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Label indication AMJEVITA 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 rheumatoid arthritis . FDA label
Also known as AMJEVITA™, Adalimumab-atto
ABP 501 · 2 trials · 1 indication
Adverse events (AEs) were graded for severity according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 according to the following scale: 1 = mild; 2 = moderate; 3 = severe; 4 = life-threatening; 5 = fatal. A treatment-related AE is defined as an event where the answer to the question "is there a reasonable possibility that the event may have been caused by the Investigational Medicinal Product" was yes. A serious adverse event is defined as an AE that meets at least 1 of the following serious criteria: * fatal * life threatening (places the subject at immediate risk of death) * requires inpatient hospitalization or prolongation of existing hospitalization * results in persistent or significant disability/incapacity * congenital anomaly/birth defect * other medically important serious event.
Laboratory results were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 according to the following scale: 1 = mild; 2 = moderate; 3 = severe; 4 = life-threatening; 5 = fatal.
Two validated assays were used to detect the presence of anti-drug antibodies. All samples were first tested in an electrochemiluminescence (ECL)-based bridging immunoassay to detect anti-drug antibodies against ABP 501 (Binding Antibody Assay). Samples confirmed to be positive for binding antibodies were subsequently tested in a non-cell based bioassay to determine neutralizing activity against ABP 501. If a sample was positive for binding antibodies and demonstrated neutralizing activity at the same time point, the sample was defined as positive for neutralizing antibodies. Preexisting antibody positive indicates participants with a positive result at baseline of the extension study. Developing antibody positive indicates participants with a negative or no result at baseline of the extension study who were positive at any time point post-baseline during the extension study.
A participant was a responder if the following 3 criteria for improvement from Baseline were met: * ≥ 20% improvement in tender joint count; * ≥ 20% improvement in swollen joint count; and * ≥ 20% improvement in at least 3 of the 5 following parameters: * Patient's assessment of pain (measured on a 100 mm visual analog scale \[VAS\]); * Patient's global assessment of disease activity (measured on a likert scale from 0 to 10); * Physician's global assessment of disease activity (measured on a likert scale from 0 to 10); * Patient's self-assessment of physical function (Health Assessment Questionnaire - Disability Index \[HAQ-DI\]); * C-Reactive Protein level.
| Arm | Type | Description |
|---|---|---|
| ABP 501 | EXPERIMENTAL | Participants received ABP 501 40 mg subcutaneously (SC) every other week for up to 18 months. |
| Adalimumab | ACTIVE_COMPARATOR | Participants received adalimumab 40 mg subcutaneously on day 1 and every 2 weeks thereafter until week 22. |
| Name | Type | Description |
|---|---|---|
| ABP 501 | BIOLOGICAL | Solution for subcutaneous injection in a syringe containing 40 mg/0.8 mL ABP 501 |
| Adalimumab | BIOLOGICAL | Solution for subcutaneous injection in pre-filled syringe |
Inclusion Criteria: * Subject was randomized into protocol 20120262 (NCT01970475) and completed the week 26 visit Exclusion Criteria: * Subject experienced a serious adverse event (SAE) or an adverse event (AE) in the 20120262 study that could cause extension treatment to be detrimental * Subject...
ABP 501 is being developed for the treatment of rheumatoid arthritis, a form of arthritis. It is a monoclonal antibody studied in adults with moderate to severe rheumatoid arthritis. Both of its Phase 3 trials enrolled patients with this condition, and it is not studied in other indications based on the available program.
ABP 501 is being developed by Amgen Inc., which trades on Nasdaq under the ticker AMGN. Amgen is the sponsor of the clinical program, which includes two completed Phase 3 trials in rheumatoid arthritis conducted across sites in the United States, Canada, and several European countries.
ABP 501 is in Phase 3 development. Two Phase 3 trials have been completed, and there are currently no active trials listed for the program. The studies were randomized, double-blind, and actively controlled, which is a late-stage design intended to support regulatory review.
ABP 501 has been studied in two completed Phase 3 trials. NCT01970475 compared ABP 501 to adalimumab in 526 subjects with moderate to severe rheumatoid arthritis. NCT02114931 evaluated long-term safety and efficacy in 467 subjects with the same condition. Together the trials enrolled 993 participants.
ABP 501 is a monoclonal antibody. It was studied as a treatment for moderate to severe rheumatoid arthritis, a condition driven by immune system activity. The clinical program evaluated its efficacy and safety against an active comparator in randomized, double-blind Phase 3 trials.
ABP 501 is an investigational product and remains in clinical development. Its two Phase 3 trials in rheumatoid arthritis are completed, and no active trials are ongoing. The program has not reached a stage where approval has been established based on the development information available.