Ignite Creation Date:
2025-12-25 @ 2:36 AM
Ignite Modification Date:
2026-03-04 @ 5:58 AM
Study NCT ID:
NCT00112034
Status:
COMPLETED
Last Update Posted:
2008-05-09
First Post:
2005-05-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
AVONEX® Combination Trial - "ACT"
Sponsor:
Biogen
Organization:
Study Overview
Official Title:
A Multi-Center, Randomized, Blinded, Parallel-Group Study of AVONEX Compared With AVONEX in Combination With Oral Methotrexate, Intravenous Methylprednisolone, or Both in Subjects With Relapsing Remitting MS Who Have Breakthrough Disease on AVONEX Monotherapy.
Status:
COMPLETED
Status Verified Date:
2008-05
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:
None
Brief Summary:
The purpose of this study is to determine the efficacy and safety of combination therapy with AVONEX plus low dose oral methotrexate (MTX), every other month courses of intravenous methylprednisolone (IVMP), or both in patients with continued disease activity on AVONEX monotherapy.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: