E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Multiple sclerosis |
Multiple sclerose |
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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 | 14.0 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10004504 |
E.1.2 | Term | Beta interferon therapy |
E.1.2 | System Organ Class | 10042613 - Surgical and medical procedures |
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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 |
Primary: Does immunomodulation brought about by interferon beta-1a (Rebif) enhance or prolong functional reorganization in subjects with RRMS?
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E.2.2 | Secondary objectives of the trial |
Secondary: Does interferon beta-1a (Rebif) also affects functional connectivity as measured by resting-state functional Magnetic Resonance Imaging (fMRI) in subjects affected by relapsing SPMS? Does enhanced functional adaptation, induced by interferon beta-1a (Rebif) treatment, will reduce physical disability and cognitive decline in subjects affected by RRMS and relapsing SPMS? Does interferon beta-1a (Rebif) enhance functional brain adaptation over time, both in subjects affected by RRMS and relapsing SPMS? |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
age 18-65
RRMS or relapsing SPMS
Meet safety criteria for MRI
Group 1: Subjects affected by RRMS starting or recently started with Interferon beta-1a treatment
Group 2: Subjects affected by relapsing SPMS on interferon beta-1a treatment.
Group 3: Untreated Subjects affected by RRMS or relapsing SPMS
Group 4: Healthy controls |
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E.4 | Principal exclusion criteria |
MS other than RRMS or relapsing SPMS
presence or history of psychiatric disease
presence or history of neurological disease
presence or history of alcohol or drug abuse
presence of contra-indications for MRI
presence of contra-indications for Rebif
Use of immunosupressive agents |
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E.5 End points |
E.5.1 | Primary end point(s) |
Primary Endpoints: The mean change of each subject affected by RRMS or relapsing SPMS from baseline in functional connectivity (resting-state) fMRI at month 24. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
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E.5.2 | Secondary end point(s) |
Secondary Endpoints: Clinicial measures (progression of disability) will be measured through change in Extended Disability Status Scale (EDSS) and Multiple Sclerosis Functional Composite (MSFC). Clinical measures (progression of disease activity) as measured through the number of relapses and annualized relapse rate. Cognitive decline as measured by change in Brief Repeatable Battery – Neuropsychological tests (BRB-N) scores. Correlations fMRI and clinical/cognitive outcomes. And Requirement for treatment with corticosteroids due to relapses. |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
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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 | No |
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 |
observational study regarding the effect of registered IMP on brain connectivity in MS |
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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) | 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 | Yes |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | Yes |
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 | No |
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 | Yes |
E.8.2.3.1 | Comparator description |
healthy controles, patients without medication |
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E.8.2.4 | Number of treatment arms in the trial | 4 |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
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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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 2 |
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 | 2 |
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 |