E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Relapsing-remitting Multiple Sclerosis |
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E.1.1.1 | Medical condition in easily understood language |
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E.1.1.2 | Therapeutic area | Diseases [C] - Nervous System Diseases [C10] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 14.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10063399 |
E.1.2 | Term | Relapsing-remitting multiple sclerosis |
E.1.2 | System Organ Class | 10029205 - Nervous system disorders |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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.
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E.2.2 | Secondary objectives of the trial |
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.
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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. |
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E.4 | Principal 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 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. |
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E.5 End points |
E.5.1 | 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. |
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E.5.1.1 | 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
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E.5.2 | 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. |
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E.5.2.1 | 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 |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | Yes |
E.6.13.1 | Other scope of the trial description |
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E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | Yes |
E.8.1.7.1 | Other trial design description |
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E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 3 |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 5 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 43 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
Czech Republic |
Germany |
Hungary |
India |
Poland |
Russian Federation |
Ukraine |
United Kingdom |
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E.8.7 | Trial has a data monitoring committee | Yes |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 1 |
E.8.9.2 | In all countries concerned by the trial months | 6 |
E.8.9.2 | In all countries concerned by the trial days | 0 |