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

Astellas

Status and phase: Completed; Phase 4

Conditions: Rheumatoid Arthritis

Treatments: Drug: tacrolimus; Drug: placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00319917

API-506-RA05

Details and patient eligibility

About

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.

Enrollment: 123 patients

Sex: All

Ages: 20 to 64 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

123 participants in 2 patient groups, including a placebo group

1

Experimental group

Treatment:

Drug: tacrolimus

2

Placebo Comparator group

Treatment:

Drug: placebo