Evaluating the safety and effectiveness of Jyseleca tablet in Korean patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Soonchunhyang University Cheonan Hospital
  Cheonan, Chungcheongnam-do, South Korea Recruiting
• Kangwon National University Hospital
  Chuncheon, Gangwon-do, South Korea Recruiting
• Wonju Severance Christian Hospital
  Wŏnju, Gangwon-do, South Korea Recruiting
• Korea University Ansan Hospital
  Ansan, Gyeonggi-do, South Korea Recruiting
• The Catholic University of Korea Bucheon St. Mary's Hospital
  Bucheon-si, Gyeonggi-do, South Korea Recruiting
• Inje University Ilsan Paik Hospital
  Goyang-si, Gyeonggi-do, South Korea Recruiting

+9 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: Serena SoYoun Kwon
• Email: s-kwon@eisaikorea.com
• Phone: +82-2-3451-5533

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.