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

NCT ID: NCT00168766

Last Updated: 2013-09-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

345 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-01-31

Study Completion Date

2008-11-30

Brief Summary

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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

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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.

Conditions

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Relapsing-remitting Multiple Sclerosis

Keywords

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Combination therapy for multiple sclerosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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1

interferon-beta-1a in combination with methylprednisolone

Group Type EXPERIMENTAL

Interferon-beta-1a (Avonex) plus methylprednisolone

Intervention Type DRUG

oral administration given on 3 consecutive days, monthly as described in protocol.

2

interferon-beta-1a in combination with placebo

Group Type PLACEBO_COMPARATOR

Interferon-beta-1a (Avonex) plus methylprednisolone

Intervention Type DRUG

oral administration given on 3 consecutive days, monthly as described in protocol.

Interventions

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Interferon-beta-1a (Avonex) plus methylprednisolone

oral administration given on 3 consecutive days, monthly as described in protocol.

Intervention Type DRUG

Other Intervention Names

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Avonex

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Biogen

INDUSTRY

Sponsor Role lead

Responsible Party

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Biogen Idec International

Locations

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CUB Hôpital Erasme

Brussels, , Belgium

Site Status

Coordinating Research Site

Copenhagen, , Denmark

Site Status

Rigshospitalet

Skleroseklinikken, , Denmark

Site Status

Tampereen yliopistollinen sairaala - Neurologian klinikka

Tampere, , Finland

Site Status

Stichting MS Centrum

Nijemegen, , Netherlands

Site Status

Ullevål Universitetssykehus

Oslo, , Norway

Site Status

Neurologkliniken

Stockholm, , Sweden

Site Status

Kantonspital

Sankt Gallen, , Switzerland

Site Status

Queens Medical Centre - Division of Neurology

Nottingham, , United Kingdom

Site Status

Countries

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Belgium Denmark Finland Netherlands Norway Sweden Switzerland United Kingdom

References

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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.

Reference Type DERIVED
PMID: 20542736 (View on PubMed)

Other Identifiers

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Mecombin

Identifier Type: -

Identifier Source: secondary_id

NOR-03-01

Identifier Type: -

Identifier Source: org_study_id

NCT00492180

Identifier Type: -

Identifier Source: nct_alias