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

Graft-versus-Host Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05621733
• Other study ID #: CINC424C2415
• Status: Recruiting
• Start date: April 7, 2023
• Est. completion date: May 13, 2026

Study information

• Verified date: October 2023
• Source: Novartis
• Contact: Novartis Pharmaceuticals
• Phone: +41613241111
• Email: novartis.email[@]novartis.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 127
• Est. completion date: May 13, 2026
• Est. primary completion date: May 13, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Graft vs Host Disease
• Graft-versus-Host Disease

Intervention

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.

Locations

Country	Name	City	State
Korea, Republic of	Novartis Investigative Site	Busan
Korea, Republic of	Novartis Investigative Site	Busan
Korea, Republic of	Novartis Investigative Site	Busan
Korea, Republic of	Novartis Investigative Site	Jeollanam
Korea, Republic of	Novartis Investigative Site	Jinju
Korea, Republic of	Novartis Investigative Site	Seoul
Korea, Republic of	Novartis Investigative Site	Taegu
Korea, Republic of	Novartis Investigative Site	Wonju-si	Gangwon-do

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of patients with an AE/ ADR	Proportion of patients with an adverse event (AE)/ adverse drug reaction (ADR) will be provided	Up to 24 weeks
Primary	Proportion of patients with a SAE/ SADR	Proportion of patients with a serious AE (SAE)/ serious ADR (SADR) will be provided	Up to 24 weeks
Primary	Proportion of patients with an UAE/ UADR	Proportion of patients with an unexpected AE (UAE)/ unexpected ADR (UADR) will be provided	Up to 24 weeks
Primary	Proportion of patients with a SUAE/ SUADR	Proportion of patients with a serious unexpected AE (SUAE)/ serious unexpected ADR (SUADR) will be provided	Up to 24 weeks
Secondary	Overall response rate (ORR)	ORR will be analyzed to the proportion of all participants demonstrating complete response (CR) or partial response (PR).	Week 4 and Week 24
Secondary	Treatment failure rate	Treatment failure will be analyzed to the proportion of all participants demonstrating lack of response except for CR or PR.	Week 4 and Week 24
Secondary	Death rate	Death rate will be provided	Week 4 and Week 24
Secondary	Percentage change in CBC	Percentage change in CBC (hemoglobin, hematocrit, platelets, white blood cell (WBC) counts) will be provided	Baseline and Week 24