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The Clinical Efficacy of Immunomodulators in RA Patients
Sponsor: Qilu Hospital of Shandong University
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.
Official title: The Clinical Study to Observe the Efficacy and Safety of Immunomodulators in Rheumatoid Arthritis Patients for 6 Months Treatment in China
Key Details
Gender
All
Age Range
18 Years - 80 Years
Study Type
INTERVENTIONAL
Enrollment
400
Start Date
2021-12-22
Completion Date
2026-12-31
Last Updated
2022-11-29
Healthy Volunteers
No
Conditions
Interventions
Iguratimod
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.
Methotrexate
Methotrexate,10mg, po, quaque week (qw) prescribed at the beginning and adjusted due to patient response. Then may titer down until the endpoint.
Adalimumab 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.
Leflunomide
Leflunomide,20mg, po, quaque day (qd) prescribed at the beginning and adjusted due to patient response. Then may titer down until the endpoint.
Hydroxychloroquine
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