Avonex (Interferon-beta-1a) and Avonex Plus Methylprednisolone for the Treatment of Relapsing-remitting MS

Relapsing-remitting Multiple Sclerosis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00168766
• Other study ID #: NOR-03-01
• Secondary ID: Mecombin
• Status: Completed
• Phase: Phase 4
• First received: September 13, 2005
• Last updated: September 12, 2013
• Start date: January 2003
• Est. completion date: November 2008

Study information

• Verified date: April 2011
• Source: Biogen
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish Medicines Agency
• Study type: Interventional

Clinical Trial 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.

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.

Other known NCT identifiers

• NCT00492180

Recruitment information / eligibility

• Status: Completed
• Enrollment: 345
• Est. completion date: November 2008
• Est. primary completion date: November 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

Inclusion Criteria:

• Informed consent

• Relapsing remitting MS according to Poser criteria or McDonell criteria and naïve to therapy

• Disability EDSS score of 4.0 or less at baseline

• Clinical activity as defined by at least one relapse in the last year

Exclusion Criteria:

• Relapse in the month prior to enrolment

• Treatment with immunosuppressive drugs for MS

• History of major depression

• Former severe reactions to corticosteroids

• Pregnant women

• Diabetes mellitus, and drug or alcohol dependency

• Known or suspected allergy to trial products

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Multiple Sclerosis
• Multiple Sclerosis, Relapsing-Remitting
• Relapsing-remitting Multiple Sclerosis
• Sclerosis

Intervention

Drug:
• Interferon-beta-1a (Avonex) plus methylprednisolone
oral administration given on 3 consecutive days, monthly as described in protocol.

Locations

Country	Name	City	State
Belgium	CUB Hôpital Erasme	Bruxelles
Denmark	Coordinating Research Site	Copenhagen
Denmark	Rigshospitalet	Skleroseklinikken
Finland	Tampereen yliopistollinen sairaala - Neurologian klinikka	Tampere
Netherlands	Stichting MS Centrum	Nijemegen
Norway	Ullevål Universitetssykehus	Oslo
Sweden	Neurologkliniken	Stockholm
Switzerland	Kantonspital	St. Gallen
United Kingdom	Queens Medical Centre - Division of Neurology	Nottingham

Sponsors (1)

Lead Sponsor	Collaborator
Biogen

Countries where clinical trial is conducted

Belgium,  Denmark,  Finland,  Netherlands,  Norway,  Sweden,  Switzerland,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To estimate the effect interferon-beta-1a in combination with methylprednisolone vs interferon-beta-1a in combination with placebo on the time to onset of disability progression sustained over at least 6 months based on change from randomization in EDSS		4 years	No