NCT05566535Not yet recruitingNot Applicable
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 enrollmentStarted: October 1, 2022Last updated:
Conditions
Drugs
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 32
- Primary Endpoint
- Change From Baseline in QoL as per SF-36 questionnaire domains at 3 and 9 months of Ruxo treatment
Study 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
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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)
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