Overview

This trial is active, not recruiting.

Condition rheumatoid arthritis
Treatment etanercept and methotrexate
Phase phase 4
Sponsor Japan Biological Agent Study Integrated Consortium
Start date June 2005
End date May 2008
Trial size 150 participants
Trial identifier NCT00688103, Etanercept-01

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)

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Active Comparator)
Etanercept alone treatment group (25mg, twice/week, s.c.)
etanercept and methotrexate
etanercept 25 mg, twice a week, alone or with methotrexate 6-8 mg/week
(Active Comparator)
Etanercept combined with MTX group (25mg, twice/week, s.c.+MTX 6-8mg/week)
etanercept and methotrexate
etanercept 25 mg, twice a week, alone or with methotrexate 6-8 mg/week

Primary Outcomes

Measure
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 Outcomes

Measure
secondary endpoints: ACR 20 and 70 responses
time frame: at 24

Eligibility Criteria

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

Additional Information

Official title Efficacy and Safety of Etanercept on Active RA Despite MTX Therapy in Japan
Trial information was received from ClinicalTrials.gov and was last updated in May 2008.
Information provided to ClinicalTrials.gov by Japan Biological Agent Study Integrated Consortium.