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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

127 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-04-07

Study Completion Date

2026-05-09

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

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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.

Conditions

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Graft-versus-Host Disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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ruxolitinib

Patients currently receiving or going to receive Jakavi® treatment according to locally approved label

ruxolitinib

Intervention Type OTHER

Prospective observational study. There is no treatment allocation. Patients prescribed with ruxolitinib in the commercial setting are eligible to enroll into this study.

Interventions

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ruxolitinib

Prospective observational study. There is no treatment allocation. Patients prescribed with ruxolitinib in the commercial setting are eligible to enroll into this study.

Intervention Type OTHER

Other Intervention Names

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Jakavi

Eligibility Criteria

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Inclusion Criteria

1. Patients who diagnosed with GvHD and currently receiving or going to receive Jakavi® treatment according to locally approved label
2. Patients who are willing to provide written informed consent prior to study enrollment

Exclusion Criteria

1. Patients under 12 years old
2. Patients with contraindication according to locally approved label of Jakavi®
3. Patients who receive or are going to receive any investigational medicine during the observation period.

Minimum Eligible Age

12 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No