Multiple Sclerosis Clinical Trial

Effect of BG00012 on Lymphocyte Subsets and Immunoglobulins in Subjects With Relapsing Remitting Multiple Sclerosis (RRMS).

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.

View Eligibility Criteria

Eligibility Criteria

Key Inclusion Criteria:

Subjects of childbearing potential (including female subjects who are post-menopausal for less than 1 year) must practice effective contraception during the study and be willing and able to continue contraception for 30 days after their last dose of study treatment.
Must have a confirmed diagnosis of RRMS according to the revised McDonald criteria (2010) [Polman 2011]

Key Exclusion Criteria:

History of or positive test result at Screening for:
human immunodeficiency virus
hepatitis C virus antibody
hepatitis B infection
Drug or alcohol abuse within 1 year prior to Screening.
Prior treatment with any of the following:
cladribine
mitoxantrone
total lymphoid irradiation
alemtuzumab
T-cell or T-cell receptor vaccination
any therapeutic monoclonal antibody, with the exception of natalizumab or daclizumab
Treatment with any of the following medications or procedures within 6 months prior to Baseline (Day 1):
DMF (given as Fumaderm®) or BG00012; enrollment will be limited to no more than 40 subjects (out of 200) with prior DMF exposure
cyclosporine
azathioprine
methotrexate
mycophenolate mofetil
intravenous (IV) Ig
plasmapheresis or cytapheresis

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply

Study is for people with:

Multiple Sclerosis

Phase:

Phase 3

Estimated Enrollment:

218

Study ID:

NCT02525874

Recruitment Status:

Completed

Sponsor:

Biogen

Check Your Eligibility

Let’s see if you might be eligible for this study.

What is your age and gender ?

Submit

There are 31 Locations for this study

See Locations Near You

Research Site
Gilbert Arizona, 85234, United States
Research Site
Long Beach California, 90806, United States
Research Site
Ocala Florida, 34471, United States
Research Site
Oldsmar Florida, 34677, United States
Research Site
Tampa Florida, 33609, United States
Research Site
Tampa Florida, 33612, United States
Research Site
Atlanta Georgia, 30342, United States
Research Site
Overland Park Kansas, 66212, United States
Research Site
Baltimore Maryland, 33612, United States
Research Site
Traverse City Michigan, 49684, United States
Research Site
Raleigh North Carolina, 27607, United States
Research Site
Spartanburg South Carolina, 29307, United States
Research Site
San Antonio Texas, 78258, United States
Research Site
Salt Lake City Utah, 84103, United States
Research Site
Tacoma Washington, 98405, United States
Research Site
La Louviere Hainaut, 7100, Belgium
Research Site
Brugge West-Vlaanderen, 8000, Belgium
Research Site
Brasschaat , 2930, Belgium
Research Site
Plaven , 5800, Bulgaria
Research Site
Pleven , 5800, Bulgaria
Research Site
Sofia , 1113, Bulgaria
Research Site
Sofia , 1606, Bulgaria
Research Site
Sofia , , Bulgaria
Research Site
Kuwait City , 00001, Kuwait
Research Site
Kaunas , LT-50, Lithuania
Research Site
Klaipeda , 92288, Lithuania
Research Site
Vilnius , LT-08, Lithuania
Research Site
Bydgoszcz , 85-79, Poland
Research Site
Katowice , 40-59, Poland
Research Site
Katowice , 40-65, Poland
Research Site
Lodz , 90-32, Poland
Research Site
Plewiska , 62-06, Poland
Research Site
Szczecin , 70-21, Poland
Research Site
Umuttepe Kocaeli, 41380, Turkey

How clear is this clinincal trial information?

Study is for people with:

Multiple Sclerosis

Phase:

Phase 3

Estimated Enrollment:

218

Study ID:

NCT02525874

Recruitment Status:

Completed

Sponsor:


Biogen

How clear is this clinincal trial information?

×

Introducing, the Journey Bar

Use this bar to access information about the steps in your cancer journey.

Please confirm you are a US based health care provider:

Yes, I am a health care Provider No, I am not a health care provider