Status:

COMPLETED

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

Lead Sponsor:

Astellas Pharma Inc

Conditions:

Rheumatoid Arthritis

Eligibility:

All Genders

20-64 years

Phase:

PHASE4

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.

Eligibility Criteria

Inclusion

  • 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

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

Key Trial Info

Start Date :

April 1 2006

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

October 1 2008

Estimated Enrollment :

123 Patients enrolled

Trial Details

Trial ID

NCT00319917

Start Date

April 1 2006

End Date

October 1 2008

Last Update

August 21 2014

Active Locations (8)

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Page 1 of 2 (8 locations)

1

Chyugoku Region, Japan

2

Hokkaido Region, Japan

3

Hokuriku Region, Japan

4

Kansai Region, Japan