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

Rheumatoid Arthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00319917
• Other study ID #: API-506-RA05
• Status: Completed
• Phase: Phase 4
• First received: April 27, 2006
• Last updated: August 19, 2014
• Start date: April 2006
• Est. completion date: October 2008

Study information

• Verified date: August 2014
• Source: Astellas Pharma Inc
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 123
• Est. completion date: October 2008
• Est. primary completion date: October 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 64 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Intervention

Drug:
• tacrolimus
oral
• placebo
oral

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Astellas Pharma Inc

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Radiographic progression of structural joint damage		52 Weeks	No
Secondary	Signs and symptoms of rheumatoid arthritis		52 Weeks	No

External Links

•   Link to Results on JAPIC - enter 140533 in the JapicCTI-RNo. field