Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT05444972




Registration number
NCT05444972
Ethics application status
Date submitted
23/06/2022
Date registered
6/07/2022
Date last updated
11/12/2023

Titles & IDs
Public title
A Study to Explore Treatment Patterns, Treatment Outcomes, Healthcare Resource Utilization in Adult Participants With Myelofibrosis Through Chart Review
Scientific title
A Multi-Country, Real-World Study to Explore Treatment Patterns, Effectiveness and Healthcare Resource Utilization for Patients Diagnosed With Myelofibrosis Through Chart Review
Secondary ID [1] 0 0
H23-122
Universal Trial Number (UTN)
Trial acronym
METER
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Myelofibrosis 0 0
Condition category
Condition code
Musculoskeletal 0 0 0 0
Other muscular and skeletal disorders
Human Genetics and Inherited Disorders 0 0 0 0
Other human genetics and inherited disorders
Cancer 0 0 0 0
Leukaemia - Chronic leukaemia

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Participants Undergoing Chart Review - Participants treated for myelofibrosis undergoing chart review.
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Time from Diagnosis of Myelofibrosis (MF) to Initial Treatment
Timepoint [1] 0 0
Up to Week 156
Primary outcome [2] 0 0
Duration of Initial Treatment
Timepoint [2] 0 0
Up to Week 156
Primary outcome [3] 0 0
Duration of Second Treatment
Timepoint [3] 0 0
Up to Week 156
Primary outcome [4] 0 0
Duration of Subsequent Treatments
Timepoint [4] 0 0
Up to Week 156

Eligibility
Key inclusion criteria
- Treated for myelofibrosis (MF) [primary myelofibrosis (PMF) and secondary
myelofibrosis (SMF)].

- Must have initiated their first treatment on or after the first date when ruxolitinib
was approved in their country of residence and no later than 31 December 2021.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Having received MF treatment in a clinical trial setting.

Study design
Purpose
Duration
Selection
Timing
Retrospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
23/08/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
14/11/2023
Sample size
Target
Accrual to date
Final
998
Recruitment in Australia
Recruitment state(s)
QLD,SA,WA
Recruitment hospital [1] 0 0
Townsville University Hospital /ID# 246585 - Douglas
Recruitment hospital [2] 0 0
Royal Adelaide Hospital /ID# 246583 - Adelaide
Recruitment hospital [3] 0 0
Fiona Stanley Hospital /ID# 246584 - Murdoch
Recruitment hospital [4] 0 0
Royal Perth Hospital /ID# 246586 - Perth
Recruitment postcode(s) [1] 0 0
4814 - Douglas
Recruitment postcode(s) [2] 0 0
5000 - Adelaide
Recruitment postcode(s) [3] 0 0
6150 - Murdoch
Recruitment postcode(s) [4] 0 0
6000 - Perth
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Massachusetts
Country [4] 0 0
United States of America
State/province [4] 0 0
Ohio
Country [5] 0 0
Argentina
State/province [5] 0 0
Buenos Aires
Country [6] 0 0
Argentina
State/province [6] 0 0
Ciuadad Autonoma De Buenos Aires
Country [7] 0 0
Brazil
State/province [7] 0 0
Sao Paulo
Country [8] 0 0
Canada
State/province [8] 0 0
British Columbia
Country [9] 0 0
Canada
State/province [9] 0 0
Nova Scotia
Country [10] 0 0
Canada
State/province [10] 0 0
Ontario
Country [11] 0 0
Canada
State/province [11] 0 0
Quebec
Country [12] 0 0
Colombia
State/province [12] 0 0
Atlantico
Country [13] 0 0
Colombia
State/province [13] 0 0
Cundinamarca
Country [14] 0 0
Colombia
State/province [14] 0 0
Cali
Country [15] 0 0
Colombia
State/province [15] 0 0
Medellin
Country [16] 0 0
Greece
State/province [16] 0 0
Attiki
Country [17] 0 0
Greece
State/province [17] 0 0
Kriti
Country [18] 0 0
Greece
State/province [18] 0 0
Alexandroupolis
Country [19] 0 0
Greece
State/province [19] 0 0
Athens
Country [20] 0 0
Greece
State/province [20] 0 0
Ioannina
Country [21] 0 0
Greece
State/province [21] 0 0
Piraeus
Country [22] 0 0
Greece
State/province [22] 0 0
RION Patras Achaia
Country [23] 0 0
Italy
State/province [23] 0 0
Ferrara
Country [24] 0 0
Italy
State/province [24] 0 0
Lazio
Country [25] 0 0
Italy
State/province [25] 0 0
Umbria
Country [26] 0 0
Italy
State/province [26] 0 0
Bologna
Country [27] 0 0
Italy
State/province [27] 0 0
Brescia
Country [28] 0 0
Italy
State/province [28] 0 0
Milan
Country [29] 0 0
Italy
State/province [29] 0 0
Novara
Country [30] 0 0
Italy
State/province [30] 0 0
Palermo
Country [31] 0 0
Italy
State/province [31] 0 0
Varese
Country [32] 0 0
Italy
State/province [32] 0 0
Viterbo
Country [33] 0 0
Mexico
State/province [33] 0 0
Ciudad De Mexico
Country [34] 0 0
Mexico
State/province [34] 0 0
Nuevo Leon
Country [35] 0 0
Mexico
State/province [35] 0 0
Ciudad de Mexico
Country [36] 0 0
Poland
State/province [36] 0 0
Mazowieckie
Country [37] 0 0
Poland
State/province [37] 0 0
Pomorskie
Country [38] 0 0
Poland
State/province [38] 0 0
Orzesze
Country [39] 0 0
Poland
State/province [39] 0 0
Lódz
Country [40] 0 0
Portugal
State/province [40] 0 0
Coimbra
Country [41] 0 0
Portugal
State/province [41] 0 0
Lisboa
Country [42] 0 0
Portugal
State/province [42] 0 0
Porto
Country [43] 0 0
Romania
State/province [43] 0 0
Brasov
Country [44] 0 0
Romania
State/province [44] 0 0
Bucharest
Country [45] 0 0
Romania
State/province [45] 0 0
Bucuresti
Country [46] 0 0
Romania
State/province [46] 0 0
Cluj Napoca
Country [47] 0 0
Taiwan
State/province [47] 0 0
Kaohsiung
Country [48] 0 0
Taiwan
State/province [48] 0 0
Taipei City
Country [49] 0 0
Turkey
State/province [49] 0 0
Ankara
Country [50] 0 0
Turkey
State/province [50] 0 0
Diyarbakir
Country [51] 0 0
Turkey
State/province [51] 0 0
Edirne, Istanbul
Country [52] 0 0
Turkey
State/province [52] 0 0
Istanbul
Country [53] 0 0
Turkey
State/province [53] 0 0
Izmir
Country [54] 0 0
Turkey
State/province [54] 0 0
Malatya

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
AbbVie
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Myelofibrosis (MF) is a rare blood cancer, characterized by extensive fibrosis (scarring) of
the bone marrow. It is one of a group of cancers known as myeloproliferative neoplasms (MPNs)
in which bone marrow cells that produce blood cells develop and function abnormally. This
study will evaluate treatment patterns, treatment outcomes, healthcare resource utilization
in adult participants with Myelofibrosis.

Data from approximately 1000 participants will be collected. No participants will be enrolled
in this study.

Participants' charts will be reviewed. No drug will be administered as a part of this study.
The duration of the observation period is up to 156 weeks.

There is no additional burden for participants in this trial. All visits must be completed
prior to data extraction and participants will be followed for up to 156 weeks.
Trial website
https://clinicaltrials.gov/ct2/show/NCT05444972
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
ABBVIE INC.
Address 0 0
AbbVie
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT05444972