Efficacy and Safety of Etanercept in Active RA Despite Methotrexate Therapy in Japan

• Status: Completed
• Trial end date: 2010-10-01
• Target enrollment: 0
• Participant gender: All

Summary

Multi-center, parallel-group, randomized, open control study. All patients will be selected to two treatment groups.

1. Etanercept alone treatment group (25mg, twice/week, s.c.)

2. Etanercept combined with MTX group (25mg, twice/week, s.c.+MTX 6-8mg/week)

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Japan Biological Agent Study Integrated Consortium
• Treatments: Etanercept; Methotrexate

Criteria

Inclusion Criteria:

• Patients had to be at least 18 years of age

• fulfilled the 1987 revised classification criteria for RA by in American College of Rheumatology (ACR)

• met the guidelines for the proper use of ETN in Japan (having at least 6 tender joints and 6 swollen joints

• either serum C-reactive protein more than 2 mg/dl or ESR no less than 28 mm at 1 hour, with adequate safety profiles)

• be ACR functional class I-III

• have been receiving MTX 6 mg/week for a minimum of 3 months at a stable dose for at least 4 weeks at the time of study enrollment

Exclusion Criteria:

• Patients who required concurrent use of prednisone (PSL) >10 mg/day, or its equivalent, were excluded from study entry

• the start of dose increment of PSL equivalents within 3 months of the study enrollment

• experience of antirheumatic therapy except for MTX and PSL equivalents

• previous treatment with ETN or any other biological treatment