Skip to main content
OpenTrials
Completed

NCT Number: NCT05621733

A PMS of Jakavi® 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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Graft-Versus-Host Disease Graft vs Host Disease Immune System Diseases

Age range

12 year–100 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Novartis Investigative Site, Daegu, Dalseo gu, South Korea

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Ruxolitinib

Other

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

Primary outcomes

  1. Proportion of patients with an AE/ ADR

    Time frame: Up to 24 weeks

    Proportion of patients with an adverse event (AE)/ adverse drug reaction (ADR) will be provided

  2. Proportion of patients with a SAE/ SADR

    Time frame: Up to 24 weeks

    Proportion of patients with a serious AE (SAE)/ serious ADR (SADR) will be provided

  3. Proportion of patients with an UAE/ UADR

    Time frame: Up to 24 weeks

    Proportion of patients with an unexpected AE (UAE)/ unexpected ADR (UADR) will be provided

  4. Proportion of patients with a SUAE/ SUADR

    Time frame: Up to 24 weeks

    Proportion of patients with a serious unexpected AE (SUAE)/ serious unexpected ADR (SUADR) will be provided

Secondary outcomes

  1. Overall response rate (ORR)

    Time frame: Week 4 and Week 24

    ORR will be analyzed to the proportion of all participants demonstrating complete response (CR) or partial response (PR).

  2. Treatment failure rate

    Time frame: Week 4 and Week 24

    Treatment failure will be analyzed to the proportion of all participants demonstrating lack of response except for CR or PR.

  3. Death rate

    Time frame: Week 4 and Week 24

    Death rate will be provided

  4. Percentage change in CBC

    Time frame: Baseline and Week 24

    Percentage change in CBC (hemoglobin, hematocrit, platelets, white blood cell (WBC) counts) will be provided

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Nov 18, 2022
Registry last updated
Jul 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.