An observational study in Graft-versus-Host Disease, sponsored by Novartis Pharmaceuticals. Completed at 14 sites in South Korea. Open to participants aged 12 Years to 100 Years. Per ClinicalTrials.gov, last updated 2026-08-13.
Sponsored by Novartis Pharmaceuticals · Observational
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
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.
806 studies on the registry are indexed under Graft vs Host Disease; 138 are open to participants now.
This study's enrollment of 140 is above the median of 94 across 102 observational studies indexed under Graft vs Host Disease.
Browse Graft vs Host Disease studies →Novartis Pharmaceuticals is the lead sponsor of 2,673 studies on the registry; 228 are open to participants now.
Of its 576 completed or terminated interventional studies of FDA-regulated products, 431 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
Patients who are going to receive Jakavi® for the first time or those who are currently taking Jakavi® per clinical judgment
Exclusion Criteria:
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.
Also known as: Jakavi
Proportion of patients with an AE/ ADR
Proportion of patients with an adverse event (AE)/ adverse drug reaction (ADR) will be provided
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Up to 24 weeks
Overall response rate (ORR)
ORR will be analyzed to the proportion of all participants demonstrating complete response (CR) or partial response (PR).
Time frame: 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.
Time frame: Week 4 and Week 24
Death rate
Death rate will be provided
Time frame: Week 4 and Week 24
Percentage change in CBC
Percentage change in CBC (hemoglobin, hematocrit, platelets, white blood cell (WBC) counts) will be provided
Time frame: Baseline and Week 24
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Novartis Pharmaceuticals