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
Qualifiers
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 design
Treatments tested in this trial
- Non-interventional
Treatment groups
2,040 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov