Condition category
Nervous System Diseases
Date applied
31/03/2004
Date assigned
01/04/2004
Last edited
29/03/2012
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Mads Ravnborg

ORCID ID

Contact details

Rigshospitalet
Department of Neurology
2082
Blegdamsvej 9
Copenhagen
DK-2100
Denmark
+45 3545 8076
MADSRH03794RAVNBORG@rh.dk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

NCT00168766

Protocol/serial number

MECOMBIN

Study information

Scientific title

Acronym

MECOMBIN

Study hypothesis

Added as of 21/05/2008:
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.

Ethics approval

Not provided at time of registration

Study design

Multicentre, randomised, double-blind, placebo-controlled, parallel group trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Not Specified

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Relapsing Remitting Multiple Sclerosis (MS)

Intervention

Interventions are standard interferon beta-1a therapy plus randomisation to either monthly oral methylprednisolone pulsed therapy (1.5 g/month) or matching placebo

Intervention type

Drug

Phase

Phase IV

Drug names

Methylprednisolone, Interferon-beta-1a

Primary outcome measures

Added as of 21/05/2008:
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 randomisation in EDSS (Time Frame: 4 years)

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/01/2003

Overall trial end date

30/11/2008

Reason abandoned

Eligibility

Participant inclusion criteria

Current inclusion criteria as of 21/05/2008:
1. Informed consent
2. Relapsing remitting MS according to Poser criteria or McDonell criteria and naïve to therapy
3. Extended Disability Status Scale (EDSS) score of 4.0 or less at baseline
4. Clinical activity as defined by at least one relapse in the last year

Previous inclusion criteria:
Adult subjects aged 18-55 with relapsing remitting MS, previously untreated with immunomodulatory drugs.

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

400

Participant exclusion criteria

Exclusion criteria added as of 21/05/2008:
1. Relapse in the month prior to enrolment
2. Treatment with immunosuppressive drugs for MS
3. History of major depression
4. Former severe reactions to corticosteroids
5. Pregnant women
6. Diabetes mellitus, and drug or alcohol dependency
7. Known or suspected allergy to trial products

Recruitment start date

01/01/2003

Recruitment end date

30/11/2008

Locations

Countries of recruitment

Belgium, Denmark, Finland, Netherlands, Norway, Sweden, Switzerland, United Kingdom

Trial participating centre

Rigshospitalet
Copenhagen
DK-2100
Denmark

Sponsor information

Organisation

Biogen Idec

Sponsor details

Klaus Krasilnikoff MD
Biogen Idec
Lyngbyvej 28
Copenhagen
DK-2100
Denmark
+45 3916 9191
klaus.krasilnikoff@biogenidec.com

Sponsor type

Not defined

Website

Funders

Funder type

Industry

Funder name

Investigator led study, supported by funding from Biogen Idec.

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

1. 2010 results in http://www.ncbi.nlm.nih.gov/pubmed/20542736

Publication citations

  1. Results

    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, 9, 7, 672-680, doi: 10.1016/S1474-4422(10)70132-0.

Additional files

Editorial Notes