E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Relapsing-remitting multiple sclerosis (RRMS) |
|
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 7.0 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10028245 |
|
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 evaluate the efficacy of Cladribine versus Placebo in the reduction of qualifying relapse rate during 96 weeks of treatment in subjects with RRMS. |
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E.2.2 | Secondary objectives of the trial |
- To assess the effect of Cladribine on progression of disability in subjects with RRMS - To assess the effect of Cladribine in reducing the lesion activity compared to placebo as measured by MRI in subjects with RRMS - To assess the safety of Cladribine in subjects with RRMS - To assess population pharmacokinetics in subjects with RRMS - To identify DNA polymorfisms or gene expression profiles associated with certain traits (i.e. response, adverse events) of cladribine used in the treatment of multiple sclerosis as well as potential susceptibility loci for multiple sclerosis |
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E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal inclusion criteria |
The subjects must fulfill all of the following criteria prior to Study Day 1: - Be male or female, between 18 and 65 years of age (inclusive, at time of informed consent) - Have definite MS according to the McDonald criteria - Have relapsing-remitting disease with one or more relapses within twelve months prior to Study Day 1 - Must be clinically stable and not have had a relapse within 28 days prior to Study Day 1 - Have MRI consistent with MS at the Pre-Study Evaluation, according to the Fazekas criteria - Have an EDSS from 0-5.5, inclusive |
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E.4 | Principal exclusion criteria |
The subjects must not meet any of the following criteria: - Have Secondary Progressive MS (SPMS) or Primary Progressive MS (PPMS) - Prior use of Disease Modifying Drugs (DMDs) within the last three months prior to Study Day 1 - Have previously failed treatment with two or more DMDs on the basis of efficacy (could have previously failed treatment based on tolerability and/or convenience) - Prior or current history of malignancy - History of persistent anemia, leukopenia, neutropenia, or thrombocytopenia after immunosuppressive therapy - Have platelet and absolute neutrophil counts below the lower limits of normal range within 28 days prior to Study Day 1 - Have significant leukopenia (white blood cell count <0.5 times the lower limit of normal of the central laboratory) within 28 days prior to Study Day 1. |
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E.5 End points |
E.5.1 | Primary end point(s) |
The primary endpoint is qualifying relapse rate at 96 weeks |
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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 | Yes |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | Information not present in EudraCT |
E.6.11 | Pharmacogenomic | Yes |
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) | Yes |
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 | Yes |
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 | Yes |
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.8.5 | The trial involves multiple Member States | Yes |
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 |
|
E.8.7 | Trial has a data monitoring committee | Information not present in EudraCT |
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
|
Date of the final clinical database lock |
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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 | 3 |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 3 |
E.8.9.2 | In all countries concerned by the trial months | 6 |