Ignite Creation Date:
2024-05-05 @ 4:34 PM
Last Modification Date:
2024-10-26 @ 9:21 AM
Study NCT ID:
NCT00262314
Status:
COMPLETED
Last Update Posted:
2013-11-14
First Post:
2005-12-05
Brief Title:
Prospective Open-label Tolerability and Safety Monitoring Study of Novantrone in a Selected Cohort of Multiple Sclerosis Patients
Sponsor:
EMD Serono
Organization:
EMD Serono
Study Overview
Official Title:
Prospective Open-label Tolerability and Safety Monitoring Study of Novantrone in a Selected Cohort of Multiple Sclerosis Patients
Status:
COMPLETED
Status Verified Date:
2013-10
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:
RENEW
Brief Summary:
The overall objective of this study is to collect data relevant to the tolerability of Novantrone therapy in patients with multiple sclerosis MS using dosing and monitoring recommendations specified in the package insert
Detailed Description:
This phase IV multicenter prospective open-label tolerability and safety monitoring study will enroll a select cohort of 500 multiple sclerosis patients receiving commercially available Novantrone The patients will be assessed every 3 months during treatment followed by annual assessment for a total of five 5 years
The select cohort of MS patients enrolled will have secondary chronic progressive progressive relapsing or worsening relapsing-remitting disease ie patients whose neurological status is significantly abnormal between relapses
The overall objective of this study is to collect data relevant to the tolerability of Novantrone therapy in patients with multiple sclerosis MS using dosing and monitoring recommendations specified in the package insert
The select cohort of MS patients enrolled will have secondary chronic progressive progressive relapsing or worsening relapsing-remitting disease ie patients whose neurological status is significantly abnormal between relapses
The overall objective of this study is to collect data relevant to the tolerability of Novantrone therapy in patients with multiple sclerosis MS using dosing and monitoring recommendations specified in the package insert
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 |
|---|---|---|---|
| 19-297 | None | None | None |