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

Novartis

Status

Enrolling

Conditions

Graft-versus-Host Disease

Treatments

Other: ruxolitinib

Study type

Observational

Funder types

Industry

Identifiers

NCT05621733

CINC424C2415

Details and patient eligibility

About

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

Full 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.

Enrollment

127 estimated patients

Sex

All

Ages

12 to 100 years old

Volunteers

No 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.