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Long Term Safety and Efficacy Study of Teriflunomide 7 mg or 14 mg in Patients With Relapsing-Remitting Multiple Sclerosis

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Sanofi
ClinicalTrials.gov Identifier:
NCT00803049
First received: December 1, 2008
Last updated: October 17, 2014
Last verified: October 2014
  Purpose

The primary objective of this study is to document the long-term safety and tolerability of teriflunomide in Multiple Sclerosis (MS) patients with relapse.

The secondary objective is to document the long-term efficacy on disability progression, relapse rate and Magnetic Resonance Imaging (MRI) parameters.


Condition Intervention Phase
Multiple Sclerosis
Drug: teriflunomide (HMR1726)
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official 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

Resource links provided by NLM:


Further study details as provided by Sanofi:

Primary Outcome Measures:
  • Number of patients with adverse events [ Time Frame: Up to a maximum of 292 weeks (4 weeks after last treatment intake) or until teriflunomide is commercially available in the country where patient lives ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Time to disability progression as assessed by Expanded Disability Status Scale (EDSS) [ Time Frame: Up to a maximum of 288 weeks or until teriflunomide is commercially available in the country where patient lives ] [ Designated as safety issue: No ]
  • Proportion of patients free of disability progression [ Time Frame: Up to a maximum of 288 weeks or until teriflunomide is commercially available in the country where patient lives ] [ Designated as safety issue: No ]
  • Annualized relapse rate (number of confirmed relapses per patient-year) [ Time Frame: Up to a maximum of 288 weeks or until teriflunomide is commercially available in the country where patient lives ] [ Designated as safety issue: No ]
  • Burden of disease : Change from baseline in the volume of abnormal brain tissue as measured by brain MRI [ Time Frame: Up to a maximum of 288 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 1080
Study Start Date: October 2006
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Teriflunomide 7 mg Drug: teriflunomide (HMR1726)
Tablet, oral administration once daily.
Experimental: Teriflunomide 14 mg Drug: teriflunomide (HMR1726)
Tablet, oral administration once daily.

Detailed Description:

Patients completing the EFC6049 (HMR1726D/3001) study are given the opportunity to continue in the extension study;

  • patients receiving teriflunomide 7 mg or 14 mg are blindly maintained on the same dose of teriflunomide.
  • patients receiving placebo are randomized to teriflunomide 7 mg or 14 mg.

The study period per patient is broken down as follows:

  • Double-blind treatment: up to a maximum of 288 weeks or until teriflunomide is commercially available in the country where patient lives,
  • Post-washout follow-up: 4 weeks after last treatment intake. No post-washout follow up if patient continues on teriflunomide treatment by obtaining it's commercial form after end of the study.

The total duration of the extension is 292 weeks (about 6 years) from the first patient enrolled or until teriflunomide is commercially available in the country where patient lives.

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patient who has completed the previous double-blind placebo-controlled study EFC6049 and who does not meet criteria for treatment withdrawal.
  • Willingness to participate in a long-term safety/efficacy trial.

Exclusion Criteria:

  • Any known condition or circumstance that would prevent in the investigator's opinion, compliance or completion of the study.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00803049

  Show 21 Study Locations
Sponsors and Collaborators
Sanofi
Investigators
Study Director: Clinical Sciences & Operations Sanofi
  More Information

No publications provided

Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT00803049     History of Changes
Other Study ID Numbers: LTS6050, 2006-003361-14
Study First Received: December 1, 2008
Last Updated: October 17, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Sanofi:
Multiple Sclerosis
Oral treatment

Additional relevant MeSH terms:
Multiple Sclerosis
Multiple Sclerosis, Relapsing-Remitting
Sclerosis
Autoimmune Diseases
Autoimmune Diseases of the Nervous System
Demyelinating Autoimmune Diseases, CNS
Demyelinating Diseases
Immune System Diseases
Nervous System Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on November 23, 2014