[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"enthesitis-related-arthritis\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:enthesitis-related-arthritis":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,45],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":29,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":44},"100567437","phase-3-an-open-label-study-to-evaluate-the-pharmacokinetics-and-safety-of-bimekizumab-in-pediatric-study-participants-with-active-juvenile-idiopathic-arthritis-subtypes-enthesitis-related-arthritis-including-juvenile-onset-ankylosing-spondylitis-and-juvenile-psoriatic-arthritis-100567437",false,"NCT06668181","An Open-label Study to Evaluate the Pharmacokinetics and Safety of Bimekizumab in Pediatric Study Participants With Active Juvenile Idiopathic Arthritis Subtypes Enthesitis-related Arthritis (Including Juvenile-onset Ankylosing Spondylitis) and Juvenile Psoriatic Arthritis","Open-Label, Single-Arm Trial to Evaluate the Pharmacokinetics and Safety of Bimekizumab in Pediatric Study Participants From 2 to Less Than 18 Years of Age With Active Juvenile Idiopathic Arthritis Subtypes Enthesitis-Related Arthritis (Including Juvenile-Onset Ankylosing Spondylitis) and Juvenile Psoriatic Arthritis","Inclusion Criteria:\n\n* Study participant must be 2 to \\\u003C18 years of age inclusive, at the Baseline Visit.\n* Study participants who have confirmed diagnosis of enthesitis-related arthritis (ERA; including juvenile-onset ankylosing spondylitis (JAS)) and\u002For juvenile psoriatic arthritis (JPsA) according to the juvenile-International League of Associations for Rheumatology (JIA-ILAR) classification criteria of at least 3 months duration prior to the Screening Visit.\n* Study participants who have active disease (ERA \\[including JAS\\] and\u002For JPsA) defined as having at least 3 active joints, each of which needs to be included in the joints assessed in the JADAS27, and for ERA at least 1 site of enthesitis at Baseline or documented by history.\n* Study participants with inadequate response (at least 1 month) or intolerance to at least 1 nonsteroidal anti-inflammatory drug (NSAID).\n* Study participants taking concomitant methotrexate or sulfasalazine are allowed to continue the medication if it has been used for the past 12 weeks with a stable dose for the 4 weeks prior to Baseline, with no change in dose for the first 16 weeks of treatment foreseen. (Note: prior or concomitant use of methotrexate or sulfasalazine is NOT required for study participation.)\n* Study participants with no concomitant use of second line agents such as disease-modifying and\u002For immunosuppressive drugs with the exception of methotrexate or sulfasalazine.\n* Body weight of ≥10kg.\n* Male and female.\n* A female study participant will be eligible to participate if she is not pregnant, not breastfeeding, and at least 1 of the following conditions applies:\n\n  1. Not a woman of childbearing potential (WOCBP) OR\n  2. A WOCBP who agrees to follow the contraceptive guidance during the Initial Treatment Period, the Open-label Extension (OLE) Period, and for at least 20 weeks after the final dose of investigational medicinal product (IMP; ie, the Safety Follow-up (SFU) Period)\n* Capable of giving\u002Fhaving parent(s) or legal representative provide signed informed consent\u002Fassent (where appropriate), which includes compliance with the requirements and restrictions listed in the Informed Consent Form (ICF) and assent and in this protocol.\n\nExclusion Criteria:\n\n* Study participants fulfilling any International League of Associations for Rheumatology (ILAR) diagnostic juvenile idiopathic arthritis (JIA) category other than enthesitis-related arthritis (ERA; including juvenile-onset ankylosing spondylitis (JAS)) and\u002For juvenile psoriatic arthritis (JPsA).\n* Study participant has history of inflammatory bowel disease (IBD) or signs\u002Fsymptoms suggestive of IBD.\n* Study participant has active uncontrolled uveitis.\n* Study participant has history of active tuberculosis (TB) unless successfully treated, latent TB unless prophylactically treated.\n* Study participant has had major surgery (including joint surgery) within the 3 months prior to the Baseline Visit or has planned major surgery within 6 months after entering the study.