Full Text View
Tabular View
No Study Results Posted
Related Studies
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
This study has been completed.
First Received: June 30, 2005   Last Updated: September 2, 2009   History of Changes
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

  Hide Study Locations
Locations
United States, Alabama
Local Institution
Birmingham, Alabama, United States
Local Institution
Huntsville, Alabama, United States
United States, Arizona
Local Institution
Tucson, Arizona, United States
Local Institution
Paradise Valley, Arizona, United States
Local Institution
Peoria, Arizona, United States
United States, California
Local Institution
Palo Alto, California, United States
Local Institution
San Diego, California, United States
Local Institution
Santa Monica, California, United States
Local Institution
Palm Springs, California, United States
Local Institution
Long Beach, California, United States
Local Institution
Long Beach, California, United States
United States, Colorado
Local Institution
Denver, Colorado, United States
Local Institution
Colorado Springs, Colorado, United States
United States, Connecticut
Local Institution
Hamden, Connecticut, United States
Local Institution
Trumbull, Connecticut, United States
Local Institution
Danbury, Connecticut, United States
United States, District of Columbia
Local Institution
Washington, District of Columbia, United States
United States, Florida
Local Institution
Aventura, Florida, United States
Local Institution
Jupiter, Florida, United States
Local Institution
Clearwater, Florida, United States
Local Institution
Ft. Lauderdale, Florida, United States
Local Institution
Largo, Florida, United States
Local Institution
Sarasota, Florida, United States
United States, Georgia
Local Institution
Atlanta, Georgia, United States
Local Institution
Macon, Georgia, United States
Local Institution
Blue Ridge, Georgia, United States
United States, Illinois
Local Institution
Morton Grove, Illinois, United States
United States, Indiana
Local Institution
Indianapolis, Indiana, United States
Local Institution
Evansville, Indiana, United States
United States, Iowa
Local Institution
Des Moines, Iowa, United States
United States, Kansas
Local Institution
Kansas City, Kansas, United States
Local Institution
Prairie Village, Kansas, United States
United States, Kentucky
Local Institution
Louisville, Kentucky, United States
Local Institution
Bowling Green, Kentucky, United States
United States, Louisiana
Local Institution
New Orleans, Louisiana, United States
Local Institution
New Orleans, Louisiana, United States
United States, Massachusetts
Local Institution
Boston, Massachusetts, United States
Local Institution
Peabody, Massachusetts, United States
Local Institution
Springfield, Massachusetts, United States
Local Institution
Worcester, Massachusetts, United States
Local Institution
Springfield, Massachusetts, United States
United States, Michigan
Local Institution
Ann Arbor, Michigan, United States
Local Institution
Grand Rapids, Michigan, United States
Local Institution
Lansing, Michigan, United States
Local Institution
Petockey, Michigan, United States
Local Institution
East Lansing, Michigan, United States
United States, Minnesota
Local Institution
St. Paul, Minnesota, United States
Local Institution
Minneapolis, Minnesota, United States
Local Institution
St. Paul, Minnesota, United States
United States, Nebraska
Local Institution
Omaha, Nebraska, United States
United States, Nevada
Local Institution
Las Vegas, Nevada, United States
United States, New Hampshire
Local Institution
Lebanon, New Hampshire, United States
Local Institution
Nashua, New Hampshire, United States
United States, New Jersey
Local Institution
Cherry Hill, New Jersey, United States
Local Institution
Voorhees, New Jersey, United States
Local Institution
Manalapan, New Jersey, United States
Local Institution
New Brunswick, New Jersey, United States
Local Institution
Teaneck, New Jersey, United States
Local Institution
Dover, New Jersey, United States
Local Institution
Somerset, New Jersey, United States
United States, New York
Local Institution
Brooklyn, New York, United States
Local Institution
Hewlett, New York, United States
Local Institution
Lake Success, New York, United States
Local Institution
Mineola, New York, United States
Local Institution
Olean, New York, United States
Local Institution
Orchard Park, New York, United States
Local Institution
Rochester, New York, United States
Local Institution
Smithtown, New York, United States
Local Institution
New York, New York, United States
Local Institution
Schenectady, New York, United States
Local Institution
Albany, New York, United States
Local Institution
Syracuse, New York, United States
Local Institution
New York, New York, United States
United States, North Carolina
Local Institution
Asheville, North Carolina, United States
Local Institution
Charlotte, North Carolina, United States
Local Institution
Wilmington, North Carolina, United States
Local Institution
Hickory, North Carolina, United States
United States, North Dakota
Local Institution
Bismark, North Dakota, United States
United States, Ohio
Local Institution
Akron, Ohio, United States
Local Institution
Beachwood, Ohio, United States
Local Institution
Columbus, Ohio, United States
Local Institution
Mayfield Village, Ohio, United States
Local Institution
Youngstown, Ohio, United States
Local Institution
Cleveland, Ohio, United States
United States, Oregon
Local Institution
Portland, Oregon, United States
Local Institution
Portland, Oregon, United States
United States, Pennsylvania
Local Institution
Bethlehem, Pennsylvania, United States
Local Institution
Camp Hill, Pennsylvania, United States
Local Institution
Philadelphia, Pennsylvania, United States
Local Institution
Meadville, Pennsylvania, United States
Local Institution
Philadelphia, Pennsylvania, United States
Local Institution
Pittsburgh, Pennsylvania, United States
Local Institution
West Reading, Pennsylvania, United States
Local Institution
Wexford, Pennsylvania, United States
Local Institution
Duncansville, Pennsylvania, United States
Local Institution
Willow Grove, Pennsylvania, United States
Local Institution
Bala Cynwyd, Pennsylvania, United States
Local Institution
Erie, Pennsylvania, United States
United States, Rhode Island
Local Institution
Providence, Rhode Island, United States
United States, South Carolina
Local Institution
Simpsonville, South Carolina, United States
Local Institution
Myrtle Beach, South Carolina, United States
United States, South Dakota
Local Institution
Sioux Falls, South Dakota, United States
United States, Tennessee
Local Institution
Hixson, Tennessee, United States
Local Institution
Knoxville, Tennessee, United States
United States, Texas
Local Institution
Corpus Christi, Texas, United States
Local Institution
Dallas, Texas, United States
Local Institution
Galveston, Texas, United States
Local Institution
Houston, Texas, United States
Local Institution
Lubbock, Texas, United States
Local Institution
San Antonio, Texas, United States
Local Institution
Sugarland, Texas, United States
Local Institution
Austin, Texas, United States
United States, Virginia
Local Institution
Burke, Virginia, United States
Local Institution
Fairfax, Virginia, United States
Local Institution
Salem, Virginia, United States
Local Institution
Chesapeake, Virginia, United States
United States, Washington
Local Institution
Seattle, Washington, United States
Local Institution
Vancouver, Washington, United States
United States, Wisconsin
Local Institution
La Crosse, Wisconsin, United States
Local Institution
Madison, Wisconsin, United States
Local Institution
Glendale, Wisconsin, United States
Belgium
Local Institution
Bruxelles, Belgium
Local Institution
Leuven, Belgium
Local Institution
Bruxelles, Belgium
Czech Republic
Local Institution
Prague 2, Czech Republic
France
Local Institution
Boisguillaume, France
Local Institution
Bordeaux Cedex, France
Local Institution
Montpellier, France
Local Institution
Paris, France
Local Institution
Strasbourg Cedex, France
Local Institution
Toulouse, France
Local Institution
Brest Cedex, France
Local Institution
Chambray Les Tours, France
Local Institution
Nice Cedex 03, France
Local Institution
Rennes Cedex 9, France
Germany
Local Institution
Freiburg, Germany
Local Institution
Kiel, Germany
Local Institution
Leipzig, Germany
Local Institution
Hamburg, Germany
Local Institution
Tuebingen, Germany
Ireland
Local Institution
Cork, Ireland
Italy
Local Institution
Genova, Italy
Local Institution
Milano, Italy
Local Institution
Torino, Italy
Mexico
Local Institution
Distrito Federal, Mexico
Local Institution
Distrito Federal, Mexico
Mexico, Jalisco
Local Institution
Guadalajara, Jalisco, Mexico
Spain
Local Institution
Alicante, Spain
Local Institution
Barcelona, Spain
Local Institution
Santander, Spain
Local Institution
Guipuzcoa, Spain
Local Institution
Madrid, Spain
Local Institution
Valencia, Spain
United Kingdom, Cambridgeshire
Local Institution
Cambridge, Cambridgeshire, United Kingdom
United Kingdom, Greater Manchester
Local Institution
Manchester, Greater Manchester, United Kingdom
United Kingdom, Kent
Local Institution
Maidstone, Kent, United Kingdom
United Kingdom, North Yorkshire
Local Institution
Leeds, North Yorkshire, United Kingdom
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
Study Director: Bristol-Myers Squibb 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



Contact Help Desk
Lister Hill National Center for Biomedical Communications,  U.S. National Library of Medicine,
U.S. National Institutes of Health,  U.S. Department of Health & Human Services,
USA.gov,  Copyright,  Privacy,  Accessibility,  Freedom of Information Act

U.S. National Institutes of Health U.S. National Library of Medicine U.S. Department of Health & Human Services