NCT05621733

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

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
127

participants targeted

Target at P50-P75 for all trials

Timeline
0mo left

Started Apr 2023

Typical duration for all trials

Geographic Reach
1 country

11 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 10, 2022

Completed
8 days until next milestone

First Posted

Study publicly available on registry

November 18, 2022

Completed
5 months until next milestone

Study Start

First participant enrolled

April 7, 2023

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 9, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 9, 2026

Last Updated

August 11, 2025

Status Verified

August 1, 2025

Enrollment Period

3.1 years

First QC Date

November 10, 2022

Last Update Submit

August 6, 2025

Conditions

Graft-versus-Host Disease

Keywords

Graft-versus-Host diseaseGvHDNISKorearuxolitinibJakavi

Outcome Measures

Primary Outcomes (4)

  • 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 Outcomes (4)

  • Overall response rate (ORR)

    Week 4 and Week 24

  • Treatment failure rate

    Week 4 and Week 24

  • Death rate

    Week 4 and Week 24

  • Percentage change in CBC

    Baseline and Week 24

Study Arms (1)

ruxolitinib

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

Other: ruxolitinib

Interventions

ruxolitinibOTHER

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

Also known as: Jakavi
ruxolitinib

Eligibility Criteria

Age12 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-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

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (11)

Novartis Investigative Site

Daegu, Dalseo gu, 42602, South Korea

RECRUITING

Novartis Investigative Site

Wŏnju, Gangwon-do, 26426, South Korea

RECRUITING

Novartis Investigative Site

Seoul, Seocho gu, 06591, South Korea

RECRUITING

Novartis Investigative Site

Busan, 48108, South Korea

RECRUITING

Novartis Investigative Site

Busan, 49241, South Korea

RECRUITING

Novartis Investigative Site

Busan, 602-030, South Korea

RECRUITING

Novartis Investigative Site

Jeollanam, 519763, South Korea

RECRUITING

Novartis Investigative Site

Jinju, 660-702, South Korea

RECRUITING

Novartis Investigative Site

Seoul, 02841, South Korea

RECRUITING

Novartis Investigative Site

Seoul, 05505, South Korea

RECRUITING

Novartis Investigative Site

Taegu, 41944, South Korea

RECRUITING

MeSH Terms

Conditions

Graft vs Host Disease

Interventions

ruxolitinib

Condition Hierarchy (Ancestors)

Immune System Diseases

Study Officials

  • Novartis Pharmaceuticals

    Novartis Pharmaceuticals

    STUDY DIRECTOR

Central Study Contacts

Novartis Pharmaceuticals

CONTACT

+41613241111novartis.email@novartis.com

Novartis Pharmaceuticals

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 10, 2022

First Posted

November 18, 2022

Study Start

April 7, 2023

Primary Completion (Estimated)

May 9, 2026

Study Completion (Estimated)

May 9, 2026

Last Updated

August 11, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will not share

Locations

KR(11)