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Polycythemia VeraPAVENCT05853445

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

An observational study of Polycythemia Vera, run by Novartis Pharmaceuticals at 99 sites in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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… Read more about this study

Who is it for?
Ages 18 to 120 years
Conditions the study is for
Polycythemia Vera
What is being tested?
Jakavi
How many people
467 participants
Where
99 sitesGermany
Study dates
17 Aug 2015to 3 May 2023
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 120 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Adult male and female patients with PV for whom Jakavi® therapy is indicated.

Who may be able to join

  • 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

Who cannot join

None listed.

Trial locations and contacts

99 sites in 1 country.

99 sites in 1 country

Germany99 sites

  • Novartis Investigative Site

    Altötting, 84503

  • Novartis Investigative Site

    Aschaffenburg, Bavaria, 63739

  • Novartis Investigative Site

    Augsburg, Bavaria, 86152

  • Novartis Investigative Site

    Augsburg, 86150

  • Novartis Investigative Site

    Bad Homburg, 61348

  • Novartis Investigative Site

    Bad Salzuflen, Northrhine Westfalia, 32105

  • Novartis Investigative Site

    Bad Soden, 65812

  • Novartis Investigative Site

    Bautzen, Saxony, 02625

  • Novartis Investigative Site

    Berlin, 12351

  • Novartis Investigative Site

    Berlin, 13357

  • Novartis Investigative Site

    Bielefeld, 33604

  • Novartis Investigative Site

    Bottrop, 46236

  • Novartis Investigative Site

    Brake, Lower Saxony, 26919

  • Novartis Investigative Site

    Chemnitz, 09113

  • Novartis Investigative Site

    Cologne, 50671

  • Novartis Investigative Site

    Cologne, 51103

  • Novartis Investigative Site

    Donauwörth, Bavaria, 86609

  • Novartis Investigative Site

    Dortmund, 44263

  • Novartis Investigative Site

    Dresden, Saxony, 01127

  • Novartis Investigative Site

    Dresden, 01307

  • Novartis Investigative Site

    Duisburg, North Rhine-Westphalia, 47166

  • Novartis Investigative Site

    Duisburg, 47166

  • Novartis Investigative Site

    Düren, 52353

  • Novartis Investigative Site

    Erfurt, Thuringia, 99084

  • Novartis Investigative Site

    Erfurt, 99085

  • Novartis Investigative Site

    Erlangen, Bavaria, 91052

  • Novartis Investigative Site

    Essen, 45136

  • Novartis Investigative Site

    Essen, 45147

  • Novartis Investigative Site

    Frankfurt (Oder), Brandenburg, 15236

  • Novartis Investigative Site

    Fürth, 90766

  • Novartis Investigative Site

    Gera, 07548

  • Novartis Investigative Site

    Goslar, 38642

  • Novartis Investigative Site

    Göttingen, Lower Saxony, 37073

  • Novartis Investigative Site

    Halberstadt, 38820

  • Novartis Investigative Site

    Halle, 06110

  • Novartis Investigative Site

    Hamburg, 20259

  • Novartis Investigative Site

    Hamburg, 22081

  • Novartis Investigative Site

    Hamelin, 31785

  • Novartis Investigative Site

    Hamm, 59063

  • Novartis Investigative Site

    Hamm, 59065

  • Novartis Investigative Site

    Hanover, 30161

  • Novartis Investigative Site

    Hanover, 30170

  • Novartis Investigative Site

    Heidelberg, 69115

  • Novartis Investigative Site

    Heidenheim, Baden-Wurttemberg, 89518

  • Novartis Investigative Site

    Heilbronn, 74072

  • Novartis Investigative Site

    Herrsching am Ammersee, Bavaria, 82211

  • Novartis Investigative Site

    Hildesheim, 31134

  • Novartis Investigative Site

    Hildesheim, 31135

  • Novartis Investigative Site

    Hof, 95028

  • Novartis Investigative Site

    Idar-Oberstein, 55743

  • Novartis Investigative Site

    Iserlohn, Northrhine Westfalia, 58644

  • Novartis Investigative Site

    Kaiserslautern, 67655

  • Novartis Investigative Site

    Koblenz, 56068

  • Novartis Investigative Site

    Kronach, 96317

  • Novartis Investigative Site

    Landshut, Bvaria, 84036

  • Novartis Investigative Site

    Leipzig, 04289

  • Novartis Investigative Site

    Lemgo, 32657

  • Novartis Investigative Site

    Loerrach, 79539

  • Novartis Investigative Site

    Lübeck, Schleswig-Holstein, 23563

  • Novartis Investigative Site

    Lüdenscheid, 58507

  • Novartis Investigative Site

    Magdeburg, 39104

  • Novartis Investigative Site

    Mannheim, Baden-Wurttemberg, 68305

  • Novartis Investigative Site

    Marburg, 35037

  • Novartis Investigative Site

    Mayen, 56727

  • Novartis Investigative Site

    Memmingen, 87700

  • Novartis Investigative Site

    Minden, 32429

  • Novartis Investigative Site

    Moers, 47441

  • Novartis Investigative Site

    Mülheim, 45468

  • Novartis Investigative Site

    Munich, Bavaria, 80639

  • Novartis Investigative Site

    Munich, Bavaria, 81241

  • Novartis Investigative Site

    Münster, 48149

  • Novartis Investigative Site

    Naunhof, 04683

  • Novartis Investigative Site

    Nordhorn, 48527

  • Novartis Investigative Site

    Nuremberg, 90403

  • Novartis Investigative Site

    Nuremberg, 90419

  • Novartis Investigative Site

    Nuremberg, 90449

  • Novartis Investigative Site

    Offenburg, 77654

  • Novartis Investigative Site

    Oldenburg, 26121

  • Novartis Investigative Site

    Passau, 94036

  • Novartis Investigative Site

    Pirna, Saxony, 01796

  • Novartis Investigative Site

    Porta Westfalica, 32457

  • Novartis Investigative Site

    Potsdam, 14467

  • Novartis Investigative Site

    Reutlingen, Baden-Wurttemberg, 72764

  • Novartis Investigative Site

    Rostock, 18057

  • Novartis Investigative Site

    Rostock, 18059

  • Novartis Investigative Site

    Rüsselsheim am Main, 65428

  • Novartis Investigative Site

    Schöneck, 08621

  • Novartis Investigative Site

    Schorndorf, 73614

  • Novartis Investigative Site

    Stolberg, 52222

  • Novartis Investigative Site

    Stuttgart, 70174

  • Novartis Investigative Site

    Stuttgart, 70178

  • Novartis Investigative Site

    Twistringen, Lower Saxony, 27239

  • Novartis Investigative Site

    Westerstede, 26655

  • Novartis Investigative Site

    Wiesbaden, 65189

  • Novartis Investigative Site

    Winnenden, Baden-Wurttemberg, 71364

  • Novartis Investigative Site

    Wittenberg, 06886

  • Novartis Investigative Site

    Wolfsburg, 38440

  • Novartis Investigative Site

    Würselen, 52146

  • Novartis Investigative Site

    Würzburg, 97080

Other trials in Germany

About this study

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

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.

Read the 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.

Being tested
Jakavi
Keywords
ruxolitinib, polycythemia vera, PV, jakavi
Medical subject headings
Polycythemia Vera

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • JakaviOther

    Also called Ruxolitinib

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

Study groups in NCT05853445
Study groupRoleWhat they receive
JAK inhibitor naiveJAK inhibitor naive patients
Receives: Other: Jakavi
JAK inhibitor pre-treatedJAK inhibitor pre-treated patients (Jakavi® or any other JAK inhibitor for ≥3 months)
Receives: Other: Jakavi

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Dosing

    Number of patients by initial dosing and number of patients with dose modifications will be provided

    Measured: Up to 36 months

  2. Treatment interruptions

    Number of patients with treatment interruptions

    Measured: Up to 36 months

  3. Overall survival

    Overall survival for JAK inhibitor naive and pretreated patients

    Measured: Up to 36 months

  4. Hematology

    Number of patients with changes in different blood count values over time (hematocrit, erythrocytes, thrombocytes, leukocytes)

    Measured: Up to 36 months

  5. Number of phlebotomies

    Total number of phlebotomies

    Measured: Up to 36 months

  6. Change in spleen size (or volume)

    Measured by palpation/sonography/CT/MRI

    Measured: Up to 36 months

  7. 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.

    Measured: Up to 36 months

  8. Thromboembolic events

    Number of patients with thromboembolic events.

    Measured: Up to 36 months

Secondary outcomes (5)

  1. 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)

    Measured: Up to 36 months

  2. Change in constitutional symptoms

    Number of patients with change in constitutional symptoms

    Measured: Up to 36 months

  3. 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.

    Measured: Up to 36 months

  4. Bone marrow aspiration and biopsy

    Number of Biopsies per visit

    Measured: Up to 36 months

  5. Molecular examination

    Number of performed assessments of JAK2V617F mutation per visist

    Measured: Up to 36 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 May 2023
  2. Study start17 Aug 2015
  3. Primary completion3 May 2023
  4. Study completion3 May 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
467 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05853445
Sponsor's protocol ID
CINC424BDE12
Acronym
PAVE
Status last verified
May 2024
First submitted
2 May 2023
Last updated
6 May 2024
Results posted
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Polycythemia Vera, run by Novartis Pharmaceuticals at 99 sites in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 May 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 99 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Dosing (time frame: Up to 36 months). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05853445.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2024.

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