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

October 12, 2017 updated by: Incyte Corporation

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

110

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Antwerpen, Belgium
      • Brugge, Belgium
  • Germany
      • Aachen, Germany
      • Berlin, Germany
      • Freiburg, Germany
      • Hamburg, Germany
      • Stuttgart, Germany
      • Ulm, Germany
  • Ireland
      • Galway, Ireland
  • Italy
      • Firenze, Italy
      • Reggio Calabria, Italy
      • Varese, Italy
  • Spain
      • Barcelona, Spain
      • Pamplona, Spain
      • Salamanca, Spain
  • United Kingdom
      • Boston, United Kingdom
      • Leicester, United Kingdom
      • Nottingham, United Kingdom
      • West Bromwich, United Kingdom
  • United States
    • Arizona
      • Scottsdale, Arizona, United States
    • Arkansas
      • Fayetteville, Arkansas, United States
    • California
      • Burbank, California, United States
      • Glendale, California, United States
      • La Jolla, California, United States
      • Los Angeles, California, United States
      • San Diego, California, United States
    • Colorado
      • Aurora, Colorado, United States
    • Connecticut
      • Stamford, Connecticut, United States
    • District of Columbia
      • Washington, D.C., District of Columbia, United States
    • Florida
      • Boynton Beach, Florida, United States
      • Orlando, Florida, United States
    • Georgia
      • Atlanta, Georgia, United States
    • Illinois
      • Chicago, Illinois, United States
      • Niles, Illinois, United States
      • Springfield, Illinois, United States
    • Iowa
      • Ames, Iowa, United States
    • Kansas
      • Westwood, Kansas, United States
    • Louisiana
      • Alexandria, Louisiana, United States
    • Maryland
      • Baltimore, Maryland, United States
    • Michigan
      • Southfield, Michigan, United States
    • Minnesota
      • Minneapolis, Minnesota, United States
    • Missouri
      • Columbia, Missouri, United States
      • Saint Louis, Missouri, United States
    • Nevada
      • Henderson, Nevada, United States
      • Las Vegas, Nevada, United States
    • New Jersey
      • East Orange, New Jersey, United States
      • Morristown, New Jersey, United States
      • Somerville, New Jersey, United States
    • New York
      • Albany, New York, United States
      • Armonk, New York, United States
      • Mineola, New York, United States
      • New York, New York, United States
    • Ohio
      • Canton, Ohio, United States
    • Pennsylvania
      • Bethlehem, Pennsylvania, United States, USA
    • South Carolina
      • Charleston, South Carolina, United States
    • Tennessee
      • Chattanooga, Tennessee, United States
    • Texas
      • Amarillo, Texas, United States
      • Bedford, Texas, United States
      • Dallas, Texas, United States
      • Garland, Texas, United States
      • Houston, Texas, United States
      • Longview, Texas, United States
      • Midland, Texas, United States
      • San Antonio, Texas, United States
      • Temple, Texas, United States
      • Tyler, Texas, United States
    • Utah
      • Salt Lake City, Utah, United States
    • Virginia
      • Alexandria, Virginia, United States
    • Washington
      • Seattle, Washington, United States
    • Wisconsin
      • Milwaukee, Wisconsin, United States

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Subjects must currently be reporting symptoms while on a stable dose of HU monotherapy and be eligible to continue HU on study after randomization.
  • Before screening, the subject must have been receiving HU for at least 12 weeks AND be receiving a stable dose.
  • Subjects must meet baseline symptom criteria

  • Subjects should meet at least 1 of the following criteria:

    • No more than 2 phlebotomies within the 6 months before screening OR
    • No palpable splenomegaly.
  • Subjects must have a hematocrit that can be controlled within 35% to 48% (inclusive) before randomization.

Exclusion Criteria:

  • Subjects with inadequate liver or renal function at screening.
  • Subjects with clinically significant infection that requires therapy
  • Subjects with known active hepatitis A, B, or C at screening or with known HIV positivity.
  • Subjects with an active malignancy over the previous 2 years
  • Subjects with clinically significant cardiac disease (Class III or IV).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: ruxolitinib and hydroxyurea (HU)-placebo
Drug: Ruxolitinib
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.
Drug: HU-placebo

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.
Active Comparator: HU and ruxolitinib-placebo
Drug: Hydroxyurea (HU)
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.
Drug: Ruxolitinib-placebo

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
From Baseline to Week 16

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
From Baseline to Week 16
Proportion of Subjects Randomized to Ruxolitinib Who Achieved ≥ 50% Improvement From Baseline in Total Symptom Score-Cytokine and the Individual Symptom Scores at Week 16 That Were Maintained at Week 48
Time Frame: Week 48
Durable Response on TSS-C/individual symptoms defined as a ≥ 50% reduction in TSS-C/individual symptoms at Week 16 that were maintained at Week 48
Week 48

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Incyte Corporation

Investigators

  • Study Director: Mark Jones, M.D., Incyte Corporation

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2012

Primary Completion (Actual)

March 1, 2014

Study Completion (Actual)

May 1, 2016

Study Registration Dates

First Submitted

June 29, 2012

First Submitted That Met QC Criteria

July 2, 2012

First Posted (Estimate)

July 3, 2012

Study Record Updates

Last Update Posted (Actual)

November 14, 2017

Last Update Submitted That Met QC Criteria

October 12, 2017

Last Verified

October 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 18424-357

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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