drugset / Trial / NCT02097524
Single-dose Study to Describe the Pharmacodynamics (PD) and Safety of Sarilumab (REGN88/SAR153191) and Tocilizumab in Adults With Rheumatoid Arthritis (RA)
RandomizedParallel-groupOpen-labelBasic science
Summary
The main purposes of this study are to describe the pharmacodynamic effects, safety and pharmacokinetics of a single dose of sarilumab.
Timeline
- Start
- 2014-03
- Primary completion
- 2015-04
- Completion
- 2015-04
Publications
- Kovalenko P, Paccaly A, Boyapati A, Xu C, St John G, Nivens MC, Davis JD, Rippley R, DiCioccio AT. Population Pharmacodynamic Model of Neutrophil Margination and Tolerance to Describe Effect of Sarilumab on Absolute Neutrophil Count in Patients with Rheumatoid Arthritis. CPT Pharmacometrics Syst Pharmacol. 2020 Jul;9(7):405-416. doi: 10.1002/psp4.12534. Epub 2020 Jun 20.
- Emery P, Rondon J, Parrino J, Lin Y, Pena-Rossi C, van Hoogstraten H, Graham NMH, Liu N, Paccaly A, Wu R, Spindler A. Safety and tolerability of subcutaneous sarilumab and intravenous tocilizumab in patients with rheumatoid arthritis. Rheumatology (Oxford). 2019 May 1;58(5):849-858. doi: 10.1093/rheumatology/key361.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Sarilumab | Monoclonal antibody | 150 mg | Subcutaneous |
| Subject | Sarilumab | Monoclonal antibody | 200 mg | Subcutaneous |
| Comparator | Tocilizumab | Monoclonal antibody | 4 mg/kg | — |
| Comparator | Tocilizumab | Monoclonal antibody | 8 mg/kg | — |