Status:
COMPLETED
Avonex (Interferon-beta-1a) and Avonex Plus Methylprednisolone for the Treatment of Relapsing-remitting MS
Lead Sponsor:
Biogen
Conditions:
Relapsing-remitting Multiple Sclerosis
Eligibility:
All Genders
18-55 years
Phase:
PHASE4
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 stu...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2008
Estimated Enrollment :
345 Patients enrolled
Trial Details
Trial ID
NCT00168766
Start Date
January 1 2003
End Date
November 1 2008
Last Update
September 16 2013
Active Locations (9)
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1
CUB Hôpital Erasme
Brussels, Belgium
2
Coordinating Research Site
Copenhagen, Denmark
3
Rigshospitalet
Skleroseklinikken, Denmark
4
Tampereen yliopistollinen sairaala - Neurologian klinikka
Tampere, Finland