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

Ruxolitinib will be orally self-administered at a starting dose of 10 mg (two 5 mg tablets) twice a day. Dose increases of 5 mg (1 tablet) in twice-daily increments are permitted after 4 weeks and again after 8 weeks of therapy for subjects who meet prespecified criteria for inadequate efficacy.

Hydroxyurea (500 mg capsules) will be orally self-administered at the dose that the subject was receiving previously. The dose may be increased after 4 weeks and again after 8 weeks of therapy to optimize efficacy for subjects meeting prespecified criteria.

"All placebo will be self-administered, and dosing will be the same as with the blinded dose.~When adjustments are made to the ruxolitinib dose, the dose of HU-placebo will be adjusted concurrently."

"All placebo will be self-administered, and dosing will be the same as with the blinded dose.~When adjustments are made to the HU dose, the dose of ruxolitinib-placebo will be adjusted concurrently."