A Phase III Study of BMS-188667 in Subjects With Active Rheumatoid Arthritis - Full Text View

A Phase III Study of BMS-188667 in Subjects With Active Rheumatoid Arthritis

This study has been completed.

Sponsored by:	Bristol-Myers Squibb
Information provided by:	Bristol-Myers Squibb
ClinicalTrials.gov Identifier:	NCT00048932

Purpose

The purpose of this clinical research study is to learn if BMS-188667 is safe when co-administered with other approved rheumatoid arthritis medications.

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

MedlinePlus related topics:

Rheumatoid Arthritis

Drug Information available for:

Abatacept

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment

Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:

incidence of AE, SAE, discontinuation due to AE

Arms	Assigned Interventions
A1: Active Comparator	Drug: Abatacept Concentrate and diluted in a solution, IV, 500 mg (BW < 60 Kg); 750 mg (BW 60-100 Kg); 1000 mg (BW > 100 Kg), Once daily, Day 1, 15, and 29.
A2: Placebo Comparator	Drug: Placebo Concentrate and diluted in a solution, IV, 0 mg, Once daily, Day 1, 15, and 29.
B: Active Comparator	Drug: Abatacept Concentrate and diluted in a solution, IV, 500 mg (BW < 60 Kg); 750 mg (BW 60-100 Kg); 1000 mg (BW > 100 Kg), Once daily, Every 28 days.

Eligibility

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

Criteria

Inclusion Criteria:

Meet criteria of American Rheumatism Association for the diagnosis of rheumatoid arthritis and the American College of Rheumatology functional classes I, II III or IV
Subjects must be taking 1 or more DMARDs and/or biologic approved for RA for at least 3 months and be on a stable dose for 28 days prior to Day 1.

Exclusion:

Other auto-immune disease as a main diagnosis (e.g. SLE, Scleroderma)
Active TB requiring Rx within last 3 years

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00048932

Show 44 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:	IM101-031
First Received:	November 11, 2002
Last Updated:	September 30, 2008
ClinicalTrials.gov Identifier:	NCT00048932
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

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 November 20, 2008