Efficacy and Safety Study of Abatacept to Treat Lupus Nephritis
NCT ID: NCT00430677
Last Updated: 2015-03-20
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE2/PHASE3
423 participants
INTERVENTIONAL
2007-06-30
2011-08-31
Brief Summary
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Detailed Description
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Open Label Period: Prevention, Single Group Assignment, Open Label, Uncontrolled, Safety/Efficacy Study
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Abatacept 30 mg/kg+Corticosteroids+MMF
Short-term Period
Corticosteroids (prednisone or prednisolone)
tablets, oral, 0.5-0.8 mg/kg, daily
Abatacept
intravenous solution, injectable, 30 mg/kg, every 28 days
Mycophenolate mofetil (MMF)
tablets, oral, 1.5 to 2 g, daily
Abatacept 10 mg/kg+Corticosteroids+MMF
Short-term Period
Corticosteroids (prednisone or prednisolone)
tablets, oral, 0.5-0.8 mg/kg, daily
Abatacept
intravenous solution, injectable, 10 mg/kg, every 28 days
Mycophenolate mofetil (MMF)
tablets, oral, 1.5 to 2 g, daily
Placebo+Corticosteroids+MMF
Short-term Period
Corticosteroids (prednisone or prednisolone)
tablets, oral, 0.5-0.8 mg/kg, daily
Mycophenolate mofetil (MMF)
tablets, oral, 1.5 to 2 g, daily
Abatacept 10mg/kg
Long-term Extension Period
Abatacept
intravenous solution, injectable, 10 mg/kg, every 28 days
Interventions
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Corticosteroids (prednisone or prednisolone)
tablets, oral, 0.5-0.8 mg/kg, daily
Abatacept
intravenous solution, injectable, 30 mg/kg, every 28 days
Abatacept
intravenous solution, injectable, 10 mg/kg, every 28 days
Mycophenolate mofetil (MMF)
tablets, oral, 1.5 to 2 g, daily
Abatacept
intravenous solution, injectable, 10 mg/kg, every 28 days
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Renal biopsy within 12 months prior to screening visit indicating active proliferative lupus glomerulonephritis (met ISN/RPS Class III or IV classification criteria \[2003\], excluding Class III \[C\], IV-S \[C\] and IV-G \[C\], or the World Health Organization Class III or IV classification criteria \[1982\], excluding Class IIIc, IVd). If the renal biopsy was performed \>3 months but ≤12 months prior to screening visit, at least 1 of the following 3 serologies (performed locally) must have been abnormal prior to screening visit: complement (C3 or C4) level below normal range OR anti-dsDNA \>upper limit of normal range.
* A stable serum creatinine ≤3 mg/dL
Exclusion Criteria
* Subjects with drug-induced SLE, as opposed to idiopathic SLE
* Subjects with severe, unstable and/or progressive Central nervous system (CNS) lupus
* Subjects with autoimmune disease other than SLE as their main diagnosis (e.g.; Rheumatoid arthritis (RA), Multiple Sclerosis \[MS\])
* Subjects who have received treatment with cyclophosphamide within 3 months of randomization (Day 1).
