Trial · NCT01632904

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

NCT01632904, Phase 3, Completed, Incyte Corporation; results first posted 2015-04-07

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Randomized Switch Study From Hydroxyurea to Ruxolitinib for RELIEF of Polycythemia Vera Symptoms: The Relief Study. Trials, record NCT01632904. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01632904

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Randomized Switch Study From Hydroxyurea to Ruxolitinib for RELIEF of Polycythemia Vera Symptoms: The Relief Study
NCT number: NCT01632904
Status: Completed
Phases: Phase 3
Enrollment: 110 participants, actual
Lead sponsor: Incyte Corporation
Conditions: Polycythemia Vera
Interventions: Ruxolitinib, Hydroxyurea (HU), HU-placebo, Ruxolitinib-placebo
First posted: 2012-07-03
Last updated: 2017-11-14
Results first posted: 2015-04-07

Source ClinicalTrials.gov

Registered outcomes3

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	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	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.
Secondary	Percentage of Subjects Achieving ≥ 50% Improvement From Baseline in the Individual Symptom Scores for TSS-C at Week 16	From Baseline to Week 16	The TSS-C cluster includes tiredness, itching, muscle aches, night sweats, and sweats while awake.
Secondary	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	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

Source ClinicalTrials.gov

Outcomes3

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	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	From Baseline to Week 16	Intent-to-Treat (ITT); all subjects randomized in the study. For the overall TSS-C score, only those subjects with a baseline score of 0 and a Week 16 score of 0 or missing were excluded from the analysis.	Percentage of participants	NUMBER
SECONDARY	Percentage of Subjects Achieving ≥ 50% Improvement From Baseline in the Individual Symptom Scores for TSS-C at Week 16	From Baseline to Week 16	Intent-to-Treat (ITT); all subjects randomized in the study. For individual symptom scores within the TSS-C cluster, only those subjects with a baseline score of 0 and a Week 16 score of 0 or missing were excluded from the analysis.	Percentage of participants	NUMBER
SECONDARY	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	Intent-to-Treat (ITT); all subjects randomized to Ruxolitinib in the study. For TSS-C/individual symptoms, subject without baseline value was excluded from the analysis.	percentage of participants	NUMBER

Source ClinicalTrials.gov

Results by group18

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Units
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	Ruxolitinib		43.4	Percentage of participants
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	Hydroxyurea		29.6	Percentage of participants
Percentage of Subjects Achieving ≥ 50% Improvement From Baseline in the Individual Symptom Scores for TSS-C at Week 16	Ruxolitinib	Tiredness (n= 50, 53)	40.0	Percentage of participants
Percentage of Subjects Achieving ≥ 50% Improvement From Baseline in the Individual Symptom Scores for TSS-C at Week 16	Hydroxyurea	Tiredness (n= 50, 53)	26.4	Percentage of participants
Percentage of Subjects Achieving ≥ 50% Improvement From Baseline in the Individual Symptom Scores for TSS-C at Week 16	Ruxolitinib	Itching (n= 48, 50)	54.2	Percentage of participants
Percentage of Subjects Achieving ≥ 50% Improvement From Baseline in the Individual Symptom Scores for TSS-C at Week 16	Hydroxyurea	Itching (n= 48, 50)	32.0	Percentage of participants
Percentage of Subjects Achieving ≥ 50% Improvement From Baseline in the Individual Symptom Scores for TSS-C at Week 16	Ruxolitinib	Muscle aches (n= 47, 49)	38.3	Percentage of participants
Percentage of Subjects Achieving ≥ 50% Improvement From Baseline in the Individual Symptom Scores for TSS-C at Week 16	Hydroxyurea	Muscle aches (n= 47, 49)	30.6	Percentage of participants
Percentage of Subjects Achieving ≥ 50% Improvement From Baseline in the Individual Symptom Scores for TSS-C at Week 16	Ruxolitinib	Night sweats (n= 42, 48)	47.6	Percentage of participants
Percentage of Subjects Achieving ≥ 50% Improvement From Baseline in the Individual Symptom Scores for TSS-C at Week 16	Hydroxyurea	Night sweats (n= 42, 48)	41.7	Percentage of participants

1 to 10 of 18Source ClinicalTrials.gov

See all 18 results by group

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Ruxolitinib	54
Overall Study	STARTED	Hydroxyurea	56
Overall Study	COMPLETED	Ruxolitinib	47
Overall Study	COMPLETED	Hydroxyurea	50
Overall Study	NOT COMPLETED	Ruxolitinib	7
Overall Study	NOT COMPLETED	Hydroxyurea	6

Source ClinicalTrials.gov

Adverse events154

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
other	Headache	Nervous system disorders	Ruxolitinib	9	54
other	Headache	Nervous system disorders	Hydroxyurea	3	56
other	Rash	Skin and subcutaneous tissue disorders	Ruxolitinib	6	54
other	Rash	Skin and subcutaneous tissue disorders	Hydroxyurea	0	56
other	Fatigue	General disorders	Ruxolitinib	11	54
other	Fatigue	General disorders	Hydroxyurea	6	56
other	Anemia	Blood and lymphatic system disorders	Ruxolitinib	8	54
other	Anemia	Blood and lymphatic system disorders	Hydroxyurea	5	56
other	Nausea	Gastrointestinal disorders	Ruxolitinib	6	54
other	Nausea	Gastrointestinal disorders	Hydroxyurea	3	56

1 to 10 of 154Source ClinicalTrials.gov

See all 154 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Ruxolitinib
Total, all-cause mortality	Hydroxyurea
Total, other adverse events	Ruxolitinib	50	54
Total, other adverse events	Hydroxyurea	45	56
Total, serious adverse events	Ruxolitinib	5	54
Total, serious adverse events	Hydroxyurea	4	56

Source ClinicalTrials.gov

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons1

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison
Ruxolitinib vs Hydroxyurea: serious adverse events

Source Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT01632904

GET https://conductscience.org/api/trials/v1/NCT01632904/events?page=2

API reference For AI assistants