Overview

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

Status:
Recruiting

Trial end date:
2024-05-31

Target enrollment:
0

Participant gender:
All

Summary

Rheumatoid arthritis (RA) is a chronic progressive autoimmune disease with predominantly joint involvement. To compare the efficacy and difference between elamod and tofacitib in the treatment of rheumatoid factor-positive and negative rheumatoid arthritis in RA patients with poor outcome after csDMARDs dosing, in order to better inform the clinical management.

Phase:

Phase 4

Accepts Healthy Volunteers?

Details

Lead Sponsor:

Yanfeng Hou

Treatments:

Tofacitinib

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