drugset / Trial / NCT01864148
Study to Assess the Efficacy, Safety, Tolerability, and Pharmacokinetics of BIIB033 in Participants With Relapsing Forms of Multiple Sclerosis When Used Concurrently With Avonex
RandomizedParallel-groupDouble-blindTreatment
Summary
The primary objective of the study is to evaluate the efficacy of BIIB033 in participants with active relapsing multiple sclerosis (MS) when used concurrently with Avonex. Secondary objectives of this study in this study population are to assess the safety, tolerability, and population pharmacokinetics of BIIB033 when used concurrently with Avonex.
Timeline
- Start
- 2013-08
- Primary completion
- 2015-12
- Completion
- 2016-03
Publications
- Cadavid D, Mellion M, Hupperts R, Edwards KR, Calabresi PA, Drulovic J, Giovannoni G, Hartung HP, Arnold DL, Fisher E, Rudick R, Mi S, Chai Y, Li J, Zhang Y, Cheng W, Xu L, Zhu B, Green SM, Chang I, Deykin A, Sheikh SI; SYNERGY study investigators. Safety and efficacy of opicinumab in patients with relapsing multiple sclerosis (SYNERGY): a randomised, placebo-controlled, phase 2 trial. Lancet Neurol. 2019 Sep;18(9):845-856. doi: 10.1016/S1474-4422(19)30137-1. Epub 2019 Jul 5.
- Wilhelm H, Schabet M. The Diagnosis and Treatment of Optic Neuritis. Dtsch Arztebl Int. 2015 Sep 11;112(37):616-25; quiz 626. doi: 10.3238/arztebl.2015.0616.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | opicinumab | Protein / enzyme biologic | 3 mg/kg | Intravenous |
| Subject | opicinumab | Protein / enzyme biologic | 10 mg/kg | Intravenous |
| Subject | opicinumab | Protein / enzyme biologic | 30 mg/kg | Intravenous |
| Subject | opicinumab | Protein / enzyme biologic | 100 mg/kg | Intravenous |
| Background | Interferon beta-1a | Protein / enzyme biologic | — | Intramuscular |