An observational study in Arthritis, Rheumatoid, sponsored by Eisai Korea Inc.. Completed at 15 sites in Korea, Republic of. Per ClinicalTrials.gov, last updated 2020-12-16.
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 20th largest by enrollment of the 33 observational ones that give a count, is one of 7 that started in 2017, is one of 33 observational ones, and was the 147th 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+
Eisai Korea Inc. · Sites in Korea, Republic of
Ages 18+
Gangnam Severance Hospital · Sites in Korea, Republic of
Ages 19+
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: 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. 7 started in 2017.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 212 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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This study will be conducted to observe the disease activity change of Conventional Disease Modifying Anti-Rheumatic Drugs (cDMARD) plus anti-tumour necrosis factor (anti-TNF) from baseline to 6 months compared with cDMARDs, as measured by the disease activity score with the erythrocyte sedimentation rate (DAS28-ESR).
Male and female participants diagnosed with rheumatoid arthritis (RA), who have no experience with anti-tumor necrosis factor (anti-TNF) and who have experienced two or more Conventional Disease Modifying Anti-Rheumatic Drugs (cDMARDs) of a stable dose for at least 3 months.
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.
Participants who change the treatment regimen to one of the following according to the opinion of the investigator:
Exclusion Criteria:
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.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
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.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
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.
Male and female participants diagnosed with rheumatoid arthritis (RA), who have no experience with anti-tumor necrosis factor (anti-TNF) and who have experienced two or more Conventional Disease Modifying Anti-Rheumatic Drugs (cDMARDs) of a stable dose for at least 3 months.
Change from Baseline in the disease activity score 28-erythrocyte sedimentation rate DAS28-ESR at Month 6
DAS28 is a quantitative tool used to measure and monitor disease activity and "the treatment" of rheumatoid arthritis. DAS28 uses a formula that includes the number of tender joints and swollen joints for a maximum of 28 joints. DAS28 is used to assess whether an individual participant has a significant improvement of the disease activity, compared to baseline. A DAS28 score greater than 5.1 implies active disease, a score less than 3.2 implies low disease activity, and a score less than 2.6 implies remission.
Time frame: Baseline; Month 6
Change from Baseline in the DAS28-ESR at Month 3
DAS28 is a quantitative tool used to measure and monitor disease activity and "the treatment" of rheumatoid arthritis. DAS28 uses a formula that includes the number of tender joints and swollen joints for a maximum of 28 joints. DAS28 is used to assess whether an individual participant has a significant improvement of the disease activity, compared to baseline. A DAS28 score greater than 5.1 implies active disease, a score less than 3.2 implies low disease activity, and a score less than 2.6 implies remission.
Time frame: Baseline; Month 3
Change from Baseline in the DAS28-ESR at Month 12
DAS28 is a quantitative tool used to measure and monitor disease activity and "the treatment" of rheumatoid arthritis. DAS28 uses a formula that includes the number of tender joints and swollen joints for a maximum of 28 joints. DAS28 is used to assess whether an individual participant has a significant improvement of the disease activity, compared to baseline. A DAS28 score greater than 5.1 implies active disease, a score less than 3.2 implies low disease activity, and a score less than 2.6 implies remission.
Time frame: Baseline; Month 12
Clinical remission rate measured by DAS28-ESR
Clinical remission is defined as no tender or swollen joints and a normal erythrocyte sedimentation rate. DAS28 will be used to measure disease activity.
Time frame: Up to 12 months
Success rates of dose-reduction and discontinuation of steroid(s)
Dose reduction is defined as a reduction by more than 50% compared to baseline.
Time frame: Up to 12 months
Scores on the Korean Health Assessment Questionnaire (KHAQ-20), as a measure of quality of life
The KHAQ-20 is a participant-assessed measure of health assessment comprised of 8 indices. Scores for each index range from 0 (no difficulty to do) to 3 (unable to do). The total score is a sum of the 8 index score and ranges from 0 to 24. Higher scores indicate more severe disease.
Time frame: Up to 12 months
Ran from Sep 2017 to primary completion in Jul 2019, 22 months.
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 22 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.
This study is completed, as verified in Mar 2020. You cannot join it, but the record below documents what was studied.
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