[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Diakonhjemmet Hospital\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":354},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,12,0,[8,47,71,100,127,171,201,223,250,277,302,329],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":14,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":27,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":41,"leadSponsor":43,"locationsCount":46},"100640769","effect-of-an-information--and-self-management-app-for-people-with-knee-osteoarthritis-100640769",false,"NCT07603973","Effect of an Information- and Self-management App for People With Knee Osteoarthritis","OA-AID","Inclusion Criteria:\n\n* Men and women \\> 50 years referred to specialist healthcare for knee OA management\n\nExclusion Criteria:\n\n* Received joint replacement or are under consideration for revision in the referred joint\n* Have undergone joint replacement surgery in opposite knee\n* Have uncontrolled serious comorbidities\n* Have cognitive deficits\n* Are seeking care for recent knee trauma conditions (less than 6 months after trauma) or mainly psoriatic\u002Frheumatoid arthritis\n* Unable to understand Norwegian\n* Do not possess a smartphone","ALL","50 Years",{"count":19,"type":20},204,"ESTIMATED","INTERVENTIONAL",[23],"NA","The primary aim of the trial is to assess if an information- and self-management app provided in the period between referral and consultation in specialist healthcare can improve knowledge about osteoarthritis and decision quality during consultation in patients with knee osteoarthritis.\n\n204 patients will be randomized to either being on the waiting list for consultation, accessing publically available information about osteoarthritis (control group) or getting access to an 8-week information- and self-management intervention delivered through the Genus app prior to consultation.\n\nPasients with answer questionnaires at baseline, 4 weeks (intervention group only), 8 weeks, post consultation and 1 and 2 years after consultation.\n\nThe Genus app contains information videos, exercise videos, quizzes, feedback and questionnaires provided in a progressive order over an 8 week period.",[26],"Knee Osteoarthritis",[28,29,30,31,32,33],"knee osteoarthritis","digital support tool","app","evidence-based treatment","information","self-management","RECRUITING","2026-05-17",{"date":37,"type":38},"2026-05-22","ACTUAL",{"date":40,"type":38},"2025-10-30",{"date":42,"type":20},"2035-12-31",{"name":44,"class":45},"Diakonhjemmet Hospital","OTHER",1,{"id":48,"slug":49,"hasResults":11,"nctId":50,"briefTitle":51,"officialTitle":51,"acronym":52,"eligibilityCriteria":53,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":54,"targetDuration":4,"studyType":21,"phases":56,"briefSummary":57,"conditions":58,"keywords":61,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":65,"startDateStruct":67,"completionDateStruct":69,"leadSponsor":70,"locationsCount":46},"100593245","remote-monitoring-after-knee-replacement-surgery-100593245","NCT07003932","Remote Monitoring After Knee Replacement Surgery","OA-AID TKR","Inclusion Criteria:\n\n* Men and women, 50 years of age or older\n* Referred to total or unicondylar knee replacement surgery due to knee osteoarthritis\n\nExclusion Criteria:\n\n* Revision of previous knee replacement surgery\n* Serious comorbidities (such as severe malignancies, severe diabetes mellitus, severe infections, uncontrollable hypertension, severe cardiovascular disease, severe respiratory disease)\n* Congitive dysfunction\n* Knee replacement surgery due to trauma or inflammatory joint disease (such as psoriatic arthritis or rheumatoid arthritis)\n* Unable to understand Norwegian\n* Low digital competency\u002F cannot answer questionnaires digitally (lack BankID, do not possess a smartphone)\n* Deemed inappropriate for remote monitoring by orthopedic surgeon",{"count":55,"type":20},140,[23],"The goal of this clinical trial is to evaluate the effect, cost-effectiveness, safety and satisfaction with replacing standardized, pre-scheduled face-to-face visits with remote monitoring and video consultations or face-to-face consultations only when needed after knee replacement surgery due to knee osteoarthritis.\n\nThe primary outcome is the probability of being a OMERACT-OARSI responder at 6 months post-surgery. This is a composite index where participants are classified as a responder or non-responder based on improvement in pain, function and\u002For disease activity. Health-related quality of life and healthcare costs will be used to determine cost-effectiveness. Patient-reported adverse events and statisfaction will be used to determine safety and satisfaction.\n\nPatients will be recruited from Diakonhjemmet Hospital. Patients undergoing knee replacement surgery will be randomly allocated to a control group who are summoned for a face-to-face consultation at Diakonhjemmet Hospital at 2 and 12 months, or a remote monitoring group who will not be scheduled for hospital visits but will answer patient-reported outcomes throught a web-application at 1, 2, 3, 6 and 12 months post-surgery and only be scheduled for hospital visits when needed.\n\nAn additional study with follow-up after 5 and 10 years will be conducted.",[59,60],"Knee Arthroplasty, Total","Knee Replacement Arthroplasty",[62,63,64],"knee arthroplasty","remote follow-up","non-inferiority",{"date":66,"type":38},"2026-05-19",{"date":68,"type":38},"2025-06-04",{"date":42,"type":20},{"name":44,"class":45},{"id":72,"slug":73,"hasResults":11,"nctId":74,"briefTitle":75,"officialTitle":76,"acronym":77,"eligibilityCriteria":78,"healthyVolunteers":11,"sex":16,"minAge":79,"maxAge":4,"enrollmentInfo":80,"targetDuration":4,"studyType":21,"phases":82,"briefSummary":83,"conditions":84,"keywords":86,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":92,"lastUpdatePostDateStruct":93,"startDateStruct":95,"completionDateStruct":97,"leadSponsor":99,"locationsCount":46},"100630657","the-remote-monitoring-of-gout-feasibility-study-in-primary-care-100630657","NCT07490522","The Remote Monitoring of Gout Feasibility Study in Primary Care","The Self-management App 'MinUrinsyregikt' for Patients With Gout. The ReMonit Gout Feasibility Study in Primary Care","ReMonit Gout","Patients are eligible to be included in the study only if all the following criteria apply:\n\n* Adults ≥18 years of age at screening\n* Patients with a clinical diagnosis of gout\n* Serum urate level \\>360 µmol\u002FL at inclusion\n* Indication for urate lowering therapy assessed by medical doctor\n* Having a smartphone\u002Ftablet\n\nPatients are excluded from the study if any of the following criteria apply:\n\n* Pregnant or breastfeeding\n* Contraindication for urate lowering therapy\n* Does not understand Norwegian language\n* Major co-morbidities (e.g., malignancies, severe chronic kidney disease, severe mental disorders)","18 Years",{"count":81,"type":20},50,[23],"The goal of this feasibility study is to determine the feasibility of a patient self-management app (MinUrinsyregikt) for patients with gout. The primary objectives of the study are:\n\n1. To determine the feasibility of a patient self-management app for patients with gout receiving GP follow-up.\n2. To determine the feasibility of conducting a future randomised controlled trial to test the effectiveness of the app for patients with gout in primary care.\n\nParticipants will be asked to test the self-management app for 3 months. Data will be collected from the participants and their GPs.",[85],"Gout",[85,87,88,89,90,91],"Feasibility study","E-health","Primary care","Digital health","Urate-lowering Therapy (ULT)","2026-04-27",{"date":94,"type":38},"2026-04-30",{"date":96,"type":20},"2026-04",{"date":98,"type":20},"2027-12",{"name":44,"class":45},{"id":101,"slug":102,"hasResults":11,"nctId":103,"briefTitle":104,"officialTitle":105,"acronym":106,"eligibilityCriteria":107,"healthyVolunteers":11,"sex":16,"minAge":79,"maxAge":4,"enrollmentInfo":108,"targetDuration":4,"studyType":110,"phases":4,"briefSummary":111,"conditions":112,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":119,"lastUpdatePostDateStruct":120,"startDateStruct":122,"completionDateStruct":124,"leadSponsor":126,"locationsCount":46},"100571308","pain-in-inflammatory-joint-diseases-100571308","NCT06718569","Pain in Inflammatory Joint Diseases","Advancing the Understanding of Pain Mechanisms in Inflammatory Arthritis Towards Precision Pain Management","Nor-Pain","Inclusion Criteria:\n\n* All patients who initiate or switch biological or targeted synthetic DMARDs\n\nExclusion Criteria:\n\n* None",{"count":109,"type":20},350,"OBSERVATIONAL","Our primary objective is to better understand the etiology and consequences of chronic paint by using an explorative approach to identify phenotypes and endotypes of patients with inflammatory joint diseases, with a special focus on central sensitization and cognitive functioning as a key element in chronic pain. We will also examine the risk factors and clinical impact of these factors on pain, disease activity and treatment effects in a longitudinal study of patients with inflammatory joint disesases.",[113,114,115,116,117,118],"Arthritis","Arthritis, Juvenile Idiopathic","Arthritis,Rheumatoid","Arthritis, Reactive","Arthritis, Psoriatic","Spondyloarthritis (SpA)","2026-04-07",{"date":121,"type":38},"2026-04-13",{"date":123,"type":38},"2025-11-11",{"date":125,"type":20},"2027-11",{"name":44,"class":45},{"id":128,"slug":129,"hasResults":11,"nctId":130,"briefTitle":131,"officialTitle":132,"acronym":133,"eligibilityCriteria":134,"healthyVolunteers":11,"sex":16,"minAge":135,"maxAge":136,"enrollmentInfo":137,"targetDuration":4,"studyType":21,"phases":139,"briefSummary":141,"conditions":142,"keywords":144,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":162,"lastUpdatePostDateStruct":163,"startDateStruct":165,"completionDateStruct":167,"leadSponsor":169,"locationsCount":170},"100522572","phase-4-intraarticular-steroids-saline-and-occupational-therapy-in-people-with-cmc1-osteoarthritis-100522572","NCT06084364","Intraarticular Steroids, Saline and Occupational Therapy in People With CMC1 Osteoarthritis","Painful Inflammatory Carpometacarpal-1 Osteoarthritis Treated With Intraarticular Steroids, Saline or an Occupational Therapy Intervention: the PICASSO Trial.","PICASSO","Inclusion Criteria:\n\n\\- Adult (40-85 years of age) men and women\n\nIn target CMC-1 joint:\n\n* OA confirmed by radiographs or ultrasound examination, and\n* Inflammation by ultrasound (grey scale synovitis grade 1-3), and\n* Pain of at least 3 on a 0-10 Numeric Rating Scale (NRS) at rest or during activities at both pre-screening and screening.\n* Patient is assessed as eligible for the proposed use of Kenacort-T\n\nExclusion Criteria:\n\n* Use of thumb orthosis on most of the days or structured hand exercises in the last 12 weeks\n* Intraarticular injections in the target CMC-1 joint in the last 12 weeks\n* More than 3 previous IACS in the target CMC-1 joint\n* Use of oral, intramuscular or intravenous steroids in the last 12 weeks\n* Previous surgery of the target CMC-1 joint\n* Planned hand surgery in the coming 24 weeks\n* Do not want to quit using oral or topical NSAIDs on the hands (such as ibuprofen, diclofenac, etoricoxib, naproxen) in the next 12 weeks\n* Systemic inflammatory joint diseases (such as rheumatoid arthritis (RA), psoriatic arthritis or gout) or other conditions that can better explain the hand pain (such as thoracic outlet syndrome, carpal tunnel disease, diabetic cheiropathy, hand injury in previous six months, or palmar tenosynovitis\u002Ftrigger finger)\n* Diagnosis of fibromyalgia\n* Diagnosis of psoriasis\n* Infection, skin disease or wounds at joint injection site\n* Serious comorbidities, cognitive dysfunction, substance\u002Falcohol abuse or any other medical condition that makes adherence to the study protocol difficult\n* Severe or uncontrolled infections\n* Known hypersensitivity to Triamcinolone acetonide (Kenacort) or any of the excipients (sodium carboxymethylcellulose, sodium chloride, polysorbate, benzyl alcohol, sodium hydroxide or hydrochloric acid)\n* Included in another clinical study\n* Use of digitalis glycosides\n* Patients vaccinated or immunized with live virus vaccines in the last 2 weeks\n* Not being able to talk or understand Norwegian\n* Known pregnancy or planned pregnancy in the next 6 months\n* Any condition that in the view of the investigator would suggest that the patient is unable to comply with the study protocol and procedures","40 Years","85 Years",{"count":138,"type":20},354,[140],"PHASE4","A placebo-controlled randomized controlled trial exploring the effect of intraarticular steroids, saline or an occupational therapy intervention in inflammatory carpometacarpal-1 osteoarthritis",[143],"Osteoarthritis Thumb",[145,146,147,148,149,150,151,152,153,154,155,156,157,158,159,160,161],"thumb","pain","inflammation","steroids","RCT","Occupational Therapy","Carpometacarpal-1","HappyHands","CMC-1","Picasso","intraarticular corticosteroid injections","IACS injections","thumb base pain","triamcinolone acetonide","Kenacort-T","osteoarthritis","OA","2026-02-06",{"date":164,"type":38},"2026-02-10",{"date":166,"type":38},"2023-11-03",{"date":168,"type":20},"2028-10",{"name":44,"class":45},6,{"id":172,"slug":173,"hasResults":11,"nctId":174,"briefTitle":175,"officialTitle":176,"acronym":177,"eligibilityCriteria":178,"healthyVolunteers":11,"sex":16,"minAge":179,"maxAge":180,"enrollmentInfo":181,"targetDuration":4,"studyType":110,"phases":4,"briefSummary":183,"conditions":184,"keywords":188,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":192,"lastUpdatePostDateStruct":193,"startDateStruct":195,"completionDateStruct":197,"leadSponsor":199,"locationsCount":200},"100546511","dynamics-in-bone-turnover-markers-during-and-after-short-term-glucocorticoid-treatment-in-patients-with-an-inflammatory-joint-disease-100546511","NCT06395883","Dynamics in Bone Turnover Markers During and After Short-term Glucocorticoid Treatment in Patients With an Inflammatory Joint Disease","Dynamics in Bone Turnover Markers During and After Short-term Glucocorticoid Treatment in Patients With an Inflammatory Joint Disease - the BOOGIE Study","BOOGIE","Inclusion Criteria:\n\n* diagnosis of inflammatory rheumatic joint disease\n* indication of disease modifying treatment initiation with or without glucocorticoids OR\n* stable DMARD treatment with parenteral glucocorticoid injection\n\nExclusion Criteria:\n\n* known osteoporosis or osteoporosis treatment\n* women during the transitory phase\n* oestrogen treatment\n* any fracture within the last year\n* chronic glucocorticoid treatment\n* glucocorticoid treatment within the last year prior to inclusion\n* active cancer\n* kidney failure","25 Years","90 Years",{"count":182,"type":20},160,"Bone turnover markers (BTMs) are recommended as an important tool in follow-up of osteoporosis treatment. However, there is a lack of knowledge in the reliability of BTMs during and after glucocorticoid treatment. Glucocorticoids suppresses BTMs during treatment with at least 30% and, moreover, glucocorticoids increase the risk of fractures. Patients with an inflammatory joint disease are at increased risk of osteoporosis, and disease flares are often treated with glucocorticoids, which in turn can lead to loss in reliability of the BTMs in patients who also are on osteoporosis treatment.\n\nThere is a need of more knowledge on BTM changes during and after glucocorticoid treatment for optimized patientcare, reduced risk of side effects and reduced health economic costs.",[185,186,187],"Osteoporosis","Osteoporosis, Steroid Induced","Inflammatory Rheumatism",[189,190,191],"Bone turnover","Bone turnover markers","Glucocorticoids","2025-08-19",{"date":194,"type":38},"2025-08-24",{"date":196,"type":38},"2025-01-01",{"date":198,"type":20},"2028-12",{"name":44,"class":45},2,{"id":202,"slug":203,"hasResults":11,"nctId":204,"briefTitle":205,"officialTitle":206,"acronym":207,"eligibilityCriteria":208,"healthyVolunteers":11,"sex":16,"minAge":79,"maxAge":4,"enrollmentInfo":209,"targetDuration":4,"studyType":110,"phases":4,"briefSummary":211,"conditions":212,"keywords":213,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":215,"lastUpdatePostDateStruct":216,"startDateStruct":218,"completionDateStruct":220,"leadSponsor":222,"locationsCount":46},"100601164","early-stratification-of-acute-arthritis-100601164","NCT07106931","Early STratification of Acute ARThritis","Early STratification of Acute ARThritis (START)- A Prospective Observational Study","START","Inclusion Criteria:\n\n* Arthritis\\* in one or more joints of less than 12 weeks' duration\\*\\*\n* Adult patients (\\> 18 years) capable of understanding and signing an informed consent form\n\n  * Defined as currently active clinical synovitis (ie, swelling) in at least one joint as determined by an expert assessor which might