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 | 13.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10028245 |
E.1.2 | Term | 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 |
-To assess the effect of 2 doses of teriflunomide in comparison to placebo, on frequency of multiple sclerosis (MS) relapses in patients with relapsing MS. |
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E.2.2 | Secondary objectives of the trial |
Key secondary:
-To assess the effect of 2 doses of teriflunomide in comparison to placebo, on disability progression in patients with relapsing MS.
Other secondary:
-To assess other measures of efficicacy of 2 doses of teriflunomide in comparison to placebo, on:
-fatigue
-health-related quality of life, a measure of the impact of the patient´s health on his or her overall well being
-To evaluate the safety and tolerability of teriflunomide
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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 |
The objectives of the Pharmacogenomic Teriflunomide Substudy are to:
-test the hypothesis of an association between NAT, and hepatic safety
-assess other associations between variations in genes and clinical outcomes.
(Please refer to the previous protocol amendment 2, version 1 (electronic 2.0) dated 1 July 2009.) |
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E.3 | Principal inclusion criteria |
Patients with relapsing forms of Multiple Sclerosis meeting McDonald’s criteria for MS diagnosis at time of screening, and EDSS scores of ≤ 5.5 at screening.
Experienced at least 1 relapse in the previous 12 months preceeding randomization, or at least 2 relapses in the 24 months preceeding randomization visit.
Patients who Have provided informed consent with signature on informed consent form: the informed consent process should be complete with full discussion of approved therapies available for relapsing forms of MS. The patient must have been offered these therapies and must choose to join the study instead of accepting therapy outside of the study.
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E.4 | Principal exclusion criteria |
• <18 years of age or ≥56 years of age
• Patients with significantly impaired bone marrow function or significant anemia, leukopenia, or thrombocytopenia
• Persistent significant or severe infection
• Liver function impairment or persisting elevations (confirmed by retest) of serum glutamic pyruvic transaminase (SGPT/ALT), serum glutamic oxaloacetic transaminase (SGOT/AST), or direct bilirubin greater than 1.5-fold the upper limit of normal
• Known history of hepatitis
• Use of adrenocorticotrophic hormone (ACTH) or systemic corticosteroids for 2 weeks prior to randomization
• Human immunodeficiency virus (HIV) positive patients
• Prior or concomitant use of cladribine, mitoxantrone, or other immunosuppressant agents such as azathioprine, cyclophosphamide, cyclosporin, methotrexate or mycophenolate
• Prior or concomitant use of natalizumab (Tysabri®)
• Pregnant or breast-feeding women
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E.5 End points |
E.5.1 | Primary end point(s) |
Annualized relapse rate, defined as the number of relapses per patient-year. |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | Information not present in EudraCT |
E.6.2 | Prophylaxis | Information not present in EudraCT |
E.6.3 | Therapy | Information not present in EudraCT |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | Yes |
E.6.7 | Pharmacodynamic | Information not present in EudraCT |
E.6.8 | Bioequivalence | Information not present in EudraCT |
E.6.9 | Dose response | Information not present in EudraCT |
E.6.10 | Pharmacogenetic | Yes |
E.6.11 | Pharmacogenomic | Information not present in EudraCT |
E.6.12 | Pharmacoeconomic | Information not present in EudraCT |
E.6.13 | Others | Information not present in EudraCT |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | Information not present in EudraCT |
E.7.1.2 | Bioequivalence study | Information not present in EudraCT |
E.7.1.3 | Other | Information not present in EudraCT |
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 | Yes |
E.8.1.7.1 | Other trial design description |
Followed by an open-label extension period |
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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 | 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.8.4.1 | Number of sites anticipated in Member State concerned | 2 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 60 |
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 | Yes |
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 | 4 |
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 | 4 |
E.8.9.2 | In all countries concerned by the trial months | 6 |