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

Sponsor:	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

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

Resource links provided by NLM:

MedlinePlus related topics: Rheumatoid Arthritis

Drug Information available for: Abatacept

U.S. FDA Resources

Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:

incidence of AE, SAE, discontinuation due to AE [ Time Frame: Throughout the study, for 60 months ] [ Designated as safety issue: Yes ]

Enrollment:	1795
Study Start Date:	December 2002
Study Completion Date:	October 2009
Primary Completion Date:	October 2009 (Final data collection date for primary outcome measure)

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.

Detailed Description:

Open Label - Active study drug (solution, intravenous, Approximately 10 mg/kg fixed dose, based on subject's body weight; 500 mg for subjects weighing < 60kg; 750 mg for subjects weighing 60 to 100 kg; and 1 gram for subjects weighing > 100 kg, monthly)

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

Hide Study Locations

Locations

United States, Alabama
Local Institution
Decatur, Alabama, United States
United States, Arizona
Local Institution
Paradise, Arizona, United States
Local Institution
Phoenix, Arizona, United States
Local Institution
Tucson, Arizona, United States
United States, California
Local Institution
San Francisco, California, United States
United States, Colorado
Local Institution
Loveland, Colorado, United States
United States, Connecticut
Local Institution
Hamden, Connecticut, United States
United States, Florida
Local Institution
Lake Worth, Florida, United States
Local Institution
Largo, Florida, United States
United States, Georgia
Local Institution
Blairsville, Georgia, United States
United States, Illinois
Local Institution
Chicago, Illinois, United States
United States, Indiana
Local Institution
Evansville, Indiana, United States
Local Institution
Indianapolis, Indiana, United States
United States, Kansas
Local Institution
Wichita, Kansas, United States
United States, Kentucky
Local Institution
Louisville, Kentucky, United States
United States, Louisiana
Local Institution
New Orleans, Louisiana, United States
United States, Maryland
Local Institution
Baltimore, Maryland, United States
Local Institution
Cumberland, Maryland, United States
Local Institution
Westminster, Maryland, United States
United States, Massachusetts
Local Institution
Boston, Massachusetts, United States
United States, Michigan
Local Institution
Grand Rapids, Michigan, United States
Local Institution
Royal Oak, Michigan, United States
United States, New Jersey
Local Institution
Toms River, New Jersey, United States
United States, New Mexico
Local Institution
Los Alamos, New Mexico, United States
United States, New York
Local Institution
New York, New York, United States
United States, North Carolina
Local Institution
Hickory, North Carolina, United States
Local Instituton
Durham, North Carolina, United States
United States, Ohio
Local Institution
Canton, Ohio, United States
Local Institution
Cleveland, Ohio, United States
Local Institution
Columbus, Ohio, United States
Local Institution
Elyria, Ohio, United States
Local Institution
Youngstown, Ohio, United States
United States, Oklahoma
Local Institution
Oklahoma City, Oklahoma, United States
United States, Pennsylvania
Local Institution
Wyomissing, Pennsylvania, United States
United States, South Carolina
Local Institution
Columbia, South Carolina, United States
United States, South Dakota
Local Institution
Sioux Falls, South Dakota, United States
United States, Tennessee
Local Institution
Ducktown, Tennessee, United States
Local Institution
Nashville, Tennessee, United States
United States, Virginia
Local Institution
Richmond, Virginia, United States
United States, Washington
Local Institution
Edmonds, Washington, United States
Local Institution
Olympia, Washington, United States
Local Institution
Tacoma, Washington, United States
United States, Wisconsin
Local Institution
Menomonee Falls, Wisconsin, United States
Local Institution
Milwaukee, Wisconsin, United States

Sponsors and Collaborators

Bristol-Myers Squibb

More Information

Additional 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

No publications provided

Responsible Party:	Bristol-Myers Squibb ( Study Director )
Study ID Numbers:	IM101-031
Study First Received:	November 11, 2002
Last Updated:	October 6, 2009
ClinicalTrials.gov Identifier:	NCT00048932 History of Changes
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Autoimmune Diseases
Immunologic Factors
Immune System Diseases
Joint Diseases
Physiological Effects of Drugs
Arthritis, Rheumatoid
Rheumatic Diseases
Immunosuppressive Agents

Pharmacologic Actions
Abatacept
Musculoskeletal Diseases
Arthritis
Therapeutic Uses
Connective Tissue Diseases
Antirheumatic Agents

ClinicalTrials.gov processed this record on November 27, 2009