Ruxolitinib Adherence in Myelofibrosis and Polycythemia Vera (RAMP)

October 11, 2023 updated by: IRCCS Azienda Ospedaliero-Universitaria di Bologna
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.

Study Overview

Status

Completed

Conditions

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

Enrollment (Actual)

189

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
    • Calabria
      • Cosenza, Calabria, Italy, 87100
        • Azienda Ospedaliera Annunziata
      • Reggio Calabria, Calabria, Italy, 89124
        • Grande Ospedale Metropolitano "Bianchi Melacrino Morelli"
    • Campania
      • Napoli, Campania, Italy, 80131
        • Università degli Studi di Napoli Federico II - U.O.C. di Ematologia e Trapianti di midollo
    • Emilia Romagna
      • Bologna, Emilia Romagna, Italy, 40138
        • IRCCS Policlinico Sant'Orsola
    • Emilia-Romagna
      • Ferrara, Emilia-Romagna, Italy, 44124
        • Università degli studi di Ferrara - Nuovo Polo Ospedaliero di Cona - A.O.U. Arcispedale S. Anna
      • Parma, Emilia-Romagna, Italy, 43126
        • Azienda Ospedaliero-Universitaria di Parma
      • Piacenza, Emilia-Romagna, Italy, 29121
        • AUSL di Piacenza - Palazzine Medicine Specialistiche
      • Ravenna, Emilia-Romagna, Italy, 48121
        • Dipartimento Oncoematologico - AUSL della Romagna
      • Reggio Emilia, Emilia-Romagna, Italy, 42123
        • Arcispedale Santa Maria Nuova - IRCCS
      • Rimini, Emilia-Romagna, Italy, 47923
        • Ospedale infermi di Rimini
    • Friuli-Venezia Giulia
      • Udine, Friuli-Venezia Giulia, Italy, 33100
        • A.O.U. Integrata di Udine
    • Lazio
      • Roma, Lazio, Italy, 00144
        • Ospedale S. Eugenio
      • Roma, Lazio, Italy, 00161
        • A.O.U. Policlinico Umberto I - Università degli Studi di Roma "La Sapienza"
      • Viterbo, Lazio, Italy, 01100
        • Ospedale Belcolle
    • Liguria
      • Genova, Liguria, Italy, 16132
        • IRCCS Azienda Ospedaliera Universitaria "San Martino" - IST
    • Lombardia
      • Brescia, Lombardia, Italy, 25123
        • ASST Spedali Civili di Brescia
      • Milano, Lombardia, Italy, 20122
        • Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
      • Monza, Lombardia, Italy, 20900
        • Ospedale San Gerardo
    • Marche
      • Pesaro, Marche, Italy, 61122
        • A.O. Ospedali Riuniti Marche Nord - Presidio Ospedaliero San Salvatore
    • Piemonte
      • Orbassano, Piemonte, Italy, 10043
        • Ospedale San Luigi Gonzaga
      • Torino, Piemonte, Italy, 10124
        • Department of Oncology, University of Torino
      • Torino, Piemonte, Italy, 10126
        • A.O.U. Città della salute e della scienza - Presidio Molinette
      • Torino, Piemonte, Italy, 10128
        • A. O. Ordine Mauriziano di Torino
    • Sardegna
      • Cagliari, Sardegna, Italy, 09131
        • Ospedale "A. Businco" - Dipartimento Scienze Mediche e Sanità Pubblica Università degli Studi di Cagliari
    • Sicilia
      • Catania, Sicilia, Italy, 95124
        • A.O.U. "Policlinico-V. Emanuele"- P.O. Ferrarotto
    • Toscana
      • Siena, Toscana, Italy, 53100
        • Policlinico S.Maria alle Scotte
    • Veneto
      • Padova, Veneto, Italy, 35128
        • AOU di Padova
      • Verona, Veneto, Italy, 37134
        • A.O.U. Integrata Verona - Borgo Roma

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adherence
Time Frame: 2 years
Incidence of low adherence to ruxolitinib therapy, and the features associated with low adherence
2 years
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)
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 18, 2021

Primary Completion (Actual)

June 30, 2023

Study Completion (Actual)

June 30, 2023

Study Registration Dates

First Submitted

October 5, 2023

First Submitted That Met QC Criteria

October 5, 2023

First Posted (Actual)

October 11, 2023

Study Record Updates

Last Update Posted (Actual)

October 12, 2023

Last Update Submitted That Met QC Criteria

October 11, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1064/2020/Oss/AOUBo

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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