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 (NCT)	NCT00168766
Protocol serial number	MECOMBIN
Sponsor	Biogen Idec
Funder	Investigator led study, supported by funding from Biogen Idec.

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Dr Mads Ravnborg
Scientific

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

Phone	+45 3545 8076
Email	MADSRH03794RAVNBORG@rh.dk

Primary study design	Interventional
Study design	Multicentre, randomised, double-blind, placebo-controlled, parallel group trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title
Study acronym	MECOMBIN
Study objectives	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
Health condition(s) or problem(s) studied	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 / device / biological / vaccine name(s)	Methylprednisolone, Interferon-beta-1a
Primary outcome measure(s)	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)
Key secondary outcome measure(s)	Not provided at time of registration
Completion date	30/11/2008

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Upper age limit	55 Years
Sex	All
Target sample size at registration	400
Key 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.
Key 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
Date of first enrolment	01/01/2003
Date of final enrolment	30/11/2008

Rigshospitalet

Copenhagen
DK-2100
Denmark

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/07/2010		Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes