Efficacy and Safety of Etanercept on Active Rheumatoid Arthritis (RA) Despite Methotrexate (MTX) Therapy in Japan
This trial is active, not recruiting.
|Treatment||etanercept and methotrexate|
|Sponsor||Japan Biological Agent Study Integrated Consortium|
|Start date||June 2005|
|End date||May 2008|
|Trial size||150 participants|
|Trial identifier||NCT00688103, Etanercept-01|
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)
|Intervention model||parallel assignment|
primary endpoint: ACR 50% and DAS28 good response
time frame: at 24 weeks
joint destruction (total modified sharp score)
time frame: at 52 weeks
secondary endpoints: ACR 20 and 70 responses
time frame: at 24
Male or female participants at least 18 years old.
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
|Official title||Efficacy and Safety of Etanercept on Active RA Despite MTX Therapy in Japan|
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