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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01632904
Recruitment Status : Completed
First Posted : July 3, 2012
Results First Posted : April 7, 2015
Last Update Posted : November 14, 2017
Sponsor:
Information provided by (Responsible Party):
Incyte Corporation

Tracking Information
First Submitted Date  ICMJE June 29, 2012
First Posted Date  ICMJE July 3, 2012
Results First Submitted Date  ICMJE March 26, 2015
Results First Posted Date  ICMJE April 7, 2015
Last Update Posted Date November 14, 2017
Study Start Date  ICMJE June 2012
Actual Primary Completion Date March 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 14, 2015)
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 Measures  ICMJE
 (submitted: July 2, 2012)
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. ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 12, 2017)
  • 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.
  • 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
Original Secondary Outcome Measures  ICMJE
 (submitted: July 2, 2012)
  • 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). ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Randomized Switch Study From Hydroxyurea to Ruxolitinib for RELIEF of Polycythemia Vera Symptoms: The Relief Study
Official Title  ICMJE 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
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 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  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Polycythemia Vera
Intervention  ICMJE
  • 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: 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: 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.

  • 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.

Study Arms  ICMJE
  • Experimental: ruxolitinib and hydroxyurea (HU)-placebo
    Interventions:
    • Drug: Ruxolitinib
    • Drug: HU-placebo
  • Active Comparator: HU and ruxolitinib-placebo
    Interventions:
    • Drug: Hydroxyurea (HU)
    • Drug: Ruxolitinib-placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 2, 2012)
110
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE May 2016
Actual Primary Completion Date March 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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).
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Belgium,   Germany,   Ireland,   Italy,   Spain,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01632904
Other Study ID Numbers  ICMJE 18424-357
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Incyte Corporation
Study Sponsor  ICMJE Incyte Corporation
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Mark Jones, M.D. Incyte Corporation
PRS Account Incyte Corporation
Verification Date October 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP