NCT02275299

Study of Iguratimod Plus Methotrexate Compared to Leflunomid Plus Methotrexate in Patients With Rheumatoid Arthritis

A Randomized, Double-blind Study to Evaluate the Efficacy and Safety of Iguratimod or Leflunomide in Combination With Methotrexate in Patients With Active Rheumatoid Arthritis

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 240 (estimated)
• Sponsor: Jiangsu Simcere Pharmaceutical Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

This study is intended to evaluate the efficacy and safety of Iguratimod Plus Methotrexate Compared to Leflunomid Plus Methotrexate in patients with active Rheumatoid Arthritis (RA).

Conditions

• Rheumatoid Arthritis

Interventions

Type	Name	Description
DRUG	Iguratimod	Iguratimod 25 mg/tablet, taken orally, 2 tablets/day (bid),52 weeks
DRUG	Leflunomide	Leflunomide 10 mg/tablet, taken orally, 2 tablets/day (bid),52 weeks
DRUG	Methotrexate	Methotrexate 2.5 mg/tablet, taken orally once a week, 4 tablets/week,52 weeks

Timeline

• Start date: 2013-09-01
• Primary completion: 2016-02-01
• Completion: 2016-02-01
• First posted: 2014-10-27
• Last updated: 2014-10-27

Locations

1 site across 1 country: China