Biogen Completes Enrollment for Relapsing Multiple Sclerosis Study
Biogen Idec has completed enrollment in the Assurance trial, a long-term follow-up study which will assess up to 15 years of Avonex treatment in an effort to provide detailed data on the long-term efficacy of the drug.
Assurance is a multi-center, open-label follow-up study of patients with relapsing multiple sclerosis (MS) treated with Avonex or placebo for at least two years in the Phase III pivotal trial.
In the trial, 136 of a possible 172 patients were identified for this study at four major MS centers including Cleveland Clinic Foundation, The State University of New York at Buffalo, Oregon Health and Science University and Georgetown University Medical Center.
The 15-year follow-up study is designed to determine the effect of long-term Avonex treatment on disability progression and quality of life. Additionally, the study will assess the impact of treatment on patients’s independent living ability. Outcomes of this study will potentially provide further evidence of the benefits of initial and continued treatment with Avonex.
The 15-year follow-up study targeted the 172 patients who completed at least two years of treatment in the original Avonex Phase III pivotal trial.
The pivotal trial showed that treatment with Avonex significantly slowed the accumulation of physical disability, and time to sustained progression in EDSS score was significantly lengthened in patients treated with Avonex as compared to placebo. Final results of the Assurance 15-year follow-up study are expected to be released in the third quarter of 2008.