RecruitingPhase 4NCT05626348

The Clinical Efficacy of Immunomodulators in RA Patients

The Clinical Study to Observe the Efficacy and Safety of Immunomodulators in Rheumatoid Arthritis Patients for 6 Months Treatment in China

Sponsor

Qilu Hospital of Shandong University

Enrollment

400 participants

Start Date

Dec 22, 2021

Study Type

INTERVENTIONAL

Conditions

Arthritis, Rheumatoid

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

Min Age: 18 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This study is examining how well immunomodulator medications work in patients with rheumatoid arthritis (RA) or osteoarthritis (OA) who have knee problems. Researchers will also compare these patients to healthy volunteers to better understand how the immune system affects joint disease. **You may be eligible if...** - You have been diagnosed with rheumatoid arthritis or osteoarthritis of the knee (based on established diagnostic criteria) - You have knee dysfunction (difficulty with movement or pain) - OR you are a healthy volunteer matched by age and sex for comparison **You may NOT be eligible if...** - (Specific exclusion criteria were not detailed in the available information — your doctor can advise based on full study requirements) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGIguratimod

Iguratimod tablet，25mg, po, twice per day (Bid) prescribed at the beginning and adjusted due to patient response. Then may titer down until the endpoint.

DRUGMethotrexate

Methotrexate，10mg, po, quaque week (qw) prescribed at the beginning and adjusted due to patient response. Then may titer down until the endpoint.

DRUGAdalimumab Injection

Adalimumab Injection，40mg，iH，every two weeks (q2w) prescribed at the beginning and adjusted due to patient response. Then may titer down until the endpoint.

DRUGLeflunomide

Leflunomide，20mg, po, quaque day (qd) prescribed at the beginning and adjusted due to patient response. Then may titer down until the endpoint.

DRUGHydroxychloroquine

Hydroxychloroquine，200mg, po, twice per day (bid) prescribed at the beginning and adjusted due to patient response. Then may titer down until the endpoint.

Locations(1)

Qilu Hospital

Jinan, Shandong, China

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NCT05626348

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