Clinical trial NCT05621733: A PMS of Jakavi® in Patients With Steroid-Refractory Graft-versus-Host Disease (SR-GvHD) in Korea
Official title: A Post Marketing Surveillance of Jakavi® (Ruxolitinib) in Patients With Steroid-Refractory Graft-versus-Host Disease (SR-GvHD) in Korea
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Graft-versus-Host Disease
Keywords: Graft-versus-Host disease
GvHD
NIS
Korea
ruxolitinib
Jakavi
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2022-11-18
Enrollment: 127
Sex: ALL
Minimum age (years): 12
Maximum age (years): 100
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who are going to receive Jakavi® for the first time or those who are currently taking Jakavi® per clinical judgment

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

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Proportion of patients with an AE/ ADR
timeFrame: Up to 24 weeks
measure: Proportion of patients with a SAE/ SADR
timeFrame: Up to 24 weeks
measure: Proportion of patients with an UAE/ UADR
timeFrame: Up to 24 weeks
measure: Proportion of patients with a SUAE/ SUADR
timeFrame: Up to 24 weeks
Secondary outcomes:
measure: Overall response rate (ORR)
timeFrame: Week 4 and Week 24
measure: Treatment failure rate
timeFrame: Week 4 and Week 24
measure: Death rate
timeFrame: Week 4 and Week 24
measure: Percentage change in CBC
timeFrame: Baseline and Week 24
Other outcomes:
Locations:
city: Wonju-si
country: Korea, Republic of
facility: Novartis Investigative Site
state: Gangwon-do
city: Busan
country: Korea, Republic of
facility: Novartis Investigative Site
city: Busan
country: Korea, Republic of
facility: Novartis Investigative Site
city: Busan
country: Korea, Republic of
facility: Novartis Investigative Site
city: Jeollanam
country: Korea, Republic of
facility: Novartis Investigative Site
city: Jinju
country: Korea, Republic of
facility: Novartis Investigative Site
city: Seoul
country: Korea, Republic of
facility: Novartis Investigative Site
city: Taegu
country: Korea, Republic of
facility: Novartis Investigative Site
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References: