drugset / Trial / NCT01403376
Study to Investigate the Immune Response to Influenza Vaccine in Patients With Multiple Sclerosis on Teriflunomide
Non-randomizedParallel-groupOpen-label
Summary
Primary Objective: Assess the antibody response to influenza vaccine in patients with relapsing form of multiple sclerosis (RMS) treated with teriflunomide compared to a reference population. Secondary Objectives: * Assess the effect of teriflunomide on immunoglobulin levels; * Assess the safety of influenza vaccination in patients with RMS treated with teriflunomide. The reference population was defined as multiple sclerosis (MS) patients with a stable treatment with interferon-β-1. Antibody response was measured using hemagglutination inhibition assay (HIA) and the hemagglutinin antigens representing the stains of H3N2, H1N1, and B as present in the influenza vaccine used.
Timeline
- Start
- 2011-09
- Primary completion
- 2012-01
- Completion
- 2012-01
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Influenza Virus Vaccine | Vaccine | — | Intramuscular |
| Comparator | Interferon beta-1a | Protein / enzyme biologic | — | Intramuscular |
| Subject | Teriflunomide | Small molecule | 7 mg | Oral |
| Subject | Teriflunomide | Small molecule | 14 mg | Oral |