A Multi-center, Double Blind, Randomized, Placebo Controlled, Parallel Group Trial Investigating Methylprednisolone in Combination with Interferon-beta-1a for the Treatment of Relapsing-Remitting Multiple Sclerosis

ISRCTN	ISRCTN68218781
DOI	https://doi.org/10.1186/ISRCTN68218781
ClinicalTrials.gov number	NCT00168766
Secondary identifying numbers	MECOMBIN

Submission date: 31/03/2004
Registration date: 01/04/2004
Last edited: 29/03/2012

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Nervous System Diseases

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English Summary

Not provided at time of registration

Contact information

Dr Mads Ravnborg
Scientific

Rigshospitalet
Department of Neurology, 2082
Blegdamsvej 9
Copenhagen
DK-2100
Denmark

Phone	+45 3545 8076
Email	MADSRH03794RAVNBORG@rh.dk

Study information

Study design	Multicentre, randomised, double-blind, placebo-controlled, parallel group trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Not specified
Study type	Not Specified
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
Scientific title
Study 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(s)	Not provided at time of registration
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
Pharmaceutical study type(s)
Phase	Phase IV
Drug / device / biological / vaccine name(s)	Methylprednisolone, Interferon-beta-1a
Primary outcome measure	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 study start date	01/01/2003
Overall study end date	30/11/2008

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Upper age limit	55 Years
Sex	Both
Target number of participants	400
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 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

Study participating centre

Rigshospitalet

Copenhagen
DK-2100
Denmark

Sponsor information

Biogen Idec
Not defined

Klaus Krasilnikoff MD
Biogen Idec
Lyngbyvej 28
Copenhagen
DK-2100
Denmark

Phone	+45 3916 9191
Email	klaus.krasilnikoff@biogenidec.com
"ROR"	https://ror.org/02jqkb192

Funders

Funder type

Industry

Investigator led study, supported by funding from Biogen Idec.

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/07/2010		Yes	No