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A PMS of Jakavi® in Patients With Steroid-Refractory Graft-versus-Host Disease (SR-GvHD) in Korea

ConditionGraft-versus-Host Disease
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age12-100
SponsorNovartis Pharmaceuticals

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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 population

Patients who are going to receive Jakavi® for the first time or those who are currently taking Jakavi® per clinical judgment

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • ruxolitinib

    Other intervention

    Prospective observational study. There is no treatment allocation. Patients prescribed with ruxolitinib in the commercial setting are eligible to enroll into this study.

Treatment groups

127 Participants
are divided into 1 treatment group
Group A: ruxolitinib1 intervention

Trial outcomes

Primary outcomes

1

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
2

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
3

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
4

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

Secondary outcomes

1

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
2

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
3

Death rate

Death rate will be provided

Time frame
Week 4 and Week 24
4

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Novartis Pharmaceuticals

Lead sponsor

Source ClinicalTrials.gov
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