Long Term Safety and Efficacy of Teriflunomide (HMR1726) in Multiple Sclerosis With Relapses

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT00228163
• Date of registration: 26/09/2005
• Primary sponsor: Sanofi-Aventis
• Public title: Long Term Safety and Efficacy of Teriflunomide (HMR1726) in Multiple Sclerosis With Relapses
• Scientific title: Extension of Protocol HMR1726D/2001, A Phase II Study of the Safety and Efficacy of Teriflunomide (HMR1726) in Multiple Sclerosis With Relapses
• Date of first enrolment: January 2002
• Target sample size: 180
• Recruitment status: Active, not recruiting
• URL: http://clinicaltrials.gov/show/NCT00228163
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Countries of recruitment

Canada, France

Contacts

• Name: Paul W O'Connor, MD
• Affiliation: St. Michael's Hospital, 30 Bond Street, 3rd floor, Toronto, ON M5B 1W8, Canada

Key inclusion & exclusion criteria

Inclusion Criteria:

- Satisfactorily completion of HMR1726D/2001 study with respect to safety.

- If female subject, non-childbearing potential or child bearing potential with
adequate contraception.

- Consent to practice/maintain adequate means of contraception throughout the study and
for 24 months after the discontinuation of treatment.

- Clinically definite Multiple Sclerosis (MS) as established on entry into
HMR1726D/2001 study.

- Extended Disability Status Score(EDSS) between 0 and 6 inclusively, when the subject
entered HMR1726D/2001 study.

- Magnetic Resonance Imaging (MRI) criteria must continue to support the diagnosis of
clinically definite MS.

- Willingness to participate in a long-term safety and efficacy trial.

Exclusion Criteria:

- Subject who did not complete HMR 1726D/2001 study for safety reasons.

- Subject who developed clinically relevant cardiovascular, hepatic, endocrine or other
major disease.

- Pregnancy.

- Breast-feeding.

- Wish to parent.

- Likelihood of requiring treatment during the study period with drugs not permitted.

- Disallowed therapies such asw immunomodulators, immunosuppressants.

- Recent history of drug or alcohol abuse.

- Liver function impairment.

- Abnormal mental conditions.



Age minimum: 18 Years
Age maximum: 65 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Multiple Sclerosis

Intervention(s)

Drug: teriflunomide (HMR1726)

Primary Outcome(s)

Number of patients with adverse events [Time Frame: Up to a maximum of 532 weeks (4 weeks after last treatment intake) or until teriflunomide is commercially available in the country where patient lives]

Secondary Outcome(s)

Annualized relapse rate (number of relapses per patient-year) [Time Frame: 528 weeks or until teriflunomide is commercially available in the country where patient lives]

Burden of disease : Change from baseline in the volume of abnormal brain tissue as measured by brain Magnetic Resonance Image (MRI) [Time Frame: 528 weeks or until teriflunomide is commercially available in the country where patient lives]

Change from baseline in Kurtzke Expanded Disability Status Scale (EDSS) score [Time Frame: 528 weeks or until teriflunomide is commercially available in the country where patient lives]

Change from baseline in Multiple Sclerosis Functional Composite (MSFC) score [Time Frame: 528 weeks or until teriflunomide is commercially available in the country where patient lives]

Change from baseline in Multiple Sclerosis Quality of Life Questionnaire-54 (MSQoL-54) score [Time Frame: 528 weeks or until teriflunomide is commercially available in the country where patient lives]

Change from baseline in subject reported fatigue as assessed by the Fatigue Impact Scale (FIS) [Time Frame: 528 weeks or until teriflunomide is commercially available in the country where patient lives]

Secondary ID(s)

HMR1726D/2002

LTS6048

Source(s) of Monetary Support

Please refer to primary and secondary sponsors