be confirmed by ultrasonography \\*\\* Prior patient reported swollen joint not confirmed as arthritis by a rheumatologist is not an exclusion\n\nExclusion Criteria:\n\n* Swollen joint related to trauma\n* Subject not capable of adhering to the study protocol",{"count":210,"type":20},400,"The prospective observational study \"Early STratification of acute inflammatory ARThritis\" (START) aims to build a platform for identification of markers for early stratification of inflammatory arthritis to ensure timely diagnosis and correct initial treatment. Management of early-stage inflammatory arthritis is a daily challenge for the rheumatologist and encompasses a range of conditions. Stratification is needed both for optimal diagnostics and for personalising therapy, but is hampered by a lack of tools. Current evaluation is inadequate for early diagnosis and treatment of inflammatory joint diseases as well as for timely diagnosis of infections. The clinical role of novel biomarkers needs to be investigated in large patient samples. In the START study, an extensive data collection will be performed to build a platform for identification and validation of biomarkers for stratification of early-stage inflammatory arthritis. The study has an ambitious goal of improving patient care by increased understanding of the disease. The project applies a unique multitude of approaches to characterisation of patients, including modern imaging techniques, analyses of synovial fluid and -biopsies, genetic and epigenetic markers, proteomics, microbiota analyses and immunological markers. The results will enable clinicians to make better informed treatment decisions for the individual patient with early-stage inflammatory arthritis.",[113],[214],"early onset arthritis","2025-08-04",{"date":217,"type":38},"2025-08-06",{"date":219,"type":38},"2024-11-05",{"date":221,"type":20},"2044-12-31",{"name":44,"class":45},{"id":224,"slug":225,"hasResults":11,"nctId":226,"briefTitle":227,"officialTitle":228,"acronym":4,"eligibilityCriteria":229,"healthyVolunteers":11,"sex":16,"minAge":79,"maxAge":4,"enrollmentInfo":230,"targetDuration":4,"studyType":110,"phases":4,"briefSummary":232,"conditions":233,"keywords":235,"overallStatus":240,"whyStopped":4,"lastUpdateSubmitDate":241,"lastUpdatePostDateStruct":242,"startDateStruct":244,"completionDateStruct":246,"leadSponsor":248,"locationsCount":249},"100576286","long-term-outcomes-of-patients-with-rheumatoid-arthritis-in-remission-100576286","NCT06783322","Long-term Outcomes of Patients with Rheumatoid Arthritis in Remission","The ARCTIC REWIND Extension Study - Long-term Outcomes of Patients with Rheumatoid Arthritis in Remission","Inclusion Criteria:\n\n* Participation in the ARCTIC REWIND trial\n* Patients able and willing to give written informed consent and comply with the requirements of the study protocol\n\nExclusion Criteria:\n\n* Psychiatric or mental disorders, alcohol abuse, other substance abuse, other factors making adherence to the study protocol impossible.",{"count":231,"type":20},259,"The goal of this multi-center prospective observational study is to develop knowledge on how to best personalize treatment and follow-up strategies for patients with RA in remission, with the intention to prevent relapse of disease activity and progression of joint damage and at the same time avoid the use of unnecessary treatment and health resources.\n\nThe investigators will perform an extensive evaluation of all patients who participated in the ARCTIC REWIND study 10 and 15 years after they achieved sustained remission and received different treatment strategies.",[234],"Rheumatoid Arthritis (RA)",[236,237,238,239],"remission","tapering","drug-free remission","long-term outcomes","NOT_YET_RECRUITING","2025-03-07",{"date":243,"type":38},"2025-03-10",{"date":245,"type":20},"2025-11",{"date":247,"type":20},"2034-01",{"name":44,"class":45},10,{"id":251,"slug":252,"hasResults":11,"nctId":253,"briefTitle":254,"officialTitle":255,"acronym":4,"eligibilityCriteria":256,"healthyVolunteers":11,"sex":16,"minAge":79,"maxAge":4,"enrollmentInfo":257,"targetDuration":4,"studyType":21,"phases":259,"briefSummary":260,"conditions":261,"keywords":264,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":269,"lastUpdatePostDateStruct":270,"startDateStruct":272,"completionDateStruct":274,"leadSponsor":276,"locationsCount":46},"100547895","evaluation-of-cognitive-behavioral-therapy-for-long-term-pain-in-rheumatic-disease-including-validation-of-ae-fs-100547895","NCT06413914","Evaluation of Cognitive Behavioral Therapy for Long-term Pain in Rheumatic Disease, Including Validation of AE-FS","Evaluation of Cognitive Behavioral Therapy for Long-term Pain in Rheumatic Disease, Including Validation the Questionnaire of AE-FS","Inclusion Criteria:\n\n* A rheumatic disorder and a long term pain condition\n* Written consent\n\nExclusion Criteria:\n\n* Participation in another therapy during the study periode",{"count":258,"type":20},200,[23],"Catastrophic thinking is a risk factor for a poor prognosis for pain in general and rheumatic disease in particular, which for many contributes to a behavioral pattern characterized by avoidance. Other people with long-term pain, on the other hand, have a pattern where they suppress thoughts and feelings of fear associated with pain, and push themselves to carry out activities. An inappropriate form of endurance can help maintain and intensify pain. The AE-FS is a short version of the Avoidance-Endurance Questionnaire with different subscales for maintaining activity despite pain. AE-FS can be of great clinical utility. The study of patients with rheumatic disease and long-term pain will validate a Norwegian version of the AE-FS as well as examine how the AE-FS seen in connection with other relevant questionnaires, including the Pain Catastrophizing Scale , reflects mechanisms for change in cognitive behavioral therapy for long-term pain. The effect of the intervention is evaluated with questionnaires at baseline\u002Fstart of treatment, end of treatment, two months after end of treatment and after six months.",[262,263],"Rheumatic Diseases","Pain, Chronic",[265,266,267,268],"\"Cognitive behavioral therapy\"","Long-term pain","Avoidance-Endurance Questionnaire","Rheumatic disease","2024-10-09",{"date":271,"type":38},"2024-10-15",{"date":273,"type":38},"2024-01-16",{"date":275,"type":20},"2030-12-31",{"name":44,"class":45},{"id":278,"slug":279,"hasResults":11,"nctId":280,"briefTitle":281,"officialTitle":282,"acronym":283,"eligibilityCriteria":284,"healthyVolunteers":11,"sex":16,"minAge":79,"maxAge":4,"enrollmentInfo":285,"targetDuration":4,"studyType":21,"phases":287,"briefSummary":288,"conditions":289,"keywords":291,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":294,"lastUpdatePostDateStruct":295,"startDateStruct":297,"completionDateStruct":299,"leadSponsor":301,"locationsCount":5},"100461681","imaging-treat-to-target-strategy-vs-conventional-treat-to-target-strategy-in-psoriatic-arthritis-100461681","NCT05291819","Imaging Treat-to-target Strategy vs Conventional Treat-to-target Strategy in Psoriatic Arthritis","A NORwegian Randomized Strategy Trial in PsoRiatic Arthritis: ImagiNg Treat-to-target vs Conventional Treat-to-target","NOR-SPRINT","Inclusion Criteria:\n\n1. Adult (\\>18 years of age)\n2. Clinical diagnosis of PsA\n3. Indication for treatment with DMARDs according to treating physician (including having attempted ≥2 non-steroidal anti-inflammatory drugs (NSAIDs) for a minimum of 4 weeks in total in predominantly axial and\u002For entheseal disease)\n4. Fulfillment of CASPAR criteria for PsA\n\nExclusion Criteria:\n\n1. Verified arthritis \\>1 year prior to inclusion\n2. Previous DMARD treatment for PsA\n3. Systemic glucocorticoid use within the last 3 months\n4. Local glucocorticoid injections within the last 4 weeks\n5. Major co-morbidities, including but not limited to relevant malignancies, severe diabetes mellitus, severe infections, uncontrolled hypertension, severe cardiovascular disease (NYHA class III or IV) and\u002For severe respiratory diseases and cirrhosis.\n6. Indications of active or latent tuberculosis (TB) as assessed by chest radiograph and TB interferon gamma release assay (IGRA). Patients with documented adequately treated latent TB can be included.\n7. Any other medical condition that according to the treated physician and\u002For local guidelines makes adherence to treatment protocol impossible\n8. Abnormal renal function, defined as serum creatinine \\>142 µmol\u002FL in female and \\>168 µmol\u002FL in male, or estimated glomerular filtration rate (eGFR) \\\u003C40 mL\u002Fmin\u002F1.73 m2\n9. Abnormal liver function (defined as Aspartate Transaminase (AST) and\u002For Alanine Transaminase (ALT) \\>1.5 x upper normal limit), active or recent hepatitis\n10. Significant anemia, leukopenia and\u002For thrombocytopenia\n11. Inadequate birth control, pregnancy, and\u002For breastfeeding (current at screening or planned within the duration of the study)\n12. Contraindications to magnetic resonance imaging\n13. Severe psychiatric or mental disorders, alcohol abuse or other substance abuse, language barriers or other factors which makes adherence to the study protocol impossible\n14. Established or suspected widespread-pain syndrome\u002Ffibromyalgia",{"count":286,"type":20},202,[23],"The main objective is to assess if a treat-to-target strategy implementing structured imaging assessments leads to better patient outcome in terms of sustained remission compared to a conventional treat-to-target strategy in psoriatic arthritis.\n\nMain inclusion criteria are: \\>18 years of age, Clinical diagnosis of psoriatic arthritis (PsA), Fulfillment of ClASsification of Psoriatic Arthritis (CASPAR) criteria, Indication for treatment with disease modifying anti-rheumatic drugs according to treating physician\n\nPrimary endpoint: Sustained remission, defined as Very Low Disease Activity (VLDA) at 16, 20 and 24 months\n\nSecondary endpoints: Individual and composite disease activity measures and remission criteria, inflammation assessed by ultrasound, health related quality of life and adverse events.\n\nStudy design: A two-arm, parallel-group, single-blind, treatment strategy study where patients are randomized 1:1 to a conventional treat-to-target follow-up strategy with structured clinical assessment of disease activity or an imaging informed treat-to-target follow-up strategy with both structured clinical assessment of disease activity and structured imaging assessment of disease activity. Duration of follow-up is 24 months.\n\nAll patients are treated according to an algorithm based on current European recommendations. The conventional treatment target, applicable to both arms and the sole target in the conventional arm, is all of: Disease Activity index in Psoriatic Arthritis (DAPSA) remission (≤3), Enthesitis ≤1, Psoriasis Body Surface Area ≤3%\n\nIntervention: A treat-to-target treatment strategy incorporating information from ultrasound assessment of joints, tendons and entheses (at every visit), and magnetic resonance imaging (MRI) of spine and sacroiliac (SI)-joints at baseline and 1 year, in addition to clinical information. Specifically, this means that these additional measures will be added to conventional treat to target:\n\n* If evidence of enthesitis or axial inflammation on imaging the patient will progress directly to biological disease modifying antirheumatic drug in the treatment algorithm\n* If evidence of ongoing inflammation (power Doppler\\>0) on ultrasound assessment of joints, tendons or enthesis, the patient will be classified as not having reached their treatment target",[290],"Psoriatic Arthritis",[292,293],"Imaging","Treat-to-target","2024-10-03",{"date":296,"type":38},"2024-10-04",{"date":298,"type":38},"2022-03-14",{"date":300,"type":20},"2027-12-31",{"name":44,"class":45},{"id":303,"slug":304,"hasResults":11,"nctId":305,"briefTitle":306,"officialTitle":307,"acronym":308,"eligibilityCriteria":309,"healthyVolunteers":11,"sex":16,"minAge":79,"maxAge":4,"enrollmentInfo":310,"targetDuration":4,"studyType":21,"phases":312,"briefSummary":313,"conditions":314,"keywords":317,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":321,"lastUpdatePostDateStruct":322,"startDateStruct":324,"completionDateStruct":326,"leadSponsor":328,"locationsCount":46},"100551657","a-digital-exercise-intervention-in-patients-with-spondyloarthritis-100551657","NCT06462937","A Digital Exercise Intervention in Patients With Spondyloarthritis","The SPARK Trial: a Digital Exercise Intervention in Patients With Spondyloarthritis","SPARK","Inclusion Criteria:\n\n* axSpA diagnosis within the last two years by a rheumatologist according to the ASAS criteria of 2009\n* active disease (ASDAS \\> 1.3)\n\nExclusion Criteria:\n\n* Active uveitis.