A Study of Jyseleca Tablet (Filgotinib Maleate) in Korean Participants
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorEisai Korea Inc.
About this trial
The purpose of this study is to collect and evaluate the following information in relation to the safety and the efficacy of Jyseleca tablet (Filgotinib Maleate) 100 milligram (mg) and 200 mg in this post marketing setting: (1) Serious adverse events and adverse drug reactions (2) Unexpected adverse events and adverse drug reactions not reflected in precautions for use (3) Known adverse drug reactions (4) Non-serious adverse events and adverse drug reactions (5) Other safety and effectiveness related information will be evaluated in accordance with the permitted articles under the actual conditions of use in Korea.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Korean local label therapeutic indications of Jyseleca tablet. In the following participants, Jyseleca tablet should be used only if they do not respond appropriately or are intolerant to existing treatments.
Participants over 65 years of age.
Participants with a high cardiovascular risk.
Participants with malignancy.
Disqualifiers
Individuals who fall under contraindications to the administration of Jyseleca tablet in accordance with the local label by the medical judgment of the investigator.
Participants with hypersensitivity to the active ingredient or other ingredients of the Jyseleca tablet.
Participants with active infections, including serious (example, sepsis) or local infections.
Participants with active tuberculosis.
Trial population
Korean participants who are prescribed with Jyseleca (Filgotinib Maleate) tablet 100 mg and 200 mg per the approved prescribing information will be enrolled in the study.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Non-interventional
Other interventionNo intervention will be administered.
Treatment groups
2,040 Participants
are divided into 1 treatment groupGroup A: All Participants1 intervention
Trial outcomes
Primary outcomes
1
Number of Participants With Serious Adverse Events (SAEs)
A SAE is defined as any undesirable medical occurrence: resulting in death; life threatening; requiring hospitalization or extension of hospitalization; resulting in persistent or significant disability or functional impairment; resulting in congenital malformation or abnormality or other medically significant events than above mentioned criteria.
Time frame
From the date of enrollment up to 24 weeks2
Number of Participants With Adverse Drug Reactions (ADRs)
An ADR is defined as harmful and unintended reaction to the proper administration/use of drugs, in which a causal relationship with the drug in question cannot be ruled out. Adverse events (AEs) with unknown causality to the drug among those voluntarily reported will be also considered ADRs.
Time frame
From the date of enrollment up to 24 weeks3
Number of Participants With Unexpected AEs
An unexpected AE is an AE with a difference in nature, severity, specificity, or outcome, which have not been mentioned in the product licensure/safety notification of the drug.
Time frame
From the date of enrollment up to 24 weeks4
Number of Participants With Unexpected ADRs
Unexpected ADR is also an unexpected AE, where unexpected AE is an AE with a difference in nature, severity, specificity, or outcome, which have not been mentioned in the product licensure/safety notification of the drug.
Time frame
From the date of enrollment up to 24 weeksSponsors and contacts
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Source ClinicalTrials.gov