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Label indication HUMIRA is a tumor necrosis factor (TNF) blocker indicated for: Reducing signs and symptoms, inducing major clinical response, inhibiting the progression of structural damage, and improving physical function in adult patients with moderately to severely active r heumatoid a rthritis . FDA label
Also known as Humira (adalimumab-EU), Adalimumab, no intervention
Humira · 1 trial · 1 indication
ACR20 response: greater than or equal to (\>=) 20 % improvement in tender joint count (TJC); \>= 20% improvement in swollen joint count (SJC); and \>= 20% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire \[HAQ\]); and C-Reactive Protein (CRP).
| Arm | Type | Description |
|---|---|---|
| 1 | ACTIVE_COMPARATOR | - |
| 2 | EXPERIMENTAL | - |
| 3 | EXPERIMENTAL | - |
| 4 | EXPERIMENTAL | - |
| 5 | EXPERIMENTAL | - |
| 6 | EXPERIMENTAL | - |
| 7 | PLACEBO_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| Adalimumab | DRUG | 40mg subcutaneous injections every other week for 6 injections during week 0-10 with oral placebo BID. Subjects switched to CP-690,550 at week 12. |
| CP-690-550 | DRUG | 15 mg BID oral plus 6 placebo subcutaneous injections (week 0-10) |
| CP-690,550 | DRUG | 3 mg BID PO plus 6 placebo subcutaneous injections (week 0-10) |
| Placebo | DRUG | Placebo by mouth plus 6 placebo subcutaneous injections (week 0-10) |
Inclusion Criteria: * Subjects must have active rheumatoid arthritis * Subjects must have failed at least 1 disease modifying anti-rheumatic drug (DMARD) * Subjects must not be currently taking any DMARD other than an antimalarial Exclusion Criteria: * Subjects who discontinued any previous TNF i...
Humira is used to treat rheumatoid arthritis, a chronic inflammatory joint condition. It is a monoclonal antibody developed by Pfizer, Inc. and studied in adult patients with a physician's diagnosis of rheumatoid arthritis. The clinical program enrolled adults 18 years and older, including both men and women, across multiple countries.
Humira targets TNF, or tumor necrosis factor, and acts as an inhibitor of this inflammatory signaling molecule. By binding TNF, the monoclonal antibody is designed to reduce the inflammatory activity associated with rheumatoid arthritis. This targeted approach is the basis for its study in immunology indications.
Humira is developed by Pfizer, Inc., which trades under the ticker PFE. The company sponsored the clinical study of Humira in rheumatoid arthritis. Pfizer is the developer listed for this asset in the immunology therapeutic area.
Humira is in Phase 2 clinical development for rheumatoid arthritis. The completed Phase 2 study evaluated the drug in patients with a physician's diagnosis of the condition. It is an investigational monoclonal antibody in this program rather than an approved product for this specific study setting.
Humira has been studied in the Phase 2 trial NCT00550446, titled A Phase 2 Study For Patients With A Physician's Diagnosis Of Rheumatoid Arthritis. The trial was completed, enrolled 386 participants, was randomized, double-blind, and placebo-controlled, and ran across the United States, Brazil, Bulgaria, Chile, Croatia, Czechia, Germany, Greece, Hungary, Italy, Mexico, Romania, Slovakia, South Korea, and Ukraine.
Yes, Humira is also known as adalimumab and adalimumab-EU. These names refer to the same monoclonal antibody asset. Readers searching for adalimumab or adalimumab-EU are looking at the same drug that Pfizer, Inc. is developing under the Humira name.