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

Launched by YANFENG HOU · Nov 24, 2023

Keywords

ClinConnect Summary

This clinical trial is studying the effectiveness of two medications, Iguratimod and Tofacitab, for treating rheumatoid arthritis (RA) in patients who have not had good results with their previous treatments. Rheumatoid arthritis is a long-term condition that causes inflammation in the joints, leading to pain and stiffness. The goal of this study is to find out if the combination of these two drugs can help people with RA, whether they test positive or negative for a specific blood marker called rheumatoid factor.

To participate in the trial, individuals must be between 18 and 65 years old, weigh at least 40 kg, and have a clear diagnosis of RA that meets certain guidelines. They should also have active symptoms of RA and have tried other treatments for at least three months without significant improvement. Participants will need to be able to administer injections themselves or have someone who can help them. If eligible, participants can expect regular visits and monitoring throughout the study to assess how well the medications are working. It's important to note that those with certain medical histories or who have recently received other specific treatments may not be eligible to join.

Gender

ALL

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