Clinical trial · Observational
Ruxolitinib for Polycythemia Vera in Patients Resistant to or Intolerant of Hydroxyurea.
Ruxolitinib for the Treatment of Polycythemia Vera in Patients Who Are Resistant to or Intolerant of Hydroxyurea: a Retrospective Non-interventional Study Using the US Optum Electronic Health Record Data Source.
NCT05421104CI-TRIAL-00059462completedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This was an analytical and descriptive, non-interventional, retrospective cohort study of PV patients aged ≥ 18 years in the US using a secondary data source, Optum EHR database.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Polycythemia Vera (PV) | Polycythemia Vera | ONTOLOGY_EXACT | 0.85 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Ruxolitinib | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- Ruxolitinib (RUX)
- description
- PV patients who were resistant to or intolerant of HU (as defined on the index date) and switched to RUX in the post-index period.
- interventionNames
- Other: Ruxolitinib
- label
- Best available therapy (BAT)
- description
- PV patients who were resistant to or intolerant of Hydroxyurea (HU) (as defined on the index date) and continued HU treatment or switched to other available therapies other than RUX in the post-index period.
Primary outcomes (2)
- measure
- Number of Thromboembolic events between the RUX and BAT group
- timeFrame
- throughout the study, approximately 13 years (Study period: From 01-Jan-2007 to 30-Jun-2020)
- description
- Thromboembolic events in overall Polycythemia Vera cohort and in the BAT and RUX groups were reported. A TE was defined using International Classification of Diseases 9th Revision (ICD-9- CM) and International Classification of Diseases 10th Revision (ICD-10-CM) codes previously curated as restrictive (RESPONSE RCT) and extensive (GEMFIN) definitions of TE's within the Diagnosis table in Optum EHR database.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 99 Years
Show eligibility criteria text
Inclusion Criteria: Included patients: * With at least one International Classification of Diseases, 9th Revision, Clinical Modification/International Classification of Diseases,10th Revision, Clinical Modification code for PV in the identification period (01-Apr-2007 until 30-Jun-2019) that had non-missing sex and year of birth data and who were treated as part of the Integrated Delivery Network * That were ≥ 18 years old at PV diagnosis * With ≥ 2 prescriptions of HU * That were classified as resistant to or intolerant of HU after a minimum of 3 months HU treatment (index date), defined as: HCT ≥ 45% with phlebotomy (last phlebotomy within last 3 months) or Platelet count \> 400 x 109/L and presence of palpable splenomegaly (palpable spleen up to 3 months after platelet count). To identify patients in the RUX group: \- With ≥ 2 prescriptions of RUX in the post-index period. Exclusion Criteria: Excluded patients: \- With a MF or AML diagnosis prior to a PV diagnosis.
References
Publications (0)
Data not yet available
No reference posted for this study.