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

Study acronym: ARISE
StatusNot Yet Recruiting
PhasePhase 4
Started2026-04
View on ClinicalTrials.gov ↗
Record status
This record was last updated May 12, 2026 (before its estimated September 2026 completion). Its status may not reflect the trial's current state.
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
Trial Details
NCT Number NCT07582146
Lead Sponsor Chinese PLA General Hospital
Conditions Axial Spondyloarthritis, Axial Spondyloarthritis, Non-Radiographic, Ankylosing Spondylitis (AS) / Radiographic Axial SpA (r-axSpA)
Enrollment 150 participants
Start Date 2026-04
Primary Completion 2026-09 (estimated)
Study Completion 2026-12 (estimated)
Updated on ClinicalTrials.gov 2026-05-12