Phase III Study With Teriflunomide Versus Placebo in Patients With First Clinical Symptom of Multiple Sclerosis (TOPIC)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Sanofi
ClinicalTrials.gov Identifier:
NCT00622700
First received: February 14, 2008
Last updated: December 16, 2013
Last verified: December 2013

February 14, 2008
December 16, 2013
February 2008
December 2012   (final data collection date for primary outcome measure)
Conversion to clinically definite MS as defined by the occurrence of a relapse [ Time Frame: 108 weeks ] [ Designated as safety issue: No ]
Conversion to clinically definite MS [ Time Frame: up to 2 years ]
Complete list of historical versions of study NCT00622700 on ClinicalTrials.gov Archive Site
  • Conversion to definite MS as demonstrated by the dissemination of cerebral Magnetic Resonance Imaging (MRI) lesions in time (revised McDonald criteria 2005) [ Time Frame: 108 weeks ] [ Designated as safety issue: No ]
  • Annualized relapse rate (number of relapses per subject/year) [ Time Frame: 108 weeks ] [ Designated as safety issue: No ]
  • Burden of disease [ Time Frame: 108 weeks ] [ Designated as safety issue: No ]
    Change from baseline in the volume of abnormal brain tissue as assessed by cerebral MRI
  • Disability progression as assessed by the Kurtzke Expanded Disability Status Scale (EDSS) [ Time Frame: 108 weeks ] [ Designated as safety issue: No ]
  • Patient reported fatigue as assessed by the Fatigue Impact Scale (FIS) [ Time Frame: 108 weeks ] [ Designated as safety issue: No ]
  • Conversion to definite MS based on MRI data as defined by the demonstration of dissemination of MRI lesions in time
  • Annualized relapse rate
  • Burden of disease and other MRI variables
  • Proportion of disability-free patients, reported fatigue and Quality of Life
  • Safety and tolerability of teriflunomide
Not Provided
Not Provided
 
Phase III Study With Teriflunomide Versus Placebo in Patients With First Clinical Symptom of Multiple Sclerosis
An International, Multi-center, Randomized, Double-blind, Placebo-controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Two Year Treatment With Teriflunomide 7 mg Once Daily and 14 mg Once Daily Versus Placebo in Patients With a First Clinical Episode Suggestive of Multiple Sclerosis Plus a Long Term Extension Period

The primary objective is to demonstrate that early intervention with Teriflunomide in patients presenting with their first clinical episode consistent with MS prevents or delays conversion to clinically definite Multiple Sclerosis [MS].

The secondary objectives are:

  • to demonstrate that Teriflunomide prevents or delays conversion to MS based on the revised McDonald Criteria and delays disability progression,
  • to evaluate the long-term safety of Teriflunomide,

in this population.

The study consists of 4 periods:

  • Screening period: up to 4 weeks,
  • Placebo-controlled treatment period: up to 108 weeks (at least 24 weeks for patients who experienced conversion to clinical definite MS),
  • Extension treatment period (without placebo-control): the extension period will continue until teriflunomide is commercially available in patient's country of residence.
  • Post-treatment washout period: 4 weeks after last treatment intake.

The maximal duration of the study period per patient is expected to be 116 weeks if he/she does not continue in the extension treatment period.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Multiple Sclerosis
  • Drug: Teriflunomide
    Tablet, oral administration once daily
    Other Names:
    • HMR1726
    • Aubagio
  • Drug: Placebo (for teriflunomide)
    Matching tablet, oral administration once daily
  • Experimental: Teriflunomide 7 mg
    Intervention: Drug: Teriflunomide
  • Experimental: Teriflunomide 14 mg
    Intervention: Drug: Teriflunomide
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo (for teriflunomide)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
618
December 2015
December 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • First acute or subacute, well-defined neurological event consistent with demyelination (i.e. optic neuritis confirmed by an ophthalmologist, spinal cord syndrome, brainstem/cerebellar syndromes),
  • Onset of MS symptoms occurring within 90 days of randomization,
  • A screening MRI scan with 2 or more T2 lesions at least 3 mm in diameter that are characteristic of MS.

Exclusion Criteria:

  • Clinically relevant cardiovascular, hepatic, neurological, endocrine or other major systemic disease,
  • Significantly impaired bone marrow function,
  • Pregnancy or nursing,
  • Alcohol or drug abuse,
  • Use of cladribine, mitoxantrone, or other immunosuppressant agents such as azathioprine, cyclophosphamide, cyclosporin, methotrexate or mycophenolate before enrollment
  • 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.

Both
18 Years to 55 Years
No
Contact information is only displayed when the study is recruiting subjects
United States,   Australia,   Austria,   Bulgaria,   Canada,   Chile,   Czech Republic,   Denmark,   Estonia,   Finland,   France,   Germany,   Hungary,   Lithuania,   Mexico,   Poland,   Romania,   Russian Federation,   Turkey,   Ukraine,   United Kingdom
 
NCT00622700
EFC6260, HMR1726D-3005, 2006-001152-12
Yes
Sanofi
Sanofi
Not Provided
Study Director: Clinical Sciences & Operations Sanofi
Sanofi
December 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP