Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study has been completed.
Information provided by (Responsible Party):
Incyte Corporation Identifier:
First received: June 29, 2012
Last updated: February 14, 2015
Last verified: February 2015

June 29, 2012
February 14, 2015
June 2012
March 2014   (final data collection date for primary outcome measure)
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. ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01632904 on Archive Site
  • Proportion of subjects with ≥ 50% reduction in individual PV-related symptoms at Week 16 compared to Baseline [ Time Frame: Baseline and Week 16. ] [ Designated as safety issue: No ]
  • Duration of symptomatic improvement in subjects experiencing relief from the cluster of PV-related symptoms [ Time Frame: Week 16 and Week 48. ] [ Designated as safety issue: No ]
  • Duration of symptomatic improvement in subjects experiencing relief from individual symptoms [ Time Frame: Week 16 and Week 48. ] [ Designated as safety issue: No ]
  • Safety of ruxolitinib and HU as measured by adverse events. [ Time Frame: Screening through the end of study participation (estimated 18 months). ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
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

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.

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.

Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Polycythemia Vera
  • Drug: ruxolitinib
    Ruxolitinib will be self-administered at a starting dose of 10 mg (two 5 mg tablets) twice a day by mouth. Doses increases of 5 mg (1 tablet) in twice daily increments are permitted after 4 weeks and again after 8 weeks of therapy.
  • 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 pre-specified criteria.
  • Drug: placebo
    All placebo will be self-administered and dosing will the same as with the blinded dose and comparator arm.
  • Experimental: ruxolitinib and hydroxyurea (HU)-placebo
    • Drug: ruxolitinib
    • Drug: placebo
  • Active Comparator: HU and ruxolitinib-placebo
    • Drug: hydroxyurea (HU)
    • Drug: placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
November 2014
March 2014   (final data collection date for primary outcome measure)

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 1 phlebotomy 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).
18 Years and older
Contact information is only displayed when the study is recruiting subjects
United States,   Belgium,   Germany,   Ireland,   Italy,   Spain,   United Kingdom
Incyte Corporation
Incyte Corporation
Not Provided
Study Director: Mark Jones, M.D. Incyte Corporation
Incyte Corporation
February 2015

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