\n* Study participant has laboratory abnormalities at Screening defined in the Protocol.\n* Study participant has an active infection or history of infections (such as serious infection, chronic infections, opportunistic infections, unusually severe infections).\n* Study participant has received drugs listed in the protocol outside the specified timeframes relative to the Baseline Visit or receives prohibited concomitant treatments.\n* Study participant had previous therapy with bimekizumab or prior treatment with other IL-17 biologic response modifier.\n* Study participant had prior treatment with more than one biologic response modifier (other than an IL-17).\n* Presence of active suicidal ideation, or positive suicide behavior.\n* Study participant has been diagnosed with severe depression in the past 6 months.","ALL","2 Years","18 Years",{"count":20,"type":21},40,"ESTIMATED","INTERVENTIONAL",[24],"PHASE3","The purpose of this study is to assess plasma bimekizumab concentrations following subcutaneous (sc) bimekizumab administration.",[27,28],"Enthesitis-related Arthritis","Juvenile Psoriatic Arthritis",[30,31],"Arthritis","Bimekizumab","RECRUITING","2026-06-18",{"date":35,"type":36},"2026-06-22","ACTUAL",{"date":38,"type":36},"2025-03-11",{"date":40,"type":21},"2030-07-31",{"name":42,"class":43},"UCB Biopharma SRL","INDUSTRY",23,{"id":46,"slug":47,"hasResults":11,"nctId":48,"briefTitle":49,"officialTitle":50,"acronym":51,"eligibilityCriteria":52,"healthyVolunteers":11,"sex":16,"minAge":18,"maxAge":4,"enrollmentInfo":53,"targetDuration":4,"studyType":55,"phases":4,"briefSummary":56,"conditions":57,"keywords":4,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":66,"lastUpdatePostDateStruct":67,"startDateStruct":69,"completionDateStruct":71,"leadSponsor":73,"locationsCount":76},"100574997","a-registry-study-assessing-pro-dosing-patterns-and-safety-of-vunakizumab-in-patients-with-general-rheumatic-diseases-100574997","NCT06766552","A Registry Study Assessing PRO, Dosing Patterns, and Safety of Vunakizumab in Patients With General Rheumatic Diseases.","A Multicenter Registry Study Assessing Patient Reported Outcome, Dosing Patterns, and Safety of Vunakizumab in Patients With General Rheumatic Diseases.","V-MIRACLE","Inclusion Criteria:\n\n1. Diagnosed with rheumatic autoimmune diseases such as ankylosing spondylitis\u002Fradiologically negative axial spondyloarthritis\u002Fpsoriatic arthritis\u002Fpolymyalgia rheumatica\u002FTakayasu arteritis\u002Fgiant cell arteritis\u002F non-ocular Behcet's disease\u002F enthesitis-related arthritis;\n2. Currently receiving or planning to receive fulvezinib treatment;\n3. Can follow up according to the doctor's advice;\n4. Able to understand and sign the informed consent form, understand the purpose of this study, and voluntarily participate in this study.\n\nExclusion Criteria:\n\n1.Investigator believes will prevent the subject from following and completing the study protocol",{"count":54,"type":21},10000,"OBSERVATIONAL","Ankylosing spondylitis, radiographically negative axial spondyloarthritis, psoriatic arthritis, polymyalgia rheumatica, Takayasu arteritis, giant cell arteritis, non-ocular Behcet's disease, and enthesitis-related arthritis are common diseases in rheumatology. Traditional anti-rheumatic drugs are less effective and have greater side effects than biological agents. At present, there has been no large-scale registration study on rheumatic autoimmune diseases such as spondyloarthritis in China. However, data such as patient characteristics, medication patterns, and patient outcome reports of different rheumatology diseases can often serve as a reference for rheumatology clinicians to reasonably select treatment methods for different patients. Therefore, a large-scale registration study is needed to fill the gap in multi-disease registration studies in rheumatology departments in China.",[58,59,60,61,62,63,64,27],"Ankylosing Spondylitis (AS)","Psoriatic Arthritis (PsA)","Nr-axSpA","Polymyalgia Rheumatica (PMR)","Takayasu Arteritis (TAK)","Giant Cell Arteritis (GCA)","Behcet's Disease","NOT_YET_RECRUITING","2025-01-08",{"date":68,"type":36},"2025-01-09",{"date":70,"type":21},"2025-01-30",{"date":72,"type":21},"2030-06-30",{"name":74,"class":75},"Second Affiliated Hospital, School of Medicine, Zhejiang University","OTHER",1]