Prospective Observational Study Of Patients With Polycythemia Vera In US Clinical Practices (REVEAL)

Completed

• Conditions: MPN (Myeloproliferative Neoplasms)

• Registration Number: NCT02252159
• Lead Sponsor: Incyte Corporation

Brief Summary

This is a Phase IV, multicenter, non-interventional, non-randomized, prospective, observational study in an adult population (patients \>18 years old) of men and women who have been diagnosed with clinically overt PV and are being followed in either community or academic medical centers in the United States who will be enrolled over a 12-month period and observed for 36 months from the date the last patient is enrolled.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-07-31
• Study First Submitted: 2014-09-23
• Study First Submitted QC: 2014-09-25
• Study First Posted: 2014-09-30
• Primary Completion: 2019-08-03
• Study Completion: 2019-08-03
• Status Verified: 2021-04
• Last Update Submitted: 2021-04-22
• Last Update Posted: 2021-04-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2544

Inclusion Criteria

• Age ≥18 years
• Diagnosis of Polycythemia Vera (PV)
• Willing and able to provide written informed consent
• Willing and able to complete patient assessment questionnaires either alone or with minimal assistance from a caregiver and/or trained site personnel
• Under the supervision of a physician for the current care of PV including but not limited to watchful waiting, acetylsalicylic acid (ASA) 81mg or greater, antithrombotic therapy, Phlebotomy (PHL), Hydroxyurea (HU), interferon (recombinant or pegylated), busulfan, anagrelide

Exclusion Criteria

• Participation in an active clinical trial in which the study treatment is blinded
• Life expectancy <6 months
• Diagnosis of myelofibrosis (MF) [including primary MF, post-PV MF, or post-essential thrombocythemia MF (post-ET MF)]
• Diagnosis of secondary Acute Myeloid Leukemia (AML)
• Diagnosis of Myelodysplastic Syndrome (MDS)
• History of or active plan to proceed to allogeneic hematopoietic stem cell transplant in next 3 months
• Splenectomy

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Description of patterns of the disease Polycythemia Vera (PV), and associations of such patterns with patients' exposures or treatments	Every 3 months for approximately 36 months
Incidence (frequency) and description of PV-related symptoms	Every 3 months for approximately 36 months
Incidence (frequency) of disease progression	Every 3 months for approximately 36 months
Incidence (frequency) of healthcare resources utilization	Every 3 months for approximately 36 months	Healthcare resources were defined as a. Medical visits (including Office visits, ER visits, and hospitalizations), b. phlebotomy (PHL) procedures and c. prescriptions (including PV-related prescriptions, PV-related over-the-counter (OTC) medications, and prescription medications for co-morbid conditions).
Incidence (frequency) of complications due to PV	Every 3 months for approximately 36 months

Secondary Outcome Measures

Name	Time	Method
Incidence (frequency) of adverse events (for those patients on active therapies, including PHL)	Baseline through end of study. Approximately 36 months
Patient-reported outcomes as assessed by Myeloproliferative Neoplasm Symptom Assessment Form Total Symptom Score (MPN-SAF TSS) for assessment of the severity of symptoms	Every 3 months for approximately 36 months	The MPN-SAF TSS is a validated 10-item instrument that efficiently assesses the prevalence and severity of PV symptoms in both clinical practice and trial settings. Higher scores indicate more severe symptoms and greater inactivity with a possible total score range of 0-100.
Burden of phlebotomy (PHL)	Every 3 months for approximately 36 months	A patients self-reported assessment of burden including pain at site, difficulty and inconvenience of scheduling and cost factors.
European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30) for Health Related Quality of Life (HRQoL)	Every 3 months for approximately 36 months
Caregiver burden	Every 3 months for approximately 36 months	The amount of health care received by a paid healthcare worker or by an unpaid caregiver
Work Productivity and Activity Impairment Questionnaire - Specific Health Problem (WPAI-SHP) score for assessment of work productivity and activity impairment	Every 3 months for approximately 36 months	WPAI-SHP is a validated 6-item instrument that measures the effect of overall health and specific symptoms on productivity at work and outside of it. All outcomes are presented as a proportion, with 0% representing minimal/no impairment and 100% representing maximal impairment or productivity loss.