\n* CRP \\> 30.\n* Former or current use of bDMARDs.\n* Pregnancy or planned pregnancy within 6 months from inclusion.\n* Absolute and relative contradictions to high intensity exercise according to the American College of Sports Medicine (ACSM)\n* Other serious disease such as cancer.\n* Patients incapable to follow the protocol or the control set-up with remote monitoring.",{"count":311,"type":20},260,[23],"This protocol describes a 6-month randomised, controlled exercise trial in patients with axial spondyloarthritis (axSpA) with re-randomization after 3-months. The primary outcome of the trial (disease activity) will be evaluated at 3-months. The exercise programme on trial comprises high intensity interval training (HIIT), muscular strength exercise and aerobic physical activity sessions of specified duration, frequency, and intensity. It also includes brief knowledge videos to empower the patient. The intervention is remotely delivered by the SPARK application with personalised follow-up including monitoring to ensure exercise progression and adherence to exercise intensity. The SPARK application is built on a platform delivered by ABEL Technologies (trademark) and is customised for patients with axSpA.",[315,316],"Spondyloarthritis","Exercise",[318,319,320],"Remote","Digital","High intensity interval training","2024-09-12",{"date":323,"type":38},"2024-09-19",{"date":325,"type":38},"2024-07-01",{"date":327,"type":20},"2030-08-01",{"name":44,"class":45},{"id":330,"slug":331,"hasResults":11,"nctId":332,"briefTitle":333,"officialTitle":334,"acronym":335,"eligibilityCriteria":336,"healthyVolunteers":11,"sex":16,"minAge":79,"maxAge":4,"enrollmentInfo":337,"targetDuration":4,"studyType":110,"phases":4,"briefSummary":339,"conditions":340,"keywords":342,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":346,"lastUpdatePostDateStruct":347,"startDateStruct":349,"completionDateStruct":351,"leadSponsor":353,"locationsCount":170},"100177230","the-norwegian-antirheumatic-drug-register-100177230","NCT01581294","The Norwegian Antirheumatic Drug Register","Long-term Safety and Effectiveness of Disease Modifying Therapies in Inflammatory Arthropathies: a Multicentre, Phase IV, Longitudinal Observational Study","NOR-DMARD","Inclusion Criteria:\n\n* Age \\>18 years\n* Diagnosis of rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, spondyloarthritis, adult juvenile idiopathic arthritis, undifferentiated arthritis, or any other inflammatory arthritis\n* Clinical indication to start a new treatment with a biological disease modifying anti-rheumatic drug or a kinase inhibitor\n\nExclusion Criteria:\n\n* Unwillingness or unability to give written informed consent\n* Psychiatric or mental disorders, alcohol abuse or other abuse of substances, language barriers or other factors which makes adherence to the study protocol impossible\n* Participation in blinded RCTs or other studies incompatible with the NOR-DMARD study protocol",{"count":338,"type":20},15000,"NOR-DMARD is a register-based longitudinal observational study of which the main objectives are to study the effectiveness of treatment of inflammatory joint diseases with biological disease modifying anti-rheumatic drugs (DMARDs) in clinical practice, by measuring disease activity, health related quality of life, function and joint damage, and to study the long-term safety of such treatment. Other objectives include the assessment of cost-effectiveness of treatment, to identify and and validate clinical, genetic and immunological predictors of efficacy and adverse events, to assess the impact of treatment with biological DMARDs on work participation and work productivity, to investigate different strategies for use of biological DMARDs, to assess the performance of different outcome measures, and to ensure a systematic and timely follow-up of patients treated with biological DMARDs.",[341],"Inflammatory Joint Diseases",[343,344,345,315],"Rheumatoid arthritis","Psoriatic arthritis","Ankylosing spondylitis","2022-08-19",{"date":348,"type":38},"2022-08-23",{"date":350,"type":4},"2012-04",{"date":352,"type":20},"2050-12",{"name":44,"class":45},""]