A PMS of Jakavi® in Patients With Steroid-Refractory Graft-versus-Host Disease (SR-GvHD) in Korea (NCT05621733) | Clinical Trial Compass
CompletedNot Applicable
A PMS of Jakavi® in Patients With Steroid-Refractory Graft-versus-Host Disease (SR-GvHD) in Korea
South Korea140 participantsStarted 2023-04-07
Plain-language 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
Who can participate
Age range
12 Years – 100 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Since this study is a post-marketing surveillance rather than a traditional clinical trial, what does that mean for how much we already know about Jakavi's safety and effectiveness for steroid-refractory GvHD compared to earlier-phase studies?
2The study has already completed and was focused on tracking adverse drug reactions and serious adverse events in Korean patients — has the safety data collected here changed your thinking at all about how you would use Jakavi for my situation?
3Because this was an observational study rather than a randomized trial, does the information gathered give us a clearer picture of real-world risks I should be aware of before considering Jakavi as a treatment option?
4Given that this surveillance was specifically conducted in Korea, do you think the safety and tolerability findings are relevant to my own background and health profile, or are there differences I should factor in?
5Are there standard treatments for steroid-refractory GvHD that you would recommend trying before Jakavi, and does what was learned in this surveillance study influence that decision at all?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.