Polycythemia VeraPhase 3NCT01632904
Randomized Switch Study From Hydroxyurea to Ruxolitinib for RELIEF of Polycythemia Vera Symptoms: The Relief Study
A Phase 3 study testing Ruxolitinib and Hydroxyurea (HU) in people with Polycythemia Vera, run by Incyte Corporation at 70 sites in 7 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Polycythemia Vera
- What is being tested?
- Ruxolitinib and Hydroxyurea (HU)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 110 participants
- Where
- 70 sitesin 7 countries
- Study dates
- Jun 2012to May 2016
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
70 sites in 7 countries.
70 sites in 7 countries
United States51 sites
Study site
Albany, New York
Study site
Alexandria, Louisiana
Study site
Alexandria, Virginia
Study site
Amarillo, Texas
Study site
Ames, Iowa
Study site
Armonk, New York
Study site
Atlanta, Georgia
Study site
Aurora, Colorado
Study site
Baltimore, Maryland
Study site
Bedford, Texas
Study site
Bethlehem, Pennsylvania, USA
Study site
Boynton Beach, Florida
Study site
Burbank, California
Study site
Canton, Ohio
Study site
Charleston, South Carolina
Study site
Chattanooga, Tennessee
Study site
Chicago, Illinois
Study site
Columbia, Missouri
Study site
Dallas, Texas
Study site
East Orange, New Jersey
Study site
Fayetteville, Arkansas
Study site
Garland, Texas
Study site
Glendale, California
Study site
Henderson, Nevada
Study site
Houston, Texas
Study site
La Jolla, California
Study site
Las Vegas, Nevada
Study site
Longview, Texas
Study site
Los Angeles, California
Study site
Midland, Texas
Study site
Milwaukee, Wisconsin
Study site
Mineola, New York
Study site
Minneapolis, Minnesota
Study site
Morristown, New Jersey
Study site
New York, New York
Study site
Niles, Illinois
Study site
Orlando, Florida
Study site
Salt Lake City, Utah
Study site
San Antonio, Texas
Study site
San Diego, California
Study site
Scottsdale, Arizona
Study site
Seattle, Washington
Study site
Somerville, New Jersey
Study site
Southfield, Michigan
Study site
Springfield, Illinois
Study site
St Louis, Missouri
Study site
Stamford, Connecticut
Study site
Temple, Texas
Study site
Tyler, Texas
Study site
Washington D.C., District of Columbia
Study site
Westwood, Kansas
Germany6 sites
Study site
Aachen
Study site
Berlin
Study site
Freiburg im Breisgau
Study site
Hamburg
Study site
Stuttgart
Study site
Ulm
United Kingdom4 sites
Study site
Boston
Study site
Leicester
Study site
Nottingham
Study site
West Bromwich
About this study
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 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.
Read the 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.
- Conditions
- Polycythemia Vera
- Being tested
- Ruxolitinib, Hydroxyurea (HU), HU-placebo, Ruxolitinib-placebo
- Keywords
- Polycythemia Vera, PV
- Medical subject headings
- Polycythemia Vera
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RuxolitinibDrug
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 (HU)Drug
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.
HU-placeboDrug
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.
Ruxolitinib-placeboDrug
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 group | Role | What they receive |
|---|---|---|
| ruxolitinib and hydroxyurea (HU)-placebo | Experimental | Not described Receives: Drug: Ruxolitinib; Drug: HU-placebo |
| HU and ruxolitinib-placebo | Active comparator | Not described Receives: Drug: Hydroxyurea (HU); Drug: Ruxolitinib-placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
The TSS-C cluster includes tiredness, itching, muscle aches, night sweats, and sweats while awake.
Measured: 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
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
Measured: Week 48
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2012 (estimated)
- Study startJun 2012
- Primary completionMar 2014
- Study completionMay 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Polycythemia VeraStudies of the same condition, open and under way.
- More trials run by Incyte CorporationThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- Incyte Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Mark Jones, M.D., Study director, Incyte Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01632904
- Sponsor's protocol ID
- 18424-357
- Status last verified
- Oct 2017
- First submitted
- 29 Jun 2012
- Last updated
- 14 Nov 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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 Patient Reported Outcomes
- ClinicalTrials.gov ID
- NCT01632904
- Acronym / sponsor ID
- 18424-357
- Conditions
- Polycythemia Vera
- Keywords
- Polycythemia Vera, PV
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- Incyte CorporationIndustry (pharma, biotech, devices)
- Study start
- Jun 2012
- Primary completion
- Mar 2014 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 3 Jul 2012 (estimated)
- Results
- Posted 7 Apr 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ruxolitinib and hydroxyurea (HU)-placebo | Experimental | Drug: Ruxolitinib, Drug: HU-placebo |
| HU and ruxolitinib-placebo | Active comparator | Drug: Hydroxyurea (HU), Drug: Ruxolitinib-placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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:
- Subjects must have a hematocrit that can be controlled within 35% to 48% (inclusive) before randomization.
Key exclusion criteria (5 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RuxolitinibRuxolitinib 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 | ruxolitinib and hydroxyurea (HU)-placebo |
| 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 and ruxolitinib-placebo |
| HU-placeboAll 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 and hydroxyurea (HU)-placebo |
| Ruxolitinib-placeboAll 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. | Drug | HU and ruxolitinib-placebo |
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.
2 secondary outcomes
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
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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mark Jones, M.D. study director
Incyte Corporation
70 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Ruxolitinib and Hydroxyurea (HU) in people with Polycythemia Vera, run by Incyte Corporation at 70 sites in 7 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 70 sites in United States, Germany, United Kingdom, Italy, Spain and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 7 Apr 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Nov 2017.