[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"axial-spondyloarthritis-axspa\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:axial-spondyloarthritis-axspa":29},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,46,77,108],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":27,"conditions":28,"keywords":30,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":45},"100596610","phase-1-east-1-erap-inhibition-in-axial-spondyloarthritis-trial---1-100596610",false,"NCT07047703","EAST-1 (ERAP-inhibition in Axial Spondyloarthritis Trial - 1)","A Multi-part, Phase I\u002FII Study to Evaluate the Safety and Tolerability of GRWD0715 in Healthy Human Volunteers and Participants With Axial Spondyloarthritis","EAST-1","Inclusion Criteria:\n\nHealthy Volunteers\n\n* Healthy male and female subjects aged 18-55 years inclusive, at the Screening visit\n* Participant must provide written informed consent to participate in the study\n* Participant must be able and willing to comply with the requirements of the protocol (including dietary restrictions and exclusion of grapefruit juice)\n* Male participants (and their female partners) \u002F female participants must be willing to adhere to contraception requirements as detailed in the protocol\n* Non-smokers or ex-smokers who have not smoked within the previous 6 months, as determined at the Screening visit\n* Participant with a Body Mass Index (BMI) of 19-30. Body Mass Index = Body weight (kg) \u002F \\[Height (m)\\]2\n\nAxSpA Participants\n\n* Male or female, 18-65 years of age\n* Participants diagnosed with Axial Spondyloarthritis, also fulfilling ASAS classification criteria including:\n\n  1. HLA-B27 +ve (local testing)\n  2. Objective evidence of inflammation at screening, specifically active sacroiliac joint inflammation on MRI fulfilling the ASAS MRI criteria (MRI+), assessed by the Principal Investigator or appropriately trained delegate, and\u002For elevated C-reactive protein (CRP+) ≥5.0mg\u002FL.\n* Symptom duration of ≥3 months\n* Age at onset of active disease of \\\u003C40 years\n* A score of ≥ 2.1 on the Ankylosing Spondylitis Disease Activity Score (ASDAS) on current treatment.\n* At least one of the following:\n\n  1. Current treatment with a NSAID, at a sufficient dose and following an appropriate dosing duration per local clinical guidelines, with inadequate clinical response OR\n  2. Intolerance to ≥1 NSAID or contraindication(s) to NSAIDs\n* Participants may have received 1 prior\u002F(Australia only) 2 prior b\u002Fts DMARD and discontinued due to intolerance or inadequate efficacy.\n* Participants who have received 1\u002F(Australia only) 2 prior treatments are required to undergo a washout at minimum:\n\n  1. Biologic DMARDs 4 weeks or 5 half-lives prior to Day 1, whichever is longer.\n  2. JAK inhibitor DMARDs 2 weeks prior to Day 1\n\nExclusion Criteria:\n\nHealthy Volunteers\n\n* History or presence of any clinically significant findings in medical history, physical examination, vital signs and\u002For laboratory tests that, in the opinion of the Investigator, would preclude inclusion in the study\n* Participation in a New Chemical Entity clinical study within the previous 124 days or a marketed drug clinical study within the previous 93 days\n* Known infection or lifestyle risk factors for human immunodeficiency virus (HIV) and\u002For hepatitis B or C infection, as determined at the Screening visit\n\nAxSpA Participants\n\n* Participants who have received \\>1\u002F(Australia only) \\>2 biologic or JAK inhibitor DMARD or are receiving any other disease-modifying antirheumatic drugs (other than those allowed), thalidomide (including previous use) and other prohibited concomitant medications.\n* Inadequate Haematologic function, defined as:\n\n  1. Haemoglobin \\\u003C10 g\u002FdL.\n  2. Absolute white blood cell count \\\u003C3.0 x 109 \u002FL (\\\u003C3000 mm3)\n  3. Absolute neutrophil count \\\u003C1.2 x 109 \u002FL (\\\u003C1200 mm3)\n  4. Absolute lymphocyte count \\\u003C1.0 x 109 \u002FL (\\\u003C1000 mm3)\n  5. Platelet count \\\u003C100 x 109 \u002FL (\\\u003C100.000 mm3)\n* Inadequate liver function, defined as; total bilirubin, aspartate aminotransferase (AST) and alanine aminotransferase (ALT) more than 1.5 times the upper limit of normal at screening visit. For subjects with Gilberts syndrome, upper limit of normal for total bilirubin will be 2.9mg\u002Fdl\n* History of any other autoimmune rheumatic disease (e.g., psoriatic arthropathy, systemic lupus erythematosus, mixed connective tissue disease, scleroderma, polymositis) or known diagnosis of fibromyalgia\n* Participants with a previous history of or currently stable psoriasis are eligible\n* Active or symptomatic inflammatory bowel disease (IBD). Participants with a history of IBD are allowed to participate\n* Presence of active anterior uveitis\n\nPlease note the following Country-Specific Inclusion Criteria, for study participants in Australia:\n\n\\- Participants with a score of ≥ 2.1 (High Disease Activity) on the Ankylosing Spondylitis Disease Activity Score (ASDAS) on current treatment.