Long-term extension of the multinational, double-blind, placebo controlled study EFC6049 (HMR1726D/3001) to document the safety of two doses of teriflunomide (7 and 14 mg) in patients with multiple sclerosis with relapses

• Register: EUCTR
• Last refreshed on: 11 April 2016
• Main ID: EUCTR2006-003361-14-DK
• Date of registration: 22/07/2008
• Prospective Registration: Yes
• Primary sponsor: sanofi-aventis recherche & développement
• Public title: Long-term extension of the multinational, double-blind, placebo controlled study EFC6049 (HMR1726D/3001) to document the safety of two doses of teriflunomide (7 and 14 mg) in patients with multiple sclerosis with relapses
• Scientific title: Long-term extension of the multinational, double-blind, placebo controlled study EFC6049 (HMR1726D/3001) to document the safety of two doses of teriflunomide (7 and 14 mg) in patients with multiple sclerosis with relapses
• Date of first enrolment: 29/08/2008
• Target sample size: 1080
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2006-003361-14
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: no Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: no Other: no

Countries of recruitment

Austria, Czech Republic, Denmark, Estonia, Finland, Germany, Italy, Netherlands, Portugal, Sweden, United Kingdom

Key inclusion & exclusion criteria

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.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

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.


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Multiple sclerosis
MedDRA version: 14.1 Level: PT Classification code 10028245 Term: Multiple sclerosis System Organ Class: 10029205 - Nervous system disorders

Intervention(s)

Product Name: teriflunomide
Product Code: HMR1726D
Pharmaceutical Form: Tablet
INN or Proposed INN: teriflunomide
CAS Number: 108605-62-5
Current Sponsor code: HMR1726D
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 7-

Product Name: teriflunomide
Product Code: HMR1726D
Pharmaceutical Form: Tablet
INN or Proposed INN: teriflunomide
CAS Number: 108605-62-5
Current Sponsor code: HMR1726D
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 14-

Primary Outcome(s)

Primary end point(s): The primary endpoint is the safety of teriflunomide.

Secondary Objective: To document the long-term effect on disability progression (key secondary endpoint), annual relapse rate and MRI variables.

Main Objective: To document the long-term safety and tolerability of two doses of teriflunomide (7 and 14 mg) in MS patients with relapses.

Secondary ID(s)

LTS6050

2006-003361-14-GB