NCT00228163

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
147

participants targeted

Target at P75+ for phase_2 multiple-sclerosis

Timeline
Completed

Started Jan 2002

Longer than P75 for phase_2 multiple-sclerosis

Geographic Reach
2 countries

16 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2002

Completed
3.7 years until next milestone

First Submitted

Initial submission to the registry

September 26, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 28, 2005

Completed
9.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2015

Completed
Last Updated

March 25, 2015

Status Verified

March 1, 2015

Enrollment Period

13 years

First QC Date

September 26, 2005

Last Update Submit

March 24, 2015

Conditions

Multiple Sclerosis

Keywords

Multiple Sclerosis Relapsing RemittingSecondary ProgressiveProgressive Relapsing

Outcome Measures

Primary Outcomes (1)

  • Number of patients with adverse events

    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 Outcomes (6)

  • Annualized relapse rate (number of relapses per patient-year)

    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

    528 weeks or until teriflunomide is commercially available in the country where patient lives

  • Change from baseline in Multiple Sclerosis Functional Composite (MSFC) score

    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)

    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

    528 weeks or until teriflunomide is commercially available in the country where patient lives

  • +1 more secondary outcomes

Study Arms (2)

Teriflunomide 7 mg

EXPERIMENTAL
Drug: teriflunomide (HMR1726)

Teriflunomide 14 mg

EXPERIMENTAL
Drug: teriflunomide (HMR1726)

Interventions

teriflunomide (HMR1726)DRUG

tablet, oral administration once daily.

Teriflunomide 14 mgTeriflunomide 7 mg

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (16)

Investigational Site Number 16

Calgary, T2N 2T9, Canada

Location

Investigational Site Number 10

Halifax, B3H 1V7, Canada

Location

Investigational Site Number 15

London, N6A 5A5, Canada

Location

Investigational Site Number 12

Montreal, H2L 4M1, Canada

Location

Investigational Site Number 11

Montreal, H3A 2B4, Canada

Location

Investigational Site Number 13

Ottawa, K1H 8L6, Canada

Location

Investigational Site Number 18

Québec, G1J 1Z4, Canada

Location

Investigational Site Number 14

Toronto, M5B 1W8, Canada

Location

Investigational Site Number 17

Vancouver, V6T 2B5, Canada

Location

Investigational Site Number 19

Winnipeg, R3E 3N4, Canada

Location

Investigational Site Number 24

Clermont-Ferrand, 63003, France

Location

Investigational Site Number 21

Lyon, 69394, France

Location

Investigational Site Number 30

Marseille, 13385, France

Location

Investigational Site Number 23

Montpellier, 34000, France

Location

Investigational Site Number 28

Nice, 06002, France

Location

Investigational Site Number 27

Rennes, 35033, France

Location

Related Publications (2)

  • 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.

    PMID: 33023488DERIVED

  • 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.

    PMID: 22307384DERIVED

MeSH Terms

Conditions

Multiple SclerosisMultiple Sclerosis, Relapsing-Remitting

Interventions

teriflunomide

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemNervous System DiseasesDemyelinating DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Paul W O'Connor, MD

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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 26, 2005

First Posted

September 28, 2005

Study Start

January 1, 2002

Primary Completion

January 1, 2015

Study Completion

January 1, 2015

Last Updated

March 25, 2015

Record last verified: 2015-03

Locations

FR(6)CA(10)