RESUMO
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 2:1:1 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.
RESUMO
The cause of multiple sclerosis (MS) is currently unknown. The hypothesis of this study is that MS is caused by a chronic bacterial infection of the central nervous system (CNS) and the ensuing immune response. We developed a sensitive two-stage polymerase chain reaction method using nested or semi-nested primers specific for the bacterial 16S ribosomal DNA to test for the presence of bacterial DNA in cerebrospinal fluid. We designed seven sets of primers to amplify DNA from spirochetes , Campylobacter, Mycoplasma, Chlamydia, Bartonella, Mycobacteria and Streptococcus and tested cerebrospinal fluid from patients with relapsing-remitting MS, primary progressive MS, transverse myelitis and controls. We did not detect DNA from any of the groups of bacteria in patients or controls. We conclude that we were unable to find evidence for CNS infection with any of these seven groups of bacteria in MS.