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 |
Relapsing-remitting multiple sclerosis |
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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 | 20.0 |
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 |
Evaluation of effectiveness of an additional alemtuzumab course in patients with relapsing remitting multiple sclerosis (RRMS) with disease activity after 2 courses. |
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E.2.2 | Secondary objectives of the trial |
-To assess changes over time in:
-Expanded Disability Status Scale (EDSS) scores,
-Magnetic resonance imaging (MRI) lesions (Gd and T2 lesions),
-Symbol Digit Modalities Test (SDMT),
-Patient Reported Indices for Multiple Sclerosis (PRIMUS),
-Euro Quality of Life (EuroQoL, EQ-5D) score,
-Work Productivity and Activity Impairment (WPAI) at each visit compared to baseline score.
-To describe the safety and tolerability of alemtuzumab after an additional treatment course.
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
-A patient with RRMS who has received two courses of alemtuzumab and has an active disease defined by clinical or imaging features.
-Patients with at least 1 relapse within 12 months prior to screening.
-Signed written consent form.
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E.4 | Principal exclusion criteria |
-Patients who have any of the contraindications noted in the Summary of Product Characteristics (SmPC) of alemtuzumab.
-Patients who received previously more than 2 courses alemtuzumab.
-Patients have received and/or have been receiving any disease modifying MS treatment (excluding corticosteroids) after the second and before the planned additional course of alemtuzumab.
-Patients who received alemtuzumab within less than last 12 months.
-Patients, who are unwilling or unable to complete the questionnaires being used in the study.
-Patients, who are currently participating in an investigational interventional study.
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E.5 End points |
E.5.1 | Primary end point(s) |
- Change in neurological examination (Confirmed relapse[s])
- Changes from baseline in EDDS score (increase of at least 1 point) |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
add 1: Visit V3 (Month 6) and V4 (Month 12 – End Of Study)
add 2: 12 months following the 3 Day course of alemtuzumab |
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E.5.2 | Secondary end point(s) |
1. Percentage of relapse-free participants
2. Percentage of participants with active MRI lesions
3. Change in number of active MRI lesions (Gd and T2 lesions)
4. Change over time in Expanded Disability Status Scale (EDSS)
5. Change over time in Symbol Digit Modality Test (SDMT)
6. Change over time in Patient Reported Outcome Indices for Multiple Sclerosis (PRIMUS)
7. Change over time in Euro Quality of Life (EQ-5D)
8. Change over time in Work Productivity and Activity Impairement Questionnaire (WPAI)
9. Number of participants with adverse events |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
1-3: V4 (Month 12 – End Of Study)
4-8: Visit V3 (Month 6) and V4 (Month 12 – End Of Study)
9: Up to Month 12 (V4) |
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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 |
patient reported outcomes, quality of life |
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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) | Yes |
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 | 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 | No |
E.8.2.4 | Number of treatment arms in the trial | 1 |
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 | 13 |
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 | |