Ignite Creation Date:
2024-05-05 @ 5:29 PM
Last Modification Date:
2024-10-26 @ 9:32 AM
Study NCT ID:
NCT00461396
Status:
COMPLETED
Last Update Posted:
2011-04-08
First Post:
2007-04-17
Brief Title:
Success of Titration Analgesics and BETA Nurse Support on Acceptance Rates in Early Multiple Sclerosis MS Treatment With Betaseron
Sponsor:
Bayer
Organization:
Bayer
Study Overview
Official Title:
Open-Label Multicenter Observational Phase IV Study to Evaluate the Adherence to Treatment With 250mcg 8MIU IFNB-1b Betaseron Given Subcutaneous Every Other Day Over a Period of up to 12 Months in Patients With a First Clinical Demyelinating Event Suggestive of Multiple Sclerosis and Patients With Onset of Relapsing-Remitting Multiple Sclerosis RRMS Within the Past 12 Months
Status:
COMPLETED
Status Verified Date:
2011-04
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:
START
Brief Summary:
The primary aim of this study is to evaluate the impact of titration analgesics and 12 month telephone follow-up period from the BETA nurse program upon adherence to treatment with Betaseron in patients with a first clinical demyelinating event suggestive of Multiple Sclerosis MS and patients with onset of RRMS within the past 12 months
Secondary outcomes include analysis of the following parameters progression of clinical severity by the expanded disability status scale EDSS score health related quality of life HrQoL and safety
Exploratory outcomes include changes over time in cytokine and neurotrophic factor production by immune cells and visual function as assessed by visual examination OCT measurements and a neuro-ophthalmologic Health-Related Quality of Life questionnaire NEI-VFQ-25 with 10-item supplement
Secondary outcomes include analysis of the following parameters progression of clinical severity by the expanded disability status scale EDSS score health related quality of life HrQoL and safety
Exploratory outcomes include changes over time in cytokine and neurotrophic factor production by immune cells and visual function as assessed by visual examination OCT measurements and a neuro-ophthalmologic Health-Related Quality of Life questionnaire NEI-VFQ-25 with 10-item supplement
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 |
|---|---|---|---|
| BF0713US | None | None | None |
| 311501 | None | None | None |