A Study of Jyseleca Tablet (Filgotinib Maleate) in Korean Participants

Condition(s) studied

Investigational drug(s) / intervention(s)

Non-interventional: No intervention will be administered.

Study summary

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

Primary outcome measure(s)

• Number of Participants With Serious Adverse Events (SAEs) — From the date of enrollment up to 24 weeks
  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.
• Number of Participants With Adverse Drug Reactions (ADRs) — From the date of enrollment up to 24 weeks
  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.
• Number of Participants With Unexpected AEs — From the date of enrollment up to 24 weeks
  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.
• Number of Participants With Unexpected ADRs — From the date of enrollment up to 24 weeks
  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.
• Number of Participants With Known ADRs — From the date of enrollment up to 24 weeks
  Known AEs are those listed in product licensure/notification of the drug and are also considered as known ADRs.
• Number of Participants With Non-serious AEs — From the date of enrollment up to 24 weeks
  Non-serious AEs are other than SAE among AEs. An AE is defined as any undesirable and unintended signs (example, abnormalities in laboratory test) or symptoms/diseases occurring during administration/use of drugs, which do not need causal relationship with relevant study drug.
• Number of Participants With Non-serious ADRs — From the date of enrollment up to 24 weeks
  Non-serious ADRs are other than SAE among ADR. 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.
• Change From Baseline in Disease Activity Score 28 Based on C-Reactive Protein (DAS28-CRP) at Week 12 and Week 24 — Baseline, Week 12 and Week 24
  The DAS28 index for rheumatoid arthritis participants was a composite score of weighted components including tender joint counts of 28, swollen joint counts of 28, participant global assessment of disease activity score, and CRP value. A DAS28-CRP score of 5.1 or above =high disease activity, a value between greater than (\>) 3.2 and 5.1 =moderate disease activity and value between 2.6 and 3.2 =low disease activity, value less than (\<) 2.6 =disease remission.
• Change From Baseline in the Mayo Clinic Score (MCS) at Week 12 and Week 24 — Baseline, Week 12 and Week 24
  The Mayo Clinic Score for ulcerative colitis participants is comprised of 4 parts: stool frequency, rectal bleeding, endoscopic findings, and physician's global assessment, each scored from 0 to 3, where 0=normal, 3=severe. The total score ranges from 0 to 12, with higher scores indicating increased severity of disease.

Trial sites (59)

+ 19 more sites — see the full list on the official registry below.

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