Clinical trial NCT06246123: A Study of Jyseleca Tablet (Filgotinib Maleate) in Korean Participants
Official title: Post Marketing Surveillance of Jyseleca Tab. (Filgotinib Maleate) in Korean Subjects
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Arthritis, Rheumatoid
Colitis, Ulcerative
Keywords: Filgotinib Maleate
Rheumatoid arthritis
Ulcerative colitis
FIL-M082-501
Lead sponsor: Eisai Inc.
Sponsor class: INDUSTRY
First posted: 2024-02-07
Enrollment: 2040
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study 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.

Brief 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 criteria: 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.

Primary outcomes:
measure: Number of Participants With Serious Adverse Events (SAEs)
timeFrame: From the date of enrollment up to 24 weeks
measure: Number of Participants With Adverse Drug Reactions (ADRs)
timeFrame: From the date of enrollment up to 24 weeks
measure: Number of Participants With Unexpected AEs
timeFrame: From the date of enrollment up to 24 weeks
measure: Number of Participants With Unexpected ADRs
timeFrame: From the date of enrollment up to 24 weeks
measure: Number of Participants With Known ADRs
timeFrame: From the date of enrollment up to 24 weeks
measure: Number of Participants With Non-serious AEs
timeFrame: From the date of enrollment up to 24 weeks
measure: Number of Participants With Non-serious ADRs
timeFrame: From the date of enrollment up to 24 weeks
measure: Change From Baseline in Disease Activity Score 28 Based on C-Reactive Protein (DAS28-CRP) at Week 12 and Week 24
timeFrame: Baseline, Week 12 and Week 24
measure: Change From Baseline in the Mayo Clinic Score (MCS) at Week 12 and Week 24
timeFrame: Baseline, Week 12 and Week 24
Secondary outcomes:
Other outcomes:
Locations:
city: Ansan
country: Korea, Republic of
facility: Site #28
city: Busan
country: Korea, Republic of
facility: Site #10
city: Busan
country: Korea, Republic of
facility: Site #11
city: Busan
country: Korea, Republic of
facility: Site #15
city: Busan
country: Korea, Republic of
facility: Site #16
city: Busan
country: Korea, Republic of
facility: Site #17
city: Busan
country: Korea, Republic of
facility: Site #5
city: Busan
country: Korea, Republic of
facility: Site #7
city: Changwon
country: Korea, Republic of
facility: Site #22
city: Cheongju
country: Korea, Republic of
facility: Site #14
city: Choonchen
country: Korea, Republic of
facility: Site #2
city: Daegu
country: Korea, Republic of
facility: Site #12
city: Daegu
country: Korea, Republic of
facility: Site #20
city: Daegu
country: Korea, Republic of
facility: Site #21
city: Daegu
country: Korea, Republic of
facility: Site #26
city: Daegu
country: Korea, Republic of
facility: Site #36
city: Daegu
country: Korea, Republic of
facility: Site #3
city: Daejeon
country: Korea, Republic of
facility: Site #6
city: Gwangju
country: Korea, Republic of
facility: Site #9
city: Gyeonggi
country: Korea, Republic of
facility: Site #35
city: Jeju
country: Korea, Republic of
facility: Site #13
city: Jeonbuk
country: Korea, Republic of
facility: Site #29
city: Jeonju
country: Korea, Republic of
facility: Site #18
city: Jeonnam
country: Korea, Republic of
facility: Site #37
city: Jinju
country: Korea, Republic of
facility: Site #23
city: Kyungpook
country: Korea, Republic of
facility: Site #31
city: Kyungpook
country: Korea, Republic of
facility: Site #33
city: Seoul
country: Korea, Republic of
facility: Site #19
city: Seoul
country: Korea, Republic of
facility: Site #1
city: Seoul
country: Korea, Republic of
facility: Site #27
city: Seoul
country: Korea, Republic of
facility: Site #30
city: Seoul
country: Korea, Republic of
facility: Site #32
city: Seoul
country: Korea, Republic of
facility: Site #34
city: Seoul
country: Korea, Republic of
facility: Site #38
city: Seoul
country: Korea, Republic of
facility: Site #39
city: Seoul
country: Korea, Republic of
facility: Site #40
city: Seoul
country: Korea, Republic of
facility: Site #41
city: Seoul
country: Korea, Republic of
facility: Site #42
city: Seoul
country: Korea, Republic of
facility: Site #8
city: Wonju
country: Korea, Republic of
facility: Site #24
city: Wonju
country: Korea, Republic of
facility: Site #4
city: Yongin
country: Korea, Republic of
facility: Site #25
Study officials:
References: