Ruxolitinib Adherence in Myelofibrosis and Polycythemia Vera (RAMP)

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ClinicalTrials.gov Identifier: NCT06078319

Recruitment Status : Completed

First Posted : October 11, 2023

Last Update Posted : October 12, 2023

View this study on the modernized ClinicalTrials.gov

Sponsor:

Information provided by (Responsible Party):

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Tracking Information

First Submitted Date

October 5, 2023

First Posted Date

October 11, 2023

Last Update Posted Date

October 12, 2023

Actual Study Start Date

January 18, 2021

Actual Primary Completion Date

June 30, 2023 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures

Adherence [ Time Frame: 2 years ]
Incidence of low adherence to ruxolitinib therapy, and the features associated with low adherence
Distress [ Time Frame: 2 years ]
Emotional distress is measured based on a visual analogue scale with the distress thermometer, a simple and quick (3-4 minutes) tool that investigates the areas most involved in distress (minimum value: 0, lower distress; maximum value: 10, higher distress)

Original Primary Outcome Measures

Adherence [ Time Frame: 2 years ]
Incidence of low adherence to ruxolitinib therapy, and the features associated with low adherence
Distress [ Time Frame: 2 years ]
Emotional distress is measured based on a visual analogue scale with the distress thermometer, a simple and quick (3-4 minutes) tool that investigates the areas most involved in distress

Change History

Current Secondary Outcome Measures

Not Provided

Original Secondary Outcome Measures

Not Provided

Current Other Pre-specified Outcome Measures

Not Provided

Original Other Pre-specified Outcome Measures

Not Provided

Descriptive Information

Brief Title

Ruxolitinib Adherence in Myelofibrosis and Polycythemia Vera

Official Title

Ruxolitinib Adherence in Myelofibrosis and Polycythemia Vera

Brief Summary

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 patient's 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 Type

Observational

Study Design

Observational Model: Cohort
Time Perspective: Prospective

Target Follow-Up Duration

Not Provided

Biospecimen

Not Provided

Sampling Method

Non-Probability Sample

Study Population

Patients diagnosed with primary MF or secondary to Essential Thrombocythemia/PV or diagnosed with PV, aged 18 years or older.

Condition

Adherence, Patient
Adherence, Treatment

Intervention

Not Provided

Study Groups/Cohorts

Not Provided

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status

Completed

Actual Enrollment

189

Original Actual Enrollment

Same as current

Actual Study Completion Date

June 30, 2023

Actual Primary Completion Date

June 30, 2023 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

Age ≥ 18 years
Patients diagnosed with Primary Myelofibrosis or secondary to Essential Thrombocythemia/Polycythemia Vera or diagnosed with Polycythemia Vera who are in the treatment with ruxolitinib therapy in accordance with normal clinical practice
Obtaining informed consent for data collection and processing
The Patient must come to the in-person visit at least once, an occasion on which informed consent to 'study membership will be offered

Exclusion Criteria:

None

Sex/Gender

Sexes Eligible for Study:

All

Ages

18 Years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Not Provided

Contacts

Contact information is only displayed when the study is recruiting subjects

Listed Location Countries

Italy

Removed Location Countries

Administrative Information

NCT Number

NCT06078319

Other Study ID Numbers

1064/2020/Oss/AOUBo

Has Data Monitoring Committee

U.S. FDA-regulated Product

Studies a U.S. FDA-regulated Drug Product:	No
Studies a U.S. FDA-regulated Device Product:	No

IPD Sharing Statement

Not Provided

Current Responsible Party

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Original Responsible Party

Same as current

Current Study Sponsor

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Original Study Sponsor

Same as current

Collaborators

Not Provided

Investigators

Not Provided

PRS Account

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Verification Date

February 2023

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