Effectiveness of Iguratimod Versus Placebo to Treat Early Rheumatoid Arthritis on MRI
NCT01893151 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 200
Last updated 2014-10-23
Summary
The purpose of this study is to evaluate the efficacy of Iguratimod versus placebo on synovial inflammation,bone erosion and bone edema as measured by MRI of wrist and Metacarpophalangeal joints in patients with early Rheumatoid Arthritis (RA).
Conditions
Interventions
- DRUG
-
Iguratimod
Iguratimod placebo:25 mg/tablet, taken orally, 2 tablets/day (bid),52week
- DRUG
-
Iguratimod placebo
Iguratimod placebo:25 mg/tablet, taken orally, 2 tablets/day (bid),24week; Iguratimod:25 mg/tablet, taken orally, 2 tablets/day (bid),28week.
Sponsors & Collaborators
-
Jiangsu Simcere Pharmaceutical Co., Ltd.
lead INDUSTRY
Principal Investigators
-
Jieruo Gu, Doctor · Third Affiliated Hospital, Sun Yat-Sen University
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- QUADRUPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 65 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2012-07-31
- Primary Completion
- 2015-12-31
- Completion
- 2015-12-31
Countries
- China
Study Locations
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