Curr Med Res Opin. 2004 Jan;20(1):25-30
Division of Neurology, Dalhousie MS Research Unit, Queen Elizabeth II Health Sciences Center, Halifax, Nova Scotia, Canada.
Previous studies comparing the two available interferon beta (IFNbeta)-1a products, Avonex and Rebif, for the treatment of relapsing-remitting multiple sclerosis (RRMS) have been limited and of short duration.
Therefore, the Prospective and Retrospective Observational Study of Avonex and Rebif (PROOF) was designed to provide long-term (up to 5 years) comparative data on the efficacy, safety, and tolerability of these two agents.
Patients with RRMS receiving treatment with either Avonex 30 microg intramuscularly once weekly or Rebif 44 microg subcutaneously three times weekly from 12 to 24 months are being enrolled and will continue their respective treatments for the 36-month duration of the study.
The primary efficacy endpoint will be change in brain parenchymal fraction, which will be evaluated through magnetic resonance imaging scans by blinded radiologists.
Secondary endpoints will include the following: