[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"spondyloarthritis\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:spondyloarthritis":29},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,13,0,[8,43,69,94,115,137,163,189,214,240,263,290,325],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":17,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":32,"startDateStruct":35,"completionDateStruct":37,"leadSponsor":39,"locationsCount":42},"100361232","identification-of-fecal-microbiota-biomarkers-of-spondyloarthritis-in-patients-suffering-from-crohns-disease-100361232",false,"NCT03983473","Identification of Fecal Microbiota Biomarkers of Spondyloarthritis in Patients Suffering From Crohn's Disease.","Identification of Fecal Microbiota Biomarkers of Spondyloarthritis in Patients Suffering From Crohn's Disease. Identification de Biomarqueurs de SPondylArthrite Chez Les Patients Atteints de Maladie de CROhn présents Dans le MICrobiote fécal.","MICROSPA","Inclusion Criteria:\n\n* Age ≥ 18 years.\n* Patients will be recruited according to 3 groups:\n* Patients with Crohn's disease and axial spondyloarthritis according to the criteria below.\n* Patients with Crohn's disease (MC patients) with a diagnosis established according to clinical, biological criteria, radiological, endoscopic and \u002F or histological studies for 3 months. With diagnosis of exclusion of a spondyloarthritis on criteria ASAS and \u002F or New York modified.\n* Patients with axial spondyloarthritis (SpA patients) with a diagnosis based on modified ASAS and \u002F or New York criteria with exclusion diagnosis of Crohn's disease.\n* Patient with the ability to give free and express informed consent.\n\nExclusion Criteria:\n\n* History of colonic resection\n* Taking antibiotics or colon preparation for colonoscopy within 8 weeks before stool collection (Temporary contraindication = removal possible before colic or first bowel preparation after the start of colonic preparation).\n* Ostomy at the time of sampling\n* BMI\\> 30\n* extreme diet\n* unbalanced diabetes\n* Pregnant woman\n* Patient under guardianship, under curatorship or under the protection of justice Contacts\u002FLocations Central Contact",true,"ALL","18 Years",{"count":21,"type":22},240,"ESTIMATED","INTERVENTIONAL",[25],"NA","The MICROSPA project aims to compare gut microbiota, serum cytokines, and PBMC of patients suffering from Crohn's disease (CD) associated or not to spondylarthritis (SpA). 3 groups of patients will be analyzed: patients suffering from CD alone, patients suffering from SpA alone, patients suffering from CD and SpA. One group of healthy controls will be analysed as a comparator. Fecal microbiota will be determined by bacteriome, virome and fungome NGS sequencing",[28,29],"Crohn Disease","Spondyloarthritis","RECRUITING","2026-06-17",{"date":33,"type":34},"2026-06-18","ACTUAL",{"date":36,"type":34},"2021-11-16",{"date":38,"type":22},"2027-12-16",{"name":40,"class":41},"Central Hospital, Nancy, France","OTHER",2,{"id":44,"slug":45,"hasResults":11,"nctId":46,"briefTitle":47,"officialTitle":48,"acronym":49,"eligibilityCriteria":50,"healthyVolunteers":11,"sex":18,"minAge":19,"maxAge":51,"enrollmentInfo":52,"targetDuration":4,"studyType":54,"phases":4,"briefSummary":55,"conditions":56,"keywords":4,"overallStatus":58,"whyStopped":4,"lastUpdateSubmitDate":59,"lastUpdatePostDateStruct":60,"startDateStruct":62,"completionDateStruct":64,"leadSponsor":66,"locationsCount":68},"100637711","guselkumab-for-overlap-inflammatory-bowel-disease-and-spondyloarthritis-100637711","NCT07602517","Guselkumab for Overlap Inflammatory Bowel Disease and Spondyloarthritis","GLOBE-SpA - GuseLkumab for Overlap Inflammatory Bowel DiseasE and Spondyloarthritis","GLOBE-SpA","Inclusion Criteria:\n\n* Confirmed diagnosis of Crohn's disease or Ulcerative Colitis disease based on confirmatory colonoscopy with biopsies, or if small bowel only, MRE with corresponding history\n* Age between 18 to 75 years old\n* Inflammatory bowel disease unclassified (IBD-U) subjects are eligible for inclusion if based on investigator assessment, the subject meets criteria for IBD-U, defined as chronic inflammatory bowel disease with overlapping features of Crohn's disease or ulcerative colitis\n* Initiating Guselkumab therapy in the next 30 days\n* Bio-naïve or bio-experienced\\* to ≤3 mechanisms of action \\*Defined as prior exposure or failure, as defined by inadequate efficacy or intolerance\n\nExclusion Criteria:\n\n* Unable to provide consent for participation\n* Known SpA diagnosis, prior to screening\n* Has started Guselkumab therapy\n* Prior exposure to IL-23 therapy (like Mirikizumab, Ustekinumab, etc.)\n* Prior exposure to TB, active or currently undergoing treatment for latent TB\n* Pregnancy as some pregnancy symptoms could be mistaken for SpA symptoms\n* Prior exposure to combination advanced biologic therapies","75 Years",{"count":53,"type":22},75,"OBSERVATIONAL","This is an observational study of a prospective cohort of guselkumab-initiating Crohn's Disease (CD) and Ulcerative Colitis (UC) patients to identify new or incident spondyloarthritis. This study will include adult patients aged 18-75 with IBD who are undergoing guselkumab intravenous or subcutaneous induction over a 1-year timeframe.",[29,57],"Inflammatory Bowel Diseases","NOT_YET_RECRUITING","2026-05-15",{"date":61,"type":34},"2026-05-22",{"date":63,"type":22},"2026-05-20",{"date":65,"type":22},"2029-05-20",{"name":67,"class":41},"NYU Langone Health",1,{"id":70,"slug":71,"hasResults":11,"nctId":72,"briefTitle":73,"officialTitle":74,"acronym":75,"eligibilityCriteria":76,"healthyVolunteers":11,"sex":18,"minAge":19,"maxAge":77,"enrollmentInfo":78,"targetDuration":4,"studyType":54,"phases":4,"briefSummary":80,"conditions":81,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":85,"lastUpdatePostDateStruct":86,"startDateStruct":88,"completionDateStruct":90,"leadSponsor":92,"locationsCount":68},"100442271","biobank-for-inflammatory-chronic-diseases-and-osteoporosis-100442271","NCT05039216","Biobank for Inflammatory Chronic Diseases and Osteoporosis","Biobank for Inflammatory Chronic Diseases and Osteoporosis of TOULouse","BIOTOUL","Inclusion Criteria:\n\n* Chronic inflammatory rheumatism including RA, SpA or PsA or patients with primary or secondary osteoporosis\n* With National Health Assurance\n* Able to consent to the study\n\nExclusion Criteria:\n\n* Pregnancy or breastfeeding\n* Not able to give a consent\n* Severe anemia (Hb\\\u003C10g\u002FL)","99 Years",{"count":79,"type":22},2000,"The aim of this study is to constitute a biobank for patients followed in the Rheumatology center of Toulouse University Hospital for a chronic inflammatory rheumatism including rheumatoid arthritis (RA), spondyloarthritis(SpA), and psoriatic arthritis (PsA) or a chronic bone disease including osteoporosis in order to identify biomarkers associated with therapeutic response.",[82,83,29,84],"Rheumatoid Arthritis","Psoriatic Arthritis","Osteoporosis","2026-03-16",{"date":87,"type":34},"2026-03-19",{"date":89,"type":34},"2021-09-13",{"date":91,"type":22},"2031-09-01",{"name":93,"class":41},"University Hospital, Toulouse",{"id":95,"slug":96,"hasResults":11,"nctId":97,"briefTitle":98,"officialTitle":99,"acronym":100,"eligibilityCriteria":101,"healthyVolunteers":17,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":102,"targetDuration":4,"studyType":23,"phases":104,"briefSummary":105,"conditions":106,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":107,"lastUpdatePostDateStruct":108,"startDateStruct":110,"completionDateStruct":112,"leadSponsor":113,"locationsCount":68},"100431520","analysis-of-intestinal-microbiota-as-a-predictor-of-response-to-treatment-of-spondyloarthritis-with-biotherapy-100431520","NCT04899154","Analysis of Intestinal Microbiota as a Predictor of Response to Treatment of Spondyloarthritis With Biotherapy","MEDIBIOTE 3: Analysis of Intestinal Microbiota as a Predictor of Response to Treatment of Spondyloarthritis With Biotherapy","MEDIBIOTE 3","Inclusion Criteria:\n\nFor patient with spondyloarthritis:\n\n* Diagnosed for spondyloarthritis or pure axial or axial type psoriatic rheumatism according to Assessment of Spondyloarthritis International Society (ASAS) criteria.