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

Arthritis, Rheumatoid Clinical Trial

Official title:

Post Marketing Surveillance of Jyseleca Tab. (Filgotinib Maleate) in Korean Subjects

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06246123
• Other study ID #: FIL-M082-501
• Status: Recruiting
• Start date: February 27, 2024
• Est. completion date: November 1, 2027

Study information

• Verified date: January 2024
• Source: Eisai Inc.
• Contact: Serena SoYoun Kwon
• Phone: +82-2-3451-5533
• Email: s-kwon[@]eisaikorea.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2040
• Est. completion date: November 1, 2027
• Est. primary completion date: November 1, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Individuals who are being administered with Jyseleca tablet in accordance with the Korean approved label therapeutic indications.

• 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.
• Following:

1. Participants over 65 years of age.

2. Participants with a high cardiovascular risk.

3. Participants with malignancy.

• Rheumatoid arthritis:

1. For treatment of moderately to severely active rheumatoid arthritis in adults who have responded inadequately to, or who are intolerant to one or more disease-modifying anti-rheumatic drugs (DMARDs).

2. Jyseleca tablet may be used as monotherapy or in combination with methotrexate (MTX).

3. Jyseleca tablet should not be used in combination with biological DMARDs (bDMARDs) or other Janus kinase (JAK) inhibitors.

• Ulcerative colitis:

a. For treatment of moderately to severely active ulcerative colitis in adults who have an inadequate response with, lost response to, or were intolerant to either conventional therapy (corticosteroids, immunosuppressants, etc.) or biological agents.

• The investigator should refer to local label and contraindications in Korea regarding the inclusion criteria.

Exclusion Criteria:

1. Individuals who fall under contraindications to the administration of Jyseleca tablet in accordance with the local label by the medical judgment of the investigator.

• Contraindication for Jyseleca tablet in accordance with the Korean label:

1. Participants with hypersensitivity to the active ingredient or other ingredients of the Jyseleca tablet.

2. Participants with active infections, including serious (example, sepsis) or local infections.

3. Participants with active tuberculosis.

4. Participants with severe hepatic disorder.

5. Participants with end-stage renal disorder.

6. Participants with absolute neutrophil count (ANC) <1*10^9 cells/liters (L)

7. Participants with absolute lymphocyte count (ALC) <0.5*10^9 cells/L

8. Participants with hemoglobin level <8 grams per deciliter (g/dL)

9. Pregnant or potentially pregnant women, lactating women

10. Jyseleca tablet should not be administered to participants with genetic problems such as galactose intolerance, total lactase deficiency, or glucose-galactose malabsorption as it contains lactose.

2. Individuals who are administered Filgotinib in a clinical study other than this post marketing surveillance.

3. Individuals who are considered incompatible with participate in this surveillance by the medical judgment of the investigator.

• The investigator should refer to local label and contraindications in Korea regarding the exclusion criteria.

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Colitis
• Colitis, Ulcerative

Intervention

Other:
• Non-interventional
No intervention will be administered.

Locations

Country	Name	City	State
Korea, Republic of	Site #10	Busan
Korea, Republic of	Site #11	Busan
Korea, Republic of	Site #15	Busan
Korea, Republic of	Site #16	Busan
Korea, Republic of	Site #17	Busan
Korea, Republic of	Site #5	Busan
Korea, Republic of	Site #7	Busan
Korea, Republic of	Site #22	Changwon
Korea, Republic of	Site #14	Cheongju
Korea, Republic of	Site #2	Choonchen
Korea, Republic of	Site #12	Daegu
Korea, Republic of	Site #20	Daegu
Korea, Republic of	Site #21	Daegu
Korea, Republic of	Site #26	Daegu
Korea, Republic of	Site #3	Daegu
Korea, Republic of	Site #6	Daejeon
Korea, Republic of	Site #9	Gwangju
Korea, Republic of	Site #13	Jeju
Korea, Republic of	Site #18	Jeonju
Korea, Republic of	Site #23	Jinju
Korea, Republic of	Site #1	Seoul
Korea, Republic of	Site #19	Seoul
Korea, Republic of	Site #8	Seoul
Korea, Republic of	Site #24	Wonju
Korea, Republic of	Site #4	Wonju
Korea, Republic of	Site #25	Yongin

Sponsors (1)

Lead Sponsor	Collaborator
Eisai Korea Inc.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	From the date of enrollment up to 24 weeks
Primary	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.	From the date of enrollment up to 24 weeks
Primary	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.	From the date of enrollment up to 24 weeks
Primary	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.	From the date of enrollment up to 24 weeks
Primary	Number of Participants With Known ADRs	Known AEs are those listed in product licensure/notification of the drug and are also considered as known ADRs.	From the date of enrollment up to 24 weeks
Primary	Number of Participants With Non-serious AEs	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.	From the date of enrollment up to 24 weeks
Primary	Number of Participants With Non-serious ADRs	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.	From the date of enrollment up to 24 weeks
Primary	Change From Baseline in Disease Activity Score 28 Based on C-Reactive Protein (DAS28-CRP) at 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.	Baseline, Week 12 and Week 24
Primary	Change From Baseline in the Mayo Clinic Score (MCS) at 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.	Baseline, Week 12 and Week 24