Polycythemia VeraQoL-PV-RNCT05566535
Changes in QoL and Symptoms in Patients With Polycythemia Vera Receiving Ruxo in a Routine Clinical Practice
An observational study of Polycythemia Vera, run by Multinational Center for Quality of Life Research, Russia.
Trial summary
The purpose of this multicenter observational prospective cohort study is to examine changes in QoL and symptoms in patients with polycythemia vera (PV) during treatment with ruxolitinib (Ruxo), and to evaluate efficacy and safety of Ruxo in a real-world setting Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Polycythemia Vera
- What is being tested?
- Ruxolitinib
- How many people
- 32 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2022to 1 Aug 2024
- 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
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients with PV will be enrolled after being prescribed with Ruxo. The eligibility criteria for this study are broader than those for patients to be treated with Ruxo in randomized clinical trials, so as to be reflective of routine clinical practice
Who may be able to join
- Patients who have confirmed diagnosis of PV
- Patients whose age - 18 years and older
- Patients who signed informed consent
- Patients who able to fill out questionnaires
Who cannot join
- Patients enrolled in clinical trials
- Patients with contraindications to Ruxo in accordance with instruction for use
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Changes in Quality of Life (QoL) and Symptoms in Patients With Polycythemia Vera (PV) Receiving Ruxolitinib (Ruxo) in a Routine Clinical Practice
The purpose of this multicenter observational prospective cohort study is to examine changes in QoL and symptoms in patients with polycythemia vera (PV) during treatment with ruxolitinib (Ruxo), and to evaluate efficacy and safety of Ruxo in a real-world setting
- Conditions
- Polycythemia Vera
- Being tested
- Ruxolitinib
- Keywords
- ruxolitinib, quality of life
- Medical subject headings
- Polycythemia Vera
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RuxolitinibDrug
Ruxo will be administered to patients with PV in a real-world setting. Treatment with Ruxo is according to local approved label. Ruxo treatment should be administered according to drug official instruction and in compliance with clinical practice at the certain medical center.
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in QoL as per SF-36 questionnaire domains at 3 and 9 months of Ruxo treatment
The difference in QoL means of SF-36 domains at 3 and 9 months as compared to their Baseline will be analyzed
Measured: Baseline, 3 and 9 months of Ruxo treatment
Secondary outcomes (8)
Change From Baseline in MPN10 Total score over time
The difference in MPN10 Total Symptom Score means by MPN10 at different time-points of Ruxo treatment as compared to their Baseline will be analyzed. Also the percentage of patients with the lowest symptom burden, corresponding to MPN10 Total scores of 0 - 7 (quartile 1), at different treatment time-points (Baseline, 1, 3, 6, 9 and 12 months) will be calculated
Measured: Baseline, 1, 3, 6, 9 and 12 months of Ruxo treatment
Change From Baseline in severity of each symptom by MPN10 over time
The difference in MPN10 symptom score means at different time-points of Ruxo treatment as compared to their Baseline will be analyzed
Measured: Baseline, 1, 3, 6, 9 and 12 months of Ruxo treatment
Percentage of patients achieving a ≥ 50% improvement from Baseline in MPN10 Total Symptom Score over time
The number of patients with MPN10 Total Symptom Score decrease ≥ 50% at 1, 3, 6, 9 and 12 months of Ruxo treatment as compared to its' Baseline will be calculated
Measured: 1, 3, 6, 9 and 12 months of Ruxo treatment
Change From Baseline in QoL as per SF-36 questionnaire domains over 12 months of Ruxo treatment
The difference in QoL means of SF-36 domains at different time-points of Ruxo treatment as compared to their Baseline will be analyzed
Measured: Baseline, 1, 3, 6, 9 and 12 months of Ruxo treatment
The percentage of patients who achieved overall clinicohematologic response at 9 months of treatment with Ruxo
Overall clinicohematologic response will be defined as any participant who achieved a complete or partial clinicohematologic response per the National criteria for response in polycythemia vera (2021) and European LeukNet recommendations (2013). A complete response (CR) will be defined as: hematocrit control (<45%) with the absence of phlebotomy eligibility ≥12 weeks, spleen volume reduction at least 35% from baseline, platelet count less than or equal to 400 x 109/L, and white blood cell count less than or equal to 10 x 109/L, and symptom regress during ≥12 weeks as well as histological remission. A Partial Response (PR) will be defined as all the above criteria excluding histological remission
Measured: 9 months
The Percentage of patients who achieved hematocrit (Hct) control at 9 months of treatment with Ruxo
Hematocrit control is Ht <45% with the absence of phlebotomy eligibility beginning at 3 months visit and continuing through 9 months
Measured: 9 months
The percentage of patients with positive changes of wellbeing during Ruxo treatment
The number of patients who reported improvement as per Patient Global Impression of Changes scale at different time-points of treatment will be analyzed
Measured: 1, 3, 6, 9 and 12 months of Ruxo treatment
The percentage of patients satisfied/dissatisfied with Ruxo treatment over time
The number of patients satisfied/dissatisfied with treatment according to Patient' Treatment Satisfaction Checklist at different time-points of treatment will be analyzed
Measured: 1, 3, 6, 9 and 12 months of Ruxo treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2022
- Study start1 Oct 2022 (estimated)
- Primary completion1 May 2024 (estimated)
- Study completion1 Aug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Polycythemia VeraStudies of the same condition, open and under way.
