[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100638927":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":19,"centralContacts":20,"locations":29,"responsibleParty":45,"collaborators":19,"id":49,"slug":50,"hasResults":51,"nctId":52,"briefTitle":53,"officialTitle":54,"acronym":55,"eligibilityCriteria":56,"healthyVolunteers":51,"sex":57,"minAge":58,"maxAge":59,"enrollmentInfo":60,"targetDuration":19,"studyType":63,"phases":64,"briefSummary":66,"conditions":67,"keywords":71,"overallStatus":74,"whyStopped":19,"lastUpdateSubmitDate":75,"lastUpdatePostDateStruct":76,"startDateStruct":79,"completionDateStruct":81,"leadSponsor":83,"locationsCount":84},{"fullName":5,"class":6},"Chinese PLA General Hospital","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Acemetacin","EXPERIMENTAL","After signing the Informed Consent Form (ICF), subjects entered the screening period and completed screening evaluations according to the visit schedule in the trial flow chart. The screening period lasted up to 7 days, and subjects who met all inclusion criteria and did not meet any exclusion criteria entered the treatment period. The study planned to enroll 150 subjects with axial spondyloarthritis, all of whom received acemetacin sustained-release capsules. All subjects were administered acemetacin: 1 capsule per dose, once daily, for 4 weeks.",[13],"Drug: Acemetacin",[15],{"type":16,"name":9,"description":17,"armGroupLabels":18,"otherNames":19},"DRUG","Acemetacin is a non-steroidal anti-inflammatory drug (NSAID) belonging to the indole derivative class and serves as a prodrug of indomethacin. After oral administration, it is hydrolyzed in vivo to indomethacin, exerting anti-inflammatory, analgesic, and antipyretic effects.",[9],null,[21,26],{"name":22,"role":23,"phone":24,"phoneExt":19,"email":25},"Xiaojian Ji, M.D.","CONTACT","+86 010-55499314","jixiaojian1990@163.com",{"name":27,"role":23,"phone":24,"phoneExt":19,"email":28},"Qianqian Zhao, M.M.","zqq20901@163.com",[30],{"facility":31,"status":19,"city":32,"state":33,"zip":34,"country":35,"countryCode":36,"cosmosGeoPoint":37,"geoPoint":42,"contacts":43},"Department of Rheumatology and Immunology, the First Medical Center, Chinese PLA General Hospital","Beijing","Beijing Municipality","100853","China","CN",{"type":38,"coordinates":39},"Point",[40,41],116.39723,39.9075,{"lat":41,"lon":40},[44],{"name":22,"role":23,"phone":24,"phoneExt":19,"email":25},{"type":46,"investigatorFullName":47,"investigatorTitle":48,"investigatorAffiliation":5,"oldNameTitle":19,"oldOrganization":19},"PRINCIPAL_INVESTIGATOR","Jian Zhu","Chief Physician and Professor, Department of Rheumatology and Immunology, First Medical Center, Chinese PLA General Hospital","100638927","phase-4-effectiveness-and-safety-of-acemetacin-in-active-axial-spondyloarthritis-a-real-world-study-100638927",false,"NCT07582146","Effectiveness and Safety of Acemetacin in Active Axial Spondyloarthritis: A Real-world Study","Effectiveness and Safety of Acemetacin in Patients With Active Axial Spondyloarthritis: A Prospective, Multicenter, Observational Real-World Study","ARISE","Inclusion Criteria:\n\n* Subjects who fully understand the purpose and procedures of the trial and voluntarily sign the Informed Consent Form (ICF);\n* Subjects aged 18-65 years (inclusive), regardless of gender;\n* Meet the 2025 ASAS-SPARTAN Revised Classification Criteria for Axial Spondyloarthritis;\n* ASDAS score \\> 2.1.\n\nExclusion Criteria:\n\n* Subjects with known allergy to acemetacin, other NSAIDs, or any excipients;\n* Subjects with active gastrointestinal ulcer\u002Fbleeding, or a history of recurrent ulcer\u002Fbleeding;\n* Subjects with severe cardiac or renal dysfunction, or hepatic dysfunction;\n* Subjects with ulcerative colitis or Crohn's disease;\n* Subjects who received systemic glucocorticoids or intra-articular glucocorticoid injections within 3 months prior to the study start;\n* Subjects who received targeted therapy within 3 months prior to the study start;\n* Any other condition that, in the investigator's opinion, makes the subject unsuitable for participation in this study.","ALL","18 Years","65 Years",{"count":61,"type":62},150,"ESTIMATED","INTERVENTIONAL",[65],"PHASE4","The goal of this observational study is to evaluate the effectiveness and safety of acemetacin in adults (18-65 years) with active axial spondyloarthritis (axSpA) who meet the 2025 ASAS-SPARTAN revised classification criteria and have an ASDAS score greater than 2.1.\n\nThe main questions this study aims to answer are:\n\n* Does acemetacin reduce overall pain assessed by visual analog scale (VAS) after 4 weeks of treatment?\n* What proportion of patients achieve clinical remission (ASDAS ≤1.3) or low disease activity (1.3\\\u003CASDAS≤2.1) at week 4?\n* What medical problems (side effects) occur during acemetacin treatment, with particular attention to gastrointestinal and cardiovascular events?\n\nParticipants will:\n\n* Undergo screening assessments including blood tests, imaging of the sacroiliac joints (MRI, CT, X-ray), and physical examination within 7 days before starting treatment\n* Take acemetacin 90 mg by mouth once daily for 4 weeks\n* Complete a phone follow-up at week 2 and an in-clinic visit at week 4\n* Have pain scores, disease activity measures (ASDAS, BASDAI, BASFI, ASAS HI, BASMI), and laboratory tests (CRP, ESR) recorded at each visit\n* Be monitored for adverse events throughout the treatment period",[68,69,70],"Axial Spondyloarthritis","Axial Spondyloarthritis, Non-Radiographic","Ankylosing Spondylitis (AS) \u002F Radiographic Axial SpA (r-axSpA)",[9,68,72,73],"NSAIDs","Real-World Study","NOT_YET_RECRUITING","2026-05-06",{"date":77,"type":78},"2026-05-12","ACTUAL",{"date":80,"type":62},"2026-04",{"date":82,"type":62},"2026-12",{"name":5,"class":6},1]