Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
ABP 710 · 1 trial · 1 indication
The primary efficacy endpoint was the response difference (RD) of 20% improvement in ACR core set measurements (ACR20) at week 22. A positive ACR20 response is defined if the following 3 criteria for improvement from baseline were met: * ≥ 20% improvement in 68 tender joint count; * ≥ 20% improvement in 66 swollen joint count; and * ≥ 20% improvement in at least 3 of the 5 following parameters: * Patient's assessment of disease-related pain (measured on a 100 mm visual analog scale \[VAS\]); * Patient's global health assessment (measured on a 100 mm VAS); * Investigator's global health assessment (measured on a 100 mm VAS); * Patient's self-assessment of physical function (Health Assessment Questionnaire - Disability Index \[HAQ-DI\]); * C-reactive protein concentration.
| Arm | Type | Description |
|---|---|---|
| ABP 710 | EXPERIMENTAL | Participants randomized to receive a 3 mg/kg intravenous (IV) infusion of ABP 710 on day 1, at weeks 2 and 6, and every 8 weeks thereafter until week 22. At week 22 participants continued receiving 3 mg/kg ABP 710 every 8 weeks through week 46. |
| Infliximab | ACTIVE_COMPARATOR | Participants randomized to receive a 3 mg/kg IV infusion of infliximab on day 1, at weeks 2 and 6, and every 8 weeks thereafter until week 22. At week 22 participants were re-randomized in a 1:1 ratio to either continue receiving 3 mg/kg infliximab every 8 weeks or transition to receive 3 mg/kg ABP 710 every 8 weeks through week 46. |
| Name | Type | Description |
|---|---|---|
| ABP 710 | BIOLOGICAL | Administered by intravenous infusion |
| Infliximab | BIOLOGICAL | Administered by intravenous infusion |
Inclusion Criteria: * Subject (man or woman) is ≥ 18 and ≤ 80 years old. * Subject is diagnosed with rheumatoid arthritis (RA) as determined by meeting the 2010 American College of Rheumatology (ACR)/European League Against Rheumatism classification criteria for RA. * Subject has RA duration of at ...
ABP 710 is an investigational monoclonal antibody being developed for the treatment of moderate to severe rheumatoid arthritis. It is currently in Phase 3 clinical development and has been studied in patients with this condition.
ABP 710 is being developed by Amgen Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol AMGN.
ABP 710 is in Phase 3 clinical development. It is an investigational drug and has not been approved by regulatory authorities. One Phase 3 trial has been completed.
ABP 710 has been studied in a Phase 3 clinical trial with the identifier NCT02937701. This trial assessed the safety and effectiveness of ABP 710 compared to infliximab in patients with moderate to severe rheumatoid arthritis.
ABP 710 is being studied as a potential biosimilar to infliximab. In clinical trials, it has been compared directly to infliximab to assess whether it is safe and effective for treating moderate to severe rheumatoid arthritis.
The Phase 3 trial of ABP 710 was a randomized, double-blind, active-controlled study. It enrolled 558 participants across multiple countries, including the United States, Australia, Bulgaria, Canada, Czechia, Germany, Hungary, Poland, and Spain.