Avonex (Interferon-Beta-1a) and Avonex Plus Methylprednisolone for the Treatment of Relapsing-Remitting MS - Full Text View

Sponsor:	Biogen Idec
Information provided by:	Biogen Idec
ClinicalTrials.gov Identifier:	NCT00168766

Purpose

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.

Condition	Intervention	Phase
Relapsing-Remitting Multiple Sclerosis	Drug: Interferon-beta-1a (Avonex) plus methylprednisolone	Phase IV

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study
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

Resource links provided by NLM:

MedlinePlus related topics: Multiple Sclerosis

Drug Information available for: Interferon beta Interferon-beta Methylprednisolone Interferon beta 1a Interferons

U.S. FDA Resources

Further study details as provided by Biogen Idec:

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 [ Time Frame: 4 years ] [ Designated as safety issue: No ]

Estimated Enrollment:	345
Study Start Date:	January 2003
Estimated Study Completion Date:	November 2008
Estimated Primary Completion Date:	November 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental interferon-beta-1a in combination with methylprednisolone	Drug: Interferon-beta-1a (Avonex) plus methylprednisolone oral administration given on 3 consecutive days, monthly as described in protocol.
2: Placebo Comparator interferon-beta-1a in combination with placebo	Drug: Interferon-beta-1a (Avonex) plus methylprednisolone oral administration given on 3 consecutive days, monthly as described in protocol.

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.

Eligibility

Ages Eligible for Study:	18 Years to 55 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00168766

Locations

Belgium
CUB Hôpital Erasme
Bruxelles, Belgium, B-1070
Denmark
Rigshospitalet
Skleroseklinikken, Denmark, N2082
Finland
Tampereen yliopistollinen sairaala - Neurologian klinikka
Tampere, Finland, FIN-33521
Netherlands
Stichting MS Centrum
Nijemegen, Netherlands, NL-6533
Norway
Ullevål Universitetssykehus
Oslo, Norway, 0407
Sweden
Neurologkliniken
Stockholm, Sweden, 171 76
Switzerland
Kantonspital
St. Gallen, Switzerland, 9007
United Kingdom, NG7 2UH
Queens Medical Centre - Division of Neurology
Nottingham, NG7 2UH, United Kingdom

Sponsors and Collaborators

Biogen Idec

Investigators

Principal Investigator:

Mads Ravnborg

Rigshospitalet, Denmark

More Information

No publications provided

Responsible Party:	Biogen Idec International ( Biogen Idec MD, Nordic Medical Director )
Study ID Numbers:	NOR-03-01, Mecombin
Study First Received:	September 13, 2005
Last Updated:	December 20, 2007
ClinicalTrials.gov Identifier:	NCT00168766 History of Changes
Health Authority:	Denmark: Danish Medicines Agency

Keywords provided by Biogen Idec:

Combination therapy for multiple sclerosis

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Anti-Infective Agents
Interferon Type I, Recombinant
Immunologic Factors
Antineoplastic Agents
Methylprednisolone
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Antiemetics
Prednisolone acetate
Hormones
Neuroprotective Agents
Multiple Sclerosis, Relapsing-Remitting
Pathologic Processes
Multiple Sclerosis

Therapeutic Uses
Interferon beta 1a
Growth Inhibitors
Angiogenesis Modulating Agents
Autoimmune Diseases of the Nervous System
Methylprednisolone Hemisuccinate
Autoimmune Diseases
Antineoplastic Agents, Hormonal
Immune System Diseases
Demyelinating Diseases
Growth Substances
Interferons
Nervous System Diseases
Adjuvants, Immunologic
Gastrointestinal Agents

ClinicalTrials.gov processed this record on November 27, 2009