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

Biogen Idec0 个研究点目标入组 1,700 人开始时间: 待定最近更新: 2021年11月24日

试验速览

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•1. Ability to understand the purpose and risks of the study and provide signed and dated informed consent.
•2. Subjects who participated in and completed as per protocol previous BG00012 clinical studies 109MS301 or 109MS302.
•3. All male subjects 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 study treatment.

•1. Any significant change in medical history or current clinically significant condition that in the opinion of the Investigator would have excluded the subject's participation.
•2. Subjects who discontinued oral study treatment due to an AE or due to reasons other than protocol-defined relapse/disability progression.
•3. Subjects who discontinued study treatment due to disability progression or relapses and did not follow the modified visit schedule.
•4. History of malignancy, severe allergic or anaphylactic reactions.
•5. Female subjects considering becoming pregnant while in the study, currently pregnant, or breast feeding.
•6. Unwillingness or inability to comply with the requirements of the protocol.
•Other unspecified reasons that, in the opinion of the Investigator or Biogen Idec, make the subject unsuitable for enrollment.

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