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RecruitingNCT05665192Updated Dec 27, 2022

A Study to Assess Real-World Patient-Reported Outcomes With Fedratinib for Myelofibrosis Post-Ruxolitinib

An observational study in Myelofibrosis, sponsored by Bristol-Myers Squibb. Recruiting at 1 site in Austria. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-12-27.

Sponsored by Bristol-Myers Squibb · Observational

From the registry’s dates

  • Primary completion was expected by Jun 2024, 2 years 3 months ago, but the record still lists the study as recruiting.
  • Started Aug 2021; still recruiting 5 years 2 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
50
Ages
18 Years and older
Sex
All
01

Study summary

The purpose of this study is to determine real-world patient-reported outcomes with fedratinib (FEDR) therapy for myelofibrosis (MF) in the real-world (RW) setting.

02

Conditions studied

  • Myelofibrosis

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Keywords

  • Primary Myelofibrosis
  • Thrombocythemia Myelofibrosis
  • Fedratinib
  • Ruxolitinib
03

In context

Primary Myelofibrosis

419 studies on the registry are indexed under Primary Myelofibrosis; 117 are open to participants now.

This study's planned enrollment of 50 is below the median of 137 across 53 observational studies indexed under Primary Myelofibrosis.

Browse Primary Myelofibrosis studies →

Lead sponsor

Bristol-Myers Squibb is the lead sponsor of 1,538 studies on the registry; 116 are open to participants now.

Of its 429 completed or terminated interventional studies of FDA-regulated products, 223 (52%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

The study population will consist of participants who have discontinued RUX and will be initiating FEDR prospectively.

Inclusion criteria

  • Diagnosed with Primary myelofibrosis (PMF), post- Essential thrombocythemia (ET) Myelofibrosis (MF), or post- Polycythemia vera (PV) MF
  • Treated with FEDR and initiated treatment after 16 August 2019.
  • Received prior treatment with RUX.
  • Had spleen assessed at time of initiation of FEDR by palpation.
  • Able to read and speak English
  • Willing to provide informed consent
  • Willing to provide permission to the site to release her/his medical information to the study investigators according to the study-specific eCRF
  • Willing to complete the baseline survey prior to first FEDR

Exclusion criteria

Exclusion Criteria:

  • Past or current participant in any FEDR-related clinical trial
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
50 participants (estimated)
Patient registry
No

Groups and cohorts

  • Cohort 1

    Participants that have discontinued RUX therapy and initiated FEDR prospectively

06

What researchers measure

Primary outcomes

  1. Percentage change in Total Symptom Score (TSS) assessed by Myelofibrosis Symptom Assessment Form (MFSAF)

    Time frame: At Baseline, 3 and 6 months post-FEDR initiation

  2. Absolute change in TSS assessed by MFSAF

    Time frame: At Baseline, 3 and 6 months post-FEDR initiation

  3. Proportion of participants reporting individual symptoms in TSS assessed by MFSAF

    Time frame: At Baseline, 3 and 6 months post-FEDR initiation

  4. Severity of each reported symptom in TSS assessed by MFSAF

    Time frame: At Baseline, 3 and 6 months post-FEDR initiation

  5. Frequency of report of domain assessed by Patients' Global Impression of Change (PGIC)

    Time frame: At Baseline, 3 and 6 months post-FEDR initiation

  6. Absolute reduction assessed by Patient-Reported Outcomes Measurement Information System Global-10 (PROMIS-10)

    Time frame: At Baseline, 3 and 6 months post-FEDR initiation

07

Study locations

1 of 1 sites recruiting
  • Local Institution
    City, State 00000, Austria
    Recruiting
08

References and documents

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 27, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05665192
Lead sponsor
Bristol-Myers Squibb
Responsible party
Sponsor
First posted
Dec 27, 2022
Start date
Aug 2, 2021
Primary completion
Jun 30, 2024 (estimated)
Completion
Dec 31, 2025 (estimated)
Last update
Dec 27, 2022

Study contacts

BMS Study Connect Contact Center www.BMSStudyConnect.com
Contact
Clinical.Trials@bms.com
855-907-3286
First line of the email MUST contain the NCT# and Site #.
Contact
Bristol-Myers Squibb
study director · Bristol-Myers Squibb
View the source record on ClinicalTrials.gov ↗

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