To evaluate the safety and efficacy of DAC HYP in subjects with Multiple Sclerosis who have completed treatment in study 205MS201 (SELECT).
- Conditions
- Health Condition 1: null- Relapsing Remitting Multiple Sclerosis
- Registration Number
- CTRI/2010/091/001093
- Lead Sponsor
- Biogen Idec
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 600
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. 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 4 months after their last dose of study treatment. For further details
of contraceptive requirements for this study
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
re-review 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
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. An assessment of safety and immunogenicity of extended treatment with DAC HYP when administered to MS subjects who have completed 52 weeks of active therapy with DAC HYP in Study 205MS201. 2. An assessment of safety and immunogenicity during a 6-month washout period from DAC HYP. 3. An assessment of safety and immunogenicity during re-initiation of therapy with DAC HYP after a 6-month washout period. 4. An assessment of safety and immunogenicity of DAC HYP when administered to MS subjects who previously received placebo during study 205MS201Timepoint: After the patient completes week 52 in study 205MS201
- Secondary Outcome Measures
Name Time Method to assess the durability of the effect of DAC HYP on MS disease activity as measured by brain magnetic resonance imaging (MRI) scans and clinical MS relapses.Timepoint: After the patient completes week 52 in study 205MS201.