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 | 14.1 |
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 document the long-term safety and tolerability of two doses of teriflunomide (7 and 14 mg) in MS patients with relapses. |
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E.2.2 | Secondary objectives of the trial |
To document the long-term effect on disability progression (key secondary endpoint), annual relapse rate and MRI variables. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- Patients who have completed the last study visit of the previous study (EFC6049) and do not meet criteria for treatment withdrawal
- Female patients of childbearing potential must agree to comply with the contraception requirement described in section 7.4 of the protocol.
- Female patients have demonstrated not to be pregnant by serum pregnancy test or breast feeding at the time of study entry.
- McDonald's criteria must continue to support the diagnosis of clinically definite MS (see protocol appendix A).
- An informed consent must be obtain in writing from the patient for this extension study prior to enrollment. Patients must demonstrate a willingness and ability to participate in a long term safety and efficacy trial with the opportunity to continue treatment on either 7 mg or 14 mg/day of teriflunomide under double-blind conditions, until availability of the results for study EFC6049 (HMR1726D/3001). Patients must actively refuse existing approved therapies.
In addition a supplemental HIV-testing informed consent will be required for patients who have not yet signed it in the main study (EFC6049) in order to have an HIV testing at baseline and yearly. |
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E.4 | Principal exclusion criteria |
- Patients who do not complete the EFC6049 (HMR1726D/3001) study.
- Patients who developed clinically relevant cardiovascular, hepatic, endocrine, or other major systematic disease making implementation of the protocol or interpretation of the study results difficult or that would put the patient at risk by participing in the study.
- Any known condition or circumstance that would prevent in the investigator's opinion, compliance or completion of the study.
- Pregnancy
- Breast-feeding
- Women of child-bearing potential, except if they satisfy all conditions described in protocol section7.4.
- Patients wishing to parent children during the course of the trial, or following the trial except if they agree to follow the appropriate drug washout procedure when they stop their study participation (protocol section 10.2)
- Patients requiring treatment during the study period with drugs not permitted by the study protocol (Protocol section 8.9.2)
- Prior use within 4 weeks before randomization or concomitant use of cholestyramine and/or activated charcoal
- Patients with a history of recent and clinically significant drug or alcohol abuse
- Liver function impairment or persisting ALT or direct bilirubin elevations of more than 1.5-fold the upper limit of normal
- Mental conditions rendering the patient unable to understand the nature, scope and possible consequence of the study. |
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E.5 End points |
E.5.1 | Primary end point(s) |
The primary endpoint is the safety of teriflunomide. |
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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 | No |
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 | No |
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 | No |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| Information not present in EudraCT |
E.8.4 | The trial involves multiple sites in the Member State concerned | Information not present in EudraCT |
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 | 128 |
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 | 7 |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 7 |