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

NCT00688103 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 151

Last updated 2015-10-01

Study results available
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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)

Conditions

Interventions

DRUG

ETN Alone

etanercept (25 mg, twice/week, s.c.)

DRUG

ETN+MTX

etanercept (25 mg, twice/week, s.c.) combined with methotrexate (6-8 mg/week)

Sponsors & Collaborators

  • Japan Biological Agent Study Integrated Consortium

    lead NETWORK

Principal Investigators

  • Tsutomu Takeuchi, MD, PhD · JBASIC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-06-30
Primary Completion
2008-10-31
Completion
2010-10-31

Countries

  • Japan

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00688103 on ClinicalTrials.gov