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

NCT07582146 · Status: NOT_YET_RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2026-05-12

No results posted yet for this 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

Conditions

  • Axial Spondyloarthritis
  • Axial Spondyloarthritis, Non-Radiographic
  • Ankylosing Spondylitis (AS) / Radiographic Axial SpA (r-axSpA)

Interventions

DRUG

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.

Sponsors & Collaborators

  • Chinese PLA General Hospital

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-04-30
Primary Completion
2026-09-30
Completion
2026-12-31

Countries

  • China

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07582146 on ClinicalTrials.gov