- 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
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Multinational Center for Quality of Life Research, Russia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05566535
- Sponsor's protocol ID
- CINC424BRU04T
- Acronym
- QoL-PV-R
- Status last verified
- Sep 2022
- First submitted
- 30 Sep 2022
- Last updated
- 4 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Changes in Quality of Life (QoL) and Symptoms in Patients With Polycythemia Vera (PV) Receiving Ruxolitinib (Ruxo) in a Routine Clinical Practice
- ClinicalTrials.gov ID
- NCT05566535
- Acronym / sponsor ID
- QoL-PV-R / CINC424BRU04T
- Conditions
- Polycythemia Vera
- Keywords
- ruxolitinib, quality of life
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- Multinational Center for Quality of Life Research, RussiaUniversity, hospital or other
- Study start
- 1 Oct 2022 (estimated)
- Primary completion
- 1 May 2024 (estimated)
- Study completion
- 1 Aug 2024 (estimated)
- First posted
- 4 Oct 2022 (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 purpose of this multicenter observational prospective cohort study is to examine changes in QoL and symptoms in patients with polycythemia vera (PV) during treatment with ruxolitinib (Ruxo), and to evaluate efficacy and safety of Ruxo in a real-world setting
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients with PV will be enrolled after being prescribed with Ruxo. The eligibility criteria for this study are broader than those for patients to be treated with Ruxo in randomized clinical trials, so as to be reflective of routine clinical practice
Key inclusion criteria (4 listed)
- Patients who have confirmed diagnosis of PV
- Patients whose age - 18 years and older
- Patients who signed informed consent
- Patients who able to fill out questionnaires
Key exclusion criteria (2 listed)
- Patients enrolled in clinical trials
- Patients with contraindications to Ruxo in accordance with instruction for use
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RuxolitinibRuxo will be administered to patients with PV in a real-world setting. Treatment with Ruxo is according to local approved label. Ruxo treatment should be administered according to drug official instruction and in compliance with clinical practice at the certain medical center. | Drug | – |
Primary outcome
Change From Baseline in QoL as per SF-36 questionnaire domains at 3 and 9 months of Ruxo treatment
Time frame: Baseline, 3 and 9 months of Ruxo treatment
The difference in QoL means of SF-36 domains at 3 and 9 months as compared to their Baseline will be analyzed
8 secondary outcomes
Change From Baseline in MPN10 Total score over time
Time frame: Baseline, 1, 3, 6, 9 and 12 months of Ruxo treatment
Change From Baseline in severity of each symptom by MPN10 over time
Time frame: Baseline, 1, 3, 6, 9 and 12 months of Ruxo treatment
Percentage of patients achieving a ≥ 50% improvement from Baseline in MPN10 Total Symptom Score over time
Time frame: 1, 3, 6, 9 and 12 months of Ruxo treatment
Change From Baseline in QoL as per SF-36 questionnaire domains over 12 months of Ruxo treatment
Time frame: Baseline, 1, 3, 6, 9 and 12 months of Ruxo treatment
The percentage of patients who achieved overall clinicohematologic response at 9 months of treatment with Ruxo
Time frame: 9 months
The Percentage of patients who achieved hematocrit (Hct) control at 9 months of treatment with Ruxo
Time frame: 9 months
The percentage of patients with positive changes of wellbeing during Ruxo treatment
Time frame: 1, 3, 6, 9 and 12 months of Ruxo treatment
The percentage of patients satisfied/dissatisfied with Ruxo treatment over time
Time frame: 1, 3, 6, 9 and 12 months of Ruxo treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Oct 2022.
- Individual participant dataSharing planned: No
Related trials for Polycythemia Vera
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A Phase 3 Study of Pelabresib (DAK539) and Ruxolitinib in Myelofibrosis (MF)
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RecruitingPhase 2/3
A Clinical Trial of Bomedemstat in Participants With Polycythemia Vera (MK-3543-025).
Polycythemia Vera
RecruitingPhase 2
Study of Momelotinib in Combination With Luspatercept in Participants With Transfusion Dependent Myelofibrosis
Primary Myelofibrosis, Myelofibrosis; Primary Myelofibrosis; Post-polycythemia Vera Myelofibrosis; Post-essential Thrombocythemia Myelofibrosis
RecruitingPhase 2
A Study of Ropeg-Interferon in People With Polycythemia Vera
Polycythemia Vera (PV), JAK2 Mutation
Active, not recruitingPhase 2
A Phase 2, Open-Label Study of DISC-3405 in Participants With Polycythemia Vera (PV)
Polycythemia Vera (PV)
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.
Questions about this trial
What is this clinical trial studying?
An observational study of Polycythemia Vera, run by Multinational Center for Quality of Life Research, Russia.
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 2 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: status not confirmed, as of the sponsor's last update on 4 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Tatiana Nikitina, MD, PhD (89627101712, tnikitina_74@mail.ru), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline in QoL as per SF-36 questionnaire domains at 3 and 9 months of Ruxo treatment (time frame: Baseline, 3 and 9 months of Ruxo treatment). 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 4 Oct 2022.