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Completed

NCT Number: NCT05044026

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

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

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Key information

Conditions

Primary Myelofibrosis Bone Marrow Diseases Hematologic Diseases Hemic and Lymphatic Diseases Myeloproliferative Disorders Post-essential Thrombocythemia Myelofibrosis Post-polycythemia Vera Myelofibrosis

Age range

18 year–120 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Novartis Investigative Site

Aachen, 52074, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

-

Treatment and study plan

Jakavi

Other

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

Other names: Ruxolitinib

Primary outcomes

  1. Safety and tolerability

    Time frame: Up to 36 months

    Evaluation of all occurring adverse events, serious adverse events and serious and non-serious adverse drug reactions

  2. Spleen size (or volume) reduction

    Time frame: Up to 36 months

    Spleen size (or volume) reduction was measured by palpation

  3. Eastern Cooperative Oncology Group (ECOG) performance status

    Time frame: 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).

  4. Change in the number of patients with constitutional symptoms

    Time frame: Up to 36 months

    Number of patients with change in constitutional symptoms was collected

  5. Assessment of the Quality of Life (QoL) - Myeloproliferative Neoplasm - Symptom Assessment Form (MPN-SAF)

    Time frame: Baseline, month 1, month 3, month 6, month 12, month 24 and month 36

    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.

  6. Assessment of the Quality of Life (QoL) - Short Form-36 (SF-36)

    Time frame: Baseline month 6, month 12, month 24 and month 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.

  7. Overall survival

    Time frame: Up to 36 months

    Overall survival for JAK inhibitor naive and pretreated patients

  8. Ruxolitinib start and end dose

    Time frame: Up to 36 months

    Ruxolitinib start and end dose was collected

  9. Therapy discontinuation and dose adjustments

    Time frame: Up to 36 months

    Number of participants with therapy discontinuation and dose adjustments was collected

  10. Number of patients with co-morbidities

    Time frame: Up to 36 months

    Number of patients with co-morbidities was collected

  11. Blood transfusion dependency

    Time frame: Up to 36 months

    Number of patients with blood transfusion dependency was collected

  12. Number of patients with concomitant medications

    Time frame: Up to 36 months

    Number of patients with concomitant medications prescribed for myelofibrosis therapy and for the management of side effects was collected

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Official study title

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

Acronym: JAKoMo

Important dates

Study start
2012
Primary completion
2022
Study completion
2022
First posted
Sep 14, 2021
Registry last updated
Sep 21, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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