At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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.
In Brief
A Phase 2 clinical trial evaluating dimethyl fumarate, tetanus diphtheria toxoids vaccine, and 3 other interventions for Relapsing Forms of Multiple Sclerosis. Completed, enrolled 71 participants across 14 sites.
Detailed Summary
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) \[T cell-dependent neoantigen response\].
Study Details
Timeline
Interventions
Throughout the study participants will remain on their existing, stable dosing regimen of Tecfidera.
Administered as described in the treatment arm
Administered as described in the treatment arm
Administered as described in the treatment arm
Throughout the study participants will remain on their existing, stable dosing regimen of non-pegylated IFN.