Ruxolitinib Adherence in Myelofibrosis and Polycythemia Vera

Adherence, Patient Clinical Trial

— RAMP  

Official title:

Ruxolitinib Adherence in Myelofibrosis and Polycythemia Vera

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06078319
• Other study ID #: 1064/2020/Oss/AOUBo
• Status: Completed
• Start date: January 18, 2021
• Est. completion date: June 30, 2023

Study information

• Verified date: February 2023
• Source: IRCCS Azienda Ospedaliero-Universitaria di Bologna
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 189
• Est. completion date: June 30, 2023
• Est. primary completion date: June 30, 2023
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Adherence, Patient
• Adherence, Treatment
• Polycythemia
• Polycythemia Vera
• Primary Myelofibrosis

Locations

Country	Name	City	State
Italy	IRCCS Policlinico Sant'Orsola	Bologna	Emilia Romagna
Italy	ASST Spedali Civili di Brescia	Brescia	Lombardia
Italy	Ospedale "A. Businco" - Dipartimento Scienze Mediche e Sanità Pubblica Università degli Studi di Cagliari	Cagliari	Sardegna
Italy	A.O.U. "Policlinico-V. Emanuele"- P.O. Ferrarotto	Catania	Sicilia
Italy	Azienda Ospedaliera Annunziata	Cosenza	Calabria
Italy	Università degli studi di Ferrara - Nuovo Polo Ospedaliero di Cona - A.O.U. Arcispedale S. Anna	Ferrara	Emilia-Romagna
Italy	IRCCS Azienda Ospedaliera Universitaria "San Martino" - IST	Genova	Liguria
Italy	Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico	Milano	Lombardia
Italy	Ospedale San Gerardo	Monza	Lombardia
Italy	Università degli Studi di Napoli Federico II - U.O.C. di Ematologia e Trapianti di midollo	Napoli	Campania
Italy	Ospedale San Luigi Gonzaga	Orbassano	Piemonte
Italy	AOU di Padova	Padova	Veneto
Italy	Azienda Ospedaliero-Universitaria di Parma	Parma	Emilia-Romagna
Italy	A.O. Ospedali Riuniti Marche Nord - Presidio Ospedaliero San Salvatore	Pesaro	Marche
Italy	AUSL di Piacenza - Palazzine Medicine Specialistiche	Piacenza	Emilia-Romagna
Italy	Dipartimento Oncoematologico - AUSL della Romagna	Ravenna	Emilia-Romagna
Italy	Grande Ospedale Metropolitano "Bianchi Melacrino Morelli"	Reggio Calabria	Calabria
Italy	Arcispedale Santa Maria Nuova - IRCCS	Reggio Emilia	Emilia-Romagna
Italy	Ospedale Infermi di Rimini	Rimini	Emilia-Romagna
Italy	A.O.U. Policlinico Umberto I - Università degli Studi di Roma "La Sapienza"	Roma	Lazio
Italy	Ospedale S. Eugenio	Roma	Lazio
Italy	Policlinico S.Maria alle Scotte	Siena	Toscana
Italy	A. O. Ordine Mauriziano di Torino	Torino	Piemonte
Italy	A.O.U. Città della Salute e della Scienza - Presidio Molinette	Torino	Piemonte
Italy	Department of Oncology, University of Torino	Torino	Piemonte
Italy	A.O.U. Integrata di Udine	Udine	Friuli-Venezia Giulia
Italy	A.O.U. Integrata Verona - Borgo Roma	Verona	Veneto
Italy	Ospedale Belcolle	Viterbo	Lazio

Sponsors (1)

Lead Sponsor	Collaborator
IRCCS Azienda Ospedaliero-Universitaria di Bologna

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adherence	Incidence of low adherence to ruxolitinib therapy, and the features associated with low adherence	2 years
Primary	Distress	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