An observational study in Arthritis, Rheumatoid and Colitis, Ulcerative, sponsored by Eisai Korea Inc.. Recruiting at 59 sites in South Korea. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-06.
Sponsored by Eisai Korea Inc. (part of Eisai Co., Ltd.) · Observational
Among 188 studies in Arthritis, Rheumatoid with a site in Korea, Republic of — 10 open to participants now, 16 under way, 2 of them phase 3. Arthritis, Rheumatoid · Korea, Republic of.
Among the 188 studies in Arthritis, Rheumatoid with a site in Korea, Republic of, this one is the 5th largest by planned enrollment of the 33 observational ones that give a count, is one of 3 that started in 2024, is one of 33 observational ones, reaches primary completion later than 10 of the 15 other live ones, and was the 182nd registered.
3,334 studies on the registry are indexed under Arthritis, Rheumatoid; 444 are open to participants now.
Browse Arthritis, Rheumatoid studies →10 of the 188 studies in Arthritis, Rheumatoid with a site in Korea, Republic of are open now. Recruiting first, the newest first:
AbbVie · Sites in Korea, Republic of, United States, Canada and 9 more countries
Ages 18+
Seoul National University Bundang Hospital · Sites in Korea, Republic of
Ages 18+
Konkuk University Medical Center · Sites in Korea, Republic of
Ages 19+
Gangnam Severance Hospital · Sites in Korea, Republic of
Ages 19+
Yuhan Corporation · Sites in Korea, Republic of
Ages 19–74
A study can be open while its sites in Korea, Republic of have not opened yet or have stopped. Only those recruiting at a site in Korea, Republic of →
Of the 293 Arthritis, Rheumatoid studies recruiting now, 150 (51%) set no upper age limit and 109 (37%) stop at 75 or younger; 15 take children under 18; 36 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
188 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 21 · Phase 2 32 · Phase 3 74 · Phase 4 20
First in 2002; this study’s year is marked. 3 started in 2024.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 2,040 is above the median of 176 across 1,017 observational studies indexed under Arthritis, Rheumatoid.
Median enrollment 300 across the 155 interventional studies, 425 across the 33 observational. Of the 155 that completed or were terminated, 93 (60%) have results posted.
This tab as a report to print or save as PDF → With an account.
166 of 188 have an industry lead sponsor. The 10 most frequent:
This study is registered under Eisai Korea Inc., one of the names counted as Eisai Co., Ltd.. Under that name alone:
Eisai Korea Inc. is the lead sponsor of 31 studies on the registry; 2 are open to participants now.
Eisai Co., Ltd. has 9 studies filed under Arthritis, Rheumatoid — fewer than ten, so there is no comparison to draw.
4 of the studies in Arthritis, Rheumatoid with a site in Korea, Republic of that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT03626038Zimmer BiometPost Market Clinical Follow-up (PMCF) Study of the A.L.P.S. Proximal Humerus Plating System | 2026-12 |
| NCT07675226Oscotec Inc.Bioequivalence Study of SKI-O-703 in Healthy Adults Under Fed Conditions | 2026-12-31 |
| NCT06972446AbbVieA Study to Evaluate Different Targeted Therapies for Patients With Rheumatoid Arthritis | 2027-02 |
| NCT06246123Eisai Korea Inc.A Study of Jyseleca Tablet (Filgotinib Maleate) in Korean Participants | 2027-07-30 |
Add all 4 to your calendar (.ics) → With an account.
Among the 188 studies in Arthritis, Rheumatoid with a site in Korea, Republic of, from their registry updates:
Nothing recorded among them since 2026-09-25.
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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.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
1. Individuals who are being administered with Jyseleca tablet in accordance with the Korean approved label therapeutic indications.
Following:
Rheumatoid arthritis:
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 (, , etc.) or biological agents.
Exclusion Criteria:
Individuals who fall under 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:
Individuals who are considered incompatible with participate in this surveillance by the medical judgment of the investigator.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Absolute neutrophil count (ANC)
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Korean participants who are prescribed with Jyseleca (Filgotinib Maleate) tablet 100 mg and 200 mg per approved prescribing information of Filgotinib Maleate in the post marketing setting will be enrolled and observed for up to 24 weeks or until discontinuation of treatment due to AEs or any other reason, whichever occurs first.
