Trials / Completed
CompletedNCT02525874
Effect of BG00012 on Lymphocyte Subsets and Immunoglobulins in Subjects With Relapsing Remitting Multiple Sclerosis (RRMS).
An Open-Label Study to Assess the Effects of BG00012 on Lymphocyte Subsets in Subjects With Relapsing-Remitting Multiple Sclerosis
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 218 (actual)
- Sponsor
- Biogen · Industry
- Sex
- All
- Age
- 18 Years – 65 Years
- Healthy volunteers
- Not accepted
Summary
The primary objective of the study is to evaluate the effect of BG00012 on lymphocyte subset counts during the first year of treatment in subjects with relapsing-remitting multiple sclerosis (RRMS). A secondary objective is to evaluate the pharmacodynamic effect on absolute lymphocyte counts (ALCs) and immunoglobulins (Igs) during the first year of treatment.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | dimethyl fumarate | Initial oral dose for 7 days with maintenance dose thereafter |
Timeline
- Start date
- 2015-08-11
- Primary completion
- 2017-04-24
- Completion
- 2018-04-23
- First posted
- 2015-08-18
- Last updated
- 2019-06-27
- Results posted
- 2019-06-27
Locations
34 sites across 7 countries: United States, Belgium, Bulgaria, Kuwait, Lithuania, Poland, Turkey (Türkiye)
Source: ClinicalTrials.gov record NCT02525874. Inclusion in this directory is not an endorsement.