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A multi-center, prospective, observational real-world study evaluating the efficacy and safety of acemetacin sustained-release capsules in the treatment of active axial spondyloarthritis (axSpA)

A multi-center, prospective, observational real-world study evaluating the efficacy and safety of acemetacin sustained-release capsules in the treatment of active axial spondyloarthritis (axSpA)

Status
Active, not recruiting
Phases
Phase 4
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2600123028
Enrollment
Unknown
Registered
2026-04-21
Start date
2026-05-06
Completion date
Unknown
Last updated
2026-04-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Active axial spondyloarthritis

Interventions

Observation group:None

Sponsors

Chinese People's Liberation Army General Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Understand the purpose and procedure of the trial and voluntarily sign the informed consent form; 2. The subjects should be aged between 18 and 65, with no gender restriction; 3. Meet the revised classification criteria for axial spondyloarthritis in ASAS-SPARTAN in 2025; 4. ASDAS score > 2.1.

Exclusion criteria

Exclusion criteria: 1. Hypersensitivity to acemetacin and other NSAIDs; 2. Those with a history of digestive tract ulcer or bleeding; 3. Patients with severe cardiac or renal insufficiency or abnormal liver function; 4. Individuals with ulcerative colitis or Crohn's disease; 5. Use of systemic glucocorticoids or intra-articular injections of glucocorticoids within 3 months prior to the start of the study; 6. Have used targeted therapy within 3 months before the start of the study; 7. The researcher believes that there are any other situations that make the participant unsuitable for participating in this study.

Design outcomes

Primary

MeasureTime frame
Visual Analogue Scale;

Secondary

MeasureTime frame
Axial Spondyloarthritis Disease Activity Score;Bath Ankylosing Spondylitis Disease Activity Index;Bath Ankylosing Spondylitis Functional Index;ASAS Health Index;Bath Ankylosing Spondylitis Metrology Index;C-reactive protein;Erythrocytesedimentationrate;

Countries

China

Contacts

Public ContactJian Zhu

Chinese People's Liberation Army General Hospital

530046387@qq.com+86 155 1160 2160

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: May 1, 2026