Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01645280 | A Study of the Effectiveness and Safety of Ustekinumab (STELARA) and CNTO 1959 Administered Under the Skin of Patients With Active Rheumatoid Arthritis, Despite Existing Methotrexate Therapy | PHASE2 | COMPLETED | 274 | — | — | Aug 1, 2012 | May 1, 2014 | May 12, 2016 | 47 | United States, Argentina +9 |
The ACR 20 responders are participants with at least 20 percent (%) improvement from Baseline for tender joint count (TJC), swollen joint count (SJC), and at least 3 of the 5 remaining core set measures: 1) patient's assessment of arthritis pain-visual analog scale, 2) patient's global assessment of disease activity-visual analog scale, 3) physician's global assessment of disease activity-visual analog scale, 4) patient's assessment of physical function as measured by health assessment questionnaire-disability index (HAQ-Di), 5) C-reactive protein (CRP).
| Arm | Type | Description |
|---|---|---|
| Group 1 | PLACEBO_COMPARATOR | - |
| Group 2 | EXPERIMENTAL | - |
| Group 3 | EXPERIMENTAL | - |
| Group 4 | EXPERIMENTAL | - |
| Group 5 | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| Placebo + methotrexate (MTX) (Group 1) | DRUG | Placebo: form = solution for injection, route = subcutaneous use, at Weeks 0, 4, then every 8 weeks (Weeks 12, 20, and 28) + MTX (pre-study dose) |
| Ustekinumab + MTX (Group 2) | DRUG | Ustekinumab: type = exact number, unit = mg, number = 90, form = solution for injection, route = subcutaneous use, at Weeks 0, 4, then every 8 weeks (Weeks 12, 20, and 28) + MTX (pre-study dose) |
| Ustekinumab + MTX (Group 3) | DRUG | Ustekinumab: type = exact number, unit = mg, number = 90, form = solution for injection, route = subcutaneous use, at Weeks 0, 4, then every 12 weeks (Weeks 16 and 28) + MTX (pre-study dose) |
| CNTO 1959 + MTX (Group 4) | DRUG | CNTO 1959: type = exact number, unit = mg, number = 200, form = powder for solution for injection, route = subcutaneous use, at Weeks 0, 4, then every 8 weeks (Weeks 12, 20, and 28) + MTX (pre-study dose) |
| CNTO 1959 + MTX (Group 5) | DRUG | CNTO 1959: type = exact number, unit = mg, number = 50, form = powder for solution for injection, route = subcutaneous use, at Weeks 0, 4, then every 8 weeks (Weeks 12, 20, and 28)+ MTX (pre-study dose) |
Inclusion Criteria: * Have had RA for at least 6 months prior to screening * Have a diagnosis of RA according to the revised 1987 criteria of the American Rheumatism Association - Be positive for either anti-cyclic citrullinated peptide antibody or rheumatoid factor in serum at screening * Have bee...