Intravenously Administered Study Medication MEDI-545, in Adult Patients
with Dermatomyositis or Polymyositis
Trial Status
Open for Enrollment
What is the Purpose of this Study?
To evaluate the safety and tolerability of multiple intravenous (IV) doses
of MEDI-545 in adult patients with DM or PM who have a high level of
expression of mRNA for type I IFN-inducible genes at time of randomization.
Who is Eligible to Participate?
Patients 18 years and older with probable of definite DM or PM diagnosis.
For patients with PM, a previous muscle biopsy result that is consistent
with the diagnosis is required. Patients with both PM and DM will also
have to meet other inclusion criteria and do not meet any exclusionary
criteria which will be addressed in further detail by study coordinator
What is involved in this Study?
Patients will be randomized in a 3:1 ratio to initially receive MEDI-545
(1.0, 3.0, 10.0 or 30.0 mg/kg) or placebo every 2 weeks for 12 weeks
for a total of 7 doses. Thereafter (2 weeks later), in each dose cohort,
patients randomized to MEDI-545, will continue to receive the same dose
over an additional 12 weeks (7 doses) and patients randomized to placebo
will receive MEDI-545 at the dose specified in the dose cohort, every
2 weeks for an additional 12 weeks (7doses) for a total of 26 weeks (14
doses).
How long is the Study?
The study is approximately 1 year long, with 26 weeks of treatment.
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
or call the Main line at 602-258-3354
Polymyositis Symptoms
Cause of Polymyositis
Cures for Polymyositis
Polymyositis Treatment
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