An Extension Study to Evaluate the Safety and Efficacy of DAC HYP in Subjects with Multiple Sclerosis who have completed Treatment in the study 205MS201 (SELECT)
- Conditions
- Relapsing-remitting Multiple SclerosisMedDRA version: 14.1Level: PTClassification code 10063399Term: Relapsing-remitting multiple sclerosisSystem Organ Class: 10029205 - Nervous system disordersTherapeutic area: Diseases [C] - Nervous System Diseases [C10]
- Registration Number
- EUCTR2008-005559-46-DE
- Lead Sponsor
- Biogen Idec Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 600
Unless otherwise specified, to be eligible to participate in this study, candidates must meet the following eligibility criteria at the time of
randomization:
1. Ability to understand the purpose and risks of the study and provide signed and dated informed consent and authorization to use protected
health information (PHI) in accordance with national and local subject
privacy regulations.
2. Must be a subject from Study 205MS201 for at least 52 weeks and must have been compliant with the 205MS201 protocol in the opinion of the Investigator.
3. Women of childbearing potential must practice effective contraception during the study and be willing and able to continue contraception for 4 months after their last dose of study treatment.
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 600
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range 0
Unless otherwise specified, candidates will be excluded from study entry if any of the following exclusion criteria exist at the time of
randomization:
1. Subjects with any significant change in their medical status from Study 205MS201 that would preclude administration of DAC HYP
including laboratory results or a current clinically-significant condition that, in the opinion of the Investigator, would have excluded the subject's participation in Study 205MS201. The Investigator must rereview
the subject's medical fitness for participation and must consider any diseases that would preclude treatment with DAC HYP.
2. Any subject who has permanently discontinued study treatment in Study 205MS201 except subjects who were unblinded during evaluation of an adverse event (AE) and found to be on placebo.
3. Planned ongoing treatment with any approved or experimental treatment for MS except for the protocol-allowed use of concomitant IFN-beta.
4. Current enrollment in any investigational drug study other than 205MS201.
5. 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.
6. Other unspecified reasons that, in the opinion of the Investigator or the Biogen Idec Medical Director, make the subject unsuitable for enrollment.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method