\n* Requiring treatment with anti-TNFα or anti- IL-17 according to the treatment recommendations of the French Society of Rheumatology (SFR)\n* patient not previously treated with biotherapy\n* Aged ≥ 18 years\n* Having given free and informed written consent\n* Being affiliated to the center national security system social\n\nFor control Subject:\n\n* Healthy volunteers without diagnosis of spondyloarthritis or any other chronic disease.\n* Aged ≥ 18 years\n* Having given free and informed written consent\n* Being affiliated with or benefiting from a social security scheme.\n\nExclusion Criteria:\n\n* Persons treated with antibiotics, probiotics, prebiotics or any other treatment that may disrupt the gut microbiota within one month before stool sampling.\n* Association with another chronic pathology",{"count":103,"type":22},80,[25],"Spondyloarthritis (SpA) is a group of inflammatory rheumatic disorders that mainly manifested by inflammatory pain of the spine, pelvis and sometimes limbs. Classically, SpA has been classified into several subtypes, such as ankylosing spondylitis (AS), psoriatic arthritis (PsA), inflammatory bowel disease (IBD)-associated.\n\nSeveral studies have shown specific changes in the gut microbiota during SpA. A recent, uncontrolled study suggested that the therapeutic response to anti-TNFα (Tumor Necrosis Factor) therapy could be predicted by analysis of the gut microbiota.\n\nThe purpose of the study MEDIBIOTE 3 is to confirm that in SpA, the composition of the intestinal microbiota at the initiation of treatment is predictive of the response to treatment with biotherapy (anti-TNFα \u002F anti-IL17).",[29],"2025-09-24",{"date":109,"type":34},"2025-09-25",{"date":111,"type":34},"2019-07-16",{"date":59,"type":22},{"name":114,"class":41},"Hôpital Européen Marseille",{"id":116,"slug":117,"hasResults":11,"nctId":118,"briefTitle":119,"officialTitle":119,"acronym":120,"eligibilityCriteria":121,"healthyVolunteers":17,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":122,"targetDuration":4,"studyType":54,"phases":4,"briefSummary":124,"conditions":125,"keywords":126,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":128,"lastUpdatePostDateStruct":129,"startDateStruct":131,"completionDateStruct":133,"leadSponsor":135,"locationsCount":68},"100384927","characterisation-of-intestinal-microbiota-of-patients-with-spondyloarthritis-or-rheumatoid-arthritis-100384927","NCT04292067","Characterisation of Intestinal Microbiota of Patients With Spondyloarthritis or Rheumatoid Arthritis","MICROBIART","Inclusion Criteria:\n\nPatients:\n\n* Patient ⩾ 18 years;\n* Diagnosed as spondyloarthritis (SpA) according ASAS classification, or rheumatoid polyarthritis according ACR\u002FEULAR;\n* Affiliated to a social security scheme;\n* Have signed the written informed consent form.\n\nHealthy control subjects:\n\n* Adult women and men;\n* Subjet free of chronic pathology;\n* Affiliated to a social security scheme;\n* Have signed the written informed consent form.\n\nExclusion Criteria:\n\nPatients:\n\n* Patients unable to understand the proposed study and\u002For sign a informed consent form;\n* Pregnant women or breast feeding women;\n* Patient ⩾ 18 years;\n* Patients under guardianship or curatorship;\n* Have taken antibiotic 1 month prior to inclusion or digestive coloscopy 6 months prior inclusion;\n* Presenting acute or chronic severe pathology may likely to interfere with the interpret of outcome;\n* Foreign patients under french AME scheme;\n* Patients had have participated in the prior study Microbiart.\n\nHealthy control subjects:\n\n* Subjects unable to understand the proposed study and\u002For sign a informed consent form;\n* Pregnant women or breast feeding women;\n* Subjects \\\u003C 18 years;\n* Subjects under guardianship or curatorship;\n* Presenting acute or chronic severe pathology may likely to interfere with the interpret of outcome;\n* Refusal of subjects to participate to the study;\n* Foreign patients under french AME scheme;\n* Subjects had have participated in the prior study Microbiart.",{"count":123,"type":22},400,"The primary objective of the study aims to compare the biodiversity of intestinal microbiota between spondylarthritis (SPA) or rheumatoid arthritis (RA) patients and healthy volunteers, by microbiota DNA sequencing in order to further and respond the prior results, which suggested that there is a specific dysbiosis for each of the 2 diseases. A comparative