A Prospective, Non-interventional Study of JAKAVI® (Ruxolitinib) Treatment in Patients With Polycythemia Vera
- Conditions
- Polycythemia Vera
- Interventions
- Other: Jakavi
- Registration Number
- NCT05853445
- Lead Sponsor
- Novartis Pharmaceuticals
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 467
- 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
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description JAK inhibitor pre-treated Jakavi JAK inhibitor pre-treated patients (Jakavi® or any other JAK inhibitor for ≥3 months) JAK inhibitor naive Jakavi JAK inhibitor naive patients
- Primary Outcome Measures
Name Time Method Hematology Up to 36 months Number of patients with changes in different blood count values over time (hematocrit, erythrocytes, thrombocytes, leukocytes)
Dosing Up to 36 months Number of patients by initial dosing and number of patients with dose modifications will be provided
Change in spleen size (or volume) Up to 36 months Measured by palpation/sonography/CT/MRI
Overall survival Up to 36 months Overall survival for JAK inhibitor naive and pretreated patients
Treatment interruptions Up to 36 months Number of patients with treatment interruptions
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.Number of phlebotomies Up to 36 months Total number of phlebotomies
Thromboembolic events Up to 36 months Number of patients with thromboembolic events.
- Secondary Outcome Measures
Name Time Method Change in constitutional symptoms Up to 36 months Number of patients with change in constitutional symptoms
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)Molecular examination Up to 36 months Number of performed assessments of JAK2V617F mutation per visist
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.
Bone marrow aspiration and biopsy Up to 36 months Number of Biopsies per visit
Trial Locations
- Locations (1)
Novartis Investigative Site
🇩🇪Wuerzburg, Germany