,"locationsCount":71},"100551493","axsend-exploring-immune-and-microbiota-effects-of-a-partial-enteral-nutrition-diet-in-axial-spondyloarthritis-100551493","NCT06460805","axSEND: Exploring Immune and Microbiota Effects of a Partial Enteral Nutrition Diet in Axial Spondyloarthritis","axSEND: Exploring Immune and Microbiota Effects of a Partial Enteral Nutrition Diet in People With Axial Spondyloarthritis","axSEND","Eligibility Criteria for Participants with axSpA\n\nInclusion criteria. Participants will fulfil ALL of the following:\n\n* Diagnosis of axSpA (fulfilling the ASAS criteria)\n* Active disease (BASDAI score ≥4) on day of study visit\n* Stable on treatment \\[defined as (1) no major change to therapy (change in treatment type) in the preceding 3 months AND (2) no minor change in therapy (adjustment of treatment dosage) in the preceding 1 month\\]\n* Age ≥ 16 years\n* Willing and able to give informed written consent.\n\nExclusion. Participants will have NONE of the following:\n\n* Pregnancy or breastfeeding\n* Prior diagnosis of IBD\n* Recipient of chemotherapy\u002Fimmunotherapy\u002Fradiotherapy in prior 3 months\n* Recent systemic antibiotic use (within last 1 month)\n* Current eating disorder\n* Food allergy incompatible with diet (e.g. cow's milk allergy)\n* Following a vegan diet\n* Major surgery in prior 3 months or planned in forthcoming 3 months.\n* Unable or unwilling to give informed consent\n* Unable or unwilling to try the PEN diet.\n\nEligibility Criteria for Healthy Volunteer Participants\n\nInclusion criteria. Participants will fulfil ALL of the following:\n\n* Age ≥ 16 years\n* Current student and\u002For staff member at the University of Glasgow\n* Willing and able to give informed written consent\n\nExclusion. Participants will have NONE of the following:\n\n* Pregnancy or breastfeeding\n* Prior diagnosis of an immune-mediated inflammatory condition\n* Recipient of chemotherapy\u002Fimmunotherapy\u002Fradiotherapy in prior 3 months\n* Recent systemic antibiotic use (within last 1 month)\n* Current eating disorder\n* Food allergy incompatible with diet (e.g. cow's milk allergy)\n* Following a vegan diet\n* Major surgery in prior 3 months or planned in forthcoming 3 months.\n* Unable or unwilling to give informed consent\n* Unable or unwilling to try the PEN diet.","16 Years",{"count":43,"type":21},[54],"People with axial spondyloarthritis (axSpA) often have intestinal inflammation and intestinal microbiome dysbiosis, with some similarities to Crohn's-like inflammatory bowel disease (IBD) gut inflammation. However, research has not addressed whether Partial Enteral Nutrition (PEN), a diet formed of a liquid formula and some solid whole foods, which is effective at inducing remission in IBD, may influence the dysbiotic microbiome and inflamed, hyperpermeable intestine of axSpA patients, and whether these changes may be accompanied by alterations in systemic markers of inflammation. Thus, there is a need to determine the effects of PEN on these aspects in axSpA patients.\n\nIn this study, the investigators intend to trial a 2-week course (with optional additional 2-week extension) of a PEN diet in people with active axSpA disease. A group of healthy volunteers following the same diet will act as a control.",[28,87,552,553,554,555,556,557,558],"Inflammation","Dysbiosis","Arthritis","Spondylitis","Spondylarthritis","SpA","AxSpA",[560,561,562,563,91,564,565,566],"Partial Enteral Nutrition","Nutrition","Axial spondyloarthritis","Ankylosing spondylitis","Diet","PEN","AS","2024-06-13",{"date":569,"type":35},"2024-06-14",{"date":571,"type":35},"2024-04-25",{"date":573,"type":21},"2025-08-01",{"name":575,"class":70},"NHS Greater Glasgow and Clyde",{"id":577,"slug":578,"hasResults":12,"nctId":579,"briefTitle":580,"officialTitle":581,"acronym":582,"eligibilityCriteria":583,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":80,"enrollmentInfo":584,"targetDuration":4,"studyType":22,"phases":586,"briefSummary":587,"conditions":588,"keywords":593,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":599,"lastUpdatePostDateStruct":600,"startDateStruct":602,"completionDateStruct":604,"leadSponsor":606,"locationsCount":130},"100550785","phase-2-fecal-microbiota-transplantation-in-axial-spondyloarthritis-100550785","NCT06451588","Fecal Microbiota Transplantation in Axial Spondyloarthritis","Donor Versus Autologous Fecal Microbiota Transplantation for Axial Spondyloarthritis: a Double Blind, Placebo-Controlled, Randomized Trial","MicroSpA","Inclusion Criteria:\n\n* Axial Spondyloarthritis according to the ASAS classification criteria\n* Active disease defined as ASDAS ≥2.1 with elevated CRP ≥4 OR active inflammation on MRI within the last 3 months\n* Onset of axial SpA within last 10 years\n* Unsatisfactory relief of NSAIDs\n* On stable immunomodulatory treatment (TNFi, IL17i or JAKi) the last 3 months\n\nExclusion Criteria:\n\n* Planned dose adjustment or change in immunomodulatory treatment the next 90 days\n* Disease or disorder with life expectancy of ≤5 years\n* Severe immune deficiency (acquired, congenital og du to medication)\n* Previous treatment with FMT\n* Regular use of opioids with the exception of codeine and tramadol\n* Any specific diagnosis that could explain or contribute to the patients back pain (e.g. tumor, fracture, infection or degenerative disease)\n* Inflammatory spinal disease other than axSpA\n* Severe psychiatric disorder, alcohol- or drug abuse\n* Active inflammatory bowel disease\n* Microscopic colitis, diverticulitis or ileus\n* Active psoriasis\n* Fibromyalgia\n* Abdominal surgery excluding appendectomy, cholecystectomy, hysterectomy, caesarian section, sapling-ooforectomy and hernia surgery\n* Malignant disease excluding basalioma and melanoma stage 1\n* Conditions with expected necessary treatment with antibiotics during the study period, e.g. periodontitis end ischemic digital ulcers\n* Treatment with antibiotics 12 weeks prior to study entry\n* Pregnancy, lactation or planned pregnancy within the next 3 months\n* Contraindications for rectal catheter insertion\n* Planned rehabilitation program the next 90 days\n* Limited ability to comply with protocol requirements, including biobank participation",{"count":585,"type":21},99,[84],"Although biologic therapy have revolutionized the treatment of Spondyloarthrtitis (SpA), many patients do not experience complete relief of SpA related complaints.\n\nIt has been established that patients with SpA have an altered composition of microorganisms (microbiota) in the gut compared to healthy controls, and that this correlates to disease activity and respons to therapy.\n\nThe goal of this randomized double-blind study is to evaluate the efficacy of fecal microbiota transplantation (FMT) in patients with axial SpA with a suboptimal effect of biologic therapy.\n\nThe main questions it aims to answer are:\n\n* Can FMT reduce disease activity in axial SpA?\n* Can FMT alleviate pain and reduce fatigue in axial SpA?\n* Is the composition of microorganisms restored to normal in patients with SpA after a treatment with FMT?\n\nParticipants will receive a single treatment in the form of an enema with either donor FMT or placebo at baseline. The primary endpoint will be evaluated after 90 days, but efficacy and safety will be monitored from baseline until 365 days.",[28,87,553,589,555,554,590,591,592],"Spondyloarthritis","Musculoskeletal Diseases","Spinal Disease","Joint Diseases",[28,594,595,596,597,598],"Microbiome","Fecal Microbiota Transplantation","Microbiota","FMT","RCT","2024-06-04",{"date":601,"type":35},"2024-06-11",{"date":603,"type":35},"2024-06-01",{"date":605,"type":21},"2026-03",{"name":607,"class":70},"University Hospital of North Norway",{"id":609,"slug":610,"hasResults":12,"nctId":611,"briefTitle":612,"officialTitle":613,"acronym":614,"eligibilityCriteria":615,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":616,"enrollmentInfo":617,"targetDuration":4,"studyType":22,"phases":618,"briefSummary":620,"conditions":621,"keywords":622,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":626,"lastUpdatePostDateStruct":627,"startDateStruct":629,"completionDateStruct":631,"leadSponsor":633,"locationsCount":130},"100489563","phase-2-the-efficacy-of-fecal-microbiota-transplatation-on-axial-spondyloarthritis-patients-resistant-to-conventional-treatment-100489563","NCT05654753","The Efficacy of Fecal Microbiota Transplatation on Axial Spondyloarthritis Patients Resistant to Conventional Treatment","RANDOMIZED DOUBLE BLIND CONTROLLED STUDY ASSESSING THE EFFICACY OF FECAL MICROBIOTA TRANSPLANTATION IN PATIENTS WITH AXIAL SPONDYLOARTHRITIS RESISTANT TO CONVENTIONAL TREATMENT","FMT-SpA","Inclusion Criteria:\n\n* Adult patient (age 18 to 75 years old) with SpA, meeting the ASAS classification criteria for axial SpA, with presence of radiographic sacro-illitis (ankylosing spondylitis) or not.