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

Sponsor
Novartis Pharmaceuticals (Industry)
Overall Status
Active, not recruiting
CT.gov ID
NCT05853445
Collaborator
(none)
461
Enrollment
99
Locations
94.4
Anticipated Duration (Months)
4.7
Patients Per Site
0
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Jakavi

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.

Study Design

Study Type:
Observational
Actual Enrollment :
461 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
A Prospective, Non-interventional Study of JAKAVI® (Ruxolitinib) Treatment in Patients With Polycythemia Vera (PAVE)
Actual Study Start Date :
Aug 17, 2015
Anticipated Primary Completion Date :
Jun 30, 2023
Anticipated Study Completion Date :
Jun 30, 2023

Arms and Interventions

Arm Intervention/Treatment
JAK inhibitor naive

JAK inhibitor naive patients

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

    		•
    JAK inhibitor pre-treated

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

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Change in spleen size (or volume) [Up to 36 months]

      Measured by palpation/sonography/CT/MRI

    2. Eastern Cooperative Oncology Group (ECOG) performance status [Up to 36 months]

      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)

    3. Change in constitutional symptoms [Up to 36 months]

      Number of patients with change in constitutional symptoms

    4. Quality of Life (QoL) - MPN-SAF TSS; MPN-10 [Up to 36 months]

      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.

    5. Quality of Life (QoL) - (SF-36) [Up to 36 months]

      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.

