Effectiveness and Safety of Acemetacin in Active Axial Spondyloarthritis: A Real-world Study

Condition(s) studied

Investigational drug(s) / intervention(s)

Acemetacin: 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.

Study 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

Eligibility

Primary outcome measure(s)

• Efficacy - Changes in overall pain score — Baseline and Week 4
  The mean change in overall pain score from baseline after 4 weeks of acemetacin treatment, and the differences in changes among different subgroups.

Trial sites (1)

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