The authors report in the publication that the primary endpoint and key secondary endpoints of the Clarity trial were met. The Clarity data were presented at the 61st Annual Meeting of the American Academy of Neurology (AAN) in April 2009, and at other international scientific meetings.
Reportedly, the Clarity study was a two-year (96-week), randomised, double-blind, placebo-controlled phase III trial of Cladribine tablets in 1,326 people with relapsing-remitting multiple sclerosis (MS). The primary endpoint of the Clarity study was the relapse rate over 96 weeks. Secondary endpoints included MRI endpoints, proportion of subjects relapse-free and disability progression at 96 weeks.
In the study, the participants were randomised to one of three different treatment groups consisting of two different dose regimens of Cladribine tablets or matching placebo tablets. Cladribine tablets were given in two (3.5mg/kg total dose) or four (5.25mg/kg total dose) treatment courses in the first year, with each course consisting of once daily administration for four to five consecutive days (depending on patient weight). This means study patients took Cladribine tablets for 8 to 20 days during the year.
However, in the second year, two treatment courses were administered to all patient groups, meaning that patients took Cladribine tablets for 8 to 10 days during the year.
Gavin Giovannoni, principal investigator of the Clarity study and lead author on the publication, said: “The Clarity trial represents an important step forward in multiple sclerosis research, and we are pleased that the results have been published in The New England Journal of Medicine.”