NCT06246123 A Study of Jyseleca Tablet (Filgotinib Maleate) in Korean Participants
| NCT ID | NCT06246123 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Eisai Korea Inc. |
| Condition | Arthritis, Rheumatoid |
| Study Type | OBSERVATIONAL |
| Enrollment | 2,040 participants |
| Start Date | 2024-02-27 |
| Primary Completion | 2027-07-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 2,040 participants in total. It began in 2024-02-27 with a primary completion date of 2027-07-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06246123 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Arthritis, Rheumatoid. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06246123 currently recruiting?
Yes, NCT06246123 is actively recruiting participants. Contact the research team at s-kwon@eisaikorea.com for enrollment information.
Where is the NCT06246123 trial being conducted?
This trial is being conducted at Cheonan, South Korea, Chuncheon, South Korea, Wŏnju, South Korea, Ansan, South Korea and 11 additional locations.
Who is sponsoring the NCT06246123 clinical trial?
NCT06246123 is sponsored by Eisai Korea Inc.. The trial plans to enroll 2,040 participants.