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

Starting soon · Phase 4

Conditions studied: Axial Spondyloarthritis, Axial Spondyloarthritis, Non-Radiographic, Ankylosing Spondylitis (AS) / Radiographic Axial SpA (r-axSpA)

In brief

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

Key facts

Study ID

NCT07582146

Run by

Chinese PLA General Hospital

People needed

150

Starts

2026-04-01

Expected to finish

2026-12-01

Last updated by the study team

2026-05-12

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Department of Rheumatology and Immunology, the First Medical Center, Chinese PLA General Hospital — Beijing, Beijing Municipality, China

Full record on ClinicalTrials.gov

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