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A Multi-center, Randomized, Double-blind, Placebo-controlled Trial for the Efficacy and Safety of Iguratimod in Combination With Celecoxib in the Treatment of Ankylosing Spondylitis (AS) or Axial Spondyloarthritis (axSpA)

A Multi-center, Randomized, Double-blind, Placebo-controlled Trial for the Efficacy and Safety of Iguratimod in Combination With Celecoxib in the Treatment of Ankylosing Spondylitis (AS) or Axial Spondyloarthritis (axSpA)

Status
Recruiting
Phases
Phase 3
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2000029112
Enrollment
Unknown
Registered
2020-01-14
Start date
2019-09-01
Completion date
Unknown
Last updated
2020-01-20

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

Conditions

Ankylosing Spondylitis /Axial Spondyloarthritis

Interventions

Experimental group:lguratimod plus NSAID
placebo group:placebo plus NSAID

Sponsors

Ruijin Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Subjects aged >= 18 years; 2. Meet 1984 Criteria definition of ankylosing spondylitis (AS) or 2009 Criteria definition of Axial Spondyloarthritis (axSpA); 3. Not taking NSAIDs 1 week before entering the study or having past at least 5 half-life periods of the NSAID for the last time before entering the study; 4. Not taking csDMARDs/bDMARDs/tsDMARDs 3 week before entering the study; 5. ASDAS-CRP>=2.1; 6. Willing and able to practice a reliable method of contraception throughout the study and after 3 months; 7. Each patient must sign written informed consent.

Exclusion criteria

Exclusion criteria: 1. Patients with total ankylosis of the spine; 2. Intolerance or allergy to Iguratimod or NSAIDs; 3. Uncontrolled infection; 4. Hb1.5 ULN, AST>1.5 ULN, total bilirubin>1.5 ULN, Cr >135umol/L 5. Combined with other autoimmune disease, such as inflammatory bowel disease, psoriasis, uveitis etc.; 6. Active gastrointestinal diseasegastrointestinal bleeding, active gastrointestinal ulcer or acute gastric mucosa injury in 3 months; 7. History of sever cardiovascular disease, malignancy, systemic diseases including kidney, circulatory system and endocrine system; 8. Other systemic diseases; 9. Mental illness; 10. With poor treatment compliance; 11. Participating in other clinical study within 3 months prior to study entry; 12. For other improper reasons.

Design outcomes

Primary

MeasureTime frame
NSAID index over 28 weeks of therapy;Number of Participants Achieving the ASAS Response Criteria (ASAS 20) at Week 28;—

Secondary

MeasureTime frame
Number of Participants Achieving the ASAS Response Criteria (ASAS 20);Number of Participants Achieving the ASAS Response Criteria (ASAS 40);Number of Participants Achieving the ASAS Response Criteria (ASAS 5/6);Change of thoracic expansion;Change of spinal mobility;Change of ASDAS-CRP;Number of Participants Achieving remission;—

Countries

China

Contacts

Public ContactChengdei Yang

Ruijin Hospital

tanwenfeng@jsph.org.cn+86 13770769608

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 6, 2026