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

Primary Myelofibrosis Clinical Trial

— JAKoMo  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05044026
• Other study ID #: CINC424ADE05
• Status: Completed
• Start date: September 20, 2012
• Est. completion date: September 19, 2022

Study information

• Verified date: September 2023
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1012
• Est. completion date: September 19, 2022
• Est. primary completion date: September 19, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 120 Years

Eligibility

Inclusion Criteria:

• Male and female patients with Primary Myelofibrosis (PMF), post-Polycythemia Vera-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 written informed consent.

Exclusion Criteria:

-

Related Conditions & MeSH terms

• Polycythemia
• Polycythemia Vera
• Post-essential Thrombocythemia Myelofibrosis
• Post-polycythemia Vera Myelofibrosis
• Primary Myelofibrosis
• Thrombocythemia, Essential
• Thrombocytosis

Intervention

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

Locations

Country	Name	City	State
Germany	Novartis Investigative Site	Aachen

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety and tolerability	Evaluation of all occurring adverse events, serious adverse events and serious and non-serious adverse drug reactions	Up to 36 months
Primary	Spleen size (or volume) reduction	Spleen size (or volume) reduction was measured by palpation	Up to 36 months
Primary	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).	Up to 36 months
Primary	Change in the number of patients with constitutional symptoms	Number of patients with change in constitutional symptoms was collected	Up to 36 months
Primary	Assessment of the Quality of Life (QoL) - Myeloproliferative Neoplasm - Symptom Assessment Form (MPN-SAF)	The MPN-SAF questionnaire contains important questions that cover MF-specific symptoms whose analysis is part of the standard of care. 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.	Baseline, month 1, month 3, month 6, month 12, month 24 and month 36
Primary	Assessment of the Quality of Life (QoL) - Short Form-36 (SF-36)	This 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.	Baseline month 6, month 12, month 24 and month 36
Primary	Overall survival	Overall survival for JAK inhibitor naive and pretreated patients	Up to 36 months
Primary	Ruxolitinib start and end dose	Ruxolitinib start and end dose was collected	Up to 36 months
Primary	Therapy discontinuation and dose adjustments	Number of participants with therapy discontinuation and dose adjustments was collected	Up to 36 months
Primary	Number of patients with co-morbidities	Number of patients with co-morbidities was collected	Up to 36 months
Primary	Blood transfusion dependency	Number of patients with blood transfusion dependency was collected	Up to 36 months
Primary	Number of patients with concomitant medications	Number of patients with concomitant medications prescribed for myelofibrosis therapy and for the management of side effects was collected	Up to 36 months

External Links

•   Results for CINC424ADE05 that is getting linked from the Novartis Clinical Trials Website