Relapsing-remitting Multiple Sclerosis MedDRA version: 14.0 Level: PT Classification code 10063399 Term: Relapsing-remitting multiple sclerosis System Organ Class: 10029205 - Nervous system disorders
Conditions
Interventions
Product Name: DACLIZUMAB HYP
Product Code: BIIB019
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Daclizumab with Greek suufix
Current Sponsor code: BIIB019
Other descriptive name: D
Sponsors
Biogen Idec Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the safety and immunogenicity of extended treatment with DAC HYP. This evaluation will include the following major components: • 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. • An assessment of safety and immunogenicity during a 6-month washout period from DAC HYP. • An assessment of safety and immunogenicity during re-initiation of therapy with DAC HYP after a 6-month washout period. • An assessment of safety and immunogenicity of DAC HYP when administered to MS subjects who previously received placebo during study 205MS201 Note: The 6-month washout period is defined by the 24-week period between the last scheduled administration of DAC HYP at the Week 48 visit in 205MS201 and the re-initiation of DAC HYP at the Week 20 visit in 205MS202.;Secondary Objective: Secondary objective of this study is: • 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.;Primary end point(s): The primary end points of the study are safety as defined by the incidence of adverse events, change in laboratory evaluations, vital signs, physical examinations and immunogenicity as defined by the development of antibodies to DAC HYP.;Timepoint(s) of evaluation of this end point: Adverse events- as events occur Lab evaluations and vital signs- at baseline and then monthly Physical examinations- at baseline, and then at wk 8, 20, 32, 44, 52, 60, 72 and at early termination visit if applicable Immunogenicity- at baseline, and then at wk 4, 8, 12, 16, 20, 32, 40, 52, 72 and at early termination visit if applicable | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): The secondary endpoint is 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(s) of evaluation of this end point: MRI-at baseline and then at wk 20, 52 and at early termination visit if applicable Clinical relapse- as events occur | — |
Countries
Czech Republic, Germany, Hungary, India, Poland, Russian Federation, Ukraine, United Kingdom
Contacts
Public ContactClinical Trial Information Desk
Biogen Idec
Outcome results
None listed