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

Show 44 Study Locations

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