A Double Blind Placebo Controlled Study to Assess the Efficacy on Joint Damage in RA Patients

Phase 4

Completed

• Conditions: Rheumatoid Arthritis
• Interventions: Drug: placebo; Drug: tacrolimus

• Registration Number: NCT00319917
• Lead Sponsor: Astellas Pharma Inc

Brief Summary

The purpose of the study is to assess the efficacy on joint damage and safety in RA patients treated with DMARDs in a double blind, placebo controlled study.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-04
• Study First Submitted: 2006-04-27
• Study First Submitted QC: 2006-04-27
• Study First Posted: 2006-04-27
• Primary Completion: 2008-10
• Study Completion: 2008-10
• Status Verified: 2014-08
• Last Update Submitted: 2014-08-19
• Last Update Posted: 2014-08-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 123

Inclusion Criteria

• Clinically diagnosed as rheumatoid arthritis by the revised ACR criteria
• Those who have been treated with an adequate stable dose of either methotrexate, salazosulfapyridine or bucillamine
• Those who have at least one erosion on X-ray of hands, wrists or feet

Exclusion Criteria

• Those who have been treated with any biologic drugs or leflunomide
• Those who meet Class 4 with the Steinbrocker functional classification

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	placebo	-
1	tacrolimus	-

Primary Outcome Measures

Name	Time	Method
Radiographic progression of structural joint damage	52 Weeks

Secondary Outcome Measures

Name	Time	Method
Signs and symptoms of rheumatoid arthritis	52 Weeks