An Observational Study in Patients With Moderated to Severe Rheumatoid Arthritis Who Have Failed to Combination Therapy of Conventional Disease-modifying Antirheumatic Drugs (cDMARDs) to cDMARD Plus Anti-TNF Versus cDMARDs in Real World ["HUMAN" Study]
| Registry | NCT03264703, acronym HUMAN |
|---|---|
| Status | Completed |
| Study type | Observational |
| Enrollment | 212 (Actual) |
| Sponsor | Eisai Korea Inc. (Industry) |
| Conditions | Arthritis, Rheumatoid |
| Dates | start 2017-09-11, primary completion 2019-07-17, completion 2019-07-17, first posted 2017-08-29, last updated 2020-12-16 |
| Locations | 15 sites in South Korea |
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All trials for Arthritis, Rheumatoid
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).
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Participants with RA with cDMARD, but no anti-TNF experience | 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. |
Sex: All
Inclusion Criteria: * Diagnosed with rheumatoid arthritis within 3 years * Participants who have no experience with anti-tumor necrosis factor (anti-TNF) * Participants who have experienced two or more Conventional Disease Modifying Anti-Rheumatic Drugs (cDMARDs) of a stable dose for at least 3 months prior to informed consent * Participants who change the treatment regimen to one of the following according to the opinion of the investigator: 1. One cDMARD plus anti-TNF 2. Two or more cDMARDs: Modifications or additions of cDMARDs that have been treated prior to informed consent Exclusion Criteria: * Participants who may be pregnant or lactating women * Participants who have contraindication to anti-TNF * Participants who had participated in this study
| Facility | City | Country | Status |
|---|---|---|---|
| Eisai Trial Site # 1 | Ilsan, Gyeonggi-do | South Korea | |
| Eisai Trial Site # 1 | Busan | South Korea | |
| Eisai Trial Site # 2 | Busan | South Korea | |
| Eisai Trial Site # 3 | Busan | South Korea | |
| Eisai Trial Site # 4 | Busan | South Korea | |
| Eisai Trial Site # 1 | Daegu | South Korea | |
| Eisai Trial Site # 2 | Daegu | South Korea | |
| Eisai Trial Site # 1 | Seoul | South Korea | |
| Eisai Trial Site # 2 | Seoul | South Korea | |
| Eisai Trial Site # 3 | Seoul | South Korea | |
| Eisai Trial Site # 4 | Seoul | South Korea | |
| Eisai Trial Site # 5 | Seoul | South Korea | |
| Eisai Trial Site # 6 | Seoul | South Korea | |
| Eisai Trial Site # 7 | Seoul | South Korea | |
| Eisai Trial Site # 8 | Seoul | South Korea |