E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 12.0 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10028245 |
E.1.2 | Term | Multiple sclerosis |
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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 analyze the association between single nucleotide polymorphism (SNP) markers and treatment response. Treatment response is based on the Expanded Disability Status Scale (EDSS) progression and relapse outcomes over the first 2 years of treatment in the PRISMS trial. |
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E.2.2 | Secondary objectives of the trial |
Secondary objectives: - To assess disease evolution in subjects over the long term (15-16 years after initial randomization). - To assess long term immunogenicity of IFN-beta-1a.
Tertiary objectives: - To analyze the association between genetic markers and outcome over 2, 4, 7-8 years and 15-16 years after the initial randomization for efficacy parameters - To analyze the association between genetic markers and outcome over 2, 4, 6 and 7-8 years after initial randomization for safety parameters - To explore the association between genetic biomarkers and other possible prognostic indicators.
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
For inclusion in the trial, all of the following inclusion criteria must be fulfilled: 1. Was randomized in the PRISMS study 2. Is willing and able to comply with the protocol 3. Written informed consent given before any trial-related activities are carried out
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E.4 | Principal exclusion criteria |
Subjects are not eligible for this trial if they fulfill any of the following exclusion criteria: 1. Is unwilling or unable to participate in the study.
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E.5 End points |
E.5.1 | Primary end point(s) |
The primary endpoint is defined as the proportion of responders by group as defined by SNP markers. A responder is defined as a subject with no MS relapse and no EDSS progression during the first 24 months of treatment of PRISMS 6789. The efficacy data to be used for the primary endpoint will be: • Data at month 24 of PRISMS 6789 (year 2) from the groups of subjects initially randomized to Rebif® or placebo • Data at month 48 of PRISMS 6789 (year 4) from the group of subjects initially randomized to placebo who were re-randomized to Rebif® at month 24 of PRISMS 6789 (year 2).
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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 | Yes |
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) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | Information not present in EudraCT |
E.8.1.2 | Open | Information not present in EudraCT |
E.8.1.3 | Single blind | Information not present in EudraCT |
E.8.1.4 | Double blind | Information not present in EudraCT |
E.8.1.5 | Parallel group | Information not present in EudraCT |
E.8.1.6 | Cross over | Information not present in EudraCT |
E.8.1.7 | Other | Information not present in EudraCT |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Information not present in EudraCT |
E.8.2.2 | Placebo | Information not present in EudraCT |
E.8.2.3 | Other | Information not present in EudraCT |
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 | 4 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 13 |
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 | Information not present in EudraCT |
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 |
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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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For administrative and safety reporting purposes the end of the trial will be defined as the date of the final clinical database lock. This provides for a single and conservative definition across all trial sites. After database lock the sites will be monitored for outstanding administrative and close-out activities if applicable |
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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 |