NCT00168766

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 study will also investigate whether combination therapy has any impact on the incidence of relapse and brain atrophy as measured by MRI.

Trial Health

93
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
345

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Jan 2003

Longer than P75 for phase_4

Geographic Reach
8 countries

9 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2003

Completed
2.7 years until next milestone

First Submitted

Initial submission to the registry

September 13, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 15, 2005

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2008

Completed
Last Updated

September 16, 2013

Status Verified

April 1, 2011

Enrollment Period

5.8 years

First QC Date

September 13, 2005

Last Update Submit

September 12, 2013

Conditions

Relapsing-remitting Multiple Sclerosis

Keywords

Combination therapy for multiple sclerosis

Outcome Measures

Primary Outcomes (1)

  • 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

    4 years

Study Arms (2)

1

EXPERIMENTAL

interferon-beta-1a in combination with methylprednisolone

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

2

PLACEBO COMPARATOR

interferon-beta-1a in combination with placebo

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

Interventions

Interferon-beta-1a (Avonex) plus methylprednisoloneDRUG

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

Also known as: Avonex
12

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

CUB Hôpital Erasme

Brussels, Belgium

Location

Coordinating Research Site

Copenhagen, Denmark

Location

Rigshospitalet

Skleroseklinikken, Denmark

Location

Tampereen yliopistollinen sairaala - Neurologian klinikka

Tampere, Finland

Location

Stichting MS Centrum

Nijemegen, Netherlands

Location

Ullevål Universitetssykehus

Oslo, Norway

Location

Neurologkliniken

Stockholm, Sweden

Location

Kantonspital

Sankt Gallen, Switzerland

Location

Queens Medical Centre - Division of Neurology

Nottingham, Ng72uh, United Kingdom

Location

Related Publications (1)

  • 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.

    PMID: 20542736DERIVED

MeSH Terms

Conditions

Multiple Sclerosis, Relapsing-Remitting

Interventions

Interferon beta-1a

Condition Hierarchy (Ancestors)

Multiple SclerosisDemyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemNervous System DiseasesDemyelinating DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

Interferon-betaInterferon Type IInterferonsCytokinesIntercellular Signaling Peptides and ProteinsPeptidesAmino Acids, Peptides, and ProteinsProteinsBiological Factors

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

September 13, 2005

First Posted

September 15, 2005

Study Start

January 1, 2003

Primary Completion

November 1, 2008

Study Completion

November 1, 2008

Last Updated

September 16, 2013

Record last verified: 2011-04

Locations

CH(1)NL(1)NO(1)SE(1)BE(1)GB(1)DK(2)FI(1)