Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
ABBV-257 · 1 trial · 1 indication
This will be collected through out the study
Vital signs including blood pressure and heart rate will be assessed
Changes in any physical exam assessed by the physician will be assessed.
ECG measurements will be assessed
This will be assessed using non-compartmental methods.
This will be assessed using non-compartmental methods.
| Arm | Type | Description |
|---|---|---|
| low dose ABBV-257 | EXPERIMENTAL | Low dose every other week (eow), Weeks 0-8 |
| Medium dose of ABBV-257 | EXPERIMENTAL | Medium dose every other week (eow), Weeks 0-8 |
| high dose of ABBV-257 | EXPERIMENTAL | high dose every other week (eow), Weeks 0-8 |
| Name | Type | Description |
|---|---|---|
| ABBV-257 | BIOLOGICAL | subcutaneous injection |
| Placebo | BIOLOGICAL | Placebo for ABBV-257 |
Inclusion Criteria: * Diagnosis of Rheumatoid Arthritis based on the 2010 American College of Rheumatology (ACR)/European League against Rheumatism (EULAR) criteria, or ACR 1987 for patients with diagnosis prior 2011 ≥ 3 months. * Except for methotrexate (MTX), the subject must have discontinued al...
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ABBV-257 is an investigational monoclonal antibody being developed for the treatment of rheumatoid arthritis. It is administered by subcutaneous injection and is currently in Phase 1 clinical development. The drug is not approved and remains under study to assess its safety, tolerability, and pharmacokinetics in patients with rheumatoid arthritis.
ABBV-257 is a monoclonal antibody, but its specific molecular target has not been disclosed in available information. The drug is being studied for its potential role in treating rheumatoid arthritis, an autoimmune condition, though the precise mechanism of action is not publicly detailed.
ABBV-257 is being developed by AbbVie Inc., a biopharmaceutical company traded on the New York Stock Exchange under the ticker ABBV. AbbVie is conducting clinical research on this investigational monoclonal antibody for rheumatoid arthritis.
ABBV-257 is in Phase 1 clinical development. A Phase 1 study has been completed, evaluating the safety, tolerability, and pharmacokinetics of multiple subcutaneous injections in subjects with rheumatoid arthritis. The drug is investigational and has not received regulatory approval.
ABBV-257 has one completed clinical trial, identified as NCT02531178. This Phase 1 study assessed the safety, tolerability, and pharmacokinetics of multiple subcutaneous injections of ABBV-257 in 8 participants with rheumatoid arthritis. The trial was randomized, double-blind, and controlled, conducted in Germany.
ABBV-257 is a unique investigational drug candidate developed by AbbVie. No alternative names or brand names have been associated with this compound in available information. It is distinct from other AbbVie products and is being studied specifically for rheumatoid arthritis.