MedTrace Logo

Study of Etanercept in Subjects With Rheumatoid Arthritis Who Have Had an Inadequate Response to Adalimumab or Infliximab Plus Methotrexate

NCT01783015 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2016-01-06

Study results available
· View outcomes & findings →

Summary

The first 12 weeks of this study will compare the efficacy of etanercept 50 mg once-weekly to placebo in subjects with rheumatoid arthritis who have not responded well to infliximab or adalimumab plus methotrexate. This comparison will be performed for all subjects and separately for subjects who are anti-drug antibody positive for one of these medications. From week 12 to week 24, all subjects will receive etanercept 50 mg once-weekly. The effect of anti-drug antibody status on the efficacy of etanercept as well as the safety profile of etanercept in these subjects will also be evaluated throughout the study.

Conditions

Interventions

DRUG

Etanercept

Etanercept 50 mg once-weekly

DRUG

Etanercept

Etanercept 50 mg once-weekly

DRUG

Placebo

Etanercept placebo once-weekly

DRUG

Placebo

Etanercept placebo once-weekly

Sponsors & Collaborators

Principal Investigators

  • Pfizer CT.gov Call Center · Pfizer

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2013-09-30
Primary Completion
2014-08-31
Completion
2014-08-31

Countries

  • Australia
  • Belgium
  • France
  • Hong Kong
  • Israel
  • Russia
  • Spain

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

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 NCT01783015 on ClinicalTrials.gov