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

NCT ID: NCT05853445

Last Updated: 2024-05-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

467 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-08-17

Study Completion Date

2023-05-03

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.

Conditions

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Polycythemia Vera

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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JAK inhibitor naive

JAK inhibitor naive patients

Jakavi

Intervention Type OTHER

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

JAK inhibitor pre-treated

JAK inhibitor pre-treated patients (Jakavi® or any other JAK inhibitor for ≥3 months)

Jakavi

Intervention Type OTHER

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

Interventions

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Jakavi

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

Intervention Type OTHER

Other Intervention Names

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Ruxolitinib

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

120 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novartis Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Novartis Pharmaceuticals

Locations

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Novartis Investigative Site

Heidenheim, Baden-Wurttemberg, Germany

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Mannheim, Baden-Wurttemberg, Germany

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Reutlingen, Baden-Wurttemberg, Germany

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Winnenden, Baden-Wurttemberg, Germany

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Aschaffenburg, Bavaria, Germany

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Augsburg, Bavaria, Germany

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Donauwörth, Bavaria, Germany

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Erlangen, Bavaria, Germany

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Herrsching am Ammersee, Bavaria, Germany

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Munich, Bavaria, Germany

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Munich, Bavaria, Germany

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Frankfurt (Oder), Brandenburg, Germany

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Landshut, Bvaria, Germany

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Brake, Lower Saxony, Germany

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Göttingen, Lower Saxony, Germany

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Twistringen, Lower Saxony, Germany

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Duisburg, North Rhine-Westphalia, Germany

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Bad Salzuflen, Northrhine Westfalia, Germany

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Iserlohn, Northrhine Westfalia, Germany

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Bautzen, Saxony, Germany

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Dresden, Saxony, Germany

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Pirna, Saxony, Germany

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Lübeck, Schleswig-Holstein, Germany

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Erfurt, Thuringia, Germany

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Altötting, , Germany

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Augsburg, , Germany

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Bad Homburg, , Germany

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Bad Soden, , Germany

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Berlin, , Germany

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Berlin, , Germany

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Bielefeld, , Germany

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Bottrop, , Germany

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Chemnitz, , Germany

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Cologne, , Germany

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Cologne, , Germany

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Dortmund, , Germany

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Dresden, , Germany

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Duisburg, , Germany

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Düren, , Germany

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Erfurt, , Germany

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Essen, , Germany

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Essen, , Germany

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Fürth, , Germany

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Gera, , Germany

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Goslar, , Germany

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Halberstadt, , Germany

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Halle, , Germany

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Hamburg, , Germany

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Hamburg, , Germany

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Hamelin, , Germany

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Hamm, , Germany

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Hamm, , Germany

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Hanover, , Germany

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Hanover, , Germany

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Heidelberg, , Germany

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Heilbronn, , Germany

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Hildesheim, , Germany

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Hildesheim, , Germany

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Hof, , Germany

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Idar-Oberstein, , Germany

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Kaiserslautern, , Germany

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Koblenz, , Germany

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Kronach, , Germany

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Leipzig, , Germany

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Lemgo, , Germany

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Loerrach, , Germany

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Lüdenscheid, , Germany

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Magdeburg, , Germany

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Marburg, , Germany

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Mayen, , Germany

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Memmingen, , Germany

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Minden, , Germany

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Moers, , Germany

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Mülheim, , Germany

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Münster, , Germany

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Naunhof, , Germany

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Nordhorn, , Germany

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Nuremberg, , Germany

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Nuremberg, , Germany

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Nuremberg, , Germany

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Offenburg, , Germany

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Oldenburg, , Germany

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Passau, , Germany

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Porta Westfalica, , Germany

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Potsdam, , Germany

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Rostock, , Germany

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Rostock, , Germany

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Rüsselsheim am Main, , Germany

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Schorndorf, , Germany

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Schöneck, , Germany

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Stolberg, , Germany

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Stuttgart, , Germany

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Stuttgart, , Germany

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Westerstede, , Germany

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Wiesbaden, , Germany

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Wittenberg, , Germany

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Wolfsburg, , Germany

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Würselen, , Germany

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Würzburg, , Germany

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Countries

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Germany

Related Links

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https://www.novctrd.com/ctrdweb/trialresult/trialresults/pdf?trialResultId=18164

Results for CINC424BDE12 that is getting linked from the Novartis Clinical Trials Website

Other Identifiers

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CINC424BDE12

Identifier Type: -

Identifier Source: org_study_id

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