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Tanuja Chitnis, MD, on how the PARADIGMS trial will test the best DMD for pediatric MS patients
Tanuja Chitnis, MD, of Massachusetts General Hospital, spoke with MedPage Today at the European Committee for Treatment and Research in Multiple Sclerosis annual meeting in September, where she presented a poster on the baseline characteristics of the PARADIGMS trial, which is evaluating fingolimod versus interferon in pediatric MS patients. (Click here to download the poster). Following is a transcript of her remarks.
I’m here to present to you today the PARADIGMS baseline characteristics. This is a randomized, double-blind study of fingolimod in pediatric patients with relapsing-remitting multiple sclerosis.
Pediatric multiple sclerosis is a rare disease, approximately 3% to 5% of all MS patients have onset under the age of 18. This is the first randomized, double-blind controlled study in pediatric MS patients. The study tests fingolimod compared to Avonex, which is a beta interferon-1a weekly injection, in a randomized fashion.
Methodology
The objective of this poster is to present the baseline characteristics of the first 190 patients randomized in the PARADIGMS study. The PARADIGMS study is an ongoing, 2-year study, and our primary objectives were to compare the efficacy of fingolimod to beta interferon-1a on annualized relapse rate over a 24-month period.
There are a number of secondary outcome measures, including the number of new or enhancing T2 and T1 lesions, as well as safety and efficacy of fingolimod in this population. Another outcome measure is the pharmacokinetics and pharmacodynamics of the two drugs.
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