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. - Full Text View

Sponsored by:	Bristol-Myers Squibb
Information provided by:	Bristol-Myers Squibb
ClinicalTrials.gov Identifier:	NCT00048581

Purpose

The purpose of this clinical research study is to determine whether BMS-188667 will relieve the symptoms of rheumatoid arthritis in patients who are currently receiving anti-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 BMS-188667 will also be evaluated.

Condition	Intervention	Phase
Rheumatoid Arthritis	Drug: Abatacept Drug: Placebo	Phase III

MedlinePlus related topics: Rheumatoid Arthritis

Drug Information available for: Abatacept Cytotoxic T-lymphocyte antigen 4

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Phase III, Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of BMS-188667 in Subjects With Active Rheumatoid Arthritis on Background DMARDS Who Have Failed Anti-TNF Therapy

Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:

The clinical efficacy of a fixed dose of abatacept with placebo as assessed by the ACR 20 response rate in subjects with active RA on a background of DMARDs who have failed any anti-TNF therapy [ Time Frame: at 6 months ]

Secondary Outcome Measures:

Compare ACR 50 and ACR 70 response rates [ Time Frame: at 6 months, end of double-blind period. ]
compare ACR 20, ACR 50 and ACR 70 response rates [ Time Frame: over time ]

Estimated Enrollment:	393
Study Start Date:	December 2002

Arms	Assigned Interventions
1: Active Comparator	Drug: Abatacept Vials, IV, ~10mg/kg abatacept, One every 2 weeks for first month then every 4 weeks thereafter, 6 months.
2: Placebo Comparator	Drug: Placebo Vials, IV, 0mg, One every 2 weeks for first month then every 4 weeks thereafter, 6 months.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Eligibility Criteria:

Active rheumatoid arthritis currently failing anti-TNF therapy or have failed anti-TNF therapy in the past.

Exclusion Criteria:

Women who are pregnant or breast feeding
Current symptoms of serious medical disease
History of cancer in last 5 years other than non-melanoma skin cancer
Chronic serious infection
Active TB requiring treatment in last 5 years
Herpes zoster in last 2 months
Any active viral infection including HIV
Serious side effects associated with previous anti-TNF therapy

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00048581

Show 42 Study Locations

Sponsors and Collaborators

Bristol-Myers Squibb

More Information

BMS Clinical Trials Disclosure This link exits the ClinicalTrials.gov site

For FDA Safety Alerts and Recalls refer to the following link www.fda.gov/MEDWATCH/safety.htm This link exits the ClinicalTrials.gov site

Study ID Numbers:	IM101-029
Study First Received:	November 2, 2002
Last Updated:	September 8, 2008
ClinicalTrials.gov Identifier:	NCT00048581
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Abatacept
Autoimmune Diseases
Musculoskeletal Diseases
Joint Diseases
Arthritis

Connective Tissue Diseases
Arthritis, Rheumatoid
Rheumatic Diseases
Cytotoxic T-lymphocyte antigen 4

Additional relevant MeSH terms:

Immunologic Factors
Immune System Diseases
Therapeutic Uses
Physiological Effects of Drugs

Antirheumatic Agents
Immunosuppressive Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 15, 2009