Last updated: 05/13/2026 09:30:13
A study to evaluate participant characteristics & outcomes among participants with myelofibrosis treated with momelotinib
GSK study ID
306954
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Planned
Planned
Trial overview
Official title: Evaluation of Real-World Utilization and Outcomes of Momelotinib Among Myelofibrosis Patients Treated at US Community Oncology Centers
Trial description: The aim of this study is to characterize demographic and clinical characteristics, treatment patterns, and outcomes among participants with myelofibrosis (MF) treated with momelotinib and ruxolitinib in United States community oncology practices. The Index date is defined as initiation of treatment with momelotinib or ruxolitinib between 15 September 2023 (Food and Drug Administration [FDA] approval of momelotinib) and 30 April 2025
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
Proportion of participants with Anemia response
Timeframe: Up to 3 months post-index date
Secondary outcomes:
Number of participants with demographic and clinical characteristics
Timeframe: At Baseline (Up to 12 months prior to and including the index date)
Number of participants categorized by treatment patterns
Timeframe: Up to 22.5 months
Number of participants categorized by clinical outcomes
Timeframe: Up to 22.5 months
Interventions:
Not applicable
Enrollment:
Not applicable
Observational study model:
Cohort
Primary completion date:
2027-30-06
Time perspective:
Retrospective
Clinical publications:
Not applicable
Medical condition
Primary Myelofibrosis
Product
Not applicable
Collaborators
Not applicable
Study date(s)
June 2026 to June 2027
Type
Observational
Phase
Not applicable
Participation criteria
Sex
Female & Male
Age
18+ years
Accepts healthy volunteers
No
- Participants with a documented MF diagnosis on or after 01 January 2011.
- Participants with initiation of treatment with momelotinib or ruxolitinib between 15 September 2023 and 30 April 2025, on or after the first documented MF diagnosis (index date).
- Not applicable
Inclusion and exclusion criteria
Inclusion criteria:
- Participants with a documented MF diagnosis on or after 01 January 2011.
- Participants with initiation of treatment with momelotinib or ruxolitinib between 15 September 2023 and 30 April 2025, on or after the first documented MF diagnosis (index date).
- Participants with at least 18 years of age at the index date.
- Participants with at least one documented clinical encounter during the Baseline period.
- Participants with Janus Kinase inhibitor (JAKi)-naive at index, defined as no prior record of treatment with any JAKi (momelotinib, ruxolitinib, fedratinib, pacritinib) during the period from 16 November 2011 to the index date.
- Participants with moderate or severe anemia, defined as hemoglobin less than (<)10 grams per deciliter (g/dL) based on the value closest to the index date during the Baseline period.
- Participants with JAKi-experienced at index, defined as a prior record of treatment with ruxolitinib, fedratinib, or pacritinib during the period from 16 November 2011 to the index date.
- Participants with no anemia requirement
Exclusion criteria:
- Not applicable
Trial location(s)
No location data available.
Study documents
No study documents available.
Results overview
No study documents available
Recruitment status
Planned
Actual primary completion date
Not applicable
Actual study completion date
Not applicable
Plain language summaries
Not applicable. GSK’s transparency policy provides for Plain Language Summaries for Interventional studies.
Additional information about the trial
Not applicable
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