The Efficacy and Safety of Atacicept in Combination With Mycophenolate Mofetil Used to Treat Lupus Nephritis
NCT ID: NCT00573157
Last Updated: 2016-03-23
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE2/PHASE3
6 participants
INTERVENTIONAL
2007-12-31
2009-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Atacicept Plus Mycophenolate mofetil Plus Corticosteroids
Atacicept
Atacicept will be administered at a dose of 150 milligram (mg) subcutaneously (SC) twice weekly for 4 weeks followed by maintenance dose of 150 mg SC once weekly for 48 weeks.
Mycophenolate mofetil
MMF will be administered orally with a starting dose of 500 mg twice daily for 1 week, will be increased to 1000 mg twice daily for 1 week, then it will be adjusted to 1500 mg or lower twice daily as per investigator's discretion.
Corticosteroids
High dose CS of 0.8 mg per kilogram per day or maximum of 60 mg per day prednisone or prednisone equivalent, whichever is less will be administered for 4 Weeks and will be tapered to 7.5 to 10 mg/day up to Week 12.
Placebo Plus Mycophenolate mofetil Plus Corticosteroids
Mycophenolate mofetil
MMF will be administered orally with a starting dose of 500 mg twice daily for 1 week, will be increased to 1000 mg twice daily for 1 week, then it will be adjusted to 1500 mg or lower twice daily as per investigator's discretion.
Placebo
Placebo will be administered at a dose of 150 mg SC twice weekly for 4 weeks followed by 150 mg SC once weekly for 48 weeks.
Corticosteroids
High dose CS of 0.8 mg per kilogram per day or maximum of 60 mg per day prednisone or prednisone equivalent, whichever is less will be administered for 4 Weeks and will be tapered to 7.5 to 10 mg/day up to Week 12.
Interventions
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Atacicept
Atacicept will be administered at a dose of 150 milligram (mg) subcutaneously (SC) twice weekly for 4 weeks followed by maintenance dose of 150 mg SC once weekly for 48 weeks.
Mycophenolate mofetil
MMF will be administered orally with a starting dose of 500 mg twice daily for 1 week, will be increased to 1000 mg twice daily for 1 week, then it will be adjusted to 1500 mg or lower twice daily as per investigator's discretion.
Placebo
Placebo will be administered at a dose of 150 mg SC twice weekly for 4 weeks followed by 150 mg SC once weekly for 48 weeks.
Corticosteroids
High dose CS of 0.8 mg per kilogram per day or maximum of 60 mg per day prednisone or prednisone equivalent, whichever is less will be administered for 4 Weeks and will be tapered to 7.5 to 10 mg/day up to Week 12.
Eligibility Criteria
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Inclusion Criteria
* Renal biopsy performed consistent with active International Society of Nephrology/Renal Pathology Society (ISN/PRS) class III or IV lupus nephritis
Exclusion Criteria
* Active central nervous system SLE deemed to be severe or progressive and/or associated with significant cognitive impairment
* Any treatment with MMF, azathioprine, or cyclophosphamide within the last 6 months, or known hypersensitivity to MMF or atacicept.
* Any prior treatment with abatacept, rituximab, belimumab, or other B cell modulating agents.
16 Years
ALL
No
Sponsors
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ZymoGenetics
INDUSTRY
EMD Serono
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Responsible
Role: STUDY_DIRECTOR
EMD Serono, Inc., a subsidiary of Merck KGaA, Darmstadt, Germany
Locations
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Tulane University Hospital and Clinic Department of Internal Medicine
New Orleans, Louisiana, United States
Northwest Louisiana Nephrology Research
Shreveport, Louisiana, United States
Wayne State University Lupus Database Departments of Internal Medicine and Obstetrics & Gynecology Division of Rheumatology Wayne State University School of Medicine
Detroit, Michigan, United States
The Feinstein Institute for Medical Research
Manhasset, New York, United States
Seligman Center for Advanced Therapeutics
New York, New York, United States
Wake Forest University Health Sciences
Winston-Salem, North Carolina, United States
Rheumatology Clinical Research Unit, Division of Rheumatology University Hospitals Case Medical Center
Beachwood, Ohio, United States
University of Cincinnati College of Medicine
Cincinnati, Ohio, United States
The Ohio State University Medical Center
Columbus, Ohio, United States
Southwest Rheumatology and Research Group, LLC
Middleburg Heights, Ohio, United States
1711 St. Julian Place
Columbia, South Carolina, United States
ACME Research, LLC
Orangeburg, South Carolina, United States
Institute of Rheumatology
Prague, 128 50, , Czechia
Hospital Sultanah Bahiyah
Kedah, , Malaysia
Hospital University Kebangsaan Malaysia
Kuala Lumpur, , Malaysia
University of Malaya Medical Centre
Kuala Lumpur, , Malaysia
Hospital Pulau Pinang
Pulau Pinang, , Malaysia
Changi General Hospital
Singapore, , Singapore
Singapore General Hospital
Singapore, , Singapore
Kaohsiung Veterans General Hospital
Kaohsiung City, , Taiwan
Countries
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References
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Ginzler EM, Wax S, Rajeswaran A, Copt S, Hillson J, Ramos E, Singer NG. Atacicept in combination with MMF and corticosteroids in lupus nephritis: results of a prematurely terminated trial. Arthritis Res Ther. 2012 Feb 7;14(1):R33. doi: 10.1186/ar3738.
Other Identifiers
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493G01
Identifier Type: -
Identifier Source: secondary_id
28113
Identifier Type: -
Identifier Source: org_study_id
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