- Oral medication taken daily.
- This drug is an immunomodulator that affects the
production of T and B cells. It inhibits rapidly
dividing cells, including activated T cells, which
are thought to drive the disease process in MS. It
may inhibit nerve degeneration by reducing the
production of free radicals, possibly decreasing
the risk of infections and other complications
linked to chemotherapy-like drugs.
- The TEMSO trial for RRMS compared 7 and 14
mg of teriflunomide in 1,088 individuals. Both
doses significantly reduced the annualized
relapse rate by approximately 31 percent.
Teriflunomide (7-mg dose) resulted in a
39.4- percent reduction in brain lesion volume
on MRI compared with placebo; the 14-mg dose
resulted in a 67.4-percent reduction. The 14-mg
dose also reduced the risk of sustained disability
progression by 29.8 percent relative to placebo.
The number of gadolinium-enhancing lesions
were also reduced with both doses compared
with placebo, and there was a trend toward a
greater effect with the higher dose.
- A Phase III extension study of TEMSO is now
underway. Patients who completed the original
study and who received the drug are being
maintained on the same dose; those who
received placebo are randomized to
teriflunomide 7 mg or 14 mg. The study remains
- The TOWER efficacy study of 1,110 individuals
with RRMS is scheduled from August 2008 to
February 2013. It will test 7-mg and 14-mg doses
versus placebo. Its primary endpoint is the
annualized relapse rate; the secondary endpoint
is time to disability progression. Results of this
second of two placebo-controlled Phase III trials,
which are required to support an application for
regulatory approval, are expected in 2012.
- The ongoing Phase III TOPIC study of 780
individuals with clinically isolated syndrome (CIS)
is scheduled from February 2008 to November
2015; it is still recruiting participants. It also is
comparing 7- and 14-mg teriflunomide versus
placebo. The study's primary endpoint is the
time to conversion to clinically-definite MS after
CIS. Several secondary endpoints include: MRI
findings; relapse rate; disability and progression.
The drug's safety will also be evaluated.
- The TENERE Phase III study is comparing 7- and
14-mg teriflunomide with Rebif in 300 people. It
is scheduled from April 2009 to July 2012.
- Following a Phase II study indicating that
combined treatment with teriflunomide appears
to be superior to an interferon given alone, the
TERACLES Phase III study began in January 2011
and is scheduled for completion in April 2014; it
is currently recruiting 1,455 participants. The study
will compare relapse rateswhile taking a 7- or 14-mg
dose of teriflunomide or placebo, in combination
with an existing interferon treatment. The
primary outcome measure is the annualized
relapse rate. Secondary outcome measures
include: MRI findings; disability progression; time
to a first confirmed relapse; and the proportion
of patients who are relapse-free.