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

Information source: Biogen
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Relapsing-remitting Multiple Sclerosis

Intervention: Interferon-beta-1a (Avonex) plus methylprednisolone (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Biogen

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.

Clinical Details

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

Primary outcome: 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

Detailed description: Approximately 340 therapy-na´ve 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.

Eligibility

Minimum age: 18 Years. Maximum age: 55 Years. Gender(s): Both.

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

Locations and Contacts

CUB H├┤pital Erasme, Bruxelles, Belgium

Coordinating Research Site, Copenhagen, Denmark

Rigshospitalet, Skleroseklinikken, Denmark

Tampereen yliopistollinen sairaala - Neurologian klinikka, Tampere, Finland

Stichting MS Centrum, Nijemegen, Netherlands

Ullev├ąl Universitetssykehus, Oslo, Norway

Neurologkliniken, Stockholm, Sweden

Kantonspital, St. Gallen, Switzerland

Queens Medical Centre - Division of Neurology, Nottingham Ng72uh, United Kingdom

Additional Information

Starting date: January 2003
Last updated: September 12, 2013

Page last updated: August 23, 2015

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