Status:
COMPLETED
Efficacy and Safety of Etanercept in Active RA Despite Methotrexate Therapy in Japan
Lead Sponsor:
Japan Biological Agent Study Integrated Consortium
Conditions:
Rheumatoid Arthritis
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief 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 combine...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2010
Estimated Enrollment :
151 Patients enrolled
Trial Details
Trial ID
NCT00688103
Start Date
June 1 2005
End Date
October 1 2010
Last Update
October 1 2015
Active Locations (1)
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1
Keio University
Tokyo, Tokyo, Japan, 160-8582