Graft-versus-Host DiseaseNCT05621733
A PMS of Jakavi® in Patients With Steroid-Refractory Graft-versus-Host Disease (SR-GvHD) in Korea
An observational study of Graft-versus-Host Disease, run by Novartis Pharmaceuticals at 14 sites in South Korea.
Trial 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 Read more about this study
- Who is it for?
- Ages 12 to 100 years
- Conditions the study is for
- Graft-versus-Host Disease
- What is being tested?
- ruxolitinib
- How many people
- 140 participants
- Where
- 14 sitesSouth Korea
- Study dates
- 7 Apr 2023to 8 May 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 100 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients who are going to receive Jakavi® for the first time or those who are currently taking Jakavi® per clinical judgment
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
14 sites in 1 country.
14 sites in 1 country
South Korea14 sites
Novartis Investigative Site
Busan, 48108
Novartis Investigative Site
Busan, 49241
Novartis Investigative Site
Busan, 602-030
Novartis Investigative Site
Daegu, Dalseo gu, 42602
Novartis Investigative Site
Gyeonggi-do, Korea, 10408
Novartis Investigative Site
Jeollanam, 519763
Novartis Investigative Site
Jinju, Gyeongsangnam-do, 52727
Novartis Investigative Site
Seoul, Korea, 02841
Novartis Investigative Site
Seoul, Seoul, 06351
Novartis Investigative Site
Seoul, 05505
Novartis Investigative Site
Seoul, 06591
Novartis Investigative Site
Taegu, 41944
Novartis Investigative Site
Uijeongbu-si, Gyeonggi-do, 11759
Novartis Investigative Site
Wŏnju, Gangwon-do, 26426
About this study
Official title: A Post Marketing Surveillance of Jakavi® (Ruxolitinib) 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
Read the detailed description
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.
- Conditions
- Graft-versus-Host Disease
- Being tested
- ruxolitinib
- Keywords
- Graft-versus-Host disease, GvHD, NIS, Korea, ruxolitinib, Jakavi
- Medical subject headings
- Graft vs Host Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ruxolitinibOther
Also called Jakavi
Prospective observational study. There is no treatment allocation. Patients prescribed with ruxolitinib in the commercial setting are eligible to enroll into this study.
| Study group | Role | What they receive |
|---|---|---|
| ruxolitinib | Patients currently receiving or going to receive Jakavi® treatment according to locally approved label Receives: Other: ruxolitinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients with an AE/ ADR
Proportion of patients with an adverse event (AE)/ adverse drug reaction (ADR) will be provided
Measured: 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
Measured: 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
Measured: 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
Measured: Up to 24 weeks
Secondary outcomes (4)
Overall response rate (ORR)
ORR will be analyzed to the proportion of all participants demonstrating complete response (CR) or partial response (PR).
Measured: 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.
Measured: Week 4 and Week 24
Death rate
Death rate will be provided
Measured: Week 4 and Week 24
Percentage change in CBC
Percentage change in CBC (hemoglobin, hematocrit, platelets, white blood cell (WBC) counts) will be provided
Measured: Baseline and Week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2022
- Study start7 Apr 2023
- Primary completion8 May 2026
- Study completion8 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Graft-versus-Host DiseaseStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05621733
- Sponsor's protocol ID
- CINC424C2415
- Status last verified
- Aug 2026
- First submitted
- 10 Nov 2022
- Last updated
- 13 Aug 2026
- Results posted
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Post Marketing Surveillance of Jakavi® (Ruxolitinib) in Patients With Steroid-Refractory Graft-versus-Host Disease (SR-GvHD) in Korea
- ClinicalTrials.gov ID
- NCT05621733
- Acronym / sponsor ID
- CINC424C2415
- Conditions
- Graft-versus-Host Disease
- Keywords
- Graft-versus-Host disease, GvHD, NIS, Korea, ruxolitinib, Jakavi
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 7 Apr 2023 (actual)
- Primary completion
- 8 May 2026 (actual)
- Study completion
- 8 May 2026 (actual)
- First posted
- 18 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ruxolitinib | – | Other: ruxolitinibPatients currently receiving or going to receive Jakavi® treatment according to locally approved label |
Who may qualify
- Ages
- 12 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients who are going to receive Jakavi® for the first time or those who are currently taking Jakavi® per clinical judgment
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ruxolitinibAlso: JakaviProspective observational study. There is no treatment allocation. Patients prescribed with ruxolitinib in the commercial setting are eligible to enroll into this study. | Other | ruxolitinib |
Primary outcome
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
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
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
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
4 secondary outcomes
Overall response rate (ORR)
Time frame: Week 4 and Week 24
Treatment failure rate
Time frame: Week 4 and Week 24
Death rate
Time frame: Week 4 and Week 24
Percentage change in CBC
Time frame: Baseline and Week 24
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Novartis Pharmaceuticals study director
Novartis Pharmaceuticals
14 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Graft-versus-Host Disease, run by Novartis Pharmaceuticals at 14 sites in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients with an AE/ ADR (time frame: Up to 24 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Aug 2026.