What’s in a multiple sclerosis study?
After the 2-year pivotal trial was completed, 208 of the original 251 participants continued on in an open-label extension.3 This means that 107 people who were on placebo agreed to switch over to COPAXONE®, and 101 people already on COPAXONE® continued to take it. This study has now been going on for more than a decade and represents the longest continuous, prospective follow-up of people with RRMS ever!1,2
While this open-label extension study is highly organized, the design of the study differs from the one used for the pivotal trial in that the extension is not double-blind, randomized, or placebo-controlled.* This way, the extension study more closely mirrors the real world in which both participants and doctors know what therapy a participant is taking. Because of the necessary changes in the design of the study, the COPAXONE® extension study is not considered a “Class I” study.
Of the 208 people who were involved in the ongoing study, 108 people took COPAXONE® continuously for an average of 10 years.1 They were evaluated every 6 months and seen by a doctor within 7 days of a suspected relapse. The participants were assessed for disease progression using the EDSS scale.
*Read more information about the design of the COPAXONE® pivotal trial here.
Prospective study: This type of "forward-looking" study is designed with a specific goal (or endpoint) in mind and hopes to achieve this goal or endpoint.
Open-label: A type of study in which both the health care providers and the participants know which drug or treatment is being given. In the extension study, everyone involved knew that the participants were taking COPAXONE®. This more closely mirrors the real world since participants and doctors know what therapy a participant is taking.
The labeling for COPAXONE® does not include an indication for slowing the progression of disability.
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