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Recruiting Phase 4 NCT05626348

The Clinical Efficacy of Immunomodulators in RA Patients

Trial Parameters

Condition Arthritis, Rheumatoid
Sponsor Qilu Hospital of Shandong University
Study Type INTERVENTIONAL
Phase Phase 4
Enrollment 400
Sex ALL
Min Age 18 Years
Max Age 80 Years
Start Date 2021-12-22
Completion 2025-06-30
Interventions
IguratimodMethotrexateAdalimumab Injection

Brief Summary

This study includes naive patients and csDMARDs-IR RA patients, treated with different regimens such as Iguratimod combination of different csDMARDs, or csDMARD with TNF inhibitors for 24 weeks. The disease activity and drug response will be observed. The immune disorder and synovial function will be evaluated at the same time.

Eligibility Criteria

Inclusion Criteria: \- 1.Patients with RA who meet ACR 1987 rheumatoid arthritis classification criteria or ACR/EULAR 2010 rheumatoid arthritis Classification Criteria and have knee dysfunction. 1. ACR 1987 rheumatoid arthritis classification criteria 1. morning stiffness lasting at least 1 hour (≥6w) 2. there are 3 or more joint areas swollen (≥6w) 3. swelling of the wrist, metacarpophalangeal, and proximal phalangeal joint areas (≥6w) 4. symmetrical arthrogryposis (≥6w) 5. hand x-ray changes (at least osteoporosis and joint space narrowing) 6. positive rheumatoid factor (titer \> 1:32) RA can be diagnosed by meeting 4 of the above 7 items 2. ACR/EULAR 2010 rheumatoid arthritis Classification Criteria 1. Involved joints \- 1 large joint (0 points) * 2-10 large joints (1 point) * 1-3 small joints (with or without large joints) (2 points) * 4-10 small joints (with or without large joints) (3 points) * more than 10 small joints (at least one small joint) (5 points) 2. Serological indicat

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