A Dose-Blind, Multicenter, Extension Study to Determine the Long-Term Safety and Efficacy of Two Doses of BG00012 Monotherapy in Subjects with Relapsing-Remitting Multiple Sclerosis
- Conditions
- MSmultiple sclerosis10012303
- Registration Number
- NL-OMON47336
- Lead Sponsor
- Biogen
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 4
-written informed consent
-participated and completed previous BG00012 studies 109MS301 or 109MS302
- All male and female subjects of childbearing potential must practice effective contraception during the study and be willing and able to continue contraception for 30 days after their last dose of BG00012.
1. Any significant change in medical history in subjects from 109MS301 or 109MS302, including laboratory tests, or current clinically significant condition that in the opinion of the Investigator would have excluded the subjects' participation from their previous study. The Investigator must
re-review the subject's medical fitness for participation and consider any diseases that would preclude treatment.
2. Subjects from 109MS301 or 109MS302 who discontinued BG00012 due to an AE or due to reasons other than protocol-defined relapse/disability progression.
3. Subjects from 109MS301 or 109MS302 who discontinued BG00012 due to disability progression or relapses and did not follow the modified weekly schedule up to Week 96.
4. History of malignancy.
5. History of severe allergic or anaphylactic reactions.
6. Alanine transaminase (ALT), aspartate transaminase (AST), or gamma-glutamyltransferase.
7. Female subjects considering becoming pregnant while in the study, currently pregnant, or breast feeding.
8. Previous participation in this study (109MS303).
9. Unwillingness or inability to comply with the requirements of the protocol including the presence of any condition (physical, mental, or social) that is likely to affect the subject's ability to comply with the protocol.
10. Other unspecified reasons that, in the opinion of the Investigator or Biogen, make the subject unsuitable for enrollment. (GGT) >3 times the upper limit of normal (ULN).
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The primary objective and endpoint is to evaluate the long-term safety profile<br /><br>of BG00012.<br /><br><br /><br>The safety analysis will focus on the 8-year safety data in the extension<br /><br>study. For subjects who were dosed with BG00012 in the previous<br /><br>study, long term safety data (extension study + 2 years) may also be<br /><br>summarised.</p><br>
- Secondary Outcome Measures
Name Time Method