* Subjects who have received treatment with rituximab \< 6 months prior to the screening visit
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 Alabama At Birmingham
Birmingham, Alabama, United States
Arizona Arthritis Center
Tucson, Arizona, United States
Wallace Rheumatic Study Center
Los Angeles, California, United States
University Of Kansas Medical Center
Kansas City, Kansas, United States
Boston University School Of Medicine
Boston, Massachusetts, United States
Hennepin County Medical Center
Minneapolis, Minnesota, United States
Suny Downstate Medical Center
Brooklyn, New York, United States
Northshore Lij Health System
Lake Success, New York, United States
The Feinstein Institute For Medical Research
Manhasset, New York, United States
Suny Upstate Medical University
Syracuse, New York, United States
University Of North Carolina At Chapel Hill
Chapel Hill, North Carolina, United States
Ok Medical Research Foundation
Oklahoma City, Oklahoma, United States
Rheumatology Consultants Pllc
Knoxville, Tennessee, United States
Virginia Mason Medical Center
Seattle, Washington, United States
Local Institution
Capital Federal, Buenos Aires, Argentina
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Ciudad Autonoma de Buenos Aire, Buenos Aires, Argentina
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Córdoba, Córdoba Province, Argentina
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San Miguel de Tucumán, Tucumán Province, Argentina
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Liverpool, New South Wales, Australia
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Clayton, Victoria, Australia
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Heidelberg, Victoria, Australia
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Parkville, Victoria, Australia
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Brussels, , Belgium
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Leuven, , Belgium
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Goiânia, Goiás, Brazil
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Curitiba, Paraná, Brazil
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Rio de Janeiro, Rio de Janeiro, Brazil
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Porto Alegre, Rio Grande do Sul, Brazil
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São Paulo, São Paulo, Brazil
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Edmonton, Alberta, Canada
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Winnipeg, Manitoba, Canada
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Toronto, Ontario, Canada
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Québec, Quebec, Canada
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Beijing, Beijing Municipality, China
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Beijing, Beijing Municipality, China
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Beijing, Beijing Municipality, China
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Beijing, Beijing Municipality, China
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Guangzhou, Guangdong, China
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Shanghai, Shanghai Municipality, China
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Shanghai, Shanghai Municipality, China
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Xi’an, Shanxi, China
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Créteil, , France
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Paris, , France
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Strasbourg, , France
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Toulouse, , France
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Hong Kong, , Hong Kong
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Gujarat, Ahmedabad, India
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Secunderabad, Andhra Pradesh, India
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Ahmedabad, Gujarat, India
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Nadiād, Gujarat, India
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Bangalore, Karnataka, India
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Bangalore, Karnataka, India
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Kochi, Kerala, India
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Mumbai, Maharajhsra, India
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Hyderabad, , India
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Visakhapatnam, , India
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Aguascalientes, Aguascalientes, Mexico
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Guadalajara, Jalisco, Mexico
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Guadalajara, Jalisco, Mexico
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Mexico City, Mexico City, Mexico
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Monterrey, Nuevo León, Mexico
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San Luis Potosí City, San Luis Potosí, Mexico
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Metepec, State of Mexico, Mexico
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Mérida, Yucatán, Mexico
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Bydgoszcz, , Poland
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Gdansk, , Poland
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Wroclaw, , Poland
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Moscow, , Russia
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Yaroslaval, , Russia
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Yekaterinburg, , Russia
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Johannesburg, Gauteng, South Africa
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Observatory, Western Cape, South Africa
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Panorama, Western Cape, South Africa
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Seoul, Sungdong-Gu, South Korea
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Seoul, , South Korea
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Seoul, , South Korea
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Kaohsiung City, , Taiwan
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Taichung, , Taiwan
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Taichung, , Taiwan
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Taipei, , Taiwan
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Taoyuan District, , Taiwan
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Gaziantep, , Turkey (Türkiye)
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Cambridge, Cambridgeshire, United Kingdom
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London, Greater London, United Kingdom
Countries
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References
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Wolf BJ, Spainhour JC, Arthur JM, Janech MG, Petri M, Oates JC. Development of Biomarker Models to Predict Outcomes in Lupus Nephritis. Arthritis Rheumatol. 2016 Aug;68(8):1955-63. doi: 10.1002/art.39623.
Furie R, Nicholls K, Cheng TT, Houssiau F, Burgos-Vargas R, Chen SL, Hillson JL, Meadows-Shropshire S, Kinaszczuk M, Merrill JT. Efficacy and safety of abatacept in lupus nephritis: a twelve-month, randomized, double-blind study. Arthritis Rheumatol. 2014 Feb;66(2):379-89. doi: 10.1002/art.38260.
Wofsy D, Hillson JL, Diamond B. Comparison of alternative primary outcome measures for use in lupus nephritis clinical trials. Arthritis Rheum. 2013 Jun;65(6):1586-91. doi: 10.1002/art.37940.
Wofsy D, Hillson JL, Diamond B. Abatacept for lupus nephritis: alternative definitions of complete response support conflicting conclusions. Arthritis Rheum. 2012 Nov;64(11):3660-5. doi: 10.1002/art.34624.
Related Links
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Investigator Inquiry form
Other Identifiers
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IM101-075
Identifier Type: -
Identifier Source: org_study_id
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