INCB 18424-357 The RELIEF study
Research type
Research Study
Full title
Polycythemia Vera Symptom Study Evaluating Ruxolitinib Versus Hydroxyurea in a Randomized, Multicenter, Double-Blind, Double-Dummy, Phase 3 Efficacy and Safety Study of Patient Reported Outcomes
IRAS ID
116133
Contact name
Yasmin Hasan
Sponsor organisation
Incyte Corporation
Eudract number
2012-002318-37
Clinicaltrials.gov Identifier
Research summary
Ruxolitinib (INCB018424, INC424) is a medicine which has been approved for use in Europe for certain patients with a disease called myelofibrosis. It is not approved for patients with polycythemia vera (PV). This is a clinical research study to find out if ruxolitinib is safe and has beneficial effects in patients with PV, and also to find out if treatment with ruxolitinib helps relieve symptoms associated with PV when compared to another medicine, hydroxyurea (HU), also known as hydroxycarbamide. In this study, patients may receive either ruxolitinib or hydroxyurea. To be eligible subjects must be aged 18 years or older, diagnosed with PV, and experiencing PV-related symptoms while receiving a stable dose of hydroxyurea. Patients will have regular physical examinations and blood tests and will also be asked to use a hand held electronic diary (e-Diary) each night that will ask questions regarding their symptoms associated with PV and the intensity of those symptoms. The study is being conducted at some UK Hospitals with Haematologists that are treating PV patients. There will also be patients from Belgium, Italy and USA participating. The study will continue until all the patients have finished their treatment and this is expected to take about two years.
REC name
West Midlands - Coventry & Warwickshire Research Ethics Committee
REC reference
12/WM/0348
Date of REC Opinion
6 Nov 2012
REC opinion
Favourable Opinion