Phase IIIB Switching From Intravenous to Subcutaneous Study
NCT ID: NCT00663702
Last Updated: 2015-03-09
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
123 participants
INTERVENTIONAL
2008-05-31
2012-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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1
Abatacept
Subcutaneous injection, 125 mg/mL, once weekly, 48 months
Interventions
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Abatacept
Subcutaneous injection, 125 mg/mL, once weekly, 48 months
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Completion of final quarterly dosing visit in NCT00048581 or NCT00048568 as follows: US and Canadian participants: Day 1821 visit; Taiwanese participants: Day 1905 visit; Mexican participants: Day 1989 visit.
* Agreement to participate in BMS IM101-185 (NCT00663702) on final quarterly dosing visit in NCT00048581 or NCT00048568 study as follows: US and Canadian participants: Day 1821 visit; Taiwanese participants: Day 1905 visit; Mexican participants: Day 1989 visit.
* At the time of completion of the NCT00048581 or NCT00048568 protocol, participant did not meet any criteria requiring their discontinuation.
* Drug stabilization requirements: Participants who received concomitant medications (disease-modifying antirheumatic drugs, corticosteroids, and nonsteroidal anti-inflammatory drugs) at the time of their last quarterly dosing visit for NCT00048581 or NCT00048568 were required to maintain stable dose levels from the time they signed consent until the end of the first 3 months (Day 85) of the current study.
* Willingness to self-inject study medication (abatacept) or allow a caregiver to inject study medication.
* Willingness to adhere to study visit schedule and comply with other protocol requirements.
* Male or female (not nursing or pregnant)genders, at least 18 years of age. Women of childbearing potential (WOCBP) must have been practicing adequate contraceptive measures during the study and for up to 10 weeks after the last infusion of study medication in such a manner that the risk of pregnancy was minimized. WOCBP must have had a negative serum or urine pregnancy test result (minimum sensitivity of 25 IU/L or equivalent units of human chorionic gonadotropin \[HCG\]) within 48 hours prior to the start of study medication.
Exclusion Criteria
* Current symptoms of severe, progressive, or uncontrolled renal, hepatic, hematologic, gastrointestinal, pulmonary, cardiac, neurologic, or cerebral disease, or a concomitant medical condition that, in the opinion of the Investigator, might have placed the participation at unacceptable risk for study participation
* Any clinical laboratory test result that was considered to be abnormal or not within acceptable limits on the final quarterly dosing visit of NCT00048581 or NCT00048568. Screening laboratory test results for NCT00663702 were based on the Day 1821 visit of NCT00048581 or NCT00048568 for participants enrolled at sites in the US or Canada and on the Day 1989 visit of NCT00048568 for participants enrolled at sites in Mexico.
* Imprisonment or involuntarily incarceration for treatment of either a psychiatric or physical (eg, infectious disease) illness
* Impairment, incapacitation, inability to complete study-related assessments, or illiteracy.
18 Years
ALL
No
Sponsors
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Bristol-Myers Squibb
INDUSTRY
Responsible Party
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Principal Investigators
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Bristol-Myers Squibb
Role: STUDY_DIRECTOR
Bristol-Myers Squibb
Locations
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Rheumatology Associates Of N. Al, P.C.
Huntsville, Alabama, United States
Allergy & Rheumatology Medical Clinic, Inc.
La Jolla, California, United States
Valerius Medical Group &Research Ctr. Of Greater Long Beach
Long Beach, California, United States
Desert Medical Advances
Palm Desert, California, United States
Inland Rheumatology Clinical Trials Inc.
Upland, California, United States
Arthritis & Rheumatic Disease Specialties
Aventura, Florida, United States
Diagnostic Rheumatology And Research,Pc
Indianapolis, Indiana, United States
Graves Gilbert Clinic
Bowling Green, Kentucky, United States
Physician Research Collaboration, Llc
Lincoln, Nebraska, United States
Innovative Health Research
Las Vegas, Nevada, United States
The Center For Rheumatology, Llp
Albany, New York, United States
The Arthritis Clinic & Carolina Bone & Joint
Charlotte, North Carolina, United States
Unifour Medical Research
Hickory, North Carolina, United States
Cincinnati Rheumatic Disease Study Group
Cincinnati, Ohio, United States
Portland Rheumatology Clinic
Lake Oswego, Oregon, United States
Rheumatic Disease Associates, Ltd.
Willow Grove, Pennsylvania, United States
Walter F. Chase, Md
Austin, Texas, United States
Arthritis Centers Of Texas
Dallas, Texas, United States
Local Institution
Edmonton, Alberta, Canada
Local Institution
St. John's, Newfoundland and Labrador, Canada
Local Institution
Kitchener, Ontario, Canada
Local Institution
Toronto, Ontario, Canada
Local Institution
Montreal, Quebec, Canada
Local Institution
Québec, Quebec, Canada
Local Institution
Tijuana, Estado de Baja California, Mexico
Local Institution
Guadalajara, Jalisco, Mexico
Local Institution
Mexico City, Mexico City, Mexico
Local Institution
Mexico City, Mexico City, Mexico
Local Institution
Nuevo León, Nuevo León, Mexico
Local Institution
San Luis Potosí City, San Luis Potosí, Mexico
Countries
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References
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Alten R, Bingham CO 3rd, Cohen SB, Curtis JR, Kelly S, Wong D, Genovese MC. Antibody response to pneumococcal and influenza vaccination in patients with rheumatoid arthritis receiving abatacept. BMC Musculoskelet Disord. 2016 May 26;17:231. doi: 10.1186/s12891-016-1082-z.
Other Identifiers
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IM101-185
Identifier Type: -
Identifier Source: org_study_id
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