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NCT05853445 Clinical Trial

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

Polycythemia Vera Clinical Trial

— PAVE  

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05853445
Other study ID # CINC424BDE12
Secondary ID
Status Completed
Phase
First received
Last updated
Start date August 17, 2015
Est. completion date May 3, 2023

Study information
Verified date May 2024
Source Novartis
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 467
Est. completion date May 3, 2023
Est. primary completion date May 3, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years to 120 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• Jakavi
Prospective observational study. There is no treatment allocation. Patients administered Jakavi by prescription and administered according to the SmPC.

Locations
Country Name City State
Germany Novartis Investigative Site Altoetting
Germany Novartis Investigative Site Aschaffenburg Bayern
Germany Novartis Investigative Site Augsburg Bavaria
Germany Novartis Investigative Site Augsburg
Germany Novartis Investigative Site Bad Homburg vor der Höhe
Germany Novartis Investigative Site Bad Salzuflen Northrhine Westfalia
Germany Novartis Investigative Site Bad Soden
Germany Novartis Investigative Site Bautzen Saxony
Germany Novartis Investigative Site Berlin
Germany Novartis Investigative Site Berlin
Germany Novartis Investigative Site Bielefeld
Germany Novartis Investigative Site Bottrop
Germany Novartis Investigative Site Brake Niedersachsen
Germany Novartis Investigative Site Chemnitz
Germany Novartis Investigative Site Donauwoerth Bayern
Germany Novartis Investigative Site Dortmund
Germany Novartis Investigative Site Dresden
Germany Novartis Investigative Site Dresden Sachsen
Germany Novartis Investigative Site Dueren
Germany Novartis Investigative Site Duisburg
Germany Novartis Investigative Site Duisburg North Rhine-Westphalia
Germany Novartis Investigative Site Erfurt Thueringen
Germany Novartis Investigative Site Erfurt
Germany Novartis Investigative Site Erlangen Bayern
Germany Novartis Investigative Site Essen
Germany Novartis Investigative Site Essen
Germany Novartis Investigative Site Frankfurt Brandenburg
Germany Novartis Investigative Site Fuerth
Germany Novartis Investigative Site Gera
Germany Novartis Investigative Site Goettingen Lower Saxony
Germany Novartis Investigative Site Goslar
Germany Novartis Investigative Site Halberstadt
Germany Novartis Investigative Site Halle
Germany Novartis Investigative Site Hamburg
Germany Novartis Investigative Site Hamburg
Germany Novartis Investigative Site Hameln
Germany Novartis Investigative Site Hamm
Germany Novartis Investigative Site Hamm
Germany Novartis Investigative Site Hannover
Germany Novartis Investigative Site Hannover
Germany Novartis Investigative Site Heidelberg
Germany Novartis Investigative Site Heidenheim Baden-Wuerttemberg
Germany Novartis Investigative Site Heilbronn
Germany Novartis Investigative Site Herrsching Bavaria
Germany Novartis Investigative Site Hildesheim
Germany Novartis Investigative Site Hildesheim
Germany Novartis Investigative Site Hof
Germany Novartis Investigative Site Idar-Oberstein
Germany Novartis Investigative Site Iserlohn Northrhine Westfalia
Germany Novartis Investigative Site Kaiserslautern
Germany Novartis Investigative Site Koblenz
Germany Novartis Investigative Site Koeln
Germany Novartis Investigative Site Koeln
Germany Novartis Investigative Site Kronach
Germany Novartis Investigative Site Landshut Bvaria
Germany Novartis Investigative Site Leipzig
Germany Novartis Investigative Site Lemgo
Germany Novartis Investigative Site Loerrach
Germany Novartis Investigative Site Luebeck Schleswig-Holstein
Germany Novartis Investigative Site Luedenscheid
Germany Novartis Investigative Site Lutherstadt Wittenberg
Germany Novartis Investigative Site Magdeburg
Germany Novartis Investigative Site Mannheim Baden Wuerttemberg
Germany Novartis Investigative Site Marburg
Germany Novartis Investigative Site Mayen
Germany Novartis Investigative Site Memmingen
Germany Novartis Investigative Site Minden
Germany Novartis Investigative Site Moers
Germany Novartis Investigative Site Muelheim
Germany Novartis Investigative Site Muenchen Bavaria
Germany Novartis Investigative Site Muenchen Bayern
Germany Novartis Investigative Site Muenster
Germany Novartis Investigative Site Naunhof
Germany Novartis Investigative Site Nordhorn
Germany Novartis Investigative Site Nuernberg
Germany Novartis Investigative Site Nuernberg
Germany Novartis Investigative Site Nuernberg
Germany Novartis Investigative Site Offenburg
Germany Novartis Investigative Site Oldenburg
Germany Novartis Investigative Site Passau
Germany Novartis Investigative Site Pirna Sachsen
Germany Novartis Investigative Site Porta Westfalica
Germany Novartis Investigative Site Potsdam
Germany Novartis Investigative Site Reutlingen Baden Wuerttemberg
Germany Novartis Investigative Site Rostock
Germany Novartis Investigative Site Rostock
Germany Novartis Investigative Site Ruesselsheim
Germany Novartis Investigative Site Schöneck
Germany Novartis Investigative Site Schorndorf
Germany Novartis Investigative Site Stolberg
Germany Novartis Investigative Site Stuttgart
Germany Novartis Investigative Site Stuttgart
Germany Novartis Investigative Site Twistringen Lower Saxony
Germany Novartis Investigative Site Westerstede
Germany Novartis Investigative Site Wiesbaden
Germany Novartis Investigative Site Winnenden Baden Wuerttemberg
Germany Novartis Investigative Site Wolfsburg
Germany Novartis Investigative Site Wuerselen
Germany Novartis Investigative Site Wuerzburg

