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
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.
Study Type
OBSERVATIONAL
Enrollment
140
Prospective observational study. There is no treatment allocation. Patients prescribed with ruxolitinib in the commercial setting are eligible to enroll into this study.
Novartis Investigative Site
Daegu, Dalseo gu, South Korea
Novartis Investigative Site
Wŏnju, Gangwon-do, South Korea
Novartis Investigative Site
Uijeongbu-si, Gyeonggi-do, South Korea
Proportion of patients with an AE/ ADR
Proportion of patients with an adverse event (AE)/ adverse drug reaction (ADR) will be provided
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Up to 24 weeks
Overall response rate (ORR)
ORR will be analyzed to the proportion of all participants demonstrating complete response (CR) or partial response (PR).
Time frame: 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.
Time frame: Week 4 and Week 24
Death rate
Death rate will be provided
Time frame: Week 4 and Week 24
Percentage change in CBC
Percentage change in CBC (hemoglobin, hematocrit, platelets, white blood cell (WBC) counts) will be provided
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Novartis Investigative Site
Jinju, Gyeongsangnam-do, South Korea
Novartis Investigative Site
Gyeonggi-do, Korea, South Korea
Novartis Investigative Site
Seoul, Korea, South Korea
Novartis Investigative Site
Seoul, Seoul, South Korea
Novartis Investigative Site
Busan, South Korea
Novartis Investigative Site
Busan, South Korea
Novartis Investigative Site
Busan, South Korea
...and 4 more locations
Time frame: Baseline and Week 24