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

This study has been completed.
Information provided by (Responsible Party):
Astellas Pharma Inc
ClinicalTrials.gov Identifier:
First received: April 27, 2006
Last updated: August 19, 2014
Last verified: August 2014
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.

Condition Intervention Phase
Rheumatoid Arthritis
Drug: tacrolimus
Drug: placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: FK506 Phase 4 Study: A Double Blind Placebo Controlled Study to Assess the Efficacy on Joint Damage in RA Patients

Resource links provided by NLM:

Further study details as provided by Astellas Pharma Inc:

Primary Outcome Measures:
  • Radiographic progression of structural joint damage [ Time Frame: 52 Weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Signs and symptoms of rheumatoid arthritis [ Time Frame: 52 Weeks ] [ Designated as safety issue: No ]

Enrollment: 123
Study Start Date: April 2006
Study Completion Date: October 2008
Primary Completion Date: October 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: tacrolimus
Other Names:
  • Prograf
  • FK506
Placebo Comparator: 2 Drug: placebo


Ages Eligible for Study:   20 Years to 64 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00319917

Chyugoku region, Japan
Hokkaido region, Japan
Hokuriku region, Japan
Kansai region, Japan
Kanto region, Japan
Kyushu region, Japan
Shin-etsu region, Japan
Tohoku region, Japan
Sponsors and Collaborators
Astellas Pharma Inc
Study Chair: Central Contact Astellas Pharma Inc
  More Information

Additional Information:
Responsible Party: Astellas Pharma Inc
ClinicalTrials.gov Identifier: NCT00319917     History of Changes
Other Study ID Numbers: API-506-RA05 
Study First Received: April 27, 2006
Last Updated: August 19, 2014
Health Authority: Japan: Ministry of Health, Labor and Welfare

Keywords provided by Astellas Pharma Inc:
Rheumatoid Arthritis
Tacrolimus anhydrous

Additional relevant MeSH terms:
Arthritis, Rheumatoid
Autoimmune Diseases
Connective Tissue Diseases
Immune System Diseases
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Calcineurin Inhibitors
Enzyme Inhibitors
Immunologic Factors
Immunosuppressive Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 26, 2016