\n\nFor study participants in Part B only:\n\n* Objective evidence of inflammation may not be required for some participants with low to moderate disease activity.\n* Participants with an ASDAS score between ≥1.3 and \\\u003C 2.1 (Low to Moderate Disease Activity) will require Sponsor approval prior to screening for the study, as they may not require an MRI to provide objective evidence of inflammation if on current treatment. For participants with low to moderate disease activity, MRI should only be performed if required to confirm ASAS classification.\n\nFor axSpA participants in Part B, MRI assessment of the SI joints is only required for participant eligibility criteria evaluation to assess objective inflammation in case CRP measurement at baseline is negative and the objective evidence of inflammation is required.","ALL","18 Years","65 Years",{"count":21,"type":22},141,"ESTIMATED","INTERVENTIONAL",[25,26],"PHASE1","PHASE2","GRWD0715 is an orally administered, selective inhibitor of the Endoplasmic Reticulum Aminopeptidase 1 \\[ERAP1\\] enzyme being explored as a potential new treatment for axial spondyloarthritis (axSpA), a long term condition caused by inflammation predominantly affecting the sacroiliac joints (SIJs) and spine.",[29],"Axial Spondyloarthritis (AxSpA)",[31,32],"Axial Spondyloarthritis","AxSpA","RECRUITING","2026-06-25",{"date":36,"type":37},"2026-06-26","ACTUAL",{"date":39,"type":37},"2025-07-28",{"date":41,"type":22},"2028-09-30",{"name":43,"class":44},"Grey Wolf Therapeutics","OTHER",16,{"id":47,"slug":48,"hasResults":11,"nctId":49,"briefTitle":50,"officialTitle":51,"acronym":52,"eligibilityCriteria":53,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":54,"targetDuration":4,"studyType":23,"phases":56,"briefSummary":58,"conditions":59,"keywords":61,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":67,"lastUpdatePostDateStruct":68,"startDateStruct":70,"completionDateStruct":72,"leadSponsor":74,"locationsCount":76},"100522474","effects-of-yoga-therapy-in-rehabilitation-compared-to-physiotherapy-in-moderate-axial-spondyloarthritis-axspa-100522474","NCT06083090","Effects of Yoga Therapy in Rehabilitation Compared to Physiotherapy in Moderate Axial Spondyloarthritis (axSPA)","Effects of Yoga Therapy in Rehabilitation Compared to Physiotherapy in Moderate Axial Spondyloarthritis (axSPA): a Randomized Controlled Multicenter Study.","YOKISPA","Inclusion Criteria:\n\n* French-speaking patient aged 18 and over\n* Patient with axial spondyloarthritis (axSPA) according to Assessment of SpondyloArthritis International Society, diagnosed by a rheumatologist\n* \"Moderately active\" to \"active\" form of axSPA (basic BASDAI \\> 3)\n* Stable disease: No recent or foreseeable introduction in the next 6 months of drug treatments for axSPA (excluding analgesics)\n* Absence of disabling stress urinary incontinence\n* Geographical or organizational possibility of undergoing the study\n* Patient informed and having signed the informed consent form for participation in the research\n\nExclusion Criteria:\n\n* Pregnancy or breastfeeding\n* Recent childbirth (within the last six months)\n* Patient already practicing yoga or having practiced it in the last six months\n* Abdominal or spinal surgery in the last six months\n* Motor neurological deficit\n* Sphincter deficit\n* Any other somatic pathology preventing the practice of physiotherapy or yogatherapy according to the opinion of the evaluating clinician\n* Depressive syndrome requiring specific treatment\n* Non-affiliation to a social security scheme (beneficiary or beneficiary) or to another social protection scheme\n* Patient deprived of liberty by judicial or administrative decision or under legal protection (guardianship, safeguard of justice)\n* Currently participating in or in a period of exclusion from: another interventional research involving human participants, a clinical trial on a medical product for human, a clinical investigation on a medical device. Participation in non-interventional research is authorized.",{"count":55,"type":22},72,[57],"NA","A few studies have evaluated the effectiveness of yoga therapy in patients with axial spondyloarthritis (axSPA). On the other hand, studies conducted in other chronic rheumatisms such as low back pain, rheumatoid arthritis or other conditions such as cancer have shown that yogatherapy can have a effective action on the physical and psychological level.\n\nYogatherapy is a non-drug \"body-mind\" approach that would be likely to improve the physical symptoms (pain, stiffness, in particular spinal and pelvic), internal organs (colitis) and psychological symptoms as well as the perception of fatigue of people with axSPA. A 2021 study showed the feasibility and acceptability of regular yogatherapy practice in patients with axSPA.