analysis will allow to identify the biomarkers of the specific bacteria.",[29,82],[29,82,127],"Microbiota","2025-06-11",{"date":130,"type":34},"2025-06-15",{"date":132,"type":34},"2020-11-23",{"date":134,"type":22},"2026-11",{"name":136,"class":41},"Assistance Publique - Hôpitaux de Paris",{"id":138,"slug":139,"hasResults":11,"nctId":140,"briefTitle":141,"officialTitle":142,"acronym":143,"eligibilityCriteria":144,"healthyVolunteers":11,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":145,"targetDuration":4,"studyType":54,"phases":4,"briefSummary":146,"conditions":147,"keywords":149,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":154,"lastUpdatePostDateStruct":155,"startDateStruct":157,"completionDateStruct":159,"leadSponsor":161,"locationsCount":68},"100575798","ultra-processed-foods-consumption-and-impact-in-rheumatic-diseases-100575798","NCT06776965","Ultra Processed Foods Consumption and Impact in Rheumatic Diseases.","Impact of Ultra-processed Foods in a Population of Patients With Chronic Rheumatic Diseases (Rheumatoid Arthritis, Spondyloarthritis, Osteoarthritis).","NUTRIRIC","Inclusion Criteria:\n\n* Age \\> 18 years\n* chronic rheumatic disease (Rheumatoid arthritis, spondyloarthritis, osteoarthritis)\n* ability to perform questionnaires\n\nExclusion Criteria:\n\n* Judicial protection measure\n* Refusal to participate in the study\n* Suffering from 2 rheumatic disease simultaneously",{"count":21,"type":22},"Ultra-processed foods (UPF) represent one of the mainstays of today's diet. They are defined by the NOVA classification system. It was demonstrated that UPF consumption was associated with activity of inflammatory bowel diseases with underlying mechanisms not fully identified yet. It is suspected that UPF constituents could modify the gut microbiota, increase intestinal barrier permeability and directly engage immune surveillance systems, effects that could individually or synergistically increase the risk of immunomediated diseases. As some pathophysiological mechanisms are shared among IBD and rheumatic diseases, we have wondered if UPF consumption could be associated with increased risk of rheumatic disease and\u002For with their activity.\n\nOur primary aim will be to study the pattern of UPF consumption in patients with rheumatic diseases. Our secondary objectives will be to study the activity of diseases according to UPF consumption.",[82,29,148],"Osteoarthritis",[150,151,152,153],"Ultra-processed food","osteoarthritis","rheumatoid arthritis","spondyloarthritis","2025-04-10",{"date":156,"type":34},"2025-04-11",{"date":158,"type":34},"2025-03-31",{"date":160,"type":22},"2026-11-30",{"name":162,"class":41},"Hospices Civils de Lyon",{"id":164,"slug":165,"hasResults":11,"nctId":166,"briefTitle":167,"officialTitle":167,"acronym":4,"eligibilityCriteria":168,"healthyVolunteers":11,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":169,"targetDuration":171,"studyType":54,"phases":4,"briefSummary":172,"conditions":173,"keywords":177,"overallStatus":58,"whyStopped":4,"lastUpdateSubmitDate":181,"lastUpdatePostDateStruct":182,"startDateStruct":183,"completionDateStruct":185,"leadSponsor":187,"locationsCount":4},"100572798","cellular-and-molecular-analysis-of-synovial-tissue-of-patients-with-arthritis-100572798","NCT06737952","Cellular and Molecular Analysis of Synovial Tissue of Patients With Arthritis","Inclusion Criteria:\n\n* Age \\>18 years\n* Clinically relevant arthritis in one or more joints as assessed by the treating rheumatologist, including RA, SpA, connective tissue disease and OA.\n\nExclusion Criteria:\n\n* Known allergies to local anesthetics\n* Family history of bleeding, history of increased bleeding tendency or prolonged bleeding, current treatment with oral anticoagulants or platelet aggregation inhibitors; Quick \\\u003C 65%, international normalised ratio (INR) ≥ 1.3, thrombocyte count \\\u003C 100'000\u002Fμl, activated partial thromboplastin time (aPTT) \\> 37 sec\n* Inability or insufficient knowledge of project language to understand the information given in the informed consent form",{"count":170,"type":22},90,"5 Days","This study aims to study the inflammatory response in various forms of