E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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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 | 19.0 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10030942 |
E.1.2 | Term | Optic neuritis |
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 |
The primary objective of the study is to assess full-field visual evoked potential (FF-VEP) latency in subjects who were enrolled in Study 215ON201 at 2 years (+ up to 12 months) after the last study visit. |
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E.2.2 | Secondary objectives of the trial |
The secondary objective is to assess clinical progression and severity of CNS demyelinating disease in subjects who were enrolled in Study 215ON201 at 2 years (+ up to 12 months) after the last study visit. |
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E.2.3 | Trial contains a sub-study | Yes |
E.2.3.1 | Full title, date and version of each sub-study and their related objectives |
Multifocal Visual Evoked Potential (mfVEP) assessment for patients that participated in the mfVEP Sub-Study in Study 215ON201 |
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E.3 | Principal inclusion criteria |
1. Must have participated in Study 215ON201 and received at least 1 dose of BIIB033 or placebo, as per protocol, within 2 years (+ up to 12 months) from Day 1 of this study (2 years from Week 32 or projected Week 32 visit, if the subject did not complete all visits in Study 215ON201). 2. Ability of the subject to understand the purpose and risks of the study and provide signed and dated informed consent and authorization to use confidential health information in accordance with national and local subject privacy regulations. |
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E.4 | Principal exclusion criteria |
1. Not previously enrolled in Study 215ON201. 2. Inability to comply with study requirements. 3. Other unspecified reasons that, in the opinion of the Investigator or Biogen, make the subject unsuitable for enrolment. 4. Subjects with recent kidney function, such as serum creatinine above upper limit of normal range, will not be allowed to receive administration of gadolinium (Gd) but will otherwise be allowed to participate in the study, including MRI assessments not requiring the use of Gd. 5. Female subjects must have had a recent pregnancy test and must not be breastfeeding prior to MRI assessments with Gd. |
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E.5 End points |
E.5.1 | Primary end point(s) |
The primary endpoint is the change in FF-VEP latency of the affected eye as compared to the baseline of the fellow eye at 2 years (+ up to 12 months) after the last study visit assessment (Week 32 or projected Week 32 visit) in Study 215ON201. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
2 years (+ up to 12 months) after the last study visit assessment (Week 32 or projected Week 32 visit) in Study 215ON201. |
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E.5.2 | Secondary end point(s) |
- Evaluate incidence of CDMS and time to diagnosis of CDMS. - Evaluate severity of CNS demyelinating disease with Expanded Disability Status Scale (EDSS), Symbol-Digit Modalities Test (SDMT), and multiple sclerosis functional composite (MSFC). MSFC includes the following: Timed 25-Foot Walk (T25FW), 9-Hole Peg Test (9HPT) [dominant and nondominant hands] and (3-Second) Paced Auditory Serial Addition Test (PASAT) - Evaluate change in disease activity from baseline with brain MRI with and without gadolinium (Gd). MRI analysis will include the number of Gd-enhanced lesions and the volume of T2 lesions. |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
2 years (+ up to 12 months) after the last study visit assessment (Week 32 or projected Week 32 visit) in Study 215ON201. |
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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 | No |
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 | No |
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 | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
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 |
Follow-up study. No IMP is being administered. |
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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 | No |
E.8.2.3 | Other | No |
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 | 1 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 29 |
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 |
Australia |
Belgium |
Canada |
Czech Republic |
Denmark |
Germany |
Hungary |
Italy |
Spain |
Sweden |
United Kingdom |
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E.8.7 | Trial has a data monitoring committee | No |
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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Last subject, last visit for final collection of data. |
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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 | 0 |
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 | 0 |
E.8.9.2 | In all countries concerned by the trial days | 0 |