Ignite Creation Date:
2024-05-06 @ 7:38 PM
Last Modification Date:
2024-10-26 @ 3:10 PM
Study NCT ID:
NCT06078319
Status:
COMPLETED
Last Update Posted:
2023-10-12
First Post:
2023-10-05
Brief Title:
Ruxolitinib Adherence in Myelofibrosis and Polycythemia Vera
Sponsor:
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Organization:
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Study Overview
Official Title:
Ruxolitinib Adherence in Myelofibrosis and Polycythemia Vera
Status:
COMPLETED
Status Verified Date:
2023-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
RAMP
Brief Summary:
The prospective multicenter observational cohort study will be offered consecutively to any patient with primary or secondary myelofibrosis or with Polycythemia Vera who has initiated therapy with ruxolitinib prescribed as part of the normal course of care and completely independent of study participation The main purpose is to assess adherence to ruxolitinib using the ARMS questionnaire Each individual patient will be administered the questionnaire at the first convenient opportunity regardless of when ruxolitinib is started and again after 4 8 12 24 and 48 weeks in conjunction with drug procurement
Detailed Description:
The prospective multicenter observational cohort study will be offered consecutively to any patient with primary or secondary myelofibrosis or with Polycythemia Vera who has initiated therapy with ruxolitinib prescribed as part of the normal course of care and completely independent of study participation Laboratory tests and histologic cytogenetic molecular and radiologic investigations performed by the patient and collected for study will be conducted in accordance with clinical practice independent of the patients participation in the study In particular data related to systemic symptoms and splenomegaly will be collected at diagnosis and disease reassessments performed in the context of normal clinical practice These data will be collected at the first administration of the ARMS questionnaire and again after 12 24 and 48 weeks If performed any additional assessments will also be recorded Each individual patient will be administered the questionnaire ARMS at the first convenient opportunity regardless of the time of initiation of ruxolitinib and again after 4 8 12 24 and 48 weeks in conjunction with drug procurement If in-person data collection is not possible the mode of data collection by telephone interview will be adopted The minimum expected duration of individual patient observation is 48 weeks
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None