    6. Overall survival [Up to 36 months]

      Overall survival for JAK inhibitor naive and pretreated patients

    7. Dosing [Up to 36 months]

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

    8. Treatment interruptions [Up to 36 months]

      Number of patients with treatment interruptions

    9. Hematology [Up to 36 months]

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

    10. Thromboembolic events [Up to 36 months]

      Number of patients with thromboembolic events.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 120 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Novartis Investigative Site Reutlingen Baden Wuerttemberg Germany 72764
    2 Novartis Investigative Site Winnenden Baden Wuerttemberg Germany 71364
    3 Novartis Investigative Site Heidenheim Baden-Wuerttemberg Germany 89518
    4 Novartis Investigative Site Mannheim Baden-Wuerttemberg Germany 68305
    5 Novartis Investigative Site Augsburg Bavaria Germany 86152
    6 Novartis Investigative Site Herrsching Bavaria Germany 82211
    7 Novartis Investigative Site Muenchen Bavaria Germany 80639
    8 Novartis Investigative Site Aschaffenburg Bayern Germany 63739
    9 Novartis Investigative Site Donauwoerth Bayern Germany 86609
    10 Novartis Investigative Site Erlangen Bayern Germany 91052
    11 Novartis Investigative Site Muenchen Bayern Germany 81241
    12 Novartis Investigative Site Frankfurt Brandenburg Germany 15236
    13 Novartis Investigative Site Landshut Bvaria Germany 84036
    14 Novartis Investigative Site Goettingen Lower Saxony Germany 37073
    15 Novartis Investigative Site Twistringen Lower Saxony Germany 27239
    16 Novartis Investigative Site Brake Niedersachsen Germany 26919
    17 Novartis Investigative Site Duisburg North Rhine-Westphalia Germany 47166
    18 Novartis Investigative Site Bad Salzuflen Northrhine Westfalia Germany 32105
    19 Novartis Investigative Site Iserlohn Northrhine Westfalia Germany 58644
    20 Novartis Investigative Site Dresden Sachsen Germany 01127
    21 Novartis Investigative Site Pirna Sachsen Germany 01796
    22 Novartis Investigative Site Bautzen Saxony Germany 02625
    23 Novartis Investigative Site Luebeck Schleswig-Holstein Germany 23563
    24 Novartis Investigative Site Erfurt Thueringen Germany 99084
    25 Novartis Investigative Site Altoetting Germany 84503
    26 Novartis Investigative Site Augsburg Germany 86150
    27 Novartis Investigative Site Bad Homburg vor der Höhe Germany 61348
    28 Novartis Investigative Site Bad Soden Germany 65812
    29 Novartis Investigative Site Berlin Germany 12351
    30 Novartis Investigative Site Berlin Germany 13357
    31 Novartis Investigative Site Bielefeld Germany 33604
    32 Novartis Investigative Site Bottrop Germany 46236
    33 Novartis Investigative Site Chemnitz Germany 09113
    34 Novartis Investigative Site Dortmund Germany 44263
    35 Novartis Investigative Site Dresden Germany 01307
    36 Novartis Investigative Site Dueren Germany 52353
    37 Novartis Investigative Site Duisburg Germany 47166
    38 Novartis Investigative Site Erfurt Germany 99085
    39 Novartis Investigative Site Essen Germany 45136
    40 Novartis Investigative Site Essen Germany 45147
    41 Novartis Investigative Site Fuerth Germany 90766
    42 Novartis Investigative Site Gera Germany 07548
    43 Novartis Investigative Site Goslar Germany 38642
    44 Novartis Investigative Site Halberstadt Germany 38820
    45 Novartis Investigative Site Halle Germany 06110
    46 Novartis Investigative Site Hamburg Germany 20259
    47 Novartis Investigative Site Hamburg Germany 22081
    48 Novartis Investigative Site Hameln Germany 31785
    49 Novartis Investigative Site Hamm Germany 59063
    50 Novartis Investigative Site Hamm Germany 59065
    51 Novartis Investigative Site Hannover Germany 30161
    52 Novartis Investigative Site Hannover Germany 30170
    53 Novartis Investigative Site Heidelberg Germany 69115
    54 Novartis Investigative Site Heilbronn Germany 74072
    55 Novartis Investigative Site Hildesheim Germany 31134
    56 Novartis Investigative Site Hildesheim Germany 31135
    57 Novartis Investigative Site Hof Germany 95028
    58 Novartis Investigative Site Idar-Oberstein Germany 55743
    59 Novartis Investigative Site Kaiserslautern Germany 67655
    60 Novartis Investigative Site Koblenz Germany 56068
    61 Novartis Investigative Site Koeln Germany 50671
    62 Novartis Investigative Site Koeln Germany 51103
    63 Novartis Investigative Site Kronach Germany 96317
    64 Novartis Investigative Site Leipzig Germany 04289
    65 Novartis Investigative Site Lemgo Germany 32657
    66 Novartis Investigative Site Loerrach Germany 79539
    67 Novartis Investigative Site Luedenscheid Germany 58507
    68 Novartis Investigative Site Lutherstadt Wittenberg Germany 06886
    69 Novartis Investigative Site Magdeburg Germany 39104
    70 Novartis Investigative Site Marburg Germany 35037
    71 Novartis Investigative Site Mayen Germany 56727
    72 Novartis Investigative Site Memmingen Germany 87700
    73 Novartis Investigative Site Minden Germany 32429
    74 Novartis Investigative Site Moers Germany 47441
    75 Novartis Investigative Site Muelheim Germany 45468
    76 Novartis Investigative Site Muenster Germany 48149
    77 Novartis Investigative Site Naunhof Germany 04683
    78 Novartis Investigative Site Nordhorn Germany 48527
    79 Novartis Investigative Site Nuernberg Germany 90403
    80 Novartis Investigative Site Nuernberg Germany 90419
    81 Novartis Investigative Site Nuernberg Germany 90449
    82 Novartis Investigative Site Offenburg Germany 77654
    83 Novartis Investigative Site Oldenburg Germany 26121
    84 Novartis Investigative Site Passau Germany 94036
    85 Novartis Investigative Site Porta Westfalica Germany 32457
    86 Novartis Investigative Site Potsdam Germany 14467
    87 Novartis Investigative Site Rostock Germany 18057
    88 Novartis Investigative Site Rostock Germany 18059
    89 Novartis Investigative Site Ruesselsheim Germany 65428
    90 Novartis Investigative Site Schorndorf Germany 73614
    91 Novartis Investigative Site Schöneck Germany 08621
    92 Novartis Investigative Site Stolberg Germany 52222
    93 Novartis Investigative Site Stuttgart Germany 70174
    94 Novartis Investigative Site Stuttgart Germany 70178
    95 Novartis Investigative Site Westerstede Germany 26655
    96 Novartis Investigative Site Wiesbaden Germany 65189
    97 Novartis Investigative Site Wolfsburg Germany 38440
    98 Novartis Investigative Site Wuerselen Germany 52146
    99 Novartis Investigative Site Wuerzburg Germany 97080

    Sponsors and Collaborators

    • Novartis Pharmaceuticals

    Investigators

    • Study Director: Novartis Pharmaceuticals, Novartis Pharmaceuticals

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Novartis Pharmaceuticals
    ClinicalTrials.gov Identifier:
    NCT05853445
    Other Study ID Numbers:
    • CINC424BDE12
    First Posted:
    May 10, 2023
    Last Update Posted:
    May 17, 2023
    Last Verified:
    May 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Keywords provided by Novartis Pharmaceuticals
    ruxolitinib
    polycythemia vera
    PV
    jakavi
    Additional relevant MeSH terms:
    Polycythemia Vera
    Polycythemia

    Study Results

    No Results Posted as of May 17, 2023