Vaccination Response in Tecfidera-Treated Versus Interferon-Treated Participants With Relapsing Forms of Multiple Sclerosis.
| Status: | Recruiting |
|---|---|
| Conditions: | Neurology, Neurology |
| Therapuetic Areas: | Neurology |
| Healthy: | No |
| Age Range: | 18 - 55 |
| Updated: | 4/21/2016 |
| Start Date: | February 2015 |
| End Date: | July 2016 |
| Contact: | Biogen |
| Email: | clinicaltrials@biogen.com |
An Open-Label Study to Assess the Immune Response to Vaccination in Tecfidera® (BG00012)-Treated Versus Interferon-Treated Subjects With Relapsing Forms of Multiple Sclerosis.
Primary objective is to evaluate the immune response to vaccination with tetanus diphtheria
toxoids vaccine (Td) in participants with relapsing forms of Multiple Sclerosis (MS) who
have been treated with Tecfidera (BG00012) versus those treated with non pegylated
interferon (IFN).
Secondary objective is to evaluate the immune response to vaccination with 23-valent
pneumococcal polysaccharide vaccine (PPSV23) [a mostly T cell-independent humoral response]
and meningococcal polysaccharide diphtheria conjugate vaccine, quadrivalent (MCV4) [T
cell-dependent neoantigen response].
toxoids vaccine (Td) in participants with relapsing forms of Multiple Sclerosis (MS) who
have been treated with Tecfidera (BG00012) versus those treated with non pegylated
interferon (IFN).
Secondary objective is to evaluate the immune response to vaccination with 23-valent
pneumococcal polysaccharide vaccine (PPSV23) [a mostly T cell-independent humoral response]
and meningococcal polysaccharide diphtheria conjugate vaccine, quadrivalent (MCV4) [T
cell-dependent neoantigen response].
Key Inclusion Criteria:
- Must have a confirmed diagnosis of RRMS per the 2010 McDonald criteria.
- Must have a known tetanus immunization history with most recent tetanus vaccination
given 2 to 15 years prior to Screening and an anti-tetanus IgG titer at Screening
that is less than or equal to one-half the upper limit of detection for the assay.
- Must have been on a stable approved dose of Tecfidera (240 mg twice daily [BID])
[Group 1] for ≥6 months or on a stable approved dose of a non-pegylated IFN (e.g.,
Avonex, Betaseron, Rebif, Extavia) [Group 2] for ≥3 months prior to Day 1.
Key Exclusion Criteria:
- Clinical relapse requiring treatment within 30 days prior to Day 1.
- Pneumococcal vaccination within 5 years prior to Screening.
- Previous exposure to meningococcal vaccines.
- Known hypersensitivity to Td, PPSV23, or MCV4 or their components.
NOTE: Other protocol-defined inclusion/exclusion criteria may apply.
We found this trial at
15
sites
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