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NCT01632904 · ClinicalTrials.gov registry record · Phase 3
Randomized Switch Study From Hydroxyurea to Ruxolitinib for RELIEF of Polycythemia Vera Symptoms: The Relief Study
A Phase 3 study, sponsored by Incyte Corporation.
- Completed
- Registry status
- Phase 3
- Development phase
- 110
- Enrollment target
NCT01632904: Completed Phase 3 study, sponsored by Incyte Corporation.
NCT01632904 is a Phase 3 study that has completed, run by Incyte Corporation. The registered enrollment target is 110 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (86% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01632904, a Phase 3 study, has completed, sponsored by Incyte Corporation.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 110 participants
- Enrollment target
Study 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.
Primary Outcome
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.
Interventions
- DRUG Ruxolitinib
- DRUG Hydroxyurea (HU)
- DRUG HU-placebo
- DRUG Ruxolitinib-placebo
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 110 participants |
| Start Date | 2012-06 |
| Est. Completion | 2016-05 |
| Phase | Phase 3 |
What the finished NCT01632904 record still lists
NCT01632904 is an interventional study that assigns participants to a tested intervention. The registered 110 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (86% lower).
The record links to 0 conditions, and to 4 interventions - of which Ruxolitinib is the first listed.
NCT01632904 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01632904 about?
NCT01632904 is a clinical study titled "Randomized Switch Study From Hydroxyurea to Ruxolitinib for RELIEF of Polycythemia Vera Symptoms: The Relief Study". 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% ...
What is the current status of trial NCT01632904?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 110 participants. The study started on 2012-06. Estimated completion is 2016-05.
What interventions are being tested in trial NCT01632904?
The interventions under investigation include: Ruxolitinib (DRUG), Hydroxyurea (HU) (DRUG), HU-placebo (DRUG), Ruxolitinib-placebo (DRUG).
Who is sponsoring clinical trial NCT01632904?
This trial is sponsored by Incyte Corporation, which has 239 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01632904's enrollment target sits among peer trials
110 1657th of 2000 higher than 337 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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