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RESPONSE, a Phase III Study Investigating Ruxolitinib, Is Now Enrolling Patients With PV
Dear Healthcare Provider,
Incyte is pleased to announce that RESPONSE, a phase III study of the investigational agent ruxolitinib, is enrolling patients with polycythemia vera (PV). The RESPONSE trial is a global, randomized, open-label, multicenter, phase III study of the selective oral JAK1 and JAK2 inhibitor ruxolitinib in patients with PV who are resistant to, or intolerant of, hydroxyurea. RESPONSE is sponsored by both Incyte and Novartis.
If you have a PV patient who is at least 18 years of age and who meets the following criteria, he or she may be eligible for enrollment in RESPONSE:
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Resistant to, or intolerant of, hydroxyurea
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Phlebotomy requirement due to inadequate hematocrit control
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At least 2 phlebotomies, at least 4 weeks apart, in a 24-week period prior to screening, OR
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At least 1 phlebotomy within 16 weeks of screening, provided patient has a hematocrit >45% at screening
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Palpable splenomegaly confirmed by magnetic resonance imaging (MRI) or computed tomography (CT) to be >450 cm3 in volume
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Patients with body habitus precluding spleen palpation must have a spleen volume >450 cm3 by MRI or CT
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We invite you to visit www.responsetrial.com to find out more about RESPONSE, including trial recruitment information and brief overviews of selected topics such as the JAK signaling pathway and PV.
If you have a patient who may be eligible for RESPONSE, please call 1-877-4-PV-TRIAL.
Sincerely,
Incyte Corporation
Experimental Station
Route 141 & Henry Clay Road
Building E336
Wilmington, DE 19880
Tel: 302.498.6700
Ruxolitinib is an investigational compound for the treatment of patients with PV. Its efficacy and safety have not been established in this patient population. There is no guarantee that this compound will become commercially available for use in PV patients.
This information is intended for use by US healthcare providers only.
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