Health Condition 1: null- Relapsing-Remitting Multiple Sclerosis (RRMS)
Conditions
Interventions
Intervention1: Daclizumab High Yield Process (DAC HYP): DAC HYP 150 mg subcutaneous (SC) injection every 4 weeks for 144 weeks
Control Intervention1: Not Applicable: Not Applicable
Sponsors
Biogen Idec
Biogen Idec Biotech India Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1. Ability to understand the purpose and risks of the study and provide signed and dated informed consent and authorization to use PHI in accordance with national and local subject privacy regulations. 2. Must be a subject from Study 205MS202 who completed at least 52 weeks and must have been compliant with the 205MS202 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.
Exclusion criteria
Exclusion criteria: 1. Subjects with any significant change in their medical status from the previous study that would preclude administration of DAC HYP, including laboratory tests or a current clinically significant condition that, in the opinion of the Investigator, would have excluded the subjectâ??s participation in the 205MS201 or 205MS202 studies. The Investigator must re review the subjectâ??s medical fitness for participation and must consider any diseases that would preclude treatment. 2. Any subject who has permanently discontinued study treatment in Study 205MS202 due to an AE. 3. Current enrollment in any investigational drug study other than Study 205MS202. 4. Ongoing treatment with any approved or experimental disease-modifying treatment for MS. 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 subjectâ??s ability to comply with the protocol.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary objective of this study is to assess the safety of extended treatment with DAC HYP monotherapy in subjects with RRMSTimepoint: 144 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary objectives of this study are to assess the long-term immunogenicity of DAC HYP and to assess the durability of response to DAC HYP in preventing MS relapse, slowing disability progression, and reducing new MS lesion formation in this study population.Timepoint: â?¢ Immunogenicity â?¢ Sustained disability progression defined by at least a 1.0-point increase on the EDSS from a baseline EDSS â?¥1.0 that is sustained for 12 weeks, or at least a 1.5-point increase on the EDSS from a baseline EDSS 1.0 that is sustained for 12 weeks â?¢ Annual change in total number and volume of new or newly enlarging T2 hyperintense lesions, Gd-enhancing lesions, T1 hypointense lesions, and brain atrophy on brain MRI â?¢ ARR | — |
Countries
Czech Republic, Germany, Hungary, India, Poland, Russian Federation, Ukraine, United Kingdom
Contacts
Public ContactDr Ritika Bajaj
Biogen
Outcome results
None listed