Phase III Study of BMS-188667 (CTLA4Ig) in Patients With Rheumatoid Arthritis Who Are Currently Failing Anti-TNF Therapy or Who Have Failed Anti-TNF Therapy in the Past.
NCT ID: NCT00048581
Last Updated: 2011-11-21
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE3
738 participants
INTERVENTIONAL
2002-12-31
2009-09-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Abatacept
Short Term Portion of Study
Abatacept
Vials, intravenous (IV), \~10mg/kg abatacept, One every 2 weeks for first month then every 4 weeks thereafter, 6 months.
Placebo
Short Term Portion of Study
Placebo
Vials, IV, 0mg, One every 2 weeks for first month then every 4 weeks thereafter, 6 months.
Abatacept (Long Term)
Long Term Portion of Study:
All participants receive Active Drug
Abatacept
Vials, IV, \~10mg/kg abatacept, every 4 weeks, 5.5 years
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Abatacept
Vials, intravenous (IV), \~10mg/kg abatacept, One every 2 weeks for first month then every 4 weeks thereafter, 6 months.
Placebo
Vials, IV, 0mg, One every 2 weeks for first month then every 4 weeks thereafter, 6 months.
Abatacept
Vials, IV, \~10mg/kg abatacept, every 4 weeks, 5.5 years
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Exclusion Criteria
* Current symptoms of serious medical disease
* History of cancer in last 5 years other than non-melanoma skin cancer
* Chronic serious infection
* Active TB requiring treatment in last 5 years
* Herpes zoster in last 2 months
* Any active viral infection including Human Immunodeficiency Virus (HIV)
* Serious side effects associated with previous anti-TNF therapy
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Bristol-Myers Squibb
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Local Institution
Birmingham, Alabama, United States
Local Institution
Mobile, Alabama, United States
Local Institution
Paradise Valley, Arizona, United States
Local Institution
La Jolla, California, United States
Local Institution
Long Beach, California, United States
Local Institution
Palo Alto, California, United States
Local Institution
Rancho Mirage, California, United States
Local Institution
Denver, Colorado, United States
Local Institution
Englewood, Colorado, United States
Local Institution
Bridgeport, Connecticut, United States
Local Institution
Hamden, Connecticut, United States
Local Institution
Clearwater, Florida, United States
Local Institution
Fort Lauderdale, Florida, United States
Local Institution
Largo, Florida, United States
Local Institution
Palm Harbor, Florida, United States
Local Institution
Tampa, Florida, United States
Local Institution
Rome, Georgia, United States
Local Institution
Indianapolis, Indiana, United States
Local Institution
Wichita, Kansas, United States
Local Institution
New Orleans, Louisiana, United States
Local Institution
Boston, Massachusetts, United States
Local Institution
Springfield, Massachusetts, United States
Local Institution
Lincoln, Nebraska, United States
Local Institution
New Brunswick, New Jersey, United States
Local Institution
Albany, New York, United States
Local Institution
Syracuse, New York, United States
Local Institution
Charlotte, North Carolina, United States
Local Institution
Hickory, North Carolina, United States
Local Institution
Bismarck, North Dakota, United States
Local Institution
Cincinnati, Ohio, United States
Local Institution
Oklahoma City, Oklahoma, United States
Local Institution
Eugene, Oregon, United States
Local Institution
Portland, Oregon, United States
Local Institution
Duncansville, Pennsylvania, United States
Local Institution
Norristown, Pennsylvania, United States
Local Institution
Sellersville, Pennsylvania, United States
Local Institution
Willow Grove, Pennsylvania, United States
Local Institution
Charleston, South Carolina, United States
Local Institution
Austin, Texas, United States
Local Institution
Dallas, Texas, United States
Local Institution
Vancouver, Washington, United States
Local Institution
Milwaukee, Wisconsin, United States
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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. doi: 10.1185/030079908x297376. Epub 2008 Apr 9.
Stewart AL and Ware JE. Measuring function and well being. The Medical Outcomes Study Approach. Durham, NC: Duke University Press. 1992.
Spritzer KL, Hays RD. (2003, November). MOS Sleep Scale: A Manual For Use and Scoring, Version 1.0. Los Angeles, CA.
Alten R, Burkhardt H, Feist E, Kruger K, Rech J, Rubbert-Roth A, Voll RE, Elbez Y, Rauch C. Abatacept used in combination with non-methotrexate disease-modifying antirheumatic drugs: a descriptive analysis of data from interventional trials and the real-world setting. Arthritis Res Ther. 2018 Jan 2;20(1):1. doi: 10.1186/s13075-017-1488-5.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
IM101-029
Identifier Type: -
Identifier Source: org_study_id