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

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

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

Study Overview

• Status: Recruiting
• Conditions: Graft-versus-Host Disease
• Intervention / Treatment: 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 Type: Observational
• Enrollment (Estimated): 127

Contacts and Locations

• Study Contact: Name: Novartis Pharmaceuticals; Phone Number: +41613241111; Email: novartis.email@novartis.com
• Study Contact Backup: Name: Novartis Pharmaceuticals

Study Locations

• Korea, Republic of
  • Busan, Korea, Republic of, 48108
    • Recruiting
    • Novartis Investigative Site
  • Busan, Korea, Republic of, 602-030
    • Recruiting
    • Novartis Investigative Site
  • Busan, Korea, Republic of, 49241
    • Recruiting
    • Novartis Investigative Site
  • Jeollanam, Korea, Republic of, 519763
    • Recruiting
    • Novartis Investigative Site
  • Jinju, Korea, Republic of, 660-702
    • Recruiting
    • Novartis Investigative Site
  • Seoul, Korea, Republic of, 05505
    • Recruiting
    • Novartis Investigative Site
  • Seoul, Korea, Republic of, 02841
    • Recruiting
    • Novartis Investigative Site
  • Taegu, Korea, Republic of, 41944
    • Recruiting
    • Novartis Investigative Site
  • Dalseo gu
    • Daegu, Dalseo gu, Korea, Republic of, 42602
      • Recruiting
      • Novartis Investigative Site
  • Gangwon-do
    • Wonju-si, Gangwon-do, Korea, Republic of, 26426
      • Recruiting
      • Novartis Investigative Site
  • Seocho gu
    • Seoul, Seocho gu, Korea, Republic of, 06591
      • Recruiting
      • Novartis Investigative Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No

• 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

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
Death rate	Death rate will be provided	Week 4 and Week 24
Percentage change in CBC	Percentage change in CBC (hemoglobin, hematocrit, platelets, white blood cell (WBC) counts) will be provided	Baseline and Week 24

Collaborators and Investigators

• Sponsor: Novartis Pharmaceuticals
• Investigators: Study Director: Novartis Pharmaceuticals, Novartis Pharmaceuticals

Study record dates

Study Major Dates

• Study Start (Actual): April 7, 2023
• Primary Completion (Estimated): May 9, 2026
• Study Completion (Estimated): May 9, 2026

Study Registration Dates

• First Submitted: November 10, 2022
• First Submitted That Met QC Criteria: November 10, 2022
• First Posted (Actual): November 18, 2022

Study Record Updates

• Last Update Posted (Actual): August 11, 2025
• Last Update Submitted That Met QC Criteria: August 6, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Keywords: NIS; Jakavi; GvHD; ruxolitinib; Korea; Graft-versus-Host disease
• Additional Relevant MeSH Terms: Immune System Diseases; Graft vs Host Disease
• Other Study ID Numbers: CINC424C2415

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO