Long-term Safety and Efficacy of ABP 501 in Subjects With Moderate to Severe Rheumatoid Arthritis

Study Overview
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Brief Summary
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The purpose of this open-label study is to evaluate the long-term safety and efficacy of ABP 501 in adults with moderate to severe rheumatoid arthritis (RA).

Official Title
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An Open-label, Single-arm Extension Study to Evaluate the Long-term Safety and Efficacy of ABP 501 in Subjects With Moderate to Severe Rheumatoid Arthritis

Conditions
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Arthritis, Rheumatoid

Intervention / Treatment
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* Biological: ABP 501


Participation Criteria
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Eligibility Criteria
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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 completed study 20120262 but cannot be dosed within 4 weeks of the week 26 visit of study 20120262 Current infection requiring the use of oral or intravenous antibiotics Other Inclusion/Exclusion criteria may apply

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 81 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ABP 501<br>Participants received ABP 501 40 mg subcutaneously (SC) every other week for up to 18 months. | Biological: ABP 501<br>* Solution for subcutaneous injection in a syringe containing 40 mg/0.8 mL ABP 501<br>* Other names: Adalimumab-atto;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Adverse Events | 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. | From the first dose of study drug in the extension study to 28 days following the last dose; 72 weeks | 
| Number of Participants With Grade ≥ 3 Hematology and Chemistry Laboratory Results | 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. | From the first dose of study drug in the extension study to 28 days following the last dose; 72 weeks | 
| Percentage of Participants Who Developed Antibodies to ABP 501 | 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. | Up to