Status:
COMPLETED
Long Term Safety of Teriflunomide When Added to Interferon-Beta or Glatiramer Acetate in Patients With Multiple Sclerosis
Lead Sponsor:
Sanofi
Conditions:
Multiple Sclerosis
Eligibility:
All Genders
18-55 years
Phase:
PHASE2
Brief Summary
The primary objective was to evaluate the long-term safety and tolerability of teriflunomide when added to treatment with interferon-β \[IFN-β\] or glatiramer Acetate \[GA\] in patients with multiple ...
Detailed Description
The duration of the extension study per participants was 40 weeks broken down as follows: * 24-week double-blind treatment period, * 16-week post-treatment elimination follow-up period.
Eligibility Criteria
Inclusion
- PDY6045 or PDY6046 participant who:
- completed the week 24 visit of either study PDY6045 or PDY6046,
- was still meeting eligibility criteria for receiving treatment,
- had agreed to continue stable dose of Interferon-β \[IFN-β\] or Glatiramer Acetate \[GA\] and consented to continue on treatment.
Exclusion
- Any known condition or circumstance that would have prevented in the investigator's opinion, compliance or completion of the study
- The above information is not intended to contain all considerations relevant to patient's potential participation in a clinical trial.
Key Trial Info
Start Date :
October 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2010
Estimated Enrollment :
182 Patients enrolled
Trial Details
Trial ID
NCT00811395
Start Date
October 1 2007
End Date
April 1 2010
Last Update
December 31 2012
Active Locations (7)
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1
Sanofi-Aventis Administrative Office
Bridgewater, New Jersey, United States, 08807
2
Sanofi-Aventis Administrative Office
Vienna, Austria
3
Sanofi-Aventis Administrative Office
Laval, Canada
4
Sanofi-Aventis Administrative Office
Berlin, Germany