MedTrace Logo

Switching Anti-TNF-Alpha Agents in Rheumatoid Arthritis (RA)

NCT00796705 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 13

Last updated 2012-10-04

Study results available
· View outcomes & findings →

Summary

Rheumatoid Arthritis (RA) is a systemic inflammatory autoimmune disorder that leads to inflammation and progressive joint damage affecting 2.5 million people in the United States. The primary purpose of this study is to determine the effectiveness of switching to an alternative Tumor Necrosis Factor (TNF) alpha inhibitor in comparison to continuing treatment with an existing TNF-alpha inhibitor in adults suffering from RA in a setting of inadequate clinical response to etanercept or adalimumab.

Conditions

Interventions

DRUG

Adalimumab

40 mg injection of adalimumab administered subcutaneously

DRUG

Adalimumab placebo

1.0 ml .9% saline placebo administered subcutaneously

DRUG

Etanercept

50 mg dimeric fusion protein administered subcutaneously

Sponsors & Collaborators

  • National Institute of Allergy and Infectious Diseases (NIAID)

    lead NIH

Principal Investigators

  • Larry Moreland, MD · University of Pittsburgh

  • Mark Genovese, MD · Stanford University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-11-30
Primary Completion
2010-10-31
Completion
2010-10-31

Countries

  • United States

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 NCT00796705 on ClinicalTrials.gov