Ruxolitinib Adherence in Myelofibrosis and Polycythemia Vera (RAMP)
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| ClinicalTrials.gov Identifier: NCT06078319 |
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Recruitment Status :
Completed
First Posted : October 11, 2023
Last Update Posted : October 12, 2023
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Sponsor:
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Information provided by (Responsible Party):
IRCCS Azienda Ospedaliero-Universitaria di Bologna
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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.
| Condition or disease |
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| Adherence, Patient Adherence, Treatment |
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 |
| Actual Enrollment : | 189 participants |
| Observational Model: | Cohort |
| Time Perspective: | Prospective |
| Official Title: | Ruxolitinib Adherence in Myelofibrosis and Polycythemia Vera |
| Actual Study Start Date : | January 18, 2021 |
| Actual Primary Completion Date : | June 30, 2023 |
| Actual Study Completion Date : | June 30, 2023 |
Resource links provided by the National Library of Medicine
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)
Information from the National Library of Medicine
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| 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.
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
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06078319
Locations
Show 28 study locations
Sponsors and Collaborators
IRCCS Azienda Ospedaliero-Universitaria di Bologna
| Responsible Party: | IRCCS Azienda Ospedaliero-Universitaria di Bologna |
| ClinicalTrials.gov Identifier: | NCT06078319 |
| Other Study ID Numbers: |
1064/2020/Oss/AOUBo |
| First Posted: | October 11, 2023 Key Record Dates |
| Last Update Posted: | October 12, 2023 |
| Last Verified: | February 2023 |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
Additional relevant MeSH terms:
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Polycythemia Vera Primary Myelofibrosis Polycythemia Myeloproliferative Disorders Bone Marrow Diseases |
Hematologic Diseases Bone Marrow Neoplasms Hematologic Neoplasms Neoplasms by Site Neoplasms |