search
Back to results

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

Primary Purpose

Relapsing-remitting Multiple Sclerosis

Status
Completed
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
Interferon-beta-1a (Avonex) plus methylprednisolone
Sponsored by
Biogen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Relapsing-remitting Multiple Sclerosis focused on measuring Combination therapy for multiple sclerosis

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • CUB Hôpital Erasme
  • Coordinating Research Site
  • Rigshospitalet
  • Tampereen yliopistollinen sairaala - Neurologian klinikka
  • Stichting MS Centrum
  • Ullevål Universitetssykehus
  • Neurologkliniken
  • Kantonspital
  • Queens Medical Centre - Division of Neurology

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

1

2

Arm Description

interferon-beta-1a in combination with methylprednisolone

interferon-beta-1a in combination with placebo

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
September 13, 2005
Last Updated
September 12, 2013
Sponsor
Biogen
search

1. Study Identification

Unique Protocol Identification Number
NCT00168766
Brief Title
Avonex (Interferon-beta-1a) and Avonex Plus Methylprednisolone for the Treatment of Relapsing-remitting MS
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2011
Overall Recruitment Status
Completed
Study Start Date
January 2003 (undefined)
Primary Completion Date
November 2008 (Actual)
Study Completion Date
November 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Biogen

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Relapsing-remitting Multiple Sclerosis
Keywords
Combination therapy for multiple sclerosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
345 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
interferon-beta-1a in combination with methylprednisolone
Arm Title
2
Arm Type
Placebo Comparator
Arm Description
interferon-beta-1a in combination with placebo
Intervention Type
Drug
Intervention Name(s)
Interferon-beta-1a (Avonex) plus methylprednisolone
Other Intervention Name(s)
Avonex
Intervention Description
oral administration given on 3 consecutive days, monthly as described in protocol.
Primary Outcome Measure Information:
Title
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
Time Frame
4 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
CUB Hôpital Erasme
City
Bruxelles
Country
Belgium
Facility Name
Coordinating Research Site
City
Copenhagen
Country
Denmark
Facility Name
Rigshospitalet
City
Skleroseklinikken
Country
Denmark
Facility Name
Tampereen yliopistollinen sairaala - Neurologian klinikka
City
Tampere
Country
Finland
Facility Name
Stichting MS Centrum
City
Nijemegen
Country
Netherlands
Facility Name
Ullevål Universitetssykehus
City
Oslo
Country
Norway
Facility Name
Neurologkliniken
City
Stockholm
Country
Sweden
Facility Name
Kantonspital
City
St. Gallen
Country
Switzerland
Facility Name
Queens Medical Centre - Division of Neurology
City
Nottingham
ZIP/Postal Code
Ng72uh
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
20542736
Citation
Ravnborg M, Sorensen PS, Andersson M, Celius EG, Jongen PJ, Elovaara I, Bartholome E, Constantinescu CS, Beer K, Garde E, Sperling B. Methylprednisolone in combination with interferon beta-1a for relapsing-remitting multiple sclerosis (MECOMBIN study): a multicentre, double-blind, randomised, placebo-controlled, parallel-group trial. Lancet Neurol. 2010 Jul;9(7):672-80. doi: 10.1016/S1474-4422(10)70132-0. Epub 2010 Jun 9. Erratum In: Lancet Neurol. 2010 Aug;9(8):759.
Results Reference
derived

Learn more about this trial

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

We'll reach out to this number within 24 hrs