\n\nIt is therefore necessary to conduct randomized controlled studies to assess the effectiveness of this management strategy.",[60],"Axial Spondyloarthritis (axSPA)",[62,63,64,65,66],"Yogatherapy","Ankylosing Spondyloarthritis","Physiotherapy","Yoga","Rheumatism","2025-09-30",{"date":69,"type":37},"2025-10-01",{"date":71,"type":37},"2024-08-27",{"date":73,"type":22},"2028-08-27",{"name":75,"class":44},"Assistance Publique - Hôpitaux de Paris",5,{"id":78,"slug":79,"hasResults":11,"nctId":80,"briefTitle":81,"officialTitle":82,"acronym":83,"eligibilityCriteria":84,"healthyVolunteers":11,"sex":17,"minAge":85,"maxAge":4,"enrollmentInfo":86,"targetDuration":4,"studyType":23,"phases":88,"briefSummary":90,"conditions":91,"keywords":94,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":98,"lastUpdatePostDateStruct":99,"startDateStruct":101,"completionDateStruct":103,"leadSponsor":105,"locationsCount":107},"100605262","phase-4-redo-jak-dose-reduction-of-janus-kinase-inhibitors-in-patients-with-inflammatory-rheumatic-diseases-100605262","NCT07160231","REDO-JAK: Dose Reduction of Janus Kinase Inhibitors in Patients With Inflammatory Rheumatic Diseases","REDO-JAK: Dose REDuction Of JAnus Kinase Inhibitors in Patients With Inflammatory Rheumatic Diseases","REDO-JAK","Inclusion Criteria:\n\n* Patients ≥ 16 years of age\n* Clinical diagnosis of RA, PsA or axSpA\n* Treated with a JAKi (monotherapy or combination with csDMARDwith a JAKi dose ≥ 50% of the authorised dose)\n* LDA or remission for at least 6 months according to accepted criteria for the specific disease and\u002For the judgement of the treating rheumatologist and patient. (RA: DAS28-CRP \\\u003C 2.9; PsA: PASDAS ≤3.2 and psoriasis mBSA involvement ≤3%; axSpA: ASDAS \\\u003C2.1.)\n\nExclusion Criteria:\n\n* Comorbidity for which continued JAKi treatment is expected to be necessary (e.g. active Crohn's disease, ulcerative colitis)\n* Life expectancy ≤12 months\n* Pregnancy (JAKi are contra-indicated during pregnancy, therefore we do not expect patients using a JAKi while pregnant)\n* Patients who are enrolled in other trials that might mutually interfere\n* Not able to provide informed consent","16 Years",{"count":87,"type":22},200,[89],"PHASE4","The goal of this clinical trial is to assess the effectiveness of a disease activity guided dose reduction strategy of Janus kinase inhibitor (JAKi) compared to disease activity guided JAKi continuation in patients with rheumatoid arthritis (RA), psoriatic arthritis (PsA) and axial spondyloarthritis (axSpA) who are in a state of low disease activity or remission while on JAKi. The main question it aims to answer is:\n\nIs a disease activity guided dose reduction strategy for JAKi not inferior in terms of efficacy compared to disease activity guided JAKi continuation in patients with RA\u002FPsA\u002FaxSpA that are currently in a low disease activity\u002Fremission state?\n\nResearchers will compare a disease activity guided dose reduction strategy for JAKi to disease activity guided JAKi continuation in patients with RA\u002FPsA\u002FaxSpA that are currently in a low disease activity\u002Fremission state to see if a disease activity guided dose reduction strategy for JAKi is not inferior in terms of efficacy compared to disease activity guided JAKi continuation.\n\nParticipants will:\n\n* Follow a JAKi dose reduction strategy or will continue using JAKi in the same dose\n* Study (telemonitoring) visits are planned every 3 months\n* At every visit, patients are asked to complete patient-reported outcomes that assess daily functioning, health-related quality of life, pain, fatigue, productivity loss, medical consumption and medication adherence.",[92,93,29],"Rheumatoid Arthritis (RA)","Psoriatic Arthritis (PsA)",[95,96,97],"disease activity guided dose reduction","Janus kinase inhibitors (JAKi)","disease activity guided JAKi continuation","2025-09-16",{"date":100,"type":37},"2025-09-17",{"date":102,"type":37},"2025-09-15",{"date":104,"type":22},"2028-05-01",{"name":106,"class":44},"Sint Maartenskliniek",7,{"id":109,"slug":110,"hasResults":11,"nctId":111,"briefTitle":112,"officialTitle":113,"acronym":114,"eligibilityCriteria":115,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":116,"targetDuration":118,"studyType":119,"phases":4,"briefSummary":120,"conditions":121,"keywords":127,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":135,"lastUpdatePostDateStruct":136,"startDateStruct":138,"completionDateStruct":140,"leadSponsor":142,"locationsCount":144},"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":117,"type":22},50,"6 Months","OBSERVATIONAL","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\".",[31,29,122,123,124,125,126],"Axial Spondylarthritis (r-axSpA)","Axial Spondyloarthopathy","Axial Spondyloarthritis and Ankylosing Spondylitis","Axial Spondyloarthritis, Non-Radiographic","Axial and Peripheral Spondyloarthritis",[128,129,130,131,132,133,134],"Mobility Tracking","Patient-Reported Outcomes (PROs)","Disease Activity","Smartwatch","Study-App","Mobile Device","Movement Recommedations","2025-02-13",{"date":137,"type":37},"2025-02-18",{"date":139,"type":37},"2024-04-01",{"date":141,"type":22},"2025-11",{"name":143,"class":44},"University of Bonn",1]