Graft-versus-Host Disease
Conditions
Keywords
Graft-versus-Host disease, GvHD, NIS, Korea, ruxolitinib, Jakavi
Brief 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
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.
Interventions
OTHERruxolitinib
Prospective observational study. There is no treatment allocation. Patients prescribed with ruxolitinib in the commercial setting are eligible to enroll into this study.
Sponsors
Novartis Pharmaceuticals
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
12 Years to 100 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of patients with an AE/ ADR | 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 | 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 | 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 | Up to 24 weeks | Proportion of patients with a serious unexpected AE (SUAE)/ serious unexpected ADR (SUADR) will be provided |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall response rate (ORR) | Week 4 and Week 24 | ORR will be analyzed to the proportion of all participants demonstrating complete response (CR) or partial response (PR). |
| Treatment failure rate | Week 4 and Week 24 | Treatment failure will be analyzed to the proportion of all participants demonstrating lack of response except for CR or PR. |
| Death rate | Week 4 and Week 24 | Death rate will be provided |
| Percentage change in CBC | Baseline and Week 24 | Percentage change in CBC (hemoglobin, hematocrit, platelets, white blood cell (WBC) counts) will be provided |
Countries
South Korea
Contacts
STUDY_DIRECTORNovartis Pharmaceuticals
Novartis Pharmaceuticals
Outcome results
None listed