\n* Patient suffering of active SpA, with or without treatment, having a BASDAI score ≥ 4 (0-10) at baseline and a score of back pain ≥ 4 (0-10) despite optimal drug management for at least 6 months including at least 2 different NSAIDs at the maximum tolerated dose for at least 2 months (or less in case of intolerance or contra-indication) and at least a first line of biotherapy (anti-TNFα or anti-IL-17) for at least 4 months (or less in case of intolerance or contra-indication).\n* Subjects are allowed to continue NSAID, sulfasalazin (≤ 3 g\u002Fday) and\u002For methotrextae ( ≤ 25 mg\u002Fweek) and\u002For hydroxychloroquine (≤ 400 mg\u002Fday) and\u002For oral corticosteroid (≤ 10 mg\u002Fday of prednisone), as long as these treatments have remained at stable dose for 4 weeks prior to baseline.\n* Subjects are allowed to continue anti-TNFα, anti-IL-17 or JAKinhibitor therapies, as long as these treatments have remained at stable dose for 3 months prior to baseline.\n* Women of childbearing potential with efficient contraceptive protection at the inclusion and during at least the interventional phase (D168).\n* Patient with health insurance (AME except).\n* Patient is willing to provide written informed consent prior to enrolment and agrees to follow the protocol.\n\nExclusion Criteria:\n\n1. Patient under legal protection (guardianship or curatorship)\n2. Subject who, in the judgment of the Investigator, is likely to be non-compliant or uncooperative during the study, or unable to cooperate because of a language problem, poor mental development\n3. Pregnant or breastfeeding woman\n4. Patient with IBD in active state, according to the judgment of the Investigator\n5. Corticosteroid injection within 4 weeks before inclusion\n6. Active infection according to the judgment of the Investigator\n7. Any antibiotic (including Sulfasalazin) or antifungal treatment within 4 weeks before inclusion\n8. Probiotics intake within 4 weeks before inclusion\n9. Known infection with Clostridoides difficile or Escherichia coli within 10 days before inclusion\n10. Patients with unstable severe condition other than axial SpA on that could jeopardize treatment procedure or evaluation according to the investigator's assessment\n11. Previous FMT treatment\n12. Contra-indication to colon preparation (Moviprep® or Moviprep orange®) according to SmPC\n13. Current or past evidence of bowel obstruction\n14. Confirmed or suspected intestinal ischemia\n15. Confirmed or suspected toxic megacolon or gastrointestinal perforation\n16. Extended colectomy (\\> two-thirds of colon)\n17. Any gastro-intestinal bleeding in the past 3 months before inclusion\n18. Any history of gastro-intestinal surgery in the past 3 months before inclusion\n19. Severe organ dysfunction\n20. Any contra-indication to swallow capsules\n21. Known allergy or intolerance to IMP and \u002F or excipients according to Investigator's Brochure\n22. Lack of access to a refrigerator to store the medication (MaaT033® or MaaT030®)\n23. Concomitant participation in another interventional clinical trial","75 Years",{"count":141,"type":21},[84,619],"PHASE3","Current pharmacological management of inflammatory rheumatism and in particular axial SpA remains imperfect. Only 50% of patients respond to the most effective biotherapies, and many of them are only partially relieved. In addition, these are extremely expensive treatments that expose them to the risk of potentially serious side effects. Compelling evidence indicates that gut dybiosis could be a critical trigger of inflammation in axial SpA and thus correcting dysbiosis represents an attractive way of reversing the pathogenic process.The efficacy of FMT in patients with axial SpA has never been studied. This randomized double-blind study will be the first to assess feasability of FMT in axial SpA, the capacity of this procedure to restore healthy microbiome, its tolerance and its potential efficacy on disease activity. If sucessfull, this trial would set the path to larger-scale clinical trials of FMT to treat axial SpA.