NCT01893151

Effectiveness of Iguratimod Versus Placebo to Treat Early Rheumatoid Arthritis on MRI

A Randomized, Double-blind Study to Evaluate the Efficacy of Iguratimod Versus Placebo in Patients With Rheumatoid Arthritis on Magnetic Resonance Imaging (MRI)

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: Jiangsu Simcere Pharmaceutical Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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).

Detailed description

Magnetic resonance imaging (MRI) is a powerful imaging modality that is now widely used in both scientific research and clinical settings to visualise joints of patients with RA. MRI is able to image structural damage and soft tissue changes, ie, synovitis, bone oedema, damage to cartilage and bone, as well as tendon pathology. MRI is more responsive to change in joint damage and can be used to monitor disease progression. In this studly,MRI of the dominant wrist was performed at baseline ,24 weeks and at 52 weeks, using a 1.5T or 3.0T MRI with a dedicated high-resolution wrist phased array coil.The same scanner and wrist coil were used for three examinations. The hand was placed in the wrist coil at the patient's side with the coil anchored to the base tray to reduce motion artefacts. The MRI sequences in this study included the OMERACT recommended MRI core set of sequences.

Conditions

• Rheumatoid Arthritis

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2012-07-01
• Primary completion: 2015-12-01
• Completion: 2015-12-01
• First posted: 2013-07-08
• Last updated: 2014-10-23

Locations

1 site across 1 country: China