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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ruxolitinib | Patients currently receiving or going to receive Jakavi® treatment according to locally approved label |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of patients with an AE/ ADR | Proportion of patients with an adverse event (AE)/ adverse drug reaction (ADR) will be provided | 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 | 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 | 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 | Up to 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Overall response rate (ORR) | ORR will be analyzed to the proportion of all participants demonstrating complete response (CR) or partial response (PR). | Week 4 and Week 24 |
| Treatment failure rate |
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Inclusion Criteria:
Exclusion Criteria:
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Patients who are going to receive Jakavi® for the first time or those who are currently taking Jakavi® per clinical judgment
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Novartis Pharmaceuticals | Contact | +41613241111 | novartis.email@novartis.com | |
| Novartis Pharmaceuticals | Contact |
| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novartis Investigative Site | Recruiting | Daegu | Dalseo gu | 42602 | South Korea | |
| Novartis Investigative Site |
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|
Treatment failure will be analyzed to the proportion of all participants demonstrating lack of response except for CR or PR.
| Week 4 and Week 24 |
| Death rate | Death rate will be provided | Week 4 and Week 24 |
| Percentage change in CBC | Percentage change in CBC (hemoglobin, hematocrit, platelets, white blood cell (WBC) counts) will be provided | Baseline and Week 24 |
| Recruiting |
| Wŏnju |
| Gangwon-do |
| 26426 |
| South Korea |
| Novartis Investigative Site | Recruiting | Seoul | Seocho gu | 06591 | South Korea |
| Novartis Investigative Site | Recruiting | Busan | 48108 | South Korea |
| Novartis Investigative Site | Recruiting | Busan | 49241 | South Korea |
| Novartis Investigative Site | Recruiting | Busan | 602-030 | South Korea |
| Novartis Investigative Site | Recruiting | Jeollanam | 519763 | South Korea |
| Novartis Investigative Site | Recruiting | Jinju | 660-702 | South Korea |
| Novartis Investigative Site | Recruiting | Seoul | 02841 | South Korea |
| Novartis Investigative Site | Recruiting | Seoul | 05505 | South Korea |
| Novartis Investigative Site | Recruiting | Taegu | 41944 | South Korea |
| ID | Term |
|---|---|
| D006086 | Graft vs Host Disease |
| ID | Term |
|---|---|
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| C540383 | ruxolitinib |
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