Ignite Creation Date:
2024-05-05 @ 11:07 PM
Last Modification Date:
2024-10-26 @ 10:28 AM
Study NCT ID:
NCT01252355
Status:
TERMINATED
Last Update Posted:
2014-06-09
First Post:
2010-11-30
Brief Title:
Efficacy and Safety of Teriflunomide in Patients With Relapsing Multiple Sclerosis and Treated With Interferon-beta
Sponsor:
Sanofi
Organization:
Sanofi
Study Overview
Official Title:
A Multi-center Double-blind Parallel-group Placebo-controlled Study of the Efficacy and Safety of Teriflunomide in Patients With Relapsing Multiple Sclerosis Who Are Treated With Interferon-beta
Status:
TERMINATED
Status Verified Date:
2014-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Sponsor decision to prematurely stop the study not linked to any safety concern
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
TERACLES
Brief Summary:
The primary objective was to demonstrate the effect of teriflunomide in comparison to placebo on frequency of Multiple Sclerosis MS relapses in patients with relapsing forms of MS who are treated with Interferon-beta IFN-beta
The secondary objectives were
Assess the effect of teriflunomide in comparison to placebo when added to IFN-beta on
Disease activity as measured by brain Magnetic Resonance Imaging MRI
Disability progression
Burden of disease and disease progression as measured by brain MRI
Evaluate the safety and tolerability of teriflunomide when added to IFN-beta therapy
Assess the pharmacokinetics of teriflunomide in use in addition to baseline IFN-beta therapy
Assess associations between variations in genes and clinical outcomes safety and efficacy
Assess other measures of efficacy of teriflunomide such as fatigue and health-related quality of life
Assess measures of health economics hospitalization due to relapse including the length of stay and any admission to intensive care unit
The secondary objectives were
Assess the effect of teriflunomide in comparison to placebo when added to IFN-beta on
Disease activity as measured by brain Magnetic Resonance Imaging MRI
Disability progression
Burden of disease and disease progression as measured by brain MRI
Evaluate the safety and tolerability of teriflunomide when added to IFN-beta therapy
Assess the pharmacokinetics of teriflunomide in use in addition to baseline IFN-beta therapy
Assess associations between variations in genes and clinical outcomes safety and efficacy
Assess other measures of efficacy of teriflunomide such as fatigue and health-related quality of life
Assess measures of health economics hospitalization due to relapse including the length of stay and any admission to intensive care unit
Detailed Description:
The study period per patient was expected to be between 56 and 160 weeks depending on when the patient was randomized and this included the following
a screening period up to 4 weeks
a treatment period expected to be between 48 and 152 weeks
4-week post rapid elimination follow-up period
Patients were to continue on treatment until a fixed common end date which was approximately 48 weeks after randomization of the last patient
For those patients who completed the treatment period a long term extension study of approximately 1 year including teriflunomide alone was initially planned to be proposed
a screening period up to 4 weeks
a treatment period expected to be between 48 and 152 weeks
4-week post rapid elimination follow-up period
Patients were to continue on treatment until a fixed common end date which was approximately 48 weeks after randomization of the last patient
For those patients who completed the treatment period a long term extension study of approximately 1 year including teriflunomide alone was initially planned to be proposed
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 |
|---|---|---|---|
| 2010-023172-12 | EUDRACT_NUMBER | None | None |
| U1111-1115-2414 | OTHER | UTN | None |