Long-term Efficacy of Iguratimod Alone or Iguratimod in Combination With Methotrexate in Patients With Rheumatoid Arthritis

Phase 4 Unknown 910 enrolled Jiangsu Simcere Pharmaceutical Co., Ltd.

RandomizedParallel-groupQuadruple-blindTreatment

Summary

This study is intended to evaluate the efficacy and safety of Iguratimod alone or Iguratimod in combination with Methotrexate (MTX) versus Methotrexate alone in patients with Rheumatoid Arthritis (RA).

Timeline

Start: 2012-05
Primary completion: 2016-11
Completion: 2017-01

Outcome

Mixed primary results

paper The primary endpoints were the proportion of patients with ≥20% improvement according to the American College of Rheumatology (ACR20) response and changes in the van der Heijde-modified total Sharp score (vdH-mTSS) at week 52. PMID 39056160 ↗

paper The superiority of IGU + MTX over MTX monotherapy was confirmed in terms of the ACR20 PMID 39056160 ↗

paper but not in the vdH-mTSS (-0.68; 95% CI, -1.46-0.11; P = 0.091). PMID 39056160 ↗

Publications

Du F, Dai Q, Teng J, Lu L, Ye S, Ye P, Lin Z, Ding H, Dai M, Bao C; SMILE Group. The SMILE study: Study of long-term methotrexate and iguratimod combination therapy in early rheumatoid arthritis. Chin Med J (Engl). 2025 Jul 20;138(14):1705-1713. doi: 10.1097/CM9.0000000000003200. Epub 2024 Jul 26.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Iguratimod	Small molecule	25 mg	Oral
Subject	Methotrexate	Small molecule	15 mg	Oral