drugset / Trial / NCT03855007

The Clinical Efficacy and Safety of Iguratimod in RA and Early RA Patients for 6 Months Treatment

NCT03855007

Phase 4 Completed 400 enrolled Qilu Hospital of Shandong University
NaSingle-groupOpen-labelTreatment

Summary

This study is designed to observed prospectively the efficacy and safety of 6 months treatment of iguratimod alone, or with methotrexate (MTX), hydroxychloroquine (HCQ) and prednisone step by step on Chinese rheumatoid arthritis (RA) and early rheumatoid arthritis (ERA) patients who were naïve or shown insufficiency response or intolerance to DMARDs. If volunteered, patients who completed the 6-month study can continue to follow our plans for 24 months.

Timeline

Start
2016-01-01
Primary completion
2023-09-30
Completion
2023-10-31

Drugs

EvaluationDrugModalityDoseRoute
Subject HCQ Unknown 200 mg Oral
Subject Iguratimod Small molecule 25 mg Oral
Subject MTX Unknown 7.5 mg Oral
Subject MTX Unknown 15 mg Oral
Subject Pred Unknown 5 mg Oral
Subject Pred Unknown 15 mg Oral

Indications