Changes in QoL and Symptoms in Patients With Polycythemia Vera Receiving Ruxo in a Routine Clinical Practice

NCT05566535 | Unknown FDA Drug

• 1 other identifier: CINC424BRU04T
• Study Type: observational
• Target: 32
• Locations: 0 countries
• Sites: N/A

Brief 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

Conditions

Polycythemia Vera

Keywords

ruxolitinib; quality of life

Outcome Measures

Primary Outcomes (1)

• 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

  Baseline, 3 and 9 months of Ruxo treatment

Secondary Outcomes (8)

• Change From Baseline in MPN10 Total score over time

  Baseline, 1, 3, 6, 9 and 12 months of Ruxo treatment

• Change From Baseline in severity of each symptom by MPN10 over time

  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

  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

  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

  9 months

Interventions

Ruxolitinib DRUG

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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

You may qualify if:

• 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

You may not qualify if:

• Patients enrolled in clinical trials
• Patients with contraindications to Ruxo in accordance with instruction for use

Sponsors & Collaborators

• Multinational Center for Quality of Life Research, Russia: lead

MeSH Terms

Conditions

Polycythemia Vera

Interventions

ruxolitinib

Condition Hierarchy (Ancestors)

Bone Marrow Neoplasms; Hematologic Neoplasms; Neoplasms by Site; Neoplasms; Bone Marrow Diseases; Hematologic Diseases; Hemic and Lymphatic Diseases; Myeloproliferative Disorders

Central Study Contacts

Tatiana Nikitina, MD, PhD

CONTACT

89627101712; tnikitina_74@mail.ru

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 30, 2022
• First Posted: October 4, 2022
• Study Start: October 1, 2022
• Primary Completion: May 1, 2024
• Study Completion: August 1, 2024
• Last Updated: October 4, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share