Ignite Creation Date:
2024-05-05 @ 5:33 PM
Last Modification Date:
2024-10-26 @ 9:33 AM
Study NCT ID:
NCT00475865
Status:
COMPLETED
Last Update Posted:
2012-11-06
First Post:
2007-05-18
Brief Title:
Phase II Study of Teriflunomide as Adjunctive Therapy to Glatiramer Acetate in Subjects With Multiple Sclerosis
Sponsor:
Sanofi
Organization:
Sanofi
Study Overview
Official Title:
A Randomized Multinational Double-blind Placebo-controlled Parallel-group Design Pilot Study to Estimate the Tolerability Safety Pharmacokinetics and Pharmacodynamic Effects of Teriflunomide for 24 Weeks When Added to Treatment With Glatiramer Acetate in Subjects With Multiple Sclerosis
Status:
COMPLETED
Status Verified Date:
2012-11
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 was to estimate the tolerability and safety of 2 doses of Teriflunomide administered once daily for 24 weeks compared to placebo in patients with multiple sclerosis MS with relapses who were on a stable dose of Glatiramer Acetate GA
The secondary objectives were
to estimate the effect of the 2 doses of Teriflunomide compared to placebo in combination with a stable dose of GA on Magnetic Resonance Imaging MRI parameters relapse rate and patient-reported fatigue
to perform pharmacokinetic analyses of the 2 doses of teriflunomide in combination with a stable dose of GA
The secondary objectives were
to estimate the effect of the 2 doses of Teriflunomide compared to placebo in combination with a stable dose of GA on Magnetic Resonance Imaging MRI parameters relapse rate and patient-reported fatigue
to perform pharmacokinetic analyses of the 2 doses of teriflunomide in combination with a stable dose of GA
Detailed Description:
The duration of the study period for a participant was approximatively 44 weeks broken down as follows
Screening period up to 4 weeks
24-week double-blind treatment period
16-week post-treatment elimination follow-up period
Participants successfully completing the week 24 visit were offered the opportunity to enter the optional long-term extension study LTS6047 - NCT00811395
Screening period up to 4 weeks
24-week double-blind treatment period
16-week post-treatment elimination follow-up period
Participants successfully completing the week 24 visit were offered the opportunity to enter the optional long-term extension study LTS6047 - NCT00811395
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 |
|---|---|---|---|
| HMR1726D-2004 | OTHER | HMR | None |
| 2006-004893-29 | EUDRACT_NUMBER | None | None |