arthritis.",[174,175,148,29,176],"Arthritis","Arthritis, Rheumatoid","Synovitis",[178,179,180],"ultrasound-guided synovial biopsies (UGSB)","inflammatory response","synovial biopsy","2025-04-08",{"date":156,"type":34},{"date":184,"type":22},"2025-05",{"date":186,"type":22},"2029-12",{"name":188,"class":41},"University Hospital, Basel, Switzerland",{"id":190,"slug":191,"hasResults":11,"nctId":192,"briefTitle":193,"officialTitle":194,"acronym":195,"eligibilityCriteria":196,"healthyVolunteers":17,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":197,"targetDuration":4,"studyType":23,"phases":199,"briefSummary":200,"conditions":201,"keywords":203,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":206,"lastUpdatePostDateStruct":207,"startDateStruct":209,"completionDateStruct":211,"leadSponsor":213,"locationsCount":68},"100427991","the-role-of-intestinal-microbiota-dysbiosis-in-the-development-of-spondyloarthritis-100427991","NCT04853212","The Role of Intestinal Microbiota Dysbiosis in the Development of Spondyloarthritis","The Role of Dysbiosis of Intestinal Microbiota in the Development of Spondyloarthritis","RUMINOSPA","Inclusion Criteria:\n\nPatients with SPA:\n\n* Patients ⩾ 18 years;\n* Diagnosed as spondyloarthritis (SpA) according ASAS classification;\n* Affiliated to a social security scheme;\n* Have signed the written informed consent form.\n\nControl subjects:\n\n* Subjects ⩾ 18 years;\n* Subjects free of SPA and planned for a digestive endoscopy for another indication such as to explore the risk of colorectal cancer in family member;\n* Affiliated to a social security scheme;\n* Have signed the written informed consent form.\n\nExclusion Criteria:\n\n* Subjects unable to understand the proposed study and\u002For sign a informed consent form;\n* Pregnant women or breast feeding women;\n* Subjects under guardianship or curatorship;\n* Have taken antibiotic 1 month prior to inclusion;\n* Presenting acute or chronic severe pathology may likely to interfere with the interpret of outcome;\n* Refusal of subjects to participate to the study;\n* Foreign patients under french AME scheme.",{"count":198,"type":22},100,[25],"The primary objective of this case-control study aims to explore the role of bacterium Ruminococcus gnavus (R. gnavus) with intestinal biopsy and faecal sampling in the initiation and the development of spondyloarthritis (SPA) in comparison with health control subjets (patients without chronic disease but have indication to digestive endoscopy).",[29,202],"Ruminococcus Gnavus",[29,204,127,205],"Ruminococcus gnavus","Dysbiosis","2025-03-17",{"date":208,"type":34},"2025-03-19",{"date":210,"type":34},"2021-06-14",{"date":212,"type":22},"2026-05",{"name":136,"class":41},{"id":215,"slug":216,"hasResults":11,"nctId":217,"briefTitle":218,"officialTitle":218,"acronym":219,"eligibilityCriteria":220,"healthyVolunteers":11,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":221,"targetDuration":4,"studyType":23,"phases":222,"briefSummary":223,"conditions":224,"keywords":225,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":229,"lastUpdatePostDateStruct":230,"startDateStruct":232,"completionDateStruct":234,"leadSponsor":236,"locationsCount":239},"100461569","the-role-of-il-23-in-chronic-inflammatory-disease-exploring-the-cellular-and-molecular-targets-of-il-23-signaling-in-peripheral-and-axial-spondyloarthritis-100461569","NCT05290363","The Role of IL-23 in Chronic Inflammatory Disease: Exploring the Cellular and Molecular Targets of IL-23 Signaling in Peripheral and Axial Spondyloarthritis","SpA23","Inclusion Criteria:\n\n* Age : Adults (\\>18 years)\n* Satisfying ASAS diagnostic criteria for SpA\n* Patient has active disease, defined by the presence of active synovitis, tendinitis, or dactylitis or significant inflammatory pain of the spine, judged by the examining clinician to be due to SpA.