\n\nTwo-co primary objectives in a hierarchical design:\n\n* to evaluate the capacity of FMT to correct dysbiosis in active axial SpA despite well-conducted phamacological treatment by replacing pre-existing dysbiotic microbiota with healthier microbiota.\n* to explore the efficacy of FMT versus placebo on clinical evolution of SpA.",[28],[28,623,624,625],"dysbiotic microbiota","Fecal microbiota transplantation","eubiotic microbiota","2024-04-05",{"date":628,"type":35},"2024-04-09",{"date":630,"type":35},"2024-03-28",{"date":632,"type":21},"2027-09",{"name":318,"class":70},{"id":635,"slug":636,"hasResults":12,"nctId":637,"briefTitle":638,"officialTitle":639,"acronym":4,"eligibilityCriteria":640,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":641,"targetDuration":4,"studyType":22,"phases":643,"briefSummary":644,"conditions":645,"keywords":4,"overallStatus":92,"whyStopped":4,"lastUpdateSubmitDate":646,"lastUpdatePostDateStruct":647,"startDateStruct":649,"completionDateStruct":651,"leadSponsor":653,"locationsCount":130},"100531224","phase-2-efficacy-and-safety-of-sct650c-in-participants-with-axial-spondyloarthritis-100531224","NCT06197009","Efficacy and Safety of SCT650C in Participants With Axial Spondyloarthritis","A Randomized, Double-blinded, Phase II, Placebo-controlled Study to Evaluate the Safety and Efficacy of SCT650C in Participants With Axial Spondyloarthritis","Inclusion Criteria:\n\n1. An Institutional Review Board (IRB)\u002FIndependent Ethics Committee (IEC) approved written Informed Consent form is signed and dated by the participant.\n2. Participant is considered reliable and capable of adhering to the protocol (e.g., able to understand and complete diaries), visit schedule, and medication intake according to the judgment of the Investigator.\n3. Participant is male or female and at least 18 years of age.\n4. Participant has a documented diagnosis of adult-onset AS as defined by documented radiologic evidence (X-ray) fulfilling the Modified New York criteria for AS (1984) of at least 3 months' symptom duration and age of onset \\\u003C45 years.\n5. Participant has moderate to severe active disease at the Screening Visit as defined by each of the following:\n\n   1. BASDAI score ≥4\n   2. Spinal pain score ≥4 on a 0 to 10 numeric rating scale (NRS) (from BASDAI Item 2)\n6. Participants must have at least 1 of the following:\n\n   1. inadequate response to NSAID therapy\n   2. intolerance to administration of at least 1 NSAID\n   3. contraindication(s) to NSAID therapy An inadequate response to NSAID is defined as not improving after 4 weeks of using NSAID therapy at the recommended dose or failing to respond to at least 2 NSAIDs at the recommended dose for 2 weeks each.\n7. Participants who are regularly taking NSAIDs\u002FCOX-2 inhibitors as part of their SPA therapy are required to be on a stable dose for at least 14 days before Baseline and should remain on a stable dose up to week 16.\n8. Participants taking corticosteroids must be on an average daily dose of ≤10mg\u002Fday prednisone or equivalent for at least 14 days before Baseline and should remain on a stable dose up to week 16.\n9. Participants taking Methotrexate (MTX, ≤25mg\u002Fweek), sulfasalazine (up to 3g\u002Fday) or hydroxychloroquine (up to 400mg per day total) are allowed to continue their medication if the dose has been stable dose for at least 4 weeks before randomization. Dose, dosing schedule, and route of administration (oral or subcutaneous) should remain stable up to week 16.\n10. Subject may have prior treatment TNF inhibitor (TNFi), which must have used no more than 2 TNFi and must have been discontinued.\n11. Female participants must be postmenopausal (at least 1 year; to be confirmed hormonally as part of the screening process, if less than 2 years since last menstrual period), permanently sterilized (e.g., tubal occlusion, hysterectomy, bilateral salpingectomy) or, if of childbearing potential (and engaged in sexual activity that could result in procreation), must be willing to use a highly effective method of contraception up to 40 weeks after the last administration of IMP, and have a negative pregnancy test at Visit 1 (Screening) and immediately prior to the first dose. The following methods are considered highly effective when used consistently and correctly.