Combining Iguratimod and Tofacitab for Treating Rheumatoid Arthritis

Efficacy Study of Iguratimod Combined With Tofacitab in Patients With RF Positive/Negative Rheumatoid Arthritis

This study is testing if combining two medications, Iguratimod and Tofacitab, can help people with rheumatoid arthritis who haven't found relief with standard treatments.

Quick facts

• Phase: PHASE4
• Study type: Interventional
• Enrollment: 117 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: Qianfoshan Hospital (other)
• Drugs / interventions: cyclophosphamide, prednisone, tofacitinib
• Locations: 1 site (Jinan, Shandong)
• Trial ID: NCT06146972 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the effectiveness of combining Iguratimod with Tofacitab in patients suffering from rheumatoid arthritis (RA) who have not responded well to conventional treatments. The study involves an open, controlled design where participants will receive the combination therapy and be monitored for efficacy and safety over a 24-week period. Patients will undergo assessments at multiple time points to determine the impact of the treatment on their RA symptoms and overall health.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18-65 with active rheumatoid arthritis who have not achieved satisfactory results from previous treatments.

Not a fit: Patients with mild or well-controlled rheumatoid arthritis may not benefit from this aggressive treatment approach.

Why it matters

Potential benefit: If successful, this treatment combination could provide a new effective option for patients with difficult-to-treat rheumatoid arthritis.

How similar studies have performed: Other studies have explored similar combination therapies in rheumatoid arthritis, showing promising results, but this specific combination is relatively novel.

Eligibility criteria

Inclusion Criteria:

1. Male or female aged 18-65 years old
2. Body weight not less than 40kg
3. Patients with a clear diagnosis of rheumatoid arthritis (RA) who meet the diagnostic criteria for RA introduced by the ACR in 1987 or ACR\\EULAR in 2010
4. Joint function grade II-III
5. Active rheumatoid arthritis (defined as active rheumatoid arthritis if the following three conditions are met: ① ≥ 6 joints swollen \[66 joints count\]

   ② ≥ 6 joints tenderness \[68 joints count\]

   ③Erythrocyte sedimentation rate (ESR) \> 28 mm/h or C-reactive protein (CRP) \> 1.0 mg/dL)
6. The Patients have been treated with csDMARDs for ≥ 3 months and have been treated with stable doses of csDMARDs for 4 consecutive weeks prior to study entry, with poor therapeutic outcomes and are being considered for treatment with a combination of biologics (bDMARDs) (according to the 2018 China Rheumatoid Arthritis Treatment Guidelines, poor outcomes, i.e., no significant improvement in RA disease activity within 3 months or failure to achieve treatment goals within 6 months)
7. Subjects must be able and willing to perform subcutaneous (SC) injections on their own, or a qualified person must be available to perform SC injections
8. If taking glucocorticosteroids, prednisone should be ≤10mg or other hormone at a dose equivalent to prednisone and the dose should be kept constant for at least 28d
9. Understand the purpose of the trial and the test procedures and sign a written informed consent form voluntarily

Exclusion Criteria:

1. Patients who have used potent immunosuppressants (such as cyclophosphamide, cyclosporine, azathioprine, etc.), tripterygiam glycosides and so on that affect the evaluation of efficacy in previous rheumatoid arthritis treatment , and who have stopped taking them for less than 4 weeks
2. History of allergy to relevant test drugs
3. Previously treated with bDMARDs
4. Subject has recently received a live vaccine, or plans to use any live vaccine during the study

Where this trial is running

Jinan, Shandong

• Yanfeng Hou — Jinan, Shandong, China (RECRUITING)

Study contacts

• Study coordinator: Yanfeng Hou, Dr.

Conditions: Rheumatoid Arthritis, Therapy