Changes in Quality of Life (QoL) and Symptoms in Patients With Polycythemia Vera (PV) Receiving Ruxolitinib (Ruxo) in a Routine Clinical Practice

Multinational Center for Quality of Life Research, Russia0 sites32 target enrollmentOctober 1, 2022

ConditionsPolycythemia Vera

DrugsRuxolitinib

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Polycythemia Vera
Sponsor: Multinational Center for Quality of Life Research, Russia
Enrollment: 32
Primary Endpoint: Change From Baseline in QoL as per SF-36 questionnaire domains at 3 and 9 months of Ruxo treatment
Status: Not yet recruiting
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

The purpose of this multicenter observational prospective cohort study is to examine changes in QoL and symptoms in patients with polycythemia vera (PV) during treatment with ruxolitinib (Ruxo), and to evaluate efficacy and safety of Ruxo in a real-world setting

Registry

clinicaltrials.gov

Start Date

October 1, 2022

End Date

August 1, 2024

Last Updated

3 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Multinational Center for Quality of Life Research, Russia

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Patients who have confirmed diagnosis of PV
•Patients whose age - 18 years and older
•Patients who signed informed consent
•Patients who able to fill out questionnaires

Exclusion Criteria

•Patients enrolled in clinical trials
•Patients with contraindications to Ruxo in accordance with instruction for use

Outcomes

Primary Outcomes

Change From Baseline in QoL as per SF-36 questionnaire domains at 3 and 9 months of Ruxo treatment

Time Frame: Baseline, 3 and 9 months of Ruxo treatment

The difference in QoL means of SF-36 domains at 3 and 9 months as compared to their Baseline will be analyzed

Secondary Outcomes

Percentage of patients achieving a ≥ 50% improvement from Baseline in MPN10 Total Symptom Score over time(1, 3, 6, 9 and 12 months of Ruxo treatment)
Change From Baseline in QoL as per SF-36 questionnaire domains over 12 months of Ruxo treatment(Baseline, 1, 3, 6, 9 and 12 months of Ruxo treatment)
The percentage of patients who achieved overall clinicohematologic response at 9 months of treatment with Ruxo(9 months)
The Percentage of patients who achieved hematocrit (Hct) control at 9 months of treatment with Ruxo(9 months)
The percentage of patients with positive changes of wellbeing during Ruxo treatment(1, 3, 6, 9 and 12 months of Ruxo treatment)
The percentage of patients satisfied/dissatisfied with Ruxo treatment over time(1, 3, 6, 9 and 12 months of Ruxo treatment)
Change From Baseline in severity of each symptom by MPN10 over time(Baseline, 1, 3, 6, 9 and 12 months of Ruxo treatment)
Change From Baseline in MPN10 Total score over time(Baseline, 1, 3, 6, 9 and 12 months of Ruxo treatment)