drugset / Trial / NCT01632904

Randomized Switch Study From Hydroxyurea to Ruxolitinib for RELIEF of Polycythemia Vera Symptoms: The Relief Study

NCT01632904

Phase 3 Completed 110 enrolled Incyte Corporation
RandomizedParallel-groupQuadruple-blindTreatment

Summary

The purpose of the RELIEF study is to compare symptoms in polycythemia vera (PV) subjects treated with ruxolitinib versus subjects treated with hydroxyurea (HU) as measured by the percent of subjects who achieve a clinically meaningful symptom improvement (ie, total symptom score reduction of ≥ 50% reduction) at Week 16 compared to Baseline. The study is also designed to demonstrate that these responses are durable with continued treatment.

Timeline

Start
2012-06
Primary completion
2014-03
Completion
2016-05

Drugs

EvaluationDrugModalityDoseRoute
Comparator Hydroxyurea Other / unclassified Oral
Subject Ruxolitinib Small molecule 10 mg Oral