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

Sponsor

Novartis Pharmaceuticals (Industry)

Overall Status

Not yet recruiting

CT.gov ID

NCT05621733

Collaborator

(none)

127

Enrollment

37.4

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Graft-versus-Host Disease	Other: ruxolitinib

Detailed Description

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 Design

Study Type:

Observational

Anticipated Enrollment :

127 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Anticipated Study Start Date :

Mar 31, 2023

Anticipated Primary Completion Date :

May 13, 2026

Anticipated Study Completion Date :

May 13, 2026

Arms and Interventions

Arm	Intervention/Treatment
ruxolitinib Patients currently receiving or going to receive Jakavi® treatment according to locally approved label	Other: ruxolitinib Prospective observational study. There is no treatment allocation. Patients prescribed with ruxolitinib in the commercial setting are eligible to enroll into this study. Other Names: Jakavi

Arm

Intervention/Treatment

ruxolitinib

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

Other: ruxolitinib

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

Other Names:

Jakavi

Outcome Measures

Primary Outcome Measures

Proportion of patients with an AE/ ADR [Up to 24 weeks]
Proportion of patients with an adverse event (AE)/ adverse drug reaction (ADR) will be provided
Proportion of patients with a SAE/ SADR [Up to 24 weeks]
Proportion of patients with a serious AE (SAE)/ serious ADR (SADR) will be provided
Proportion of patients with an UAE/ UADR [Up to 24 weeks]
Proportion of patients with an unexpected AE (UAE)/ unexpected ADR (UADR) will be provided
Proportion of patients with a SUAE/ SUADR [Up to 24 weeks]
Proportion of patients with a serious unexpected AE (SUAE)/ serious unexpected ADR (SUADR) will be provided

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

12 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.