Assessing Jakavi® for patients with steroid-refractory Graft-versus-Host Disease 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 testing if Jakavi® can safely help people in Korea who have Graft-versus-Host Disease that hasn't improved with steroids.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 127 (estimated) |
| Ages | 12 Years to 100 Years |
| Sex | All |
| Sponsor | Novartis Industry-sponsored |
| Drugs / interventions | ruxolitinib |
| Locations | 11 sites (Daegu, Dalseo gu and 10 other locations) |
| Trial ID | NCT05621733 on ClinicalTrials.gov |
What this trial studies
This observational study aims to evaluate the safety and effectiveness of Jakavi® (ruxolitinib) in patients with steroid-refractory Graft-versus-Host Disease (GvHD) in Korea. It will involve a multi-center approach where patients who are newly starting or currently on Jakavi® will be monitored over a 24-week follow-up period. The study will assess the treatment's safety and durable effectiveness based on real-world clinical data. Participants will be required to provide informed consent and will be monitored for adverse events following treatment.
Who should consider this trial
Good fit: Ideal candidates for this study are patients diagnosed with GvHD who are either starting or currently receiving Jakavi® treatment.
Not a fit: Patients under 12 years old or those with contraindications to Jakavi® will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide valuable insights into the effectiveness of Jakavi® for managing steroid-refractory GvHD, potentially improving patient outcomes.
How similar studies have performed: While this study is observational, similar studies evaluating ruxolitinib for GvHD have shown promising results, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Daegu, Dalseo gu and 10 other locations
- Novartis Investigative Site — Daegu, Dalseo gu, South Korea (Recruiting)
- Novartis Investigative Site — Wŏnju, Gangwon-do, South Korea (Recruiting)
- Novartis Investigative Site — Seoul, Seocho gu, South Korea (Recruiting)
- Novartis Investigative Site — Busan, South Korea (Recruiting)
- Novartis Investigative Site — Busan, South Korea (Recruiting)
- Novartis Investigative Site — Busan, South Korea (Recruiting)
- Novartis Investigative Site — Jeollanam, South Korea (Recruiting)
- Novartis Investigative Site — Jinju, South Korea (Recruiting)
- Novartis Investigative Site — Seoul, South Korea (Recruiting)
- Novartis Investigative Site — Seoul, South Korea (Recruiting)
- Novartis Investigative Site — Taegu, South Korea (Recruiting)
Study contacts
- Study coordinator: Novartis Pharmaceuticals
- Email: novartis.email@novartis.com
- Phone: +41613241111
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.