Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
10 participants
INTERVENTIONAL
2012-01-31
2017-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
NONE
Study Groups
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open-label abatacept first, then 5 mg/kg abatacept
10 mg/kg abatacept (6 months). Then 5 mg/kg abatacept (18 months)
Abatacept
Subjects will receive approximately 10 mg/kg rounded to the nearest 25 mg for the first 6 months of the trial. At 6 months subjects will then be randomized to receive either 5 mg/kg or 10 mg/kg.
Abatacept will be administered as a 30-minute intravenous infusion. Following the initial administration, abatacept will be given at 2 and 4 weeks after the first infusion and every 4 weeks thereafter for up to 2 years.
open-label abatacept first, then 10 mg/kg abatacept
10 mg/kg abatacept (6 months). Then 10 mg/kg abatacept (18 months)
Abatacept
Subjects will receive approximately 10 mg/kg rounded to the nearest 25 mg for the first 6 months of the trial. At 6 months subjects will then be randomized to receive either 5 mg/kg or 10 mg/kg.
Abatacept will be administered as a 30-minute intravenous infusion. Following the initial administration, abatacept will be given at 2 and 4 weeks after the first infusion and every 4 weeks thereafter for up to 2 years.
Interventions
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Abatacept
Subjects will receive approximately 10 mg/kg rounded to the nearest 25 mg for the first 6 months of the trial. At 6 months subjects will then be randomized to receive either 5 mg/kg or 10 mg/kg.
Abatacept will be administered as a 30-minute intravenous infusion. Following the initial administration, abatacept will be given at 2 and 4 weeks after the first infusion and every 4 weeks thereafter for up to 2 years.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* failure to respond to prednisone and at least one other systemic immunosuppressive, or intolerance to such medications due to side effects
Exclusion Criteria
6 Years
ALL
No
Sponsors
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Bristol-Myers Squibb
INDUSTRY
Oregon Health and Science University
OTHER
Responsible Party
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Eric B. Suhler
Associate Professor
Principal Investigators
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Eric B. Suhler, MD, MPH
Role: PRINCIPAL_INVESTIGATOR
Oregon Health and Science University
James T Rosenbaum, MD
Role: STUDY_DIRECTOR
Oregon Health and Science University
Locations
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Oregon Health & Science University
Portland, Oregon, United States
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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e7035
Identifier Type: -
Identifier Source: org_study_id
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