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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Polycythemia Vera Symptom Study Evaluating Ruxolitinib Versus Hydroxyurea in a Randomized, Multicenter, Double-Blind, Double-Dummy, Phase 3 Efficacy and Safety Study of Pa

Brief 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.

Detailed Summary:

This is a Phase 3 multicenter, double-blind, double-dummy, randomized study. Only subjects with PV who have received HU for at least 12 weeks, have been receiving a stable dose before screening, and still have symptoms related to PV will be enrolled.

Subjects will be randomized (1:1) to 1 of 2 treatment arms:

A: ruxolitinib and HU-placebo B: HU and ruxolitinib-placebo

Subjects randomized to either arm may be eligible to transition to open-label ruxolitinib after Week 16.


Sponsor: Incyte Corporation

Current Primary Outcome: Percentage of Subjects Achieving a ≥ 50% Improvement From Baseline in Total Symptom Score-Cytokine (TSS-C) at Week 16, as Measured by the Modified Myeloproliferative Neoplasm Symptom Assessment Form (MPN-SAF) Diary [ Time Frame: From Baseline to Week 16 ]

Symptoms of polycythemia vera were assessed using a modified Myeloproliferative Neoplasm Symptom Assessment Form (MPN-SAF) electronic diary. Using the diary, patients rated the following symptoms on a scale from 0 (absent) to 10 (worst imaginable): tiredness, itching, muscle aches, night sweats, and sweats while awake. The total symptom score ranged from 0-50 and was calculated as the sum of the 5 symptom scores. A higher score indicates worse symptoms.


Original Primary Outcome: Proportion of subjects with ≥ 50% reduction in a cluster of PV-related symptoms, measured using a patient questionnaire, at week 16 compared to Baseline. [ Time Frame: Baseline and Week 16. ]

Current Secondary Outcome:

  • Percentage of Subjects Achieving ≥ 50% Improvement From Baseline in the Individual Symptom Scores for TSS-C at Week 16 [ Time Frame: From Baseline to Week 16 ]
    The TSS-C cluster includes tiredness, itching, muscle aches, night sweats, and sweats while awake.
  • Percentage of Subjects Achieving a Durable Response on TSS-C [ Time Frame: Week 48 ]
    Durable Response on TSS-C defined as a ≥ 50% improvement from baseline in TSS-C at Week 16 that was maintained at the Week 48 visit.
  • Percentage of Subjects Achieving a Durable Response on Individual Symptoms Scores for TSS-C [ Time Frame: Week 48 ]


Original Secondary Outcome:

  • Proportion of subjects with ≥ 50% reduction in individual PV-related symptoms at Week 16 compared to Baseline [ Time Frame: Baseline and Week 16. ]
  • Duration of symptomatic improvement in subjects experiencing relief from the cluster of PV-related symptoms [ Time Frame: Week 16 and Week 48. ]
  • Duration of symptomatic improvement in subjects experiencing relief from individual symptoms [ Time Frame: Week 16 and Week 48. ]
  • Safety of ruxolitinib and HU as measured by adverse events. [ Time Frame: Screening through the end of study participation (estimated 18 months). ]


Information By: Incyte Corporation

Dates:
Date Received: June 29, 2012
Date Started: June 2012
Date Completion:
Last Updated: August 1, 2016
Last Verified: August 2016