A Prospective, Non-interventional Study of JAKAVI® (Ruxolitinib) Treatment in Patients With Polycythemia Vera

Study Overview
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Brief Summary
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Jakavi® therapy for polycythemia vera (PV) has so far been studied exclusively in clinical trials and at selected clinical trial centres. This observational study is intended to document the therapy of PV in daily practice with a broad patient population and a geographically representative selection of German centres (both hospitals and practices). The prospective mapping of daily practice reality is thus the main goal of this project.

Detailed Description
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To achieve meaningful results in accordance with the study objective and to obtain long-term data from daily clinical practice in a real-world setting, the observation period under Jakavi® therapy is specified as 36 months.

Official Title
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A Prospective, Non-interventional Study of JAKAVI® (Ruxolitinib) Treatment in Patients With Polycythemia Vera (PAVE)

Conditions
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Polycythemia Vera

Intervention / Treatment
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* Other: Jakavi


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult male and female patients with PV for whom Jakavi® therapy is indicated according to the European summary of product characteristics Patients who have been informed about this NIS and gave written consent

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 120 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| JAK inhibitor naive<br>JAK inhibitor naive patients | Other: Jakavi<br>* Prospective observational study. There is no treatment allocation. Patients administered Jakavi by prescription and administered according to the SmPC.<br>* Other names: Ruxolitinib;|
| JAK inhibitor pre-treated<br>JAK inhibitor pre-treated patients (Jakavi® or any other JAK inhibitor for ≥3 months) | Other: Jakavi<br>* Prospective observational study. There is no treatment allocation. Patients administered Jakavi by prescription and administered according to the SmPC.<br>* Other names: Ruxolitinib;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in spleen size (or volume) | Measured by palpation/sonography/CT/MRI | Up to 36 months | 
| Eastern Cooperative Oncology Group (ECOG) performance status | The ECOG performance status is a scale used to assess how a patient's disease is progressing, assess how the disease affects the daily living abilities of the patient, and determine appropriate treatment and prognosis. The grade ranges from 0 (fully active, able to carry on all pre-disease performance without restriction) to 5 (dead) | Up to 36 months | 
| Change in constitutional symptoms | Number of patients with change in constitutional symptoms | Up to 36 months | 
| Quality of Life (QoL) - MPN-SAF TSS; MPN-10 | The Myeloproliferative Neoplasm (MPN) Symptom Assessment Form Total Symptom Score (MPN-SAF TSS; MPN-10) questionnaire contains the ten most clinically relevant symptoms reported by patients with MPNs. It includes disease related symptoms each scored from 0 (absent) to 10 (worst imaginable). Total Scores range from 0-100, with higher scores indicating a greater number of symptoms and severity. | Up to 36 months | 
| Quality of Life (QoL) - (SF-36) | The Short Form-36 questionnaire consists of questions measuring physical function, physical role limitation, pain, general health, vitality, social function, emotional role limitations, and mental health status. The scores that can be obtained from the scale vary between 0 and 100 and the increase in the scores indicates that the quality of life is high. | Up to 36 months | 
| Overall survival | Overall survival for JAK inhibitor naive and pretreated patients | Up to 36 months | 
| Dosing | Number of patients by initial dosing and number of patients with dose modifications will be provided | Up to 36 months | 
| Treatment interruptions | Number of patients with treatment interruptions | Up to 36 months | 
| Hematology | Number of patients with changes in different blood count values over time (hematocrit, erythrocytes, thrombocytes, leukocytes) | Up to 36 months | 
| Thromboembolic events | Number of patients with thromboembolic events. | Up to 36 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ruxolitinib, polycythemia vera, PV, jakavi