Last updated: 03/24/2025 15:10:11
MAIC of OS between momelotinib and BAT after discontinuation of RUX
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Recruitment complete
Recruitment complete
Trial overview
Official title: Indirect Treatment Comparisons of Momelotinib vs. BAT in Myelofibrosis Patients after Ruxolitinib Discontinuation
Trial description: This is an observational study with primary study aim to compare the overall survival (OS) between momelotinib versus best available therapy (BAT) in ruxolitinib-experienced participants suffering with myelofibrosis using indirect treatment comparison (ITC).
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
Overall Survival (OS)
Timeframe: Up to approximately 6 years
Secondary outcomes:
Not applicable
Interventions:
Not applicable
Enrollment:
0
Primary completion date:
2024-12-07
Observational study model:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Myeloproliferative Disease
Product
Not applicable
Collaborators
Not applicable
Study date(s)
July 2023 to July 2024
Type
Observational
Phase
Not applicable
Participation criteria
Sex
Female & Male
Age
18+ years
Accepts healthy volunteers
No
- Participants having myelofibrosis with high risk, intermediate-2, or intermediate-1 risk who have previously received and discontinued ruxolitinib.
- Participants with ruxolitinib discontinuation who underwent allogeneic stem cell transplantation.
- Participants who discontinued ruxolitinib and did not receive subsequent treatment.
Inclusion and exclusion criteria
Inclusion criteria:
•Participants having myelofibrosis with high risk, intermediate-2, or intermediate-1 risk who have previously received and discontinued ruxolitinib.
Exclusion criteria:
•Participants with ruxolitinib discontinuation who underwent allogeneic stem cell transplantation. •Participants who discontinued ruxolitinib and did not receive subsequent treatment.
Trial location(s)
This study does not involve prospective enrollment of participants.
Study documents
Protocol
Available language(s): English
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Refer to study documents
Recruitment status
Recruitment complete
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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