Abatacept in the Treatment and Prevention of Active Systemic Lupus Erythematosus (SLE) Flares in Combination With Prednisone
NCT ID: NCT00119678
Last Updated: 2014-09-22
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
183 participants
INTERVENTIONAL
2005-09-30
2008-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SINGLE_GROUP
PREVENTION
DOUBLE
Study Groups
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Abatacept + Prednisone
Double Blind Period
Abatacept
Injectable, intravenous, 10 mg/kg, abatacept every 28 days, 12 months
Prednisone
Tablets, oral, 30 mg, daily for 28 days then taper off, 12 months
Placebo + Prednisone
Double Blind Period
Placebo
Injectable, intravenous, 0 mg, every 28 days, 12 months
Prednisone
Tablets, oral, 30 mg, daily for 28 days then taper off, 12 months
Abatacept
Open Label
Abatacept
Injectable, intravenous, 10 mg/kg, every 28 days
Interventions
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Abatacept
Injectable, intravenous, 10 mg/kg, abatacept every 28 days, 12 months
Placebo
Injectable, intravenous, 0 mg, every 28 days, 12 months
Prednisone
Tablets, oral, 30 mg, daily for 28 days then taper off, 12 months
Abatacept
Injectable, intravenous, 10 mg/kg, every 28 days
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Stable dose of prednisone (\<30mg) for at least one month
Exclusion Criteria
* Treatment with a stable dose of azathioprine, mycophenolate mofetil, hydroxychloroquine, chloroquine, or methotrexate for less than three months prior to the study
* participants with active viral or bacterial infections
* participants with any other autoimmune disease as a main diagnosis
* Prior treatment with rituximab
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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University Of Arizona Arthritis Center
Tucson, Arizona, United States
Office Of Geoffrey S. Dolan, Md
Long Beach, California, United States
8737 Beverly Blvd.
Los Angeles, California, United States
Denver Arthritis Clinic
Denver, Colorado, United States
Cria Research
Fort Lauderdale, Florida, United States
The University Of Chicago
Chicago, Illinois, United States
Kentuckiana Center For Better Bone And Joint Health
Louisville, Kentucky, United States
Kelly, Timothy
Las Vegas, Nevada, United States
Suny Downstate Medical Center
Brooklyn, New York, United States
Columbia University Medical Center
New York, New York, United States
Ok Medical Research Foundations
Oklahoma City, Oklahoma, United States
Texas Research Center
Sugarland, Texas, United States
Local Institution
Cairns, Queensland, Australia
Local Institution
Maroochydore, Queensland, Australia
Local Institution
Clayton, Victoria, Australia
Local Institution
Heidelberg, Victoria, Australia
Local Institution
Malvern, Victoria, Australia
Local Institution
Graz, , Austria
Local Institution
Brussels, , Belgium
Local Institution
Leuven, , Belgium
Local Institution
Goiânia, Goiás, Brazil
Local Institution
Curitiba, Paraná, Brazil
Local Institution
Rio de Janeiro - Rj, Rio de Janeiro, Brazil
Local Institution
Campinas, São Paulo, Brazil
Local Institution
São Paulo, São Paulo, Brazil
Local Institution
São Paulo, São Paulo, Brazil
Local Institution
São Paulo, São Paulo, Brazil
Local Institution
São Paulo, São Paulo, Brazil
Local Institution
Vancouver, British Columbia, Canada
Local Institution
Winnipeg, Manitoba, Canada
Local Institution
Bordeaux, , France
Local Institution
Montpellier, , France
Local Institution
Paris, , France
Local Institution
Berlin, , Germany
Local Institution
Düsseldorf, , Germany
Local Institution
Freiburg im Breisgau, , Germany
Local Institution
Ferrara, , Italy
Local Institution
Aguascalientes, Aguascalientes, Mexico
Local Institution
Mexico City, Mexico City, Mexico
Local Institution
Morelia, Michioacan, Mexico
Local Institution
Ponce, , Puerto Rico
Local Institution
Berea, KwaZulu-Natal, South Africa
Local Institution
Panorama, Western Cape, South Africa
Local Institution
Seoul, Sungdong-Gu, South Korea
Local Institution
Seoul, , South Korea
Local Institution
Seoul, , South Korea
Local Institution
Seoul, , South Korea
Local Institution
Kaohsiung City, , Taiwan
Local Institution
Taichung, , Taiwan
Local Institution
Taipei, , Taiwan
Local Institution
Taipei, , Taiwan
Local Institution
London, Greater London, United Kingdom
Countries
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References
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Hu Y, Carman JA, Holloway D, Kansal S, Fan L, Goldstine C, Lee D, Somerville JE, Latek R, Townsend R, Johnsen A, Connolly S, Bandyopadhyay S, Shadick N, Weinblatt ME, Furie R, Nadler SG. Development of a Molecular Signature to Monitor Pharmacodynamic Responses Mediated by In Vivo Administration of Glucocorticoids. Arthritis Rheumatol. 2018 Aug;70(8):1331-1342. doi: 10.1002/art.40476. Epub 2018 Jul 12.
Bandyopadhyay S, Connolly SE, Jabado O, Ye J, Kelly S, Maldonado MA, Westhovens R, Nash P, Merrill JT, Townsend RM. Identification of biomarkers of response to abatacept in patients with SLE using deconvolution of whole blood transcriptomic data from a phase IIb clinical trial. Lupus Sci Med. 2017 Jul 28;4(1):e000206. doi: 10.1136/lupus-2017-000206. eCollection 2017.
Merrill JT, Burgos-Vargas R, Westhovens R, Chalmers A, D'Cruz D, Wallace DJ, Bae SC, Sigal L, Becker JC, Kelly S, Raghupathi K, Li T, Peng Y, Kinaszczuk M, Nash P. The efficacy and safety of abatacept in patients with non-life-threatening manifestations of systemic lupus erythematosus: results of a twelve-month, multicenter, exploratory, phase IIb, randomized, double-blind, placebo-controlled trial. Arthritis Rheum. 2010 Oct;62(10):3077-87. doi: 10.1002/art.27601.
Other Identifiers
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IM101-042
Identifier Type: -
Identifier Source: org_study_id
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