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

Sponsor
Chinese PLA General Hospital
Study ID
NCT07582146
Phase
PHASE4
Status
Not Yet Recruiting

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Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • Acemetacin — DRUG
    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 Details

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 Dates

Start date
Apr 30, 2026
Status verified
May 2026
Primary completion
Sep 30, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
150 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Acemetacin
    After signing the Informed Consent Form (ICF), subjects entered the screening period and completed screening evaluations according to the visit schedule in the trial flow chart. The screening period lasted up to 7 days, and subjects who met all inclusion criteria and did not meet any exclusion criteria entered the treatment period. The study planned to enroll 150 subjects with axial spondyloarthritis, all of whom received acemetacin sustained-release capsules. All subjects were administered acemetacin: 1 capsule per dose, once daily, for 4 weeks.

Primary Outcome Measure

Efficacy - Changes in overall pain score [ Time Frame: Baseline and Week 4 ]

Central Contacts

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