Study of Abatacept (BMS-188667) in Subjects With Active Rheumatoid Arthritis on Background Non-biologic DMARDS (Disease Modifying Antirheumatic Drugs) Who Have an Inadequate Response to Anti-TNF Therapy - Full Text View

Sponsor:	Bristol-Myers Squibb
Information provided by:	Bristol-Myers Squibb
ClinicalTrials.gov Identifier:	NCT00124982

Purpose

The purpose of this study is to learn if Abatacept will provide clinical efficacy to subjects who have failed an anti-TNF therapy. The safety of this treatment will also be studied.

Condition	Intervention	Phase
Rheumatoid Arthritis	Drug: Abatacept	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study
Official Title:	A Phase III, Multi-Center, Open Label Study to Evaluate the Efficacy, Tolerability and Safety of Abatacept (BMS-188667) in Subjects With Active Rheumatoid Arthritis on Background Non-Biologic DMARDs Who Have an Inadequate Response to Anti-TNF Therapy and Have Limited Therapeutic Options

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:

Assess the long term safety and tolerability of abatacept in subjects who have completed the initial 6 month open label treatment period [ Time Frame: open label treatment period ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Assess efficacy and immunogenicity of abatacept in combination with non-biologic DMARDs [ Time Frame: open label treatment period ] [ Designated as safety issue: No ]
Assess maintenance of response in subjects who eliminate or reduce their dose of concomitant non-biologic background DMARD therapy [ Time Frame: open label period ] [ Designated as safety issue: No ]

Enrollment:	535
Study Start Date:	October 2005
Study Completion Date:	August 2009
Primary Completion Date:	August 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A1: Experimental	Drug: Abatacept IV solution, IV infusion, between 500mg and 1gram based on body weight, monthly, 6 months.

Eligibility

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

Criteria

Inclusion Criteria:

Completed double-blind portion of the IM101064 study.
Rheumatoid arthritis (RA) for greater than 1 year from the time of initial diagnosis
American College of Rheumatology (ACR) functional class I, II, III
Subjects currently or previously received an anti-TNF therapy at an approved labeled dose for at least 3 months

Exclusion Criteria:

Subjects with active vasculitis of a major organ system (except subcutaneous rheumatoid nodules)
History of cancer within the last 5 years (other than non-melanoma skin cell cancers cured by local resection)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00124982

Show 157 Study Locations

Sponsors and Collaborators

Bristol-Myers Squibb

Investigators

Study Director:

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 by Bristol-Myers Squibb

Additional publications automatically indexed to this study by National Clinical Trials Identifier (NCT ID):

Schiff M, Pritchard C, Huffstutter JE, Rodriguez-Valverde V, Durez P, Zhou X, Li T, Bahrt K, Kelly S, Le Bars M, Genovese MC. The 6-month safety and efficacy of abatacept in patients with rheumatoid arthritis who underwent a washout after anti-tumour necrosis factor therapy or were directly switched to abatacept: the ARRIVE trial. Ann Rheum Dis. 2009 Nov;68(11):1708-14. Epub 2008 Dec 15.

Hassett AL, Li T, Buyske S, Savage SV, Gignac MA. The multi-faceted assessment of independence in patients with rheumatoid arthritis: preliminary validation from the ATTAIN study. Curr Med Res Opin. 2008 May;24(5):1443-53. Epub 2008 Apr 9.

Genovese MC, Schiff M, Luggen M, Becker JC, Aranda R, Teng J, Li T, Schmidely N, Le Bars M, Dougados M. Efficacy and safety of the selective co-stimulation modulator abatacept following 2 years of treatment in patients with rheumatoid arthritis and an inadequate response to anti-tumour necrosis factor therapy. Ann Rheum Dis. 2008 Apr;67(4):547-54. Epub 2007 Oct 5.

Study ID Numbers:	IM101-064
Study First Received:	June 30, 2005
Last Updated:	September 2, 2009
ClinicalTrials.gov Identifier:	NCT00124982 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