\n\n    1. progestogen-only hormonal contraception associated with inhibition of ovulation (oral, injectable, implantable)\n    2. combined (estrogen and progestogen) hormonal contraception associated with inhibition of ovulation (oral, intravaginal or transdermal)\n    3. intrauterine device (IUD)\n    4. intrauterine hormone-releasing system (IUS)\n    5. bilateral tubal occlusion\n    6. vasectomized partner (where postvasectomy testing had demonstrated sperm clearance)\n    7. Sexual abstinence if it is in accordance with a participant's preferred and common lifestyle.\n\nParticipants who use abstinence as a form of birth control must agree to abstain from heterosexual intercourse until 40 weeks after the final dose of IMP. Study personnel must confirm the continued use of abstinence is still in accordance with the participant's lifestyle at regular intervals during the study.\n\nMale participants with a partner of childbearing potential must be willing to use a condom when sexually active, until 40 weeks after the last administration of IMP.\n\nExclusion Criteria:\n\n1. Female participant who is breastfeeding, pregnant, or planning to become pregnant during the study or within 40 weeks following the final dose of IMP. Male participant planning a partner pregnancy during the study or within 40 weeks following the final dose.\n2. Participant has participated in another study of a medication under investigation within the last 3 months or at least 5 half-lives of the IMP, whichever is greater, or is currently participating in another study of a medication under investigation. Participants who participated in any clinical trial but were enrolled in placebo group and did not receive any IMP in the prior study are eligible for this study.\n3. Participant has received any IL-17 response modifier.\n4. Participant has received more than 3 bDMARDs to treat axSpA.\n5. Participant has a known hypersensitivity to any excipients of SCT650C.\n6. Participant has total ankylosis of the spine or a diagnosis of any other inflammatory arthritis e.g., RA, systemic lupus erythematosus, sarcoidosis, psoriatic arthritis, or reactive arthritis. Participants with a diagnosis of Crohn's disease or ulcerative colitis are allowed if they have no active symptomatic disease at Screening or Baseline.\n7. Participant has a secondary noninflammatory condition (e.g., osteoarthritis, fibromyalgia) that in the Investigator's opinion is symptomatic enough to interfere with the evaluation of the effect of study drug on the participant's primary diagnosis of active SpA.\n8. Participant has:\n\n   1. A history of chronic or recurrent infections (e.g., more than 3 episodes requiring systemic antibiotics or antivirals during the preceding year). Minor illnesses like common cold or transient, localized infections that may have been treated with a short course of antibiotic therapy (up to 7 days) need not be counted in this assessment.\n   2. A serious or life-threatening infection within the 6 months prior to the Baseline Visit (including herpes zoster) or hospitalization for any infection in the last 6 months.\n   3. Any current sign or symptom that may indicate an active infection (except for common cold) or has had an infection requiring systemic antibiotics within 2 weeks prior to Baseline.\n   4. A high risk of infection in the Investigator's opinion (e.g., participants with leg ulcers, indwelling urinary catheter, prior prosthetic joint infection at any time, participants who are permanently bedridden or wheelchair assisted).\n9. Participant has a history of or current clinically active infection with Histoplasma, Coccidiodes, Paracoccidioides, Pneumocystis, nontuberculous mycobacteria (NTMB), Blastomyces, or Aspergillus or current active Candidiasis (local or systemic)\n10. Participant has acute or chronic viral hepatitis B or C or human immunodeficiency virus (HIV) infection. Participants who have evidence of, or test positive for, hepatitis B or hepatitis C are excluded as follows:\n\n    1. A positive test for the hepatitis B virus (HBV) is defined as: 1) positive for hepatitis B surface antigen (HBsAg+), or 2) HBsAg is negative, HBcAb is positive and HBV-DNA test results ≥ the upper limit of the reference value of each center or need antiviral treatment.