Determination of Antiboc& Presence An antibody positive subject was defined asa subject with a neutralizing titer value greaterthan or equalto a specified threshold value at any scheduled visit. Scheduled visits were at baseline, Month 3,6, 9, 12, 15, 18,21, and 24. The pre-specified neutralizing titer threshold values were 0, 5, and 20.
Changes in the Conduct of Study That May Affect Amount of Drug Delivered At the start of the trial, liquid HSA-free AVONEXm was supplied to study subjects in a
tray containing apre-filled syringe and a separate23 Gaugex 1% ” -
presentationrequired subjects to
prior to injection. In
September2000, the study medication delivery system was changedto a pre-filled
syringe with a23 Gaugex 1l/d’-
needle,which eliminated the needto *-
use of the -needle
However, in April 2001, the study reverted back to the and syringe basedon study subjects’ preference for this method
of drug delivery.-
Subject Accountability One hundred fifty-three (153) subjects were enrolled in this study at 16investigational sites in North America and Europe. Six investigators in the United States enrolled 67 subjects, six investigators in Canadaenrolled 44 subjects, and four investigators in Europe enrolled 42 subjects.Twelve investigators each had enrolled at leastfive subjects; collectively, the subjects of thesetwelve investigators accountedfor 94% of the total subject enrollment.
Four sites eachenrolled fewer than five subjects.
The first subject received their first dose on January 31,2000, andthe last subject included in this interim report received their first doseon June 26,200O. Among the 153 subjects enrolled in the study, 124 remained in the trial and 29 (19%) had withdrawn from the study at the time of this report.
Twelve (8%) subjectswithdrew from the study due to adverseevents, 6 (4%) withdrew dueto worsening of disease,4 (3%) withdrew due to lack of tolerability to study drug (presumed also to representadverseevents), 3 (2%) withdrew due to subject request/voluntary withdrawal, 3 (2%) withdrew due to other reasons(two were pregnancies), and 1 (1%) was lost to follow up.
Duration of Exposure A total of 134 subjects (88% of those dosed) had received study drug for at least 48 weeks. One hundred and forty-two subjects (93%) had received study drug for at least 26 weeks and91 subjects (59%) had received study drug for at least 78 weeks. (Note that the duration of the study is 96 weeks, and that no data areprovided for this duration of exposure.)