Other: Non-interventional
No intervention will be administered.
Number of Participants With Serious Adverse Events (SAEs)
A SAE is defined as any undesirable medical occurrence: resulting in death; life threatening; requiring hospitalization or extension of hospitalization; resulting in persistent or significant disability or functional impairment; resulting in congenital malformation or abnormality or other medically significant events than above mentioned criteria.
Time frame: From the date of enrollment up to 24 weeks
Number of Participants With Adverse Drug Reactions (ADRs)
An ADR is defined as harmful and unintended reaction to the proper administration/use of drugs, in which a causal relationship with the drug in question cannot be ruled out. Adverse events (AEs) with unknown causality to the drug among those voluntarily reported will be also considered ADRs.
Time frame: From the date of enrollment up to 24 weeks
Number of Participants With Unexpected AEs
An unexpected AE is an AE with a difference in nature, severity, specificity, or outcome, which have not been mentioned in the product licensure/safety notification of the drug.
Time frame: From the date of enrollment up to 24 weeks
Number of Participants With Unexpected ADRs
Unexpected ADR is also an unexpected AE, where unexpected AE is an AE with a difference in nature, severity, specificity, or outcome, which have not been mentioned in the product licensure/safety notification of the drug.
Time frame: From the date of enrollment up to 24 weeks
Number of Participants With Known ADRs
Known AEs are those listed in product licensure/notification of the drug and are also considered as known ADRs.
Time frame: From the date of enrollment up to 24 weeks
Number of Participants With Non-serious AEs
Non-serious AEs are other than SAE among AEs. An AE is defined as any undesirable and unintended signs (example, abnormalities in laboratory test) or symptoms/diseases occurring during administration/use of drugs, which do not need causal relationship with relevant study drug.
Time frame: From the date of enrollment up to 24 weeks
Number of Participants With Non-serious ADRs
Non-serious ADRs are other than SAE among ADR. An ADR is defined as harmful and unintended reaction to the proper administration/use of drugs, in which a causal relationship with the drug in question cannot be ruled out.
Time frame: From the date of enrollment up to 24 weeks
Change From Baseline in Disease Activity Score 28 Based on C-Reactive Protein (DAS28-CRP) at Week 12 and Week 24
The DAS28 index for rheumatoid arthritis participants was a composite score of weighted components including tender joint counts of 28, swollen joint counts of 28, participant global assessment of disease activity score, and CRP value. A DAS28-CRP score of 5.1 or above =high disease activity, a value between greater than (\>) 3.2 and 5.1 =moderate disease activity and value between 2.6 and 3.2 =low disease activity, value less than (\<) 2.6 =disease remission.
Time frame: Baseline, Week 12 and Week 24
Change From Baseline in the Mayo Clinic Score (MCS) at Week 12 and Week 24
The Mayo Clinic Score for ulcerative colitis participants is comprised of 4 parts: stool frequency, rectal bleeding, endoscopic findings, and physician's global assessment, each scored from 0 to 3, where 0=normal, 3=severe. The total score ranges from 0 to 12, with higher scores indicating increased severity of disease.
Time frame: Baseline, Week 12 and Week 24
Not enrolling at this site — choose another above.
Not enrolling at this site — choose another above.
Plan to share: Yes — Eisai's data sharing commitment and further information on how to request data can be found on our website http://eisaiclinicaltrials.com/.
Time frame: NOTE: IPD Sharing Time Frame has not been entered.
Access criteria: NOTE: IPD Sharing Access Criteria has not been entered.
No publications or documents are linked to this record.
Started Feb 2024 (actual). Primary completion is estimated for Jul 2027, 41 months after the start.
Of 155 industry-sponsored observational studies under Arthritis, Rheumatoid, half reached primary completion within 61 months of starting (the median), counting those still running; a quarter within 32 and three quarters within 116. This study's planned 41 months is below that.
Counting every sponsor, half of 391 studies reached it within 50 months; a quarter within 25 and three quarters within 113.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
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