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Recruiting NCT05626348

The Clinical Efficacy of Immunomodulators in RA Patients

Conditions: Arthritis, Rheumatoid

Sex: All
Ages: 18 Years – 80 Years
Phase: PHASE4
Enrollment: 400
Sponsor: Qilu Hospital of Shandong University

Location: China

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.ACR 1987 rheumatoid arthritis classification criteriamorning stiffness lasting at least 1 hour (≥6w)there are 3 or more joint areas swollen (≥6w)swelling of the wrist, metacarpophalangeal, and proximal phalangeal joint areas (≥6w)symmetrical arthrogryposis (≥6w)hand x-ray changes (at least osteoporosis and joint space narrowing)positive rheumatoid factor (titer > 1:32) RA can be diagnosed by meeting 4 of the above 7 itemsACR/EULAR 2010 rheumatoid arthritis Classification CriteriaInvolved 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)Serological indicatorsRF and ACPA negative (0 points)RF and ACPA, at least one of which is low titer positive. (2 points)RF and ACPA with at least one high titer positive (3 points)Acute chronotropic reactantsBoth CRP and ESR normal (0 points)Abnormal CRP or ESR (1 point)Duration of synovitis<6 weeks (0 points)≥6 weeks (1 point)2.Patients with OA who meet the 1995 Classification Criteria for OA and have knee dysfunction 1995 Classification Criteria for Osteoarthritis of the Knee Clinical criteriaa. Knee pain most of the time in the last 1 month b. Bone rubbing sound c, morning stiffness ≤ 30 minutes d, age ≥ 38 years e, with bony enlargement Knee OA can be diagnosed if a+b+c+d or a+b+e is met3.Age-sex matched healthy volunteers who checked in our hospital.4.Age > 18 years old;5.Voluntarily participate in this study and sign an informed consent formExclusion Criteria:Patients with combined active hepatitisPatients with active tuberculosisPatients withinfection and malignancy

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Source: ClinicalTrials.gov (NCT05626348). StuddyBuddy aggregates publicly available trial information.