Clinical trial NCT00168766: Avonex (Interferon-beta-1a) and Avonex Plus Methylprednisolone for the Treatment of Relapsing-remitting MS
Official title: A Multicentre, Randomized, Double-blind, Placebo-controlled, Parallel Group Trial Investigating Methylprednisolone in Combination With Interferon-beta-1a for the Treatment of Patients With Relapsing-remitting Multiple Sclerosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Relapsing-remitting Multiple Sclerosis
Keywords: Combination therapy for multiple sclerosis
Lead sponsor: Biogen
Sponsor class: INDUSTRY
First posted: 2005-09-15
Enrollment: 345
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: 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
timeFrame: 4 years
Secondary outcomes:
Other outcomes:
Locations:
city: Bruxelles
country: Belgium
facility: CUB Hôpital Erasme
city: Copenhagen
country: Denmark
facility: Coordinating Research Site
city: Skleroseklinikken
country: Denmark
facility: Rigshospitalet
city: Tampere
country: Finland
facility: Tampereen yliopistollinen sairaala - Neurologian klinikka
city: Nijemegen
country: Netherlands
facility: Stichting MS Centrum
city: Oslo
country: Norway
facility: Ullevål Universitetssykehus
city: Stockholm
country: Sweden
facility: Neurologkliniken
city: St. Gallen
country: Switzerland
facility: Kantonspital
city: Nottingham
country: United Kingdom
facility: Queens Medical Centre - Division of Neurology
Study officials:
References:
citation: 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.