Treatment for Patients with Refractory Adult Dematomyositis (DM) and
Adult Polymyositis (PM)
Trial Status
Open for Enrollment
What is the Purpose of this Study?
To assess the efficacy
of IV rituximab in patients with DM and PM as well as to assess improvement
in muscle strength determined by a manual muscle test.
Who is Eligible to Participate?
Patients 18 years and
older with probable DM or PM diagnosis for at least 6 months prior to enrollment
and who are refractory to corticosteroids plus an adequate IS regimen.
Patients will have to meet all other inclusion criteria and not meet any
exclusionary criteria which will be addressed in further detail by the
study coordinator
What is involved in this Study?
Patients will be randomized
to a 1:1 treatment design. Group 1 will be Rituximab infused at weeks 0
and 1 followed by placebo infusion at weeks 8 and 9. Group 2 will be placebo
infused at weeks 0 and 1 followed by Rituximab infused at weeks 8 and 9.
At week 36, patients will be offered retreatment of Rituximab for an additional
44 weeks.
How long is the Study?
The study will be approximately
45 weeks long. If you want to continue on with retreatment of Rituximab,
you will be on the study for an additional 44 weeks
For More Information Contact: Lynne E. Flynn, CCRC, study coordinator,
at 602-258-2863 or lynneflynn@pnal.net or
call the Main line at 602-258-3354
Polymyositis Symptoms
Cause of Polymyositis
Cures for Polymyositis
Polymyositis Treatment
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