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

Primary outcomes

1. Number of Participants With Serious Adverse Events (SAEs)

   Time frame: 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.

2. Number of Participants With Adverse Drug Reactions (ADRs)

   Time frame: 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.

3. Number of Participants With Unexpected AEs

   Time frame: 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.

4. Number of Participants With Unexpected ADRs

   Time frame: 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.

5. Number of Participants With Known ADRs

   Time frame: 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.

6. Number of Participants With Non-serious AEs

   Time frame: 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.

7. Number of Participants With Non-serious ADRs

   Time frame: 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.

8. Change From Baseline in Disease Activity Score 28 Based on C-Reactive Protein (DAS28-CRP) at Week 12 and Week 24

   Time frame: 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.

9. Change From Baseline in the Mayo Clinic Score (MCS) at Week 12 and Week 24

   Time frame: 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.