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 - Monotherapy complementary satefy and efficacy study in MS

Biogen0 个研究点目标入组 4 人开始时间: 待定最近更新: 2024年5月6日

适应症

试验速览

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•-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).

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