Effectiveness and Safety of Acemetacin in Active Axial Spondyloarthritis: A Real-world Study (NCT07582146) | Clinical Trial Compass
Not Yet RecruitingPhase 4
Effectiveness and Safety of Acemetacin in Active Axial Spondyloarthritis: A Real-world Study
China150 participantsStarted 2026-04
Plain-language summary
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
Who can participate
Age range
18 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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 Criteria:
* 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;
* 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;
* Any other condition that, in the investigator's opinion, makes the subject unsuitable for participation in this study.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.