Jun 25, 2009
MS Trial Alert: Recruiting Patients for Study on How Adhering to Therapy Impacts MS
Summary: A new study is seeking to determine to what extent individuals’ sticking to their prescribed treatment regimen (called “compliance”) affects outcomes in relapsing-remitting MS, and whether special programs can enhance their adherence to therapy. The study focuses on compliance related to several disease-modifying therapies -- Avonex® (interferon beta-1a, Biogen Idec), Betaseron® (interferon beta-1b, Bayer HealthCare Pharmaceuticals), Copaxone® (glatiramer acetate, Teva Pharmaceutical Industries), and Rebif® (interferon beta-1a, EMD Serono and Pfizer). Three thousand people are being recruited for this study by three specialty pharmacies that provide service nationwide. Teva Neuroscience is funding this study.
Rationale: Although there is still no cure for MS, there are effective strategies available for some types of MS that modify the disease course and treat exacerbations (also called attacks, relapses, or flare-ups). Some agents can reduce disease activity for many individuals with relapsing forms of MS, including Avonex, Betaseron, Copaxone, and Rebif. However, taking a disease-modifying medication over a long period of time can be challenging, and it is possible that when individuals do not take their therapy as frequently as prescribed, its effectiveness will be compromised.
Specialty pharmacies handle injectable, infusion and other medications that require complex care, such as patient education or continuous monitoring. These pharmacies might make monthly calls to patients to determine when they need their next medication shipment, or provide additional services that might enhance adherence to therapy.
Eligibility and Details: Participants should be 18 years of age or older, with a diagnosis of MS, and are being treated with Avonex, Betaseron, Copaxone, or Rebif, which they are receiving from a participating specialty pharmacy.
Data are being collected through a combination of web-based surveys and telephone calls with participants and other methods, such as therapy shipment records.
The primary goal of the study is to determine compliance with therapy, as measured by therapy shipment dates over 24 months, and its association with outcomes including relapses, disability progression, quality of life and work/productivity.
Contact: This study is a collaboration with three specialty pharmacies that have locations nationwide; please select a contact at one of these specialty pharmacies to learn more about the enrollment criteria for this study, and to find out if you are eligible to participate:
Cora Edwards, BA, CCRP ,
Clinical Study Manager, Diplomat Specialty Pharmacy
Phone: (810) 720-6851
Kira Botkin
Study Coordinator, BioScrip, Inc.
Phone: (614) 850-1230
Christina Makowski
Study Coordinator, Medmark, A Walgreens Specialty Pharmacy
Phone: (412) 250-4703