\n* Informed consent signed\n* Beneficiary of health insurance, except for the AME\n\nOnly for patients of Group 1 • Patient is naïve to biological therapies\n\nOnly for patients of Group 2\n\n* Patient is affected by peripheral SpA (ASAS criteria) or psoriatic arthritis, with inflammation of peripheral joints\n* Patient requires aspiration, as part of standard care\n\nNon inclusion criteria:\n\n* Patient is minor\n* Patient is pregnant or breastfeeding\n* Patient is immunocompromised\n* Patient has received biological therapy with 2 or more biologics\n* Patient is receiving corticosteroid treatment \\> 10 mg per day\n* Patient is under legal protection, curators, guardianship\n* Patient refuses consent\n* Previous history of alcoholism, drug addiction, psychological problems, severe concomitant conditions that could invalidate the patient's consent or limit the patient's compliance to the treatment protocol.\n* Beneficiary of the AME\n\nOnly for group 1\n\n• Patient has received biological therapy",{"count":170,"type":22},[25],"This is a research study involving humans, of the interventional type with minimal risks and constraints (RIPH2). It is a multicentric, non randomized prospective study aiming to better understand the mechanisms of the response to anti-IL-23 biologics in Spondyloarthritis patients attending the rheumatology department of Cochin, Saint-Antoine, Henri-Mondor hospitals (APHP) and Maison-Blanche Hospital (Reims).",[29],[226,227,228,29],"interleukin-23","anti-IL-23 therapy","immune response","2025-01-21",{"date":231,"type":34},"2025-01-23",{"date":233,"type":34},"2022-10-06",{"date":235,"type":22},"2027-09-30",{"name":237,"class":238},"Institut Pasteur","INDUSTRY",4,{"id":241,"slug":242,"hasResults":11,"nctId":243,"briefTitle":244,"officialTitle":245,"acronym":246,"eligibilityCriteria":247,"healthyVolunteers":11,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":248,"targetDuration":4,"studyType":54,"phases":4,"briefSummary":250,"conditions":251,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":255,"lastUpdatePostDateStruct":256,"startDateStruct":258,"completionDateStruct":260,"leadSponsor":261,"locationsCount":68},"100377197","evolution-and-treatments-of-chronic-inflammatory-systemic-diseases-100377197","NCT04191395","Evolution and Treatments of Chronic Inflammatory Systemic Diseases","Evolution and Treatments of Chronic Inflammatory Systemic Diseases: Implementation of a Hospital Cohort in the Gastroenterology, Dermatology and Rheumatology Departments of the University Hospital of Besançon","MISTIC","Inclusion Criteria:\n\n* Patients treated for IBD (MC, UC or indeterminate colitis) in the gastroenterology department of Besançon University Hospital\n* Subject meeting the clinical, morphological and histological diagnostic criteria for MC, UC or indeterminate colitis or\n* Patients treated for chronic inflammatory rheumatism (RA, SpA, PsA) in the rheumatology department of the University Hospital of Besançon Subject meeting the ACR 2010 classification criteria of RA or modified New York criteria of Ankylosing spondylitis or ASAS criteria of axial or peripheral SpA or CASPAR criteria of PsA or\n* Patients treated for chronic inflammatory skin disease (Psoriasis, Verneuil's disease) in the dermatology department of the University Hospital of Besançon\n\nExclusion Criteria:\n\n* Opposition of the patient\n* Patients in emergency situation, persons deprived of their liberty, protected minors or adults.",{"count":249,"type":22},3000,"Patients with chronic inflammatory diseases (CID) followed in gastroenterology, dermatology and rheumatology have physiopathological, epidemiological and therapeutic focal points. The pathologies concerned are inflammatory bowel diseases (IBD - Crohn's disease \\[MC\\] and ulcerative colitis \\[RCH\\]), chronic inflammatory skin diseases (psoriasis or Verneuil's disease) and chronic inflammatory rheumatic diseases (rheumatoid arthritis \\[RA\\] and spondyloarthritis \\[SpA\\] including psoriatic arthritis \\[PsA\\]). Presenting one of these diseases is associated with a higher risk of having a second inflammatory pathology, whether the latter is ophthalmological, dermatological, rheumatological or gastroenterological. An association of extra-articular manifestations is observed in 10 to 30% of patients with SpA, and an association of extra-intestinal manifestations is observed in approximately 30% of patients with IBD. No common database for chronic systemic inflammatory diseases currently exists in France.",[57,252,28,175,29,83,253,254],"Ulcerative Colitis","Psoriasis","Verneuil's Disease","2024-11-25",{"date":257,"type":34},"2024-11-27",{"date":259,"type":34},"2019-12-11",{"date":186,"type":22},{"name":262,"class":41},"Centre Hospitalier Universitaire de Besancon",{"id":264,"slug":265,"hasResults":11,"nctId":266,"briefTitle":267,"officialTitle":268,"acronym":269,"eligibilityCriteria":270,"healthyVolunteers":11,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":271,"targetDuration":4,"studyType":23,"phases":273,"briefSummary":274,"conditions":275,"keywords":277,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":281,"lastUpdatePostDateStruct":282,"startDateStruct":284,"completionDateStruct":286,"leadSponsor":288,"locationsCount":68},"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":272,"type":22},260,[25],"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.",[29,276],"Exercise",[278,279,280],"Remote","Digital","High intensity interval training","2024-09-12",{"date":283,"type":34},"2024-09-19",{"date":285,"type":34},"2024-07-01",{"date":287,"type":22},"2030-08-01",{"name":289,"class":41},"Diakonhjemmet Hospital",{"id":291,"slug":292,"hasResults":11,"nctId":293,"briefTitle":294,"officialTitle":295,"acronym":296,"eligibilityCriteria":297,"healthyVolunteers":11,"sex":18,"minAge":19,"maxAge":298,"enrollmentInfo":299,"targetDuration":4,"studyType":23,"phases":301,"briefSummary":303,"conditions":304,"keywords":311,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":316,"lastUpdatePostDateStruct":317,"startDateStruct":319,"completionDateStruct":321,"leadSponsor":323,"locationsCount":68},"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","65 Years",{"count":300,"type":22},99,[302],"PHASE2","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.",[305,306,205,29,307,174,308,309,310],"Axial Spondyloarthritis","Ankylosing Spondylitis","Spondylitis","Musculoskeletal Diseases","Spinal Disease","Joint Diseases",[305,312,313,127,314,315],"Microbiome","Fecal Microbiota Transplantation","FMT","RCT","2024-06-04",{"date":318,"type":34},"2024-06-11",{"date":320,"type":34},"2024-06-01",{"date":322,"type":22},"2026-03",{"name":324,"class":41},"University Hospital of North Norway",{"id":326,"slug":327,"hasResults":11,"nctId":328,"briefTitle":329,"officialTitle":330,"acronym":331,"eligibilityCriteria":332,"healthyVolunteers":11,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":333,"targetDuration":4,"studyType":54,"phases":4,"briefSummary":335,"conditions":336,"keywords":4,"overallStatus":58,"whyStopped":4,"lastUpdateSubmitDate":338,"lastUpdatePostDateStruct":339,"startDateStruct":341,"completionDateStruct":343,"leadSponsor":345,"locationsCount":68},"100536215","severity-over-time-of-early-forms-of-spondyloarthritis-100536215","NCT06261931","Severity Over Time of Early Forms of Spondyloarthritis","Severity Over Time of Early Forms of Spondyloarthritis, a Prospective Observational Study.","STAR","Inclusion Criteria:\n\n* age \\&gt;18 years;\n* Diagnosis of SpA confirmed by the rheumatologist with duration of symptoms \\&lt;\n* 2 years;\n* Signature of the written informed consent to the study\n\nExclusion Criteria:\n\n* Age \\&lt; 18 years;\n* Patients suffering from other rheumatic pathologies (even in overlap), or genetic diseases such as Marfan syndrome, Ehlers Danlos syndrome\n* Any medical or psychiatric condition that in the judgment of the investigator would prevent the participant from complying with the protocol or completing the study according to the protocol.\n* Refusal to sign the informed consent to the study.",{"count":334,"type":22},387,"Spondyloarthritis (SpA) is a group of chronic inflammatory pathologies whose progression over time is poorly defined, and in particular the clinical and instrumental elements that can predispose to a condition of disease severity are not completely known. It would be important to have an idea of what the predisposing factors are, possibly already at baseline, and possibly also at follow up, of severe disease, so as to be able to act early with more aggressive and targeted therapies on these patients, so as to achieve remission.",[29,337],"Spondyloarthritis, Axial","2024-02-08",{"date":340,"type":34},"2024-02-15",{"date":342,"type":22},"2024-02-12",{"date":344,"type":22},"2044-02-28",{"name":346,"class":41},"Fondazione Policlinico Universitario Agostino Gemelli IRCCS"]