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

No results posted yet for this study

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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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01893151 on ClinicalTrials.gov