MedTrace Logo

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

NCT01303874 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 112

Last updated 2019-11-01

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Etanercept (ETN)

ETN 50 mg subcutaneous (SC) injections once weekly and MTX orally once weekly.

DRUG

Placebo

ETN-matching placebo SC injections once weekly and MTX orally once weekly.

Sponsors & Collaborators

  • University of Leeds

    lead OTHER

Principal Investigators

  • Paul Emery, Prof · University of Leeds

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-09-30
Primary Completion
2010-11-05
Completion
2010-11-05

Countries

  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
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 NCT01303874 on ClinicalTrials.gov