Status:
COMPLETED
Study of Teriflunomide in Reducing the Frequency of Relapses and Accumulation of Disability in Patients With Multiple Sclerosis
Lead Sponsor:
Sanofi
Conditions:
Multiple Sclerosis
Eligibility:
All Genders
18-55 years
Phase:
PHASE3
Brief Summary
The primary objective was to determine the effect of teriflunomide on the frequency of relapses in patients with relapsing multiple sclerosis (MS). Secondary objectives were: * to evaluate the effec...
Detailed Description
The study period per participant was approximatively 128 weeks broken down as follows: * Screening period up to 4 weeks, * 108-week double-blind treatment period (approximatively 2 years)\*, * 16-wee...
Eligibility Criteria
Inclusion
- Multiple sclerosis \[MS\] subject who was ambulatory (EDSS of ≤ 5.5)
- Exhibiting a relapsing clinical course, with or without progression (relapsing remitting, secondary progressive or progressive relapsing);
- Meeting McDonald's criteria for MS diagnosis;
- Experienced at least 1 relapse over the 1 year preceding the trial or at least 2 relapses over the 2 years preceding the trial;
- No relapse onset in the preceding 60 days prior to randomization;
- Clinically stable during the 30 days prior to randomization, without adrenocorticotrophic hormone \[ACTH\] or systemic steroid treatment.
Exclusion
- Clinically relevant cardiovascular, hepatic, neurological, endocrine or other major systemic disease;
- Significantly impaired bone marrow function;
- Pregnant or nursing woman;
- 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;
Key Trial Info
Start Date :
September 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2010
Estimated Enrollment :
1088 Patients enrolled
Trial Details
Trial ID
NCT00134563
Start Date
September 1 2004
End Date
July 1 2010
Last Update
January 4 2013
Active Locations (21)
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1
Sanofi-Aventis
Bridgewater, New Jersey, United States, 08807
2
Sanofi-Aventis Austria
Vienna, Austria
3
sanofi-aventis, Canada
Laval, Canada
4
Sanofi-Aventis
Santiago, Chile