Phase
Condition
Inflammatory Bowel Disease
Rheumatoid Arthritis
Crohn's Disease
Treatment
Non-interventional
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Individuals who are being administered with Jyseleca tablet in accordance with theKorean approved label therapeutic indications.
Korean local label therapeutic indications of Jyseleca tablet. In the followingparticipants, Jyseleca tablet should be used only if they do not respondappropriately or are intolerant to existing treatments.
Following:
Participants over 65 years of age.
Participants with a high cardiovascular risk.
Participants with malignancy.
- Rheumatoid arthritis:
For treatment of moderately to severely active rheumatoid arthritis in adultswho have responded inadequately to, or who are intolerant to one or moredisease-modifying anti-rheumatic drugs (DMARDs).
Jyseleca tablet may be used as monotherapy or in combination with methotrexate (MTX).
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 whohave an inadequate response with, lost response to, or were intolerant to eitherconventional therapy (corticosteroids, immunosuppressants, etc.) or biologicalagents.
The investigator should refer to local label and contraindications in Korearegarding the inclusion criteria.
Exclusion
Exclusion Criteria:
- Individuals who fall under contraindications to the administration of Jyselecatablet in accordance with the local label by the medical judgment of theinvestigator.
- Contraindication for Jyseleca tablet in accordance with the Korean label:
Participants with hypersensitivity to the active ingredient or otheringredients of the Jyseleca tablet.
Participants with active infections, including serious (example, sepsis)or local infections.
Participants with active tuberculosis.
Participants with severe hepatic disorder.
Participants with end-stage renal disorder.
Participants with absolute neutrophil count (ANC) <1*10^9 cells/liters (L)
Participants with absolute lymphocyte count (ALC) <0.5*10^9 cells/L
Participants with hemoglobin level <8 grams per deciliter (g/dL)
Pregnant or potentially pregnant women, lactating women
Jyseleca tablet should not be administered to participants with geneticproblems such as galactose intolerance, total lactase deficiency, orglucose-galactose malabsorption as it contains lactose.
Individuals who are administered Filgotinib in a clinical study other than this postmarketing surveillance.
Individuals who are considered incompatible with participate in this surveillance bythe medical judgment of the investigator.
- The investigator should refer to local label and contraindications in Korearegarding the exclusion criteria.
Study Design
Connect with a study center
Site #28
Ansan,
Korea, Republic ofSite Not Available
Site #10
Busan,
Korea, Republic ofSite Not Available
Site #11
Busan,
Korea, Republic ofActive - Recruiting
Site #15
Busan,
Korea, Republic ofSite Not Available
Site #16
Busan,
Korea, Republic ofSite Not Available
Site #17
Busan,
Korea, Republic ofSite Not Available
Site #5
Busan,
Korea, Republic ofActive - Recruiting
Site #7
Busan,
Korea, Republic ofActive - Recruiting
Site #22
Changwon,
Korea, Republic ofSite Not Available
Site #14
Cheongju,
Korea, Republic ofActive - Recruiting
Site #2
Choonchen,
Korea, Republic ofActive - Recruiting
Site #12
Daegu,
Korea, Republic ofActive - Recruiting
Site #20
Daegu,
Korea, Republic ofActive - Recruiting
Site #21
Daegu,
Korea, Republic ofSite Not Available
Site #26
Daegu,
Korea, Republic ofSite Not Available
Site #3
Daegu,
Korea, Republic ofSite Not Available
Site #36
Daegu,
Korea, Republic ofSite Not Available
Site #6
Daejeon,
Korea, Republic ofSite Not Available
Site #9
Gwangju,
Korea, Republic ofSite Not Available
Site #35
Gyeonggi,
Korea, Republic ofSite Not Available
Site #13
Jeju,
Korea, Republic ofActive - Recruiting
Site #29
Jeonbuk,
Korea, Republic ofSite Not Available
Site #18
Jeonju,
Korea, Republic ofActive - Recruiting
Site #37
Jeonnam,
Korea, Republic ofSite Not Available
Site #23
Jinju,
Korea, Republic ofActive - Recruiting
Site #31
Kyungpook,
Korea, Republic ofSite Not Available
Site #33
Kyungpook,
Korea, Republic ofSite Not Available
Site #1
Seoul,
Korea, Republic ofSite Not Available
Site #19
Seoul,
Korea, Republic ofActive - Recruiting
Site #27
Seoul,
Korea, Republic ofSite Not Available
Site #30
Seoul,
Korea, Republic ofSite Not Available
Site #32
Seoul,
Korea, Republic ofSite Not Available
Site #34
Seoul,
Korea, Republic ofSite Not Available
Site #38
Seoul,
Korea, Republic ofSite Not Available
Site #39
Seoul,
Korea, Republic ofSite Not Available
Site #40
Seoul,
Korea, Republic ofSite Not Available
Site #41
Seoul,
Korea, Republic ofSite Not Available
Site #42
Seoul,
Korea, Republic ofSite Not Available
Site #8
Seoul,
Korea, Republic ofActive - Recruiting
Site #24
Wonju,
Korea, Republic ofActive - Recruiting
Site #4
Wonju,
Korea, Republic ofActive - Recruiting
Site #25
Yongin,
Korea, Republic ofActive - Recruiting
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