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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline; Month 6 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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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:
Exclusion Criteria:
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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.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Eisai Trial Site # 1 | Ilsan | Gyeonggi-do | South Korea | |||
| Eisai Trial Site # 1 |
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| 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. | 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. | 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. | 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. | Up to 12 months |
| 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 |
| ID | Term |
|---|---|
| D001172 | Arthritis, Rheumatoid |
| D018771 | Arthralgia |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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