title: Early treatment of multiple sclerosis with Rebif (recombinant human interferon beta): design of the study.
abstract: Two recent properly controlled trials performed in patients with relapsing-remitting MS have demonstrated that interferon beta substantially improves the evolution of the disease. The results of the Optic Neuritis Treatment Trials suggest that early treatment of patients with isolated optic neuritis may delay the conversion to clinically definite MS (CDMS). Moreover, clinical trials in MS and in immune-mediated diseases indicate that better results are obtained in patients in the early phases of the disease. We present the design of a multicentre, randomized, double-blind, placebo-controlled study of recombinant interferon beta (Rebif-Serono) in patients with a first attack suggestive of MS. The primary objective of the study is to investigate the efficacy of Rebif, administered subcutaneously at the dose of 8 million international units (MIU) once a week for 2 years, on the risk of developing CDMS.
authors.affiliation: Centro Sclerosi Multipla, Instituto Scientifico San Raffaele, Milan, Italy.
authors.forename: G
authors.initials: G
authors.lastname: Comi
authors.forename: F
authors.initials: F
authors.lastname: Barkhof
authors.forename: L
authors.initials: L
authors.lastname: Durelli
authors.forename: G
authors.initials: G
authors.lastname: Edan
authors.forename: O
authors.initials: O
authors.lastname: Fernandez
authors.forename: M
authors.initials: M
authors.lastname: Filippi
authors.forename: H P
authors.initials: HP
authors.lastname: Hartung
authors.forename: O R
authors.initials: OR
authors.lastname: Hommes
authors.forename: P
authors.initials: P
authors.lastname: Seeldrayers
authors.forename: P
authors.initials: P
authors.lastname: Soelberg-Sorensen
mesh_terms: D000276:Adjuvants, Immunologic / Q000008:administration & dosage*; D000293:Adolescent; D000328:Adult; D017326:Clinical Trials, Phase III as Topic; D004311:Double-Blind Method; D006801:Humans; D016899:Interferon-beta / Q000008:administration & dosage*; D015337:Multicenter Studies as Topic; D009103:Multiple Sclerosis / Q000628:therapy*; D016032:Randomized Controlled Trials as Topic; D011994:Recombinant Proteins / Q000008:administration & dosage; D012107:Research Design
chemical_list: D000276:Adjuvants, Immunologic; D011994:Recombinant Proteins; D016899:Interferon-beta