Ignite Creation Date:
2024-05-05 @ 5:31 PM
Last Modification Date:
2024-10-26 @ 9:32 AM
Study NCT ID:
NCT00473213
Status:
COMPLETED
Last Update Posted:
2007-05-14
First Post:
2007-05-11
Brief Title:
Optimizing IFN Beta - 1B Dose
Sponsor:
University of Turin Italy
Organization:
University of Turin Italy
Study Overview
Official Title:
Optimizing IFN Beta - 1B Dose
Status:
COMPLETED
Status Verified Date:
2007-05
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:
Optims
Brief Summary:
BetaferonR is effective in reducing relapse rate and MRI T2-weighted lesion frequency in MS patients at the dose of 8 MIU on alternate days THE IFNB MS Study Group 1993 Relapse rate is reduced by 30-35 The IFNB MS Study Group 1993 MRI activity is decreased up to 100 in most cases Stone et al 1995 In some patients however MRI activity still occurs or reappears during treatment Stone et al 1995 MRI activity has been demonstrated to correlate with relapse occurrence McFarland et al 1992 Miller et al 1996 and in some patients relapses still occur during IFN beta treatment In other patients relapses may occur in association with the appearance after 9-18 months of treatment of anti-IFN beta NAB The IFNB M S Study Group 1995
This protocol hypothesizes that the dose of 12 MIU BetaferonR on alternate days has more pronounced MRI and clinical effects in MS patients than that of 8 MIU MS patients who do not respond to 8 MIU may take advantage of a higher dose We therefore decided to assess MRI effects after increasing the Betaferon dose 12 MIU in RRMS patients showing a residual MRI activity at least one new Gd enhancing lesion during six months of standard Betaferon dose treatment 8 MIU
This protocol hypothesizes that the dose of 12 MIU BetaferonR on alternate days has more pronounced MRI and clinical effects in MS patients than that of 8 MIU MS patients who do not respond to 8 MIU may take advantage of a higher dose We therefore decided to assess MRI effects after increasing the Betaferon dose 12 MIU in RRMS patients showing a residual MRI activity at least one new Gd enhancing lesion during six months of standard Betaferon dose treatment 8 MIU
Detailed Description:
Comparing the frequency of new Gd enhancing lesions in a group of patients presenting a residual MRI activity during the last four months of the six month standard dose 8MIU Betaferon treatment randomized to continue the standard dose or to increase the dose to 12 MIU Betaferon
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