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

NCT ID: NCT00228163

Last Updated: 2015-03-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 147 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2002-01-31
• Study Completion Date: 2015-01-31

Brief Summary

The primary objective is to assess the long-term safety of teriflunomide in multiple sclerosis subjects. The secondary objective is to assess the long-term efficacy.

Detailed Description

Subjects completing the HMR 1726D/2001 study are given the opportunity to continue or switch to teriflunomide for 528 weeks or until teriflunomide is commercially available in the country where patient lives;

• subjects on Teriflunomide 7 mg or 14 mg continue on the same dose of teriflunomide.
• subjects on placebo are randomized to teriflunomide 7 mg or 14 mg.

The total study period per subject is 532 weeks or until teriflunomide is commercially available in the country where patient lives, broken up as follows:

• Treatment: 528 weeks or until teriflunomide is commercially available in the country where patient lives,
• Post-washout follow-up: 4 weeks after last treatment intake.

Conditions

Multiple Sclerosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Teriflunomide 7 mg

Group Type: EXPERIMENTAL

teriflunomide (HMR1726)

Intervention Type: DRUG

tablet, oral administration once daily.

Teriflunomide 14 mg

Group Type: EXPERIMENTAL

teriflunomide (HMR1726)

Intervention Type: DRUG

tablet, oral administration once daily.

Interventions

teriflunomide (HMR1726)

tablet, oral administration once daily.

Intervention Type: DRUG

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sanofi

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Paul W O'Connor, MD

Role: PRINCIPAL_INVESTIGATOR

St. Michael's Hospital, 30 Bond Street, 3rd floor, Toronto, ON M5B 1W8, Canada

Locations

Investigational Site Number 16

Calgary, , Canada

Investigational Site Number 10

Halifax, , Canada

Investigational Site Number 15

London, , Canada

Investigational Site Number 12

Montreal, , Canada

Investigational Site Number 11

Montreal, , Canada

Investigational Site Number 13

Ottawa, , Canada

Investigational Site Number 18

Québec, , Canada

Investigational Site Number 14

Toronto, , Canada

Investigational Site Number 17

Vancouver, , Canada

Investigational Site Number 19

Winnipeg, , Canada

Investigational Site Number 24

Clermont-Ferrand, , France

Investigational Site Number 21

Lyon, , France

Investigational Site Number 30

Marseille, , France

Investigational Site Number 23

Montpellier, , France

Investigational Site Number 28

Nice, , France

Investigational Site Number 27

Rennes, , France

Countries

Canada; France

References

Comi G, Freedman MS, Meca-Lallana JE, Vermersch P, Kim BJ, Parajeles A, Edwards KR, Gold R, Korideck H, Chavin J, Poole EM, Coyle PK. Prior treatment status: impact on the efficacy and safety of teriflunomide in multiple sclerosis. BMC Neurol. 2020 Oct 6;20(1):364. doi: 10.1186/s12883-020-01937-4.

Reference Type: DERIVED

PMID: 33023488 (View on PubMed)

Confavreux C, Li DK, Freedman MS, Truffinet P, Benzerdjeb H, Wang D, Bar-Or A, Traboulsee AL, Reiman LE, O'Connor PW; Teriflunomide Multiple Sclerosis Trial Group. Long-term follow-up of a phase 2 study of oral teriflunomide in relapsing multiple sclerosis: safety and efficacy results up to 8.5 years. Mult Scler. 2012 Sep;18(9):1278-89. doi: 10.1177/1352458512436594. Epub 2012 Feb 3.

Reference Type: DERIVED

PMID: 22307384 (View on PubMed)

Other Identifiers

HMR1726D/2002

Identifier Type: -

Identifier Source: secondary_id

LTS6048

Identifier Type: -

Identifier Source: org_study_id