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

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Observational

Official Title: Prospective, Non-interventional Study of Disease Progression and Treatment of Patients With Polycythemia Vera in United States Academic or Community Clinical Practices

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 Summary:
Sponsor: Incyte Corporation

Current Primary Outcome:

  • Description of patterns of the disease Polycythemia Vera (PV), and associations of such patterns with patients' exposures or treatments [ Time Frame: Every 3 months for approximately 36 months ]
  • Incidence (frequency) of disease progression [ Time Frame: Every 3 months for approximately 36 months ]
  • Incidence (frequency) of healthcare resources utilization [ Time Frame: 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 [ Time Frame: Every 3 months for approximately 36 months ]
  • Incidence (frequency) and description of PV-related symptoms [ Time Frame: Every 3 months for approximately 36 months ]


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Incidence (frequency) of adverse events (for those patients on active therapies, including PHL) [ Time Frame: 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 [ Time Frame: 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.
  • Work Productivity and Activity Impairment Questionnaire - Specific Health Problem (WPAI-SHP) score for assessment of work productivity and activity impairment [ Time Frame: 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.
  • European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30) for Health Related Quality of Life (HRQoL) [ Time Frame: Every 3 months for approximately 36 months ]
  • Caregiver burden [ Time Frame: Every 3 months for approximately 36 months ]
    The amount of health care received by a paid healthcare worker or by an unpaid caregiver
  • Burden of phlebotomy (PHL) [ Time Frame: 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.


Original Secondary Outcome: Same as current

Information By: Incyte Corporation

Dates:
Date Received: September 23, 2014
Date Started: July 2014
Date Completion: October 2018
Last Updated: February 28, 2017
Last Verified: February 2017