Ignite Creation Date:
2024-05-05 @ 5:33 PM
Last Modification Date:
2024-10-26 @ 9:33 AM
Study NCT ID:
NCT00489489
Status:
COMPLETED
Last Update Posted:
2012-11-06
First Post:
2007-06-20
Brief Title:
Phase II Study of Teriflunomide as Adjunctive Therapy to Interferon-beta 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 Interferon-beta 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 with placebo in patients with multiple sclerosis MS with relapses who were on a stable dose of interferon-β IFN-β
Secondary objectives were
to estimate the effects of the 2 doses of teriflunomide compared to placebo in combination with a stable dose of IFN-β 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 IFN-β
Secondary objectives were
to estimate the effects of the 2 doses of teriflunomide compared to placebo in combination with a stable dose of IFN-β 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 IFN-β
Detailed Description:
The study period per 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-2003 | OTHER | HMR | None |
| 2006-003134-14 | EUDRACT_NUMBER | None | None |