Clinical trial · Observational

Changes in QoL and Symptoms in Patients With Polycythemia Vera Receiving Ruxo in a Routine Clinical Practice

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

NCT05566535CI-TRIAL-00061222QoL-PV-RunknownClinicalTrials.gov clinicaltrialsPublishedExplore in graph →

Summary

Brief summary (as posted)

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

Conditions

Conditions (1)

Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.

Condition (as posted)	Mapped entity	Match	Confidence
Polycythemia Vera	Polycythemia Vera	ONTOLOGY_EXACT	0.98

Interventions

Interventions (1)

Intervention	Type	Mapped drug	Match
Ruxolitinib	Drug	Ruxolitinib	ALIAS

Design

Arms and outcomes

Arms (0)

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Primary outcomes (1)

measure
Change From Baseline in QoL as per SF-36 questionnaire domains at 3 and 9 months of Ruxo treatment
timeFrame
Baseline, 3 and 9 months of Ruxo treatment
description
The difference in QoL means of SF-36 domains at 3 and 9 months as compared to their Baseline will be analyzed

Secondary outcomes (8)

measure
Change From Baseline in MPN10 Total score over time
timeFrame
Baseline, 1, 3, 6, 9 and 12 months of Ruxo treatment
description
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
measure
Change From Baseline in severity of each symptom by MPN10 over time
timeFrame

Eligibility

Eligibility (as posted)

Sex: All
Minimum age: 18 Years

Show eligibility criteria text

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

References

Publications (0)

Data not yet available

No reference posted for this study.