\n    2. A positive test for the hepatitis C virus (HCV) is defined as: 1) positive for hepatitis C antibody (anti-HCV Ab), and 2) positive via a confirmatory test for HCV (for example, HCV polymerase chain reaction).\n11. Participants with known TB infection, at high risk of acquiring TB infection, with latent TB infection (LTBI), or current or history of NTMB infection.\n12. Participant has a primary immunosuppressive condition, including taking immunosuppressive therapy following an organ transplant or has had a splenectomy.\n13. Participants with concurrent malignancy or a history of malignancy (including surgically resected uterine\u002Fcervical carcinoma-in-situ) during the past 5 years will be excluded with the following exceptions that may be included:\n\n    1. One squamous cell carcinoma of the skin (stage T1 maximum) successfully excised or ablated only (other treatments, i.e., chemotherapy, do not apply) with no signs of recurrence or metastases for more than 2 years prior to Screening.\n    2. ≤3 excised or ablated basal cell carcinomas of the skin.\n    3. Actinic keratosis(-es).\n    4. Squamous cell carcinoma-in-situ of the skin successfully excised or ablated more than 6 months prior to the Screening.\n14. Participant has a history of a lymphoproliferative disorder including lymphoma or current signs and symptoms suggestive of lymphoproliferative disease.\n15. Participant has a history of demyelinating disease (including myelitis) or neurologic symptoms suggestive of demyelinating disease.\n16. Participant has a current or recent history, as determined by the Investigator, of severe, progressive, and\u002For uncontrolled renal, hepatic hematological, endocrine, pulmonary, cardiac (e.g., congestive heart failure New York Heart Association \\[NYHA\\] Grade 3 and 4), gastrointestinal (GI) (note: participants with active peptic ulcer disease are excluded; participants with a history of peptic ulcer disease are allowed), or neurological disease.\n17. Participants have a history of uncompensated heart failure, fluid overload, or myocardial infarction, or evidence of new-onset ischemic heart disease or in the opinion of the Investigator other serious cardiac disease, within 12 weeks prior to Baseline.\n18. Participant has \\>2x upper limit of normal (ULN) of any of the following: alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase (ALP), or \\>ULN total bilirubin (≥1.5xULN total bilirubin if known Gilbert's syndrome). If participant has elevations only in total bilirubin that is\\>ULN and \\\u003C1.5xULN, fractionate bilirubin to identify possible undiagnosed Gilbert's syndrome (i.e., direct bilirubin \\\u003C35%).\n\n    An isolated elevation between 2xULN and \\\u003C3xULN of ALP is acceptable in the absence of an identified exclusionary medical condition.\n\n    Tests that result in ALT, AST, or ALP up to 25% above the exclusion limit may be repeated for confirmation during the Screening Period. Upon retesting, participants whose ALT, AST, or ALP remain above the thresholds defined above, should not be randomized.\n\n    For randomized participants with a Baseline result \\>ULN for ALT, AST, ALP, or total bilirubin, a Baseline diagnosis and\u002For the cause of any clinically meaningful elevation must be understood and recorded in the electronic Case Report form (eCRF).\n\n    If a participant has \\>ULN ALT, AST, or ALP that does not meet the exclusion limit at Screening, repeat the tests, if possible, prior to dosing to ensure there is no further ongoing clinically relevant increase. In case of a clinically relevant increase, inclusion of the participant must be discussed with the Medical Monitor.\n19. Participants with clinically significant laboratory abnormalities (e.g., creatinine \\>1.5xULN, neutropenia \\\u003C1.5x109\u002FL, hemoglobin \\\u003C8.5g\u002FdL, lymphocytes \\\u003C1.0 x109\u002FL, white blood cell (WBC) count \\\u003C3.0x109, platelets \\\u003C100 x109\u002FL). Individual screening tests for which the results are in error, borderline, or indeterminate for inclusion in the study, can be repeated once for confirmation during the Screening Period if they are within 25% of the exclusion limit. Upon retesting, participants whose results remain outside this threshold should not be randomized.\n20. Participant has an estimated glomerular filtration rate (GFR) as measured by Chronic Kidney Disease Epidemiology Collaboration \\\u003C60mL\u002Fmin\u002F1.73m2 \\[GFR (male)=(140-age)ⅹWeight\u002Fserum creatinineⅹ1.23; GFR (female)=(140-age)ⅹWeight\u002Fserum creatinineⅹ1.04\\].\n21. Participant has a 12-lead ECG with changes considered to be clinically significant upon medical review (e.g., QT corrected for heart rate \\[QTc\\] using Fridericia's correction \\[QTcF\\] \\>450ms, bundle branch block, evidence of myocardial ischemia).\n22. Participant has received any live (includes attenuated) vaccination within the 8 weeks prior to Baseline (12 months prior to Baseline for the TB Bacille Calmette-Guérin \\[BCG\\] vaccine) (e.g., inactivated influenza and pneumococcal vaccines are allowed but nasal influenza vaccination is not permitted). Live vaccines are not allowed during the study or for 40 weeks after the final dose of IMP.\n\n    Live vaccines include, but are not limited to the following:\n    1. Anthrax vaccine\n    2. Intranasal influenza vaccine\n    3. Measles-mumps-rubella (MMR) vaccine\n    4. Polio live oral vaccine (OPV)\n    5. Smallpox vaccine\n    6. Tuberculosis BCG vaccine (within 12 months prior to Baseline)\n    7. Typhoid live oral vaccine\n    8. Varicella vaccine\n    9. Yellow fever vaccine\n23. Participant has any other condition which, in the Investigator's judgment, would make the participant unsuitable for inclusion in the study.",{"count":642,"type":21},168,[84],"The purpose of this study is to assess efficacy, safety, pharmacokinetics and immunogenicity of subcutaneous SCT650C in patients with Axial Spondyloarthritis",[28],"2023-12-25",{"date":648,"type":35},"2024-01-09",{"date":650,"type":21},"2024-07-01",{"date":652,"type":21},"2026-08-01",{"name":654,"class":42},"Sinocelltech Ltd.",{"id":656,"slug":657,"hasResults":12,"nctId":658,"briefTitle":659,"officialTitle":659,"acronym":660,"eligibilityCriteria":661,"healthyVolunteers":12,"sex":17,"minAge":547,"maxAge":662,"enrollmentInfo":663,"targetDuration":4,"studyType":217,"phases":4,"briefSummary":665,"conditions":666,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":667,"lastUpdatePostDateStruct":668,"startDateStruct":670,"completionDateStruct":672,"leadSponsor":674,"locationsCount":130},"100491257","british-axial-spondyloarthritis-inception-cohort-100491257","NCT05676775","British Axial Spondyloarthritis Inception Cohort","BAxSIC","Inclusion Criteria:\n\n1. Aged ≥16 years.\n2. A physician diagnosis of axSpA (including ankylosing spondylitis) within the last 6 months prior to baseline.\n3. Willing and able to give informed consent to participate in the study.\n\nExclusion Criteria:\n\n1. Age \\\u003C16 years.\n2. Unable to communicate in English or are deemed, in any other way, to be unable to give informed consent","50 Years",{"count":664,"type":21},500,"The British Axial Spondyloarthritis Cohort (BAxSIC) study has been established under the auspices of the British Society for Spondyloarthritis (BRITSpA) in collaboration with the National Axial Spondyloarthritis Society (NASS) to provide real-world data to evaluate the impact of delay in diagnosis (from symptom onset to diagnosis) on work participation and functional outcomes and the natural history and impact of newly-diagnosed axial Spondyloarthritis, including disease activity, pain, fatigue, functional and work outcomes, comorbidities, therapies in the United Kingdom (UK). The study is a prospective cohort, enrolling patients attending rheumatology clinics in the UK who are newly diagnosed with axial Spondyloarthritis and naïve to biologic therapy.\n\nThe study will run for an initial 3 year period commencing January 2023. Financial support was provided as a Research Grant from Pfizer Limited, UCB and Novartis.",[28],"2023-07-14",{"date":669,"type":35},"2023-07-18",{"date":671,"type":35},"2023-06-09",{"date":673,"type":21},"2029-01-09",{"name":675,"class":70},"The Leeds Teaching Hospitals NHS Trust"]