Acemetacin for pain and disease activity in active axial spondyloarthritis
Looks at acemetacin for pain and safety in adults with active axial spondyloarthritis.
Plain-language title generated from the registry record
Registry title: Effectiveness and Safety of Acemetacin in Active Axial Spondyloarthritis: A Real-world Study
Key facts
- Where
- Beijing, ChinaSee the site
- Phase
- Phase 4
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 65 years old?
Source: NCT07582146, who can take part
Where in China
- Department of Rheumatology and Immunology, the First Medical Center, Chinese PLA General HospitalBeijing, ChinaNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Chinese PLA General Hospital
- Trial code
- NCT07582146
- Record updated
- 12 May 2026
- Original description
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.Read full original descriptionShow less
Effectiveness and Safety of Acemetacin in Patients With Active Axial Spondyloarthritis: A Prospective, Multicenter, Observational Real-World Study
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.
The main questions this study aims to answer are:
* Does acemetacin reduce overall pain assessed by visual analog scale (VAS) after 4 weeks of treatment? * What proportion of patients achieve clinical remission (ASDAS ≤1.3) or low disease activity (1.3<ASDAS≤2.1) at week 4? * What medical problems (side effects) occur during acemetacin treatment, with particular attention to gastrointestinal and cardiovascular events?
Participants will:
* Undergo screening assessments including blood tests, imaging of the sacroiliac joints (MRI, CT, X-ray), and physical examination within 7 days before starting treatment * Take acemetacin 90 mg by mouth once daily for 4 weeks * Complete a phone follow-up at week 2 and an in-clinic visit at week 4 * Have pain scores, disease activity measures (ASDAS, BASDAI, BASFI, ASAS HI, BASMI), and laboratory tests (CRP, ESR) recorded at each visit * Be monitored for adverse events throughout the treatment period
Inclusion: Subjects who fully understand the purpose and procedures of the trial and voluntarily sign the Informed Consent Form (ICF); Subjects aged 18-65 years (inclusive), regardless of gender; Meet the 2025 ASAS-SPARTAN Revised Classification Criteria for Axial Spondyloarthritis; ASDAS score > 2.1.
Exclusion: Subjects who received systemic glucocorticoids or intra-articular glucocorticoid injections within 3 months prior to the study start; Subjects who received targeted therapy within 3 months prior to the study start; Subjects with known allergy to acemetacin, other NSAIDs, or any excipients; Subjects with active gastrointestinal ulcer/bleeding, or a history of recurrent ulcer/bleeding; Subjects with severe cardiac or renal dysfunction, or hepatic dysfunction; Subjects with ulcerative colitis or Crohn's disease; Any other condition that, in the investigator's opinion, makes the subject unsuitable for participation in this study.