drugset / Trial / NCT01303874

Etanercept and Methotrexate in Patients to Induce Remission in Early Arthritis (EMPIRE)

NCT01303874

Phase 4 Completed 112 enrolled University of Leeds
RandomizedParallel-groupQuadruple-blindTreatment

Summary

TRIAL DESIGN 1. Description This is a 18-month, double-blind, randomized, multicentre, outpatient study. The approximate duration of subject participation will be 18 months and the approximate total duration of the study will be 42 months. The duration of subject enrollment will be approximately 24 months. 2. Discussion of Trial Design The study is designed to directly compare the effectiveness of combination therapy with MTX + ETN versus 3. Principal research question/objective To determine the number of patients in clinical remission at 12 months of follow-up, as defined as the absence of symptoms and signs of inflammatory arthritis.

Timeline

Start
2006-09
Primary completion
2010-11-05
Completion
2010-11-05

Drugs

EvaluationDrugModalityDoseRoute
Subject Etanercept Protein / enzyme biologic 50 mg Subcutaneous

Indications