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RAMP: Ruxolitinib Adherence in Myelofibrosis and Polycythemia Vera

Sponsor
IRCCS Azienda Ospedaliero-Universitaria di Bologna (Other)
Overall Status
Completed
CT.gov ID
NCT06078319
Collaborator
(none)
189
Enrollment
28
Locations
29.3
Actual Duration (Months)
6.8
Patients Per Site
0.2
Patients Per Site Per Month

Study Details

Study Description

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 Intervention/Treatment Phase

    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 Design

    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 :
    Jan 18, 2021
    Actual Primary Completion Date :
    Jun 30, 2023
    Actual Study Completion Date :
    Jun 30, 2023

    Outcome Measures

    Primary Outcome Measures

    1. Adherence [2 years]

      Incidence of low adherence to ruxolitinib therapy, and the features associated with low adherence

    2. Distress [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)

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    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

    Contacts and Locations

    Locations

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

    Sponsors and Collaborators

    • IRCCS Azienda Ospedaliero-Universitaria di Bologna

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    IRCCS Azienda Ospedaliero-Universitaria di Bologna
    ClinicalTrials.gov Identifier:
    NCT06078319
    Other Study ID Numbers:
    • 1064/2020/Oss/AOUBo
    First Posted:
    Oct 11, 2023
    Last Update Posted:
    Oct 12, 2023
    Last Verified:
    Feb 1, 2023
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Polycythemia Vera
    Primary Myelofibrosis
    Polycythemia

    Study Results

    No Results Posted as of Oct 12, 2023