Last updated: 06/04/2026 05:00:17
First‑line Momelotinib (MMB) versus (vs.) ruxolitinib (Rux) in Myelofibrosis with anemia in Loopback data
GSK study ID
308670
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Planned
Planned
Trial overview
Official title: Treatment sequence and anemia benefit of MMB vs. RUX in 1L using Loopback data
Trial description: This study will leverage a clinically rich electronic medical record dataset (a de-identified and partially curated extract from Loopback Analytics, Inc.) to describe treatment patterns, participant characteristics, and clinical outcomes in myelofibrosis, with an emphasis on anemia burden and its management.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
To describe transfusion burden for Janus kinase (JAK) inhibitor naive myelofibrosis participants initiating momelotinib
Timeframe: Up to 6 Months
Among JAK inhibitor naive myelofibrosis participants, to compare change in hemoglobin levels between those initiating momelotinib and those initiating ruxolitinib
Timeframe: Up to 6 Months
Secondary outcomes:
To describe treatment patterns (treatment sequencing, discontinuation, switching, persistence) for JAK inhibitor naive myelofibrosis participants initiating momelotinib
Timeframe: Up to 12 Months
To describe treatment patterns (treatment sequencing, discontinuation, switching, persistence) for JAK inhibitor naive participants initiating ruxolitinib and for JAK inhibitor experienced myelofibrosis participants initiating momelotinib
Timeframe: Up to 12 Months
To describe participant characteristics for JAK inhibitor naive myelofibrosis participants initiating momelotinib
Timeframe: Up to 6 Months
To describe participant characteristics for JAK inhibitor naive myelofibrosis participants initiating ruxolitinib and JAK inhibitor experienced participants initiating momelotinib
Timeframe: Up to 6 Months
Interventions:
Not applicable
Enrollment:
Not applicable
Observational study model:
Cohort
Primary completion date:
2026-30-11
Time perspective:
Retrospective
Clinical publications:
Not applicable
Medical condition
Primary Myelofibrosis
Product
Not applicable
Collaborators
Not applicable
Study date(s)
June 2026 to November 2026
Type
Observational
Phase
Not applicable
Participation criteria
Sex
Female & Male
Age
18+ years
Accepts healthy volunteers
No
- Greater than or equal to (>=)1 MMB or >= RUX dispensation/administration during the index period.
- Index date: The first MMB or RUX dispense/administration during the index period.
- Evidence of JAK inhibitor any time before the index date during the study period.
Inclusion and exclusion criteria
Inclusion criteria:
- Index date: The first MMB or RUX dispense/administration during the index period.
- Greater than or equal to 1 record with a diagnosis code indicative of MF during the study period.
- Participants aged >=18 years as of the earliest MF diagnosis date during the study period.
- Data visibility >=6 months prior to the index date.
- Data visibility >=3 months following the index date.
- For participants indexed to RUX only: >=1 record indicative of anemia during the 90-day pre-index period
Greater than or equal to (>=)1 MMB or >= RUX dispensation/administration during the index period.
Exclusion criteria:
Evidence of JAK inhibitor any time before the index date during the study period.
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
Participate in clinical trial
Access to clinical trial data by researchers
Visit website