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

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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00319917

Enrollment

123

Registered

2006-04-27

Start date

2006-04-30

Completion date

2008-10-31

Last updated

2014-08-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rheumatoid Arthritis

Keywords

Tacrolimus, Rheumatoid Arthritis, Tacrolimus anhydrous

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.

Interventions

DRUGtacrolimus

oral

DRUGplacebo

oral

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

20 Years to 64 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Radiographic progression of structural joint damage	52 Weeks

Secondary

Measure	Time frame
Signs and symptoms of rheumatoid arthritis	52 Weeks

Countries

Japan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026