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Evaluating the safety and effectiveness of Jyseleca tablet in Korean patients

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

Observational Eisai Inc. · NCT06246123

This study is testing how safe and effective the Jyseleca tablet is for Korean patients with rheumatoid arthritis and ulcerative colitis who haven't found relief with other treatments.

Quick facts

Study typeObservational
Enrollment2040 (estimated)
Ages18 Years and up
SexAll
SponsorEisai Inc. Industry-sponsored
Drugs / interventionsFilgotinib, methotrexate
Locations64 sites (Cheonan, Chungcheongnam-do and 63 other locations)
Trial IDNCT06246123 on ClinicalTrials.gov

What this trial studies

This observational study aims to collect and assess data regarding the safety and efficacy of Jyseleca tablet (Filgotinib Maleate) in Korean participants. It focuses on monitoring serious and non-serious adverse events, as well as any unexpected adverse reactions that may not be included in the product's precautions. The study will evaluate the drug's performance in real-world settings, particularly among patients with rheumatoid arthritis and ulcerative colitis who have not responded adequately to existing treatments. The data collected will help inform the ongoing use of Jyseleca in the Korean population.

Who should consider this trial

Good fit: Ideal candidates for this study are Korean individuals who are currently being treated with Jyseleca tablet for rheumatoid arthritis or ulcerative colitis.

Not a fit: Patients who are not receiving Jyseleca or those who have not been diagnosed with rheumatoid arthritis or ulcerative colitis may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide valuable insights into the safety and effectiveness of Jyseleca for patients with rheumatoid arthritis and ulcerative colitis.

How similar studies have performed: While this study is observational and focuses on post-marketing data, similar studies evaluating the safety and efficacy of treatments in real-world settings have shown success in providing critical insights.

Eligibility criteria

Show full inclusion / exclusion 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.

Where this trial is running

Cheonan, Chungcheongnam-do and 63 other locations

+14 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Arthritis, RheumatoidColitis, UlcerativeFilgotinib MaleateRheumatoid arthritisUlcerative colitisFIL-M082-501
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.