drugset / Trial / NCT00430677
Efficacy and Safety Study of Abatacept to Treat Lupus Nephritis
RandomizedParallel-groupDouble-blindTreatment
Summary
The purpose of this clinical research study is to learn if addition of abatacept is safe and improves the effectiveness of treatment of patients with active lupus nephritis who are also taking mycophenolate mofetil (MMF) and corticosteroids.
Timeline
- Start
- 2007-06
- Primary completion
- 2010-09
- Completion
- 2011-08
Publications
- 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.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Abatacept | Other / unclassified | 10 mg/kg | Intravenous |
| Background | Mycophenolate Mofetil | Small molecule | 1.5 g | Oral |
| Background | Mycophenolate Mofetil | Small molecule | 2 g | Oral |
| Background | Prednisolone | Other / unclassified | 0.5 mg/kg | Oral |
| Background | Prednisolone | Other / unclassified | 0.8 mg/kg | Oral |
| Background | Prednisone | Other / unclassified | 0.5 mg/kg | Oral |
| Background | Prednisone | Other / unclassified | 0.8 mg/kg | Oral |