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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00319917
Recruitment Status : Completed
First Posted : April 27, 2006
Last Update Posted : August 21, 2014
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Rheumatoid Arthritis Drug: tacrolimus Drug: placebo Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 123 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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
Study Start Date : April 2006
Actual Primary Completion Date : October 2008
Actual Study Completion Date : October 2008

Resource links provided by the National Library of Medicine

Drug Information available for: Tacrolimus

Arm Intervention/treatment
Experimental: 1 Drug: tacrolimus
Other Names:
  • Prograf
  • FK506

Placebo Comparator: 2 Drug: placebo

Primary Outcome Measures :
  1. Radiographic progression of structural joint damage [ Time Frame: 52 Weeks ]

Secondary Outcome Measures :
  1. Signs and symptoms of rheumatoid arthritis [ Time Frame: 52 Weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): 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

Additional Information:
Responsible Party: Astellas Pharma Inc Identifier: NCT00319917     History of Changes
Other Study ID Numbers: API-506-RA05
First Posted: April 27, 2006    Key Record Dates
Last Update Posted: August 21, 2014
Last Verified: August 2014

Keywords provided by Astellas Pharma Inc:
Rheumatoid Arthritis
Tacrolimus anhydrous

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