Viewing Study NCT00168766



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Last Modification Date: 2024-10-26 @ 9:16 AM
Study NCT ID: NCT00168766
Status: COMPLETED
Last Update Posted: 2013-09-16
First Post: 2005-09-13

Brief Title: Avonex Interferon-beta-1a and Avonex Plus Methylprednisolone for the Treatment of Relapsing-remitting MS
Sponsor: Biogen
Organization: Biogen

Study Overview

Official Title: A Multicentre Randomized Double-blind Placebo-controlled Parallel Group Trial Investigating Methylprednisolone in Combination With Interferon-beta-1a for the Treatment of Patients With Relapsing-remitting Multiple Sclerosis
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: None
Brief Summary: The primary objective of this study is to determine whether combination treatment adding methylprednisolone to Avonex reduces progression of disability over 4 years compared to Avonex alone The study will also investigate whether combination therapy has any impact on the incidence of relapse and brain atrophy as measured by MRI
Detailed Description: Approximately 340 therapy-naïve MS patients with relapsing-remitting form of the disease will be randomized to receive Avonex alone or Avonex plus methylprednisolone MP Patients will receive MP as 500 mg po for 3 days every month or matching placebo The patients are followed on a 3-monthly basis for 4 years with disability as the primary parameter of efficacy over that time

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
Mecombin None None None