6
Participants
Start Date
December 31, 2007
Primary Completion Date
April 30, 2009
Study Completion Date
April 30, 2009
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.
Seligman Center for Advanced Therapeutics, New York
The Feinstein Institute for Medical Research, Manhasset
Wake Forest University Health Sciences, Winston-Salem
ACME Research, LLC, Orangeburg
1711 St. Julian Place, Columbia
The Ohio State University Medical Center, Columbus
Rheumatology Clinical Research Unit, Division of Rheumatology University Hospitals Case Medical Center, Beachwood
Southwest Rheumatology and Research Group, LLC, Middleburg Heights
University of Cincinnati College of Medicine, Cincinnati
Northwest Louisiana Nephrology Research, Shreveport
Tulane University Hospital and Clinic Department of Internal Medicine, New Orleans
Wayne State University Lupus Database Departments of Internal Medicine and Obstetrics & Gynecology Division of Rheumatology Wayne State University School of Medicine, Detroit
Institute of Rheumatology, Prague, 128 50
Hospital Sultanah Bahiyah, Kedah
Hospital University Kebangsaan Malaysia, Kuala Lumpur
University of Malaya Medical Centre, Kuala Lumpur
Hospital Pulau Pinang, Pulau Pinang
Changi General Hospital, Singapore
Singapore General Hospital, Singapore
Kaohsiung Veterans General Hospital, Kaohsiung City
Lead Sponsor
Collaborators (1)
ZymoGenetics
INDUSTRY
EMD Serono
INDUSTRY