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

Japan Biological Agent Study Integrated Consortium

Status and phase

Completed

Phase 4

Conditions

Rheumatoid Arthritis

Treatments

Drug: ETN Alone

Drug: ETN+MTX

Study type

Interventional

Funder types

NETWORK

Identifiers

Etanercept-01

Details and patient eligibility

About

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

Enrollment

151 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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