An observational study in Adherence, Patient and Adherence, Treatment, sponsored by IRCCS Azienda Ospedaliero-Universitaria di Bologna. Completed at 28 sites in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-10-12.
Sponsored by IRCCS Azienda Ospedaliero-Universitaria di Bologna · Observational
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Among 14 studies in Patient Compliance with a site in Italy — 1 open to participants now, 1 under way, none of them phase 3. Patient Compliance · Italy.
Among the 14 studies in Patient Compliance with a site in Italy, this one is the only one that started in 2021, is one of 6 observational ones, and was the 12th registered.
752 studies on the registry are indexed under Patient Compliance; 72 are open to participants now.
Browse Patient Compliance studies →1 of the 14 studies in Patient Compliance with a site in Italy is open now. Recruiting first, the newest first:
IRCCS Burlo Garofolo · Sites in Italy
Ages up to 18
A study can be open while its sites in Italy have not opened yet or have stopped. Only those recruiting at a site in Italy →
Of the 45 Patient Compliance studies recruiting now, 25 (56%) set no upper age limit and 13 (29%) stop at 75 or younger; 11 take children under 18; 14 take healthy volunteers.
This study: 18 Years and older · all sexes.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
14 studies; the count open now beside each. This study's row is marked.
First in 2006; this study’s year is marked. 1 started in 2021.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 189 is close to the median of 184 across 208 observational studies indexed under Patient Compliance.
Median enrollment 110 across the 8 interventional studies, 165 across the 6 observational. Of the 13 that completed or were terminated, 1 (8%) have results posted.
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3 of 14 have an industry lead sponsor. The 10 most frequent:
IRCCS Azienda Ospedaliero-Universitaria di Bologna is the lead sponsor of 513 studies on the registry; 288 are open to participants now.
IRCCS Azienda Ospedaliero-Universitaria di Bologna has 1 study filed under Patient Compliance — fewer than ten, so there is no comparison to draw.
None of the studies under way reaches primary completion within a year.
Among the 14 studies in Patient Compliance with a site in Italy, from their registry updates:
Nothing recorded among them since 2026-09-25.
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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.
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.
Patients diagnosed with primary MF or secondary to Essential Thrombocythemia/PV or diagnosed with PV, aged 18 years or older.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Adherence
Incidence of low adherence to ruxolitinib therapy, and the features associated with low adherence
Time frame: 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)
Time frame: 2 years
Ran from Jan 2021 to primary completion in Jun 2023, 29 months.
Of 55 non-industry observational studies under Patient Compliance, half reached primary completion within 25 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 37. This study's 29 months is above that.
Counting every sponsor, half of 65 studies reached it within 23 months; a quarter within 10 and three quarters within 37.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Feb 2023. You cannot join it, but the record below documents what was studied.
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