Randomized Switch Study From Hydroxyurea to Ruxolitinib for RELIEF of Polycythemia Vera Symptoms: The Relief Study
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
1 other identifier
interventional
110
7 countries
70
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Jun 2012
Typical duration for phase_3
70 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2012
CompletedFirst Submitted
Initial submission to the registry
June 29, 2012
CompletedFirst Posted
Study publicly available on registry
July 3, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2014
CompletedResults Posted
Study results publicly available
April 7, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2016
CompletedNovember 14, 2017
October 1, 2017
1.7 years
June 29, 2012
March 26, 2015
October 12, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
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 Outcomes (2)
Percentage of Subjects Achieving ≥ 50% Improvement From Baseline in the Individual Symptom Scores for TSS-C at Week 16
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
Week 48
Study Arms (2)
ruxolitinib and hydroxyurea (HU)-placebo
EXPERIMENTALHU and ruxolitinib-placebo
ACTIVE COMPARATORInterventions
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (70)
Unknown Facility
Scottsdale, Arizona, United States
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Fayetteville, Arkansas, United States
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Burbank, California, United States
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Glendale, California, United States
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La Jolla, California, United States
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Los Angeles, California, United States
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San Diego, California, United States
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Aurora, Colorado, United States
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Stamford, Connecticut, United States
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Washington D.C., District of Columbia, United States
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Boynton Beach, Florida, United States
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Orlando, Florida, United States
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Atlanta, Georgia, United States
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Chicago, Illinois, United States
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Niles, Illinois, United States
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Springfield, Illinois, United States
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Ames, Iowa, United States
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Westwood, Kansas, United States
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Alexandria, Louisiana, United States
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Baltimore, Maryland, United States
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Southfield, Michigan, United States
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Minneapolis, Minnesota, United States
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Columbia, Missouri, United States
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St Louis, Missouri, United States
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Henderson, Nevada, United States
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Las Vegas, Nevada, United States
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East Orange, New Jersey, United States
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Morristown, New Jersey, United States
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Somerville, New Jersey, United States
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Albany, New York, United States
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Armonk, New York, United States
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Mineola, New York, United States
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New York, New York, United States
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Canton, Ohio, United States
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Bethlehem, Pennsylvania, USA, United States
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Charleston, South Carolina, United States
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Chattanooga, Tennessee, United States
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Amarillo, Texas, United States
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Bedford, Texas, United States
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Dallas, Texas, United States
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Garland, Texas, United States
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Houston, Texas, United States
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Longview, Texas, United States
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Midland, Texas, United States
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San Antonio, Texas, United States
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Temple, Texas, United States
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Tyler, Texas, United States
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Salt Lake City, Utah, United States
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Alexandria, Virginia, United States
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Seattle, Washington, United States
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Milwaukee, Wisconsin, United States
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Antwerp, Belgium
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Bruges, Belgium
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Aachen, Germany
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Berlin, Germany
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Freiburg im Breisgau, Germany
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Hamburg, Germany
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Stuttgart, Germany
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Ulm, Germany
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Galway, Ireland
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Florence, Italy
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Reggio Calabria, Italy
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Varese, Italy
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Barcelona, Spain
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Pamplona, Spain
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Salamanca, Spain
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Boston, United Kingdom
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Leicester, United Kingdom
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Nottingham, United Kingdom
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West Bromwich, United Kingdom
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Study Director
- Organization
- Incyte Corporation
Study Officials
- STUDY DIRECTOR
Mark Jones, M.D.
Incyte Corporation
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 29, 2012
First Posted
July 3, 2012
Study Start
June 1, 2012
Primary Completion
March 1, 2014
Study Completion
May 1, 2016
Last Updated
November 14, 2017
Results First Posted
April 7, 2015
Record last verified: 2017-10