A Phase III Study of Abatacept (BMS-188667) in Patients With Active Rheumatoid Arthritis and Inadequate Response to Methotrexate
NCT ID: NCT00048568
Last Updated: 2011-12-05
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
1250 participants
INTERVENTIONAL
2002-12-31
2009-10-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Long Term Extension: The purpose of this amendment is to provide participants who have completed the initial 12-month double-blind treatment period the opportunity to receive open label treatment with active drug treatment until abatacept is approved in the local country or until clinical development has been discontinued.
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 + Methotrexate
Short Term: Abatacept was dosed by weight with participants weighing \< 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants \> 100 kg received abatacept 1 g. Participants continued treatment with methotrexate (MTX) either orally or parenterally at a minimum dose of 15 mg.
Abatacept
Intravenous (IV) Solution, - Weight Titered (500 mg \< 60 kg); (750 mg 60-100 kg), )1 gram \> 100 kg), Day 1, Day 15, Day 29; every 28 days thereafter, 1 year
Methotrexate
Tablets, Oral, \>= 15 mg, weekly, 1 year
Placebo + Methotrexate
Short Term: Participants received a placebo solution intravenously and methotrexate at the dose employed prior to study enrollment and a minimum of 15 mg.
Methotrexate
Tablets, Oral, \>= 15 mg, weekly, 1 year
Placebo
IV solution, Intravenous, D5W, Day 1, Day 15, Day 29; every 28 days thereafter, 1 year
Abatacept + Methotrexate Open Label
Open Label: Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing \< 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants \> 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
Abatacept
Intravenous (IV) Solution, - Weight Titered (500 mg \< 60 kg); (750 mg 60-100 kg), )1 gram \> 100 kg), Day 1, Day 15, Day 29; every 28 days thereafter, 1 year
Methotrexate
Tablets, Oral, \>= 15 mg, weekly, 1 year
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Abatacept
Intravenous (IV) Solution, - Weight Titered (500 mg \< 60 kg); (750 mg 60-100 kg), )1 gram \> 100 kg), Day 1, Day 15, Day 29; every 28 days thereafter, 1 year
Methotrexate
Tablets, Oral, \>= 15 mg, weekly, 1 year
Placebo
IV solution, Intravenous, D5W, Day 1, Day 15, Day 29; every 28 days thereafter, 1 year
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.
Inclusion Criteria
* Participants must have been taking methotrexate for at least 3 months with at least a weekly dose of 15 mg.
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
Huntsville, Alabama, United States
Local Institution
Mobile, Alabama, United States
Local Institution
Phoenix, Arizona, United States
Local Institution
Scottsdale, Arizona, United States
Local Institution
Corona, California, United States
Local Institution
Irvine, California, United States
Local Institution
La Jolla, California, United States
Local Institution
Long Beach, California, United States
Local Institution
Rancho Mirage, California, United States
Local Institution
Aurora, Colorado, United States
Local Institution
Colorado Springs, Colorado, United States
Local Institution
Denver, Colorado, United States
Local Institution
Hamden, Connecticut, United States
Local Institution
Washington D.C., District of Columbia, United States
Local Institution
Fort Lauderdale, Florida, United States
Local Institution
Gainsville, Florida, United States
Local Institution
Palm Harbor, Florida, United States
Local Institution
Sarasota, Florida, United States
Local Institution
St. Petersburg, Florida, United States
Local Institution
Chicago, Illinois, United States
Local Institution
Rockford, Illinois, United States
Local Institution
Wichita, Kansas, United States
Local Institution
Coeur d'Alene, Maryland, United States
Local Institution
Cumberland, Maryland, United States
Local Institution
Springfield, Massachusetts, United States
Local Institution
Duluth, Minnesota, United States
Local Institution
Lincoln, Nebraska, United States
Local Institution
New Brunswick, New Jersey, United States
Local Institution
Albuquerque, New Mexico, United States
Local Institution
Albany, New York, United States
Local Institution
Binghamton, New York, United States
Local Institution
Mineola, New York, United States
Local Institution
New York, New York, United States
Local Institution
Syracuse, New York, United States
Local Institution
The Bronx, New York, United States
Local Institution
Wilmington, North Carolina, United States
Local Institution
Cincinnati, Ohio, United States
Local Institution
Oklahoma City, Oklahoma, 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
North Charleston, South Carolina, United States
Local Institution
Austin, Texas, United States
Local Institution
San Antonio, Texas, United States
Local Institution
Arlington, Virginia, 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.
Kremer JM, Genant HK, Moreland LW, Russell AS, Emery P, Abud-Mendoza C, Szechinski J, Li T, Ge Z, Becker JC, Westhovens R. Effects of abatacept in patients with methotrexate-resistant active rheumatoid arthritis: a randomized trial. Ann Intern Med. 2006 Jun 20;144(12):865-76. doi: 10.7326/0003-4819-144-12-200606200-00003.
Kremer JM, Peterfy C, Russell AS, Emery P, Abud-Mendoza C, Sibilia J, Becker JC, Westhovens R, Genant HK. Longterm safety, efficacy, and inhibition of structural damage progression over 5 years of treatment with abatacept in patients with rheumatoid arthritis in the abatacept in inadequate responders to methotrexate trial. J Rheumatol. 2014 Jun;41(6):1077-87. doi: 10.3899/jrheum.130263. Epub 2014 May 1.
Kremer JM, Genant HK, Moreland LW, Russell AS, Emery P, Abud-Mendoza C, Szechinski J, Li T, Teng J, Becker JC, Westhovens R. Results of a two-year followup study of patients with rheumatoid arthritis who received a combination of abatacept and methotrexate. Arthritis Rheum. 2008 Apr;58(4):953-63. doi: 10.1002/art.23397.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
IM101-102
Identifier Type: -
Identifier Source: org_study_id