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Completed

NCT Number: NCT00319917

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

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.

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Key information

Conditions

Rheumatoid Arthritis Arthritis Arthritis, Rheumatoid Autoimmune Diseases Connective Tissue Diseases Immune System Diseases Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Skin and Connective Tissue Diseases

Age range

20 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Chyugoku Region, Japan

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Tacrolimus

Drug

oral

Other names: Prograf, FK506

Placebo

Drug

oral

Primary outcomes

  1. Radiographic progression of structural joint damage

    Time frame: 52 Weeks

Secondary outcomes

  1. Signs and symptoms of rheumatoid arthritis

    Time frame: 52 Weeks

Sponsors and collaborators

Lead sponsor

Astellas Pharma Inc

Industry

Registry information

Official study title

FK506 Phase 4 Study: A Double Blind Placebo Controlled Study to Assess the Efficacy on Joint Damage in RA Patients

Important dates

Study start
2006
Primary completion
2008
Study completion
2008
First posted
Apr 27, 2006
Registry last updated
Aug 21, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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