A Prospective, Two-arm, Non-interventional Study of JAKAVI® (Ruxolitinib) in Patients With Myelofibrosis

Last updated: September 15, 2023
Sponsor: Novartis Pharmaceuticals
Overall Status: Completed

Phase

N/A

Condition

Myelofibrosis

Leukemia (Pediatric)

Platelet Disorders

Treatment

Jakavi

Clinical Study ID

NCT05044026
CINC424ADE05
  • Ages 18-120
  • All Genders

Study Summary

This was a prospective, two-arm, non-interventional study of JAKAVI® (Ruxolitinib) in patients with myelofibrosis

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Male and female patients with Primary Myelofibrosis (PMF), post-PolycythemiaVera-Myelofibrosis (PPV-MF), or post-Essential Thrombocythemia-Myelofibrosis (post-ET-MF), for whom Jakavi® therapy is indicated.
  • Patients that were informed about all aspects of this NIS and provided writteninformed consent.

Exclusion

Exclusion Criteria:

Study Design

Total Participants: 1012
Treatment Group(s): 1
Primary Treatment: Jakavi
Phase:
Study Start date:
September 20, 2012
Estimated Completion Date:
September 19, 2022

Study Description

The purpose of this NIS was to gather data from the daily clinical practice of the Jakavi®-treatment in a broad patient population. In order to evaluate the direct effect of Jakavi®, only JAK inhibitor naive patients were documented in the first study arm; patients pretreated with JAK inhibitors were documented in the second study arm to evaluate the long-term efficacy of Jakavi® in this subpopulation.

The documentation of all patients was carried out prospectively and began after the baseline visit. The medical decision on which therapeutic and diagnostic measures to take was made solely by the responsible physician. The observational period per patient was 36 months. The visit schedule after the baseline visit was set by the responsible physician according to standard clinical care, the clinical condition of the respective patients and the SmPC.

Connect with a study center

  • Novartis Investigative Site

    Aachen, 52074
    Germany

    Site Not Available

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