Status:
COMPLETED
A Study Comparing the Effectiveness and Safety of Teriflunomide and Interferon Beta-1a in Patients With Relapsing Multiple Sclerosis
Lead Sponsor:
Sanofi
Conditions:
Multiple Sclerosis
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
Primary objective was to assess the effectiveness evaluated by the time to failure of two doses of teriflunomide in comparison to interferon beta-1a in participants with relapsing Multiple Sclerosis \...
Detailed Description
The core treatment period per participant was variable depending on the enrollment in the study (maximum of approximatively 118 weeks). The two doses of teriflunomide were administered in double-blind...
Eligibility Criteria
Inclusion
- Relapsing form of MS meeting McDonald's criteria for MS diagnosis and Expanded Disability Status Scale \[EDSS\] score ≤5.5 at screening visit.
Exclusion
- Significantly impaired bone marrow function or, significant anemia, leukopenia or thrombocytopenia;
- Persistent significant or severe infection.
- Liver function impairment or known history of hepatitis.
- Use of adrenocorticotrophic hormone \[ACTH\] or systemic corticosteroids for 2 weeks prior to randomization.
- Human immunodeficiency virus \[HIV\] positive.
- Prior use of Rebif®, or prior or concomitant use of other interferons in the 3 months prior to randomization.
- Prior or concomitant use of cladribine, mitoxantrone, or other immunosuppressant agents such as azathioprine, cyclophosphamide, cyclosporin, methotrexate, mycophenolate, or natalizumab.
- Pregnant or breast-feeding woman.
- Extension criteria:
- The participants who met all the following criteria at the end of the core study period were eligible for enrolment into the open-label extension phase:
- Participants who had not discontinued treatment in the core period and who had a minimum treatment of 48 weeks and completed the EOT visit (Visit 18).
- Participants who had not met criteria for treatment withdrawal.
- An informed consent must be obtained in writing from the participant for this open-label extension phase prior to entering and prior to completion of any extension phase procedure.
- Participants who demonstrated a willingness and ability to roll over to the extension phase with the opportunity to continue treatment on 14 mg/day of teriflunomide under open-label.
- The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
Key Trial Info
Start Date :
April 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2015
Estimated Enrollment :
324 Patients enrolled
Trial Details
Trial ID
NCT00883337
Start Date
April 1 2009
End Date
May 1 2015
Last Update
June 13 2016
Active Locations (54)
Enter a location and click search to find clinical trials sorted by distance.
1
Investigational Site Number 056003
Brussels, Belgium, 1070
2
Investigational Site Number 056001
Ghent, Belgium, 9000
3
Investigational Site Number 056002
Hasselt, Belgium, B-3590
4
Investigational Site Number 124003
Lévis, Canada, G6V 3Z1