Long Term Safety of Teriflunomide When Added to Interferon-Beta or Glatiramer Acetate in Patients With Multiple Sclerosis
Completed · Phase 2 · Has a placebo group
Conditions studied: Multiple Sclerosis
In brief
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 sclerosis \[MS\] with relapses. Secondary objectives were to evaluate the long-term effect on relapse rate, disability progression and Magnetic Resonance Imaging \[MRI\] parameters. This study is the extension study of the PDY6045 (NCT00489489) and PDY6046 (NCT00475865) studies. Participants who successfully completed the initial study were offered to continue their treatment (same compound, same dose) for 24 additional weeks.
Key facts
- Study ID
- NCT00811395
- Run by
- Sanofi
- People needed
- 182
- Starts
- 2007-10-01
- Expected to finish
- 2010-04-01
- Last updated by the study team
- 2012-12-31
Who can join
Age: 18 and older, up to 55. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- Sanofi-Aventis Administrative Office — Bridgewater, New Jersey, United States
- Sanofi-Aventis Administrative Office — Vienna, Austria
- Sanofi-Aventis Administrative Office — Laval, Canada
- Sanofi-Aventis Administrative Office — Berlin, Germany
- Sanofi-Aventis Administrative Office — Milan, Italy
- Sanofi-Aventis Administrative Office — Barcelona, Spain
- Sanofi-Aventis Administrative Office — Guildford, United Kingdom
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.