Sponsors (1)
Lead Sponsor Collaborator
Novartis Pharmaceuticals

Country where clinical trial is conducted

Germany, 

Outcome
Type Measure Description Time frame Safety issue
Primary Dosing Number of patients by initial dosing and number of patients with dose modifications will be provided Up to 36 months
Primary Treatment interruptions Number of patients with treatment interruptions Up to 36 months
Primary Overall survival Overall survival for JAK inhibitor naive and pretreated patients Up to 36 months
Primary Hematology Number of patients with changes in different blood count values over time (hematocrit, erythrocytes, thrombocytes, leukocytes) Up to 36 months
Primary Number of phlebotomies Total number of phlebotomies Up to 36 months
Primary Change in spleen size (or volume) Measured by palpation/sonography/CT/MRI Up to 36 months
Primary 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
Primary Thromboembolic events Number of patients with thromboembolic events. Up to 36 months
Secondary 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
Secondary Change in constitutional symptoms Number of patients with change in constitutional symptoms Up to 36 months
Secondary 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
Secondary Bone marrow aspiration and biopsy Number of Biopsies per visit Up to 36 months
Secondary Molecular examination Number of performed assessments of JAK2V617F mutation per visist Up to 36 months
See also
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Completed NCT02912884 - Treatment of Polycythaemia Vera and Essential Thrombocythaemia: Influence on the Clot Structure
Recruiting NCT02897297 - Myeloproliferative Neoplastic Diseases Observatory From Brest
Completed NCT01949805 - Pegylated Interferon Alpha-2b Versus Hydroxyurea in Polycythemia Vera Phase 3
Completed NCT00666549 - Research Tissue Bank
Completed NCT00241241 - Efficacy and Safety of Pegylated Interferon Alfa in Polycythemia Vera Phase 2
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Completed NCT01243944 - Study of Efficacy and Safety in Polycythemia Vera Subjects Who Are Resistant to or Intolerant of Hydroxyurea: JAK Inhibitor INC424 (INCB018424) Tablets Versus Best Available Care: (The RESPONSE Trial) Phase 3
Recruiting NCT05481151 - A Study to Assess Efficacy, Safety, and Tolerability of P1101 in Adult Patients With PV Phase 3
Recruiting NCT05031897 - Reduced-Intensity Conditioning for the Prevention of Treatment-Related Mortality in Patients Who Undergo a Hematopoietic Stem Cell Transplant Phase 2
Recruiting NCT04116502 - MITHRIDATE: Ruxolitinib Versus Hydroxycarbamide or Interferon as First Line Therapy in High Risk Polycythemia Vera Phase 3
Completed NCT01901432 - A Two-part Study to Assess the Safety and Preliminary Efficacy of Givinostat in Patients With Polycythemia Vera Phase 1/Phase 2
Recruiting NCT04262141 - IMG-7289 in Patients With Essential Thrombocythemia (ET) or Polycythemia Vera (PV) Phase 2
Not yet recruiting NCT05566535 - Changes in QoL and Symptoms in Patients With Polycythemia Vera Receiving Ruxo in a Routine Clinical Practice
Active, not recruiting NCT04057040 - Hepcidin Mimetic in Patients With Polycythemia Vera (REVIVE) Phase 2
Completed NCT03907436 - The NUTRIENT Trial (NUTRitional Intervention Among myEloproliferative Neoplasms): Feasibility Phase N/A
Completed NCT01981850 - A Phase 2 Study of RO7490677 In Participants With Myelofibrosis Phase 2

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