drugset / Trial / NCT00482989
A Study to Evaluate the Safety and Tolerability of Multiple Intravenous Doses of MEDI 545 in Patients With Systemic Lupus Erythematosus
RandomizedSingle-groupDouble-blindTreatment
Summary
To evaluate the safety and tolerability of multiple IV doses of the MEDIMUNNE antibody in adult patients with SLE.
Timeline
- Start
- 2007-06
- Primary completion
- 2010-07
- Completion
- 2010-09
Publications
- Narwal R, Roskos LK, Robbie GJ. Population pharmacokinetics of sifalimumab, an investigational anti-interferon-alpha monoclonal antibody, in systemic lupus erythematosus. Clin Pharmacokinet. 2013 Nov;52(11):1017-27. doi: 10.1007/s40262-013-0085-2.
- Petri M, Wallace DJ, Spindler A, Chindalore V, Kalunian K, Mysler E, Neuwelt CM, Robbie G, White WI, Higgs BW, Yao Y, Wang L, Ethgen D, Greth W. Sifalimumab, a human anti-interferon-alpha monoclonal antibody, in systemic lupus erythematosus: a phase I randomized, controlled, dose-escalation study. Arthritis Rheum. 2013 Apr;65(4):1011-21. doi: 10.1002/art.37824.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Sifalimumab | Monoclonal antibody | 0.3 mg/kg | Intravenous |
| Subject | Sifalimumab | Monoclonal antibody | 1 mg/kg | Intravenous |
| Subject | Sifalimumab | Monoclonal antibody | 3 mg/kg | Intravenous |
| Subject | Sifalimumab | Monoclonal antibody | 10 mg/kg | Intravenous |