The CombiRx trial of combined therapy with interferon and glatiramer cetate in relapsing remitting MS: Design and baseline characteristics.
Mult Scler Relat Disord
; 1(2): 81-86, 2012 Apr 01.
Article
en En
| MEDLINE
| ID: mdl-22754793
ABSTRACT
BACKGROUND:
Interferon-ß1a (IFNB) and glatiramer acetate (GA) are distinct therapies which are both partially effective for relapsing MS. It is not known if combining the two treatments would be more effective.OBJECTIVE:
To review the rationale, design, and baseline characteristics of the CombiRx study of combined treatment with IFNB and GA.METHODS:
The key inclusion criteria included a diagnosis of relapsing MS, at least 2 episodes of MS activity in the previous 3 years, expanded disability status scale of 0 to 5.5, and no prior treatment with either IFNB or GA. Subjects were randomized to IFNB+GA, IFNB monotherapy, or GA monotherapy in a 211 ratio.RESULTS:
From 2005 to 2009, we enrolled 1008 subjects. The participants were 72.4% female and 87.6% Caucasian with a mean age of 37.7 years. The median duration of symptoms was 2 years at entry into the study, and the mean EDSS was 2.1. On the baseline MRI, the mean total lesion load was 12.2 ml, and 40% of the participants had enhancing lesions.CONCLUSION:
We have recruited a population of patients with clinical and MRI characteristics typical for early MS. The study results will aid in deciding on the optimum early treatment. This trial should serve as a model for future studies of combination therapy.
Texto completo:
1
Banco de datos:
MEDLINE
Tipo de estudio:
Clinical_trials
/
Prognostic_studies
Idioma:
En
Año:
2012
Tipo del documento:
Article