Clinical trial NCT05853445: A Prospective, Non-interventional Study of JAKAVI® (Ruxolitinib) Treatment in Patients With Polycythemia Vera
Official title: A Prospective, Non-interventional Study of JAKAVI® (Ruxolitinib) Treatment in Patients With Polycythemia Vera (PAVE)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Polycythemia Vera
Keywords: ruxolitinib
polycythemia vera
PV
jakavi
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2023-05-10
Enrollment: 467
Sex: ALL
Minimum age (years): 18
Maximum age (years): 120
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult male and female patients with PV for whom Jakavi® therapy is indicated.

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Dosing
timeFrame: Up to 36 months
measure: Treatment interruptions
timeFrame: Up to 36 months
measure: Overall survival
timeFrame: Up to 36 months
measure: Hematology
timeFrame: Up to 36 months
measure: Number of phlebotomies
timeFrame: Up to 36 months
measure: Change in spleen size (or volume)
timeFrame: Up to 36 months
measure: Quality of Life (QoL) - MPN-SAF TSS; MPN-10
timeFrame: Up to 36 months
measure: Thromboembolic events
timeFrame: Up to 36 months
Secondary outcomes:
measure: Eastern Cooperative Oncology Group (ECOG) performance status
timeFrame: Up to 36 months
measure: Change in constitutional symptoms
timeFrame: Up to 36 months
measure: Quality of Life (QoL) - (SF-36)
timeFrame: Up to 36 months
measure: Bone marrow aspiration and biopsy
timeFrame: Up to 36 months
measure: Molecular examination
timeFrame: Up to 36 months
Other outcomes:
Locations:
city: Mannheim
country: Germany
facility: Novartis Investigative Site
state: Baden Wuerttemberg
city: Reutlingen
country: Germany
facility: Novartis Investigative Site
state: Baden Wuerttemberg
city: Winnenden
country: Germany
facility: Novartis Investigative Site
state: Baden Wuerttemberg
city: Heidenheim
country: Germany
facility: Novartis Investigative Site
state: Baden-Wuerttemberg
city: Augsburg
country: Germany
facility: Novartis Investigative Site
state: Bavaria
city: Herrsching
country: Germany
facility: Novartis Investigative Site
state: Bavaria
city: Muenchen
country: Germany
facility: Novartis Investigative Site
state: Bavaria
city: Aschaffenburg
country: Germany
facility: Novartis Investigative Site
state: Bayern
city: Donauwoerth
country: Germany
facility: Novartis Investigative Site
state: Bayern
city: Erlangen
country: Germany
facility: Novartis Investigative Site
state: Bayern
city: Muenchen
country: Germany
facility: Novartis Investigative Site
state: Bayern
city: Frankfurt
country: Germany
facility: Novartis Investigative Site
state: Brandenburg
city: Landshut
country: Germany
facility: Novartis Investigative Site
state: Bvaria
city: Goettingen
country: Germany
facility: Novartis Investigative Site
state: Lower Saxony
city: Twistringen
country: Germany
facility: Novartis Investigative Site
state: Lower Saxony
city: Brake
country: Germany
facility: Novartis Investigative Site
state: Niedersachsen
city: Duisburg
country: Germany
facility: Novartis Investigative Site
state: North Rhine-Westphalia
city: Bad Salzuflen
country: Germany
facility: Novartis Investigative Site
state: Northrhine Westfalia
city: Iserlohn
country: Germany
facility: Novartis Investigative Site
state: Northrhine Westfalia
city: Dresden
country: Germany
facility: Novartis Investigative Site
state: Sachsen
city: Pirna
country: Germany
facility: Novartis Investigative Site
state: Sachsen
city: Bautzen
country: Germany
facility: Novartis Investigative Site
state: Saxony
city: Luebeck
country: Germany
facility: Novartis Investigative Site
state: Schleswig-Holstein
city: Erfurt
country: Germany
facility: Novartis Investigative Site
state: Thueringen
city: Altoetting
country: Germany
facility: Novartis Investigative Site
city: Augsburg
country: Germany
facility: Novartis Investigative Site
city: Bad Homburg vor der Höhe
country: Germany
facility: Novartis Investigative Site
city: Bad Soden
country: Germany
facility: Novartis Investigative Site
city: Berlin
country: Germany
facility: Novartis Investigative Site
city: Berlin
country: Germany
facility: Novartis Investigative Site
city: Bielefeld
country: Germany
facility: Novartis Investigative Site
city: Bottrop
country: Germany
facility: Novartis Investigative Site
city: Chemnitz
country: Germany
facility: Novartis Investigative Site
city: Dortmund
country: Germany
facility: Novartis Investigative Site
city: Dresden
country: Germany
facility: Novartis Investigative Site
city: Dueren
country: Germany
facility: Novartis Investigative Site
city: Duisburg
country: Germany
facility: Novartis Investigative Site
city: Erfurt
country: Germany
facility: Novartis Investigative Site
city: Essen
country: Germany
facility: Novartis Investigative Site
city: Essen
country: Germany
facility: Novartis Investigative Site
city: Fuerth
country: Germany
facility: Novartis Investigative Site
city: Gera
country: Germany
facility: Novartis Investigative Site
city: Goslar
country: Germany
facility: Novartis Investigative Site
city: Halberstadt
country: Germany
facility: Novartis Investigative Site
city: Halle
country: Germany
facility: Novartis Investigative Site
city: Hamburg
country: Germany
facility: Novartis Investigative Site
city: Hamburg
country: Germany
facility: Novartis Investigative Site
city: Hameln
country: Germany
facility: Novartis Investigative Site
city: Hamm
country: Germany
facility: Novartis Investigative Site
city: Hamm
country: Germany
facility: Novartis Investigative Site
city: Hannover
country: Germany
facility: Novartis Investigative Site
city: Hannover
country: Germany
facility: Novartis Investigative Site
city: Heidelberg
country: Germany
facility: Novartis Investigative Site
city: Heilbronn
country: Germany
facility: Novartis Investigative Site
city: Hildesheim
country: Germany
facility: Novartis Investigative Site
city: Hildesheim
country: Germany
facility: Novartis Investigative Site
city: Hof
country: Germany
facility: Novartis Investigative Site
city: Idar-Oberstein
country: Germany
facility: Novartis Investigative Site
city: Kaiserslautern
country: Germany
facility: Novartis Investigative Site
city: Koblenz
country: Germany
facility: Novartis Investigative Site
city: Koeln
country: Germany
facility: Novartis Investigative Site
city: Koeln
country: Germany
facility: Novartis Investigative Site
city: Kronach
country: Germany
facility: Novartis Investigative Site
city: Leipzig
country: Germany
facility: Novartis Investigative Site
city: Lemgo
country: Germany
facility: Novartis Investigative Site
city: Loerrach
country: Germany
facility: Novartis Investigative Site
city: Luedenscheid
country: Germany
facility: Novartis Investigative Site
city: Lutherstadt Wittenberg
country: Germany
facility: Novartis Investigative Site
city: Magdeburg
country: Germany
facility: Novartis Investigative Site
city: Marburg
country: Germany
facility: Novartis Investigative Site
city: Mayen
country: Germany
facility: Novartis Investigative Site
city: Memmingen
country: Germany
facility: Novartis Investigative Site
city: Minden
country: Germany
facility: Novartis Investigative Site
city: Moers
country: Germany
facility: Novartis Investigative Site
city: Muelheim
country: Germany
facility: Novartis Investigative Site
city: Muenster
country: Germany
facility: Novartis Investigative Site
city: Naunhof
country: Germany
facility: Novartis Investigative Site
city: Nordhorn
country: Germany
facility: Novartis Investigative Site
city: Nuernberg
country: Germany
facility: Novartis Investigative Site
city: Nuernberg
country: Germany
facility: Novartis Investigative Site
city: Nuernberg
country: Germany
facility: Novartis Investigative Site
city: Offenburg
country: Germany
facility: Novartis Investigative Site
city: Oldenburg
country: Germany
facility: Novartis Investigative Site
city: Passau
country: Germany
facility: Novartis Investigative Site
city: Porta Westfalica
country: Germany
facility: Novartis Investigative Site
city: Potsdam
country: Germany
facility: Novartis Investigative Site
city: Rostock
country: Germany
facility: Novartis Investigative Site
city: Rostock
country: Germany
facility: Novartis Investigative Site
city: Ruesselsheim
country: Germany
facility: Novartis Investigative Site
city: Schorndorf
country: Germany
facility: Novartis Investigative Site
city: Schöneck
country: Germany
facility: Novartis Investigative Site
city: Stolberg
country: Germany
facility: Novartis Investigative Site
city: Stuttgart
country: Germany
facility: Novartis Investigative Site
city: Stuttgart
country: Germany
facility: Novartis Investigative Site
city: Westerstede
country: Germany
facility: Novartis Investigative Site
city: Wiesbaden
country: Germany
facility: Novartis Investigative Site
city: Wolfsburg
country: Germany
facility: Novartis Investigative Site
city: Wuerselen
country: Germany
facility: Novartis Investigative Site
city: Wuerzburg
country: Germany
facility: Novartis Investigative Site
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References: