Back to resultsA Double Blind Placebo Controlled Study to Assess the Efficacy on Joint Damage in RA Patients
Primary Purpose
Rheumatoid Arthritis
Status
Completed
Phase
Phase 4
Locations
Japan
Study Type
Interventional
Intervention
tacrolimus
placebo
Sponsored by
About this trial
This is an interventional treatment trial for Rheumatoid Arthritis focused on measuring Tacrolimus, Rheumatoid Arthritis, Tacrolimus anhydrous
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
1
2
Arm Description
Outcomes
Primary Outcome Measures
Radiographic progression of structural joint damage
Secondary Outcome Measures
Signs and symptoms of rheumatoid arthritis
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00319917
Brief Title
A Double Blind Placebo Controlled Study to Assess the Efficacy on Joint Damage in RA Patients
Official Title
FK506 Phase 4 Study: A Double Blind Placebo Controlled Study to Assess the Efficacy on Joint Damage in RA Patients
Study Type
Interventional
2. Study Status
Record Verification Date
August 2014
Overall Recruitment Status
Completed
Study Start Date
April 2006 (undefined)
Primary Completion Date
October 2008 (Actual)
Study Completion Date
October 2008 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Astellas Pharma Inc
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rheumatoid Arthritis
Keywords
Tacrolimus, Rheumatoid Arthritis, Tacrolimus anhydrous
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
123 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Title
2
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
tacrolimus
Other Intervention Name(s)
Prograf, FK506
Intervention Description
oral
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
oral
Primary Outcome Measure Information:
Title
Radiographic progression of structural joint damage
Time Frame
52 Weeks
Secondary Outcome Measure Information:
Title
Signs and symptoms of rheumatoid arthritis
Time Frame
52 Weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Central Contact
Organizational Affiliation
Astellas Pharma Inc
Official's Role
Study Chair
Facility Information:
City
Chyugoku region
Country
Japan
City
Hokkaido region
Country
Japan
City
Hokuriku region
Country
Japan
City
Kansai region
Country
Japan
City
Kanto region
Country
Japan
City
Kyushu region
Country
Japan
City
Shin-etsu region
Country
Japan
City
Tohoku region
Country
Japan
12. IPD Sharing Statement
Links:
URL
http://www.clinicaltrials.jp/user/ctrSearch_e.jsp
Description
Link to Results on JAPIC - enter 140533 in the JapicCTI-RNo. field
Learn more about this trial
A Double Blind Placebo Controlled Study to Assess the Efficacy on Joint Damage in RA Patients
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