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Also known as Ustekinumab
Ustekinumab+ MTX · 1 trial · 1 indication
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...
Ustekinumab is an investigational biologic being studied for juvenile psoriatic arthritis, rheumatoid arthritis, ulcerative colitis, Crohn disease, and juvenile arthritis. It is in Phase 3 clinical development for these immunology indications.
Ustekinumab is a monoclonal antibody, indicated by its -mab suffix. It is being studied for its role in modulating immune responses in inflammatory conditions such as Crohn disease and juvenile psoriatic arthritis.
Ustekinumab is being developed by Johnson & Johnson, a company traded on the New York Stock Exchange under the ticker JNJ. The company is conducting clinical trials to evaluate the drug in pediatric and adult populations.
Ustekinumab is in Phase 3 clinical development. It is an investigational drug and has not been approved by regulatory authorities. Clinical trials are ongoing or completed to assess its safety and efficacy in various inflammatory conditions.
Ustekinumab has been studied in several clinical trials, including NCT02968108, a pharmacokinetic study in pediatric Crohn disease, and NCT04673357, a Phase 3 study in pediatric Crohn disease. Other trials include NCT05083182 for juvenile psoriatic arthritis and NCT05092269, a long-term extension study.
Ustekinumab and Guselkumab are different drugs. A clinical trial, NCT05083182, is studying both Ustekinumab and Guselkumab in pediatric participants with active juvenile psoriatic arthritis, comparing their effects in the same study population.