MedTrace Logo

Phase III Study of BMS-188667 (CTLA4Ig) in Patients With Rheumatoid Arthritis Who Are Currently Failing Anti-TNF Therapy or Who Have Failed Anti-TNF Therapy in the Past.

NCT00048581 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 738

Last updated 2011-11-21

Study results available
· View outcomes & findings →

Summary

The purpose of this clinical research study is to determine whether abatacept treatment on a background of Disease Modifying Antirheumatic Drugs (DMARDs) will relieve the symptoms of rheumatoid arthritis (RA) in participants who are currently receiving anti-tumor necrosis factor (TNF) therapy for at least 3 months and are not responding or have taken anti-TNF therapy in the last 3 months and did not respond. The safety of treatment with abatacept will also be evaluated. This study also has a 4.5-year long-term extension beginning 6 months after the start of the study.

Conditions

Interventions

DRUG

Abatacept

Vials, intravenous (IV), \~10mg/kg abatacept, One every 2 weeks for first month then every 4 weeks thereafter, 6 months.

DRUG

Placebo

Vials, IV, 0mg, One every 2 weeks for first month then every 4 weeks thereafter, 6 months.

DRUG

Abatacept

Vials, IV, \~10mg/kg abatacept, every 4 weeks, 5.5 years

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2002-12-31
Primary Completion
2009-09-30
Completion
2009-09-30

Countries

  • United States

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 NCT00048581 on ClinicalTrials.gov