Ignite Creation Date:
2024-05-05 @ 5:22 PM
Last Modification Date:
2024-10-26 @ 9:31 AM
Study NCT ID:
NCT00441103
Status:
COMPLETED
Last Update Posted:
2014-07-09
First Post:
2007-02-26
Brief Title:
A Study to Evaluate Rebif New Formulation Interferon-beta-1a in Relapsing Remitting Multiple Sclerosis
Sponsor:
Merck KGaA Darmstadt Germany
Organization:
Merck KGaA Darmstadt Germany
Study Overview
Official Title:
A Two-arm Randomized Double-blind Control Group-compared Multicenter Phase IIIb Study With Monthly MRI and Biomarker Assessments to Evaluate the Efficacy Safety and Tolerability of Rebif New Formulation IFN Beta-1a in Subjects With Relapsing Remitting Multiple Sclerosis
Status:
COMPLETED
Status Verified Date:
2014-06
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:
IMPROVE
Brief Summary:
General Note throughout this record Rebif New Formulation is used for historical and consistency purposes
Objectives
Primary To evaluate the efficacy of Rebif New Formulation Interferon-beta-1a IFN-beta-1a RNF compared to placebo in subjects with Relapsing Remitting Multiple Sclerosis and active disease by means of Magnetic Resonance Imaging MRI at the end of 16 weeks of treatment Secondary To evaluate the efficacy of RNF by comparing the mean number of combined unique CU lesions per scan per subject between the initial 16 weeks of placebo treatment and 24 weeks of RNF treatment in the same subjects originally randomized to placebo
Primary Endpoints The primary endpoint is the difference between the number of CU active MRI lesions at Week 16 in the RNF group Group 1 versus the placebo group Group 2
Secondary Endpoints The secondary endpoint is the difference in the mean number of CU active MRI lesions per scan per subject over the following treatment periods Study Day 1 - Week 16 versus Weeks 17 - 40 for the subjects randomized to Group 2
Objectives
Primary To evaluate the efficacy of Rebif New Formulation Interferon-beta-1a IFN-beta-1a RNF compared to placebo in subjects with Relapsing Remitting Multiple Sclerosis and active disease by means of Magnetic Resonance Imaging MRI at the end of 16 weeks of treatment Secondary To evaluate the efficacy of RNF by comparing the mean number of combined unique CU lesions per scan per subject between the initial 16 weeks of placebo treatment and 24 weeks of RNF treatment in the same subjects originally randomized to placebo
Primary Endpoints The primary endpoint is the difference between the number of CU active MRI lesions at Week 16 in the RNF group Group 1 versus the placebo group Group 2
Secondary Endpoints The secondary endpoint is the difference in the mean number of CU active MRI lesions per scan per subject over the following treatment periods Study Day 1 - Week 16 versus Weeks 17 - 40 for the subjects randomized to Group 2
Detailed Description:
None
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 |
|---|---|---|---|
| 2006-003037-32 | None | None | None |