NCT07582146Not yet recruitingPhase 4
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
Source: ClinicalTrials.gov · Last updated 12 May 2026
Brief summary (registry, in English)
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
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 150 (estimated)
- First submitted
- 6 May 2026
- Start date
- Apr 2026
- Primary completion date
- Sept 2026
- Lead sponsor
- Chinese PLA General Hospital
- Diseases
- Ankylosing spondylitis
- NCT number
- NCT07582146
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 150
- From Apr 2026 to the primary completion date, Sept 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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;
Other illness
- 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.
Who the study is looking for
- 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.
Age in the registry: 18 years to 65 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Department of Rheumatology and Immunology, the First Medical Center, Chinese PLA General Hospital Coordinator of this site? Confirm its status | Beijing | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.