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

Novartis

Status: Completed

Conditions: Polycythemia Vera

Treatments: Other: Jakavi

Study type: Observational

Funder types: Industry

Identifiers

NCT05853445

CINC424BDE12

Details and patient eligibility

About

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.

Full 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.

Enrollment: 467 patients

Sex: All

Ages: 18 to 120 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

467 participants in 2 patient groups

JAK inhibitor naive

Description:

JAK inhibitor naive patients

Treatment:

Other: Jakavi

JAK inhibitor pre-treated

Description:

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

Treatment:

Other: Jakavi