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:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment
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: Prednisolone Prednisolone acetate Depo-medrol Interferon beta Interferon-beta Medrol veriderm Methylprednisolone Interferon beta 1a Prednisolone sodium phosphate Prednisolone Sodium Succinate Methylprednisolone Sodium Succinate Methylprednisolone hemisuccinate 6-Methylprednisolone 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 ]

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

Arms	Assigned Interventions
Experimental: 1 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. Other Name: Avonex
Placebo Comparator: 2 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. Other Name: Avonex

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
Denmark
Coordinating Research Site
Copenhagen, Denmark
Rigshospitalet
Skleroseklinikken, Denmark
Finland
Tampereen yliopistollinen sairaala - Neurologian klinikka
Tampere, Finland
Netherlands
Stichting MS Centrum
Nijemegen, Netherlands
Norway
Ullevål Universitetssykehus
Oslo, Norway
Sweden
Neurologkliniken
Stockholm, Sweden
Switzerland
Kantonspital
St. Gallen, Switzerland
United Kingdom
Queens Medical Centre - Division of Neurology
Nottingham, United Kingdom, Ng72uh

Sponsors and Collaborators

Biogen Idec

More Information

No publications provided by Biogen Idec

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Ravnborg M, Sørensen PS, Andersson M, Celius EG, Jongen PJ, Elovaara I, Bartholomé 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. Epub 2010 Jun 9.

Responsible Party:	Biogen Idec MD, Nordic Medical Director, Biogen Idec International
ClinicalTrials.gov Identifier:	NCT00168766 History of Changes
Obsolete Identifiers:	NCT00492180
Other Study ID Numbers:	NOR-03-01, Mecombin
Study First Received:	September 13, 2005
Last Updated:	December 22, 2011
Health Authority:	Denmark: Danish Medicines Agency

Keywords provided by Biogen Idec:

Combination therapy for multiple sclerosis

Additional relevant MeSH terms:

Multiple Sclerosis
Sclerosis
Multiple Sclerosis, Relapsing-Remitting
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Pathologic Processes
Interferon-beta
Interferons
Interferon beta 1a
Methylprednisolone Hemisuccinate
Prednisolone

Methylprednisolone acetate
Prednisolone acetate
Methylprednisolone
Prednisolone phosphate
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Immunologic Factors
Physiological Effects of Drugs
Antineoplastic Agents
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents

ClinicalTrials.gov processed this record on February 12, 2012