Adherence, PatientRAMPNCT06078319
Ruxolitinib Adherence in Myelofibrosis and Polycythemia Vera
An observational study of Adherence, Patient and Adherence, Treatment, run by IRCCS Azienda Ospedaliero-Universitaria di Bologna at 28 sites in Italy.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Adherence, Patient, Adherence, Treatment
- How many people
- 189 participants
- Where
- 28 sitesItaly
- Study dates
- 18 Jan 2021to 30 Jun 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: Patients diagnosed with primary MF or secondary to Essential Thrombocythemia/PV or diagnosed with PV, aged 18 years or older.
Who may be able to join
- 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
Who cannot join
- None
Trial locations and contacts
28 sites in 1 country.
28 sites in 1 country
Italy28 sites
IRCCS Policlinico Sant'Orsola
Bologna, Emilia-Romagna, 40138
ASST Spedali Civili di Brescia
Brescia, Lombardy, 25123
Ospedale "A. Businco" - Dipartimento Scienze Mediche e Sanità Pubblica Università degli Studi di Cagliari
Cagliari, Sardinia, 09131
A.O.U. "Policlinico-V. Emanuele"- P.O. Ferrarotto
Catania, Sicily, 95124
Azienda Ospedaliera Annunziata
Cosenza, Calabria, 87100
Università degli studi di Ferrara - Nuovo Polo Ospedaliero di Cona - A.O.U. Arcispedale S. Anna
Ferrara, Emilia-Romagna, 44124
IRCCS Azienda Ospedaliera Universitaria "San Martino" - IST
Genoa, Liguria, 16132
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
Milan, Lombardy, 20122
Ospedale San Gerardo
Monza, Lombardy, 20900
Università degli Studi di Napoli Federico II - U.O.C. di Ematologia e Trapianti di midollo
Naples, Campania, 80131
Ospedale San Luigi Gonzaga
Orbassano, Piedmont, 10043
AOU di Padova
Padova, Veneto, 35128
Azienda Ospedaliero-Universitaria di Parma
Parma, Emilia-Romagna, 43126
A.O. Ospedali Riuniti Marche Nord - Presidio Ospedaliero San Salvatore
Pesaro, The Marches, 61122
AUSL di Piacenza - Palazzine Medicine Specialistiche
Piacenza, Emilia-Romagna, 29121
Dipartimento Oncoematologico - AUSL della Romagna
Ravenna, Emilia-Romagna, 48121
Grande Ospedale Metropolitano "Bianchi Melacrino Morelli"
Reggio Calabria, Calabria, 89124
Arcispedale Santa Maria Nuova - IRCCS
Reggio Emilia, Emilia-Romagna, 42123
Ospedale Infermi di Rimini
Rimini, Emilia-Romagna, 47923
Ospedale S. Eugenio
Rome, Lazio, 00144
A.O.U. Policlinico Umberto I - Università degli Studi di Roma "La Sapienza"
Rome, Lazio, 00161
Policlinico S.Maria alle Scotte
Siena, Tuscany, 53100
Department of Oncology, University of Torino
Turin, Piedmont, 10124
A.O.U. Città della Salute e della Scienza - Presidio Molinette
Turin, Piedmont, 10126
A. O. Ordine Mauriziano di Torino
Turin, Piedmont, 10128
A.O.U. Integrata di Udine
Udine, Friuli Venezia Giulia, 33100
A.O.U. Integrata Verona - Borgo Roma
Verona, Veneto, 37134
Ospedale Belcolle
Viterbo, Lazio, 01100
About this study
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.
Read the 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.
- Conditions
- Adherence, Patient, Adherence, Treatment
- Medical subject headings
- Patient Compliance, Treatment Adherence and Compliance
What is being measured
The primary outcome is the main question the study is designed to answer.
Adherence
Incidence of low adherence to ruxolitinib therapy, and the features associated with low adherence
Measured: 2 years
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)
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Oct 2023
- Study start18 Jan 2021
- Primary completion30 Jun 2023
- Study completion30 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adherence, PatientStudies of the same condition, open and under way.
- More trials run by IRCCS Azienda Ospedaliero-Universitaria di BolognaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 189 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06078319
- Sponsor's protocol ID
- 1064/2020/Oss/AOUBo
- Acronym
- RAMP
- Status last verified
- Feb 2023
- First submitted
- 5 Oct 2023
- Last updated
- 12 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ruxolitinib Adherence in Myelofibrosis and Polycythemia Vera
- ClinicalTrials.gov ID
- NCT06078319
- Acronym / sponsor ID
- RAMP / 1064/2020/Oss/AOUBo
- Conditions
- Adherence, Patient, Adherence, Treatment
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 189 participants (actual)
- Lead sponsor
- IRCCS Azienda Ospedaliero-Universitaria di BolognaUniversity, hospital or other
- Study start
- 18 Jan 2021 (actual)
- Primary completion
- 30 Jun 2023 (actual)
- Study completion
- 30 Jun 2023 (actual)
- First posted
- 11 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients diagnosed with primary MF or secondary to Essential Thrombocythemia/PV or diagnosed with PV, aged 18 years or older.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Oct 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
28 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Adherence, Patient and Adherence, Treatment, run by IRCCS Azienda Ospedaliero-Universitaria di Bologna at 28 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 28 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adherence (time frame: 2 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Oct 2023.