Ignite Creation Date:
2024-05-05 @ 12:02 PM
Last Modification Date:
2024-10-26 @ 9:19 AM
Study NCT ID:
NCT00228163
Status:
COMPLETED
Last Update Posted:
2015-03-25
First Post:
2005-09-26
Brief Title:
Long Term Safety and Efficacy of Teriflunomide HMR1726 in Multiple Sclerosis With Relapses
Sponsor:
Sanofi
Organization:
Sanofi
Study Overview
Official Title:
Extension of Protocol HMR1726D2001 A Phase II Study of the Safety and Efficacy of Teriflunomide HMR1726 in Multiple Sclerosis With Relapses
Status:
COMPLETED
Status Verified Date:
2015-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The primary objective is to assess the long-term safety of teriflunomide in multiple sclerosis subjects The secondary objective is to assess the long-term efficacy
Detailed Description:
Subjects completing the HMR 1726D2001 study are given the opportunity to continue or switch to teriflunomide for 528 weeks or until teriflunomide is commercially available in the country where patient lives
subjects on Teriflunomide 7 mg or 14 mg continue on the same dose of teriflunomide
subjects on placebo are randomized to teriflunomide 7 mg or 14 mg
The total study period per subject is 532 weeks or until teriflunomide is commercially available in the country where patient lives broken up as follows
Treatment 528 weeks or until teriflunomide is commercially available in the country where patient lives
Post-washout follow-up 4 weeks after last treatment intake
subjects on Teriflunomide 7 mg or 14 mg continue on the same dose of teriflunomide
subjects on placebo are randomized to teriflunomide 7 mg or 14 mg
The total study period per subject is 532 weeks or until teriflunomide is commercially available in the country where patient lives broken up as follows
Treatment 528 weeks or until teriflunomide is commercially available in the country where patient lives
Post-washout follow-up 4 weeks after last treatment intake
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| HMR1726D2002 | None | None | None |