Changes in QoL and Symptoms in Patients With Polycythemia Vera Receiving Ruxo in a Routine Clinical Practice (QoL-PV-R)

September 30, 2022 updated by: Multinational Center for Quality of Life Research, Russia

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

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

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

32

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Adult patients with PV will be enrolled after being prescribed with Ruxo. The eligibility criteria for this study are broader than those for patients to be treated with Ruxo in randomized clinical trials, so as to be reflective of routine clinical practice

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Baseline, 3 and 9 months of Ruxo treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline in MPN10 Total score over time
Time Frame: Baseline, 1, 3, 6, 9 and 12 months of Ruxo treatment
The difference in MPN10 Total Symptom Score means by MPN10 at different time-points of Ruxo treatment as compared to their Baseline will be analyzed. Also the percentage of patients with the lowest symptom burden, corresponding to MPN10 Total scores of 0 - 7 (quartile 1), at different treatment time-points (Baseline, 1, 3, 6, 9 and 12 months) will be calculated
Baseline, 1, 3, 6, 9 and 12 months of Ruxo treatment
Change From Baseline in severity of each symptom by MPN10 over time
Time Frame: Baseline, 1, 3, 6, 9 and 12 months of Ruxo treatment
The difference in MPN10 symptom score means at different time-points of Ruxo treatment as compared to their Baseline will be analyzed
Baseline, 1, 3, 6, 9 and 12 months of Ruxo treatment
Percentage of patients achieving a ≥ 50% improvement from Baseline in MPN10 Total Symptom Score over time
Time Frame: 1, 3, 6, 9 and 12 months of Ruxo treatment
The number of patients with MPN10 Total Symptom Score decrease ≥ 50% at 1, 3, 6, 9 and 12 months of Ruxo treatment as compared to its' Baseline will be calculated
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
Time Frame: Baseline, 1, 3, 6, 9 and 12 months of Ruxo treatment
The difference in QoL means of SF-36 domains at different time-points of Ruxo treatment as compared to their Baseline will be analyzed
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
Time Frame: 9 months
Overall clinicohematologic response will be defined as any participant who achieved a complete or partial clinicohematologic response per the National criteria for response in polycythemia vera (2021) and European LeukNet recommendations (2013). A complete response (CR) will be defined as: hematocrit control (<45%) with the absence of phlebotomy eligibility ≥12 weeks, spleen volume reduction at least 35% from baseline, platelet count less than or equal to 400 x 109/L, and white blood cell count less than or equal to 10 x 109/L, and symptom regress during ≥12 weeks as well as histological remission. A Partial Response (PR) will be defined as all the above criteria excluding histological remission
9 months
The Percentage of patients who achieved hematocrit (Hct) control at 9 months of treatment with Ruxo
Time Frame: 9 months
Hematocrit control is Ht <45% with the absence of phlebotomy eligibility beginning at 3 months visit and continuing through 9 months
9 months
The percentage of patients with positive changes of wellbeing during Ruxo treatment
Time Frame: 1, 3, 6, 9 and 12 months of Ruxo treatment
The number of patients who reported improvement as per Patient Global Impression of Changes scale at different time-points of treatment will be analyzed
1, 3, 6, 9 and 12 months of Ruxo treatment
The percentage of patients satisfied/dissatisfied with Ruxo treatment over time
Time Frame: 1, 3, 6, 9 and 12 months of Ruxo treatment
The number of patients satisfied/dissatisfied with treatment according to Patient' Treatment Satisfaction Checklist at different time-points of treatment will be analyzed
1, 3, 6, 9 and 12 months of Ruxo treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Multinational Center for Quality of Life Research, Russia

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

October 1, 2022

Primary Completion (Anticipated)

May 1, 2024

Study Completion (Anticipated)

August 1, 2024

Study Registration Dates

First Submitted

September 30, 2022

First Submitted That Met QC Criteria

September 30, 2022

First Posted (Actual)

October 4, 2022

Study Record Updates

Last Update Posted (Actual)

October 4, 2022

Last Update Submitted That Met QC Criteria

September 30, 2022

Last Verified

September 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CINC424BRU04T

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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