The SMILE study: Study of long-term methotrexate and iguratimod combination therapy in early rheumatoid arthritis.

ABSTRACT:

Background

Rheumatoid arthritis (RA) is a systemic autoimmune disease characterized by chronic inflammation and joint destruction. Iguratimod (IGU) is a novel conventional synthetic disease-modifying antirheumatic drugs (csDMARD) with good efficacy and safety for the treatment of active RA in China and Japan. However, the long-term effects of IGU on the progression of bone destruction or radiographic progression in patients with active RA remain unknown. We aimed to investigate the efficacy and safety of iguratimod (IGU), a combination of methotrexate (MTX) and IGU, and IGU in patients with active rheumatoid arthritis (RA) who were naïve to MTX.

Methods

This multicenter, double-blind, randomized, non-inferiority clinical trial was conducted at 28 centers for over 52 weeks in

SUBMITTER: Du F 

PROVIDER: S-EPMC12273664 | biostudies-literature | 2025 Jul

REPOSITORIES: biostudies-literature