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RECRUITING
NCT05626348
PHASE4

The Clinical Efficacy of Immunomodulators in RA Patients

Sponsor: Qilu Hospital of Shandong University

View on ClinicalTrials.gov

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

Interventions

DRUG

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.

DRUG

Methotrexate

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

DRUG

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.

DRUG

Leflunomide

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

DRUG

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