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

NCT07582146 | Not Yet Recruiting Phase 4 DMC

• 1 other identifier: ACM-axSpA
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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

Keywords

Acemetacin; Axial Spondyloarthritis; NSAIDs; Real-World Study

Outcome Measures

Primary Outcomes (1)

• Efficacy - Changes in overall pain score

  The mean change in overall pain score from baseline after 4 weeks of acemetacin treatment, and the differences in changes among different subgroups.

  Baseline and Week 4

Study Arms (1)

Acemetacin

EXPERIMENTAL

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.

Drug: Acemetacin

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.

Acemetacin

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Chinese PLA General Hospital: lead

Study Sites (1)

Department of Rheumatology and Immunology, the First Medical Center, Chinese PLA General Hospital

Beijing, Beijing Municipality, 100853, China

Location

Related Publications (2)

• Wanders A, Heijde Dv, Landewe R, Behier JM, Calin A, Olivieri I, Zeidler H, Dougados M. Nonsteroidal antiinflammatory drugs reduce radiographic progression in patients with ankylosing spondylitis: a randomized clinical trial. Arthritis Rheum. 2005 Jun;52(6):1756-65. doi: 10.1002/art.21054.

  PMID: 15934081 BACKGROUND

• Dougados M, Behier JM, Jolchine I, Calin A, van der Heijde D, Olivieri I, Zeidler H, Herman H. Efficacy of celecoxib, a cyclooxygenase 2-specific inhibitor, in the treatment of ankylosing spondylitis: a six-week controlled study with comparison against placebo and against a conventional nonsteroidal antiinflammatory drug. Arthritis Rheum. 2001 Jan;44(1):180-5. doi: 10.1002/1529-0131(200101)44:13.0.CO;2-K.

  PMID: 11212158 BACKGROUND

MeSH Terms

Conditions

Axial Spondyloarthritis; Non-Radiographic Axial Spondyloarthritis; Spondylitis, Ankylosing

Interventions

acemetacin

Condition Hierarchy (Ancestors)

Spondylarthropathies; Spondylarthritis; Spondylitis; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Ankylosis; Joint Diseases; Arthritis

Central Study Contacts

Xiaojian Ji, M.D.

CONTACT

+86 010-55499314; jixiaojian1990@163.com

Qianqian Zhao, M.M.

CONTACT

+86 010-55499314; zqq20901@163.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Physician and Professor, Department of Rheumatology and Immunology, First Medical Center, Chinese PLA General Hospital

Model Details: A multicenter, prospective, observational real-world study evaluating the efficacy and safety of acemetacin sustained-release capsules in patients with active axial spondyloarthritis (axSpA). Patients received acemetacin sustained-release capsules following routine clinical prescriptions, with a recommended dose of 90 mg once daily for 4 weeks.

Study Record Dates

• First Submitted: May 6, 2026
• First Posted: May 12, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: May 12, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)