A PMS of Jakavi® in Patients With Steroid-Refractory Graft-versus-Host Disease (SR-GvHD) in Korea

Study Overview
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Brief Summary
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This study is a prospective, open-label, multi-center, non-comparative, observational study to assess safety and effectiveness of Jakavi® (ruxolitinib) in the real-world clinical setting in Korean Graft-versus-Host disease (GvHD) patients

Detailed Description
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The dosage and duration of treatment may be considered and decided by the investigator in accordance with prescribing information of Jakavi®. All participants who receive at least one dose of the drug and are in the follow-up assessment or early discontinuation (withdrawal) will be the safety population. This study will enroll patients who are newly starting Jakavi® and patients who have been taking Jakavi® prior to study participation. Considering the current clinical practice, a 24 weeks follow-up period of ruxolitinib treatment is needed to assess the safety and the durable effectiveness of the treatment. Mandatory additional safety monitoring will be conducted following the last dose of the treatment for further AE assessments.

Official Title
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A Post Marketing Surveillance of Jakavi® (Ruxolitinib) in Patients With Steroid-Refractory Graft-versus-Host Disease (SR-GvHD) in Korea

Conditions
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Graft-versus-Host Disease

Intervention / Treatment
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* Other: ruxolitinib


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients who diagnosed with GvHD and currently receiving or going to receive Jakavi® treatment according to locally approved label Patients who are willing to provide written informed consent prior to study enrollment Exclusion Criteria: Patients under 12 years old Patients with contraindication according to locally approved label of Jakavi® Patients who receive or are going to receive any investigational medicine during the observation period.

Ages Eligible for Study
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Minimum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| ruxolitinib<br>Patients currently receiving or going to receive Jakavi® treatment according to locally approved label | Other: ruxolitinib<br>* Prospective observational study. There is no treatment allocation. Patients prescribed with ruxolitinib in the commercial setting are eligible to enroll into this study.<br>* Other names: Jakavi;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of patients with an AE/ ADR | Proportion of patients with an adverse event (AE)/ adverse drug reaction (ADR) will be provided | Up to 24 weeks | 
| Proportion of patients with a SAE/ SADR | Proportion of patients with a serious AE (SAE)/ serious ADR (SADR) will be provided | Up to 24 weeks | 
| Proportion of patients with an UAE/ UADR | Proportion of patients with an unexpected AE (UAE)/ unexpected ADR (UADR) will be provided | Up to 24 weeks | 
| Proportion of patients with a SUAE/ SUADR | Proportion of patients with a serious unexpected AE (SUAE)/ serious unexpected ADR (SUADR) will be provided | Up to 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall response rate (ORR) | ORR will be analyzed to the proportion of all participants demonstrating complete response (CR) or partial response (PR). | Week 4 and Week 24 | 
| Treatment failure rate | Treatment failure will be analyzed to the proportion of all participants demonstrating lack of response except for CR or PR. | Week 4 and Week 24 | 
| Death rate | Death rate will be provided | Week 4 and Week 24 | 
| Percentage change in CBC | Percentage change in CBC (hemoglobin, hematocrit, platelets, white blood cell (WBC) counts) will be provided | Baseline and Week 24 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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NIS, GvHD, Korea, Graft-versus-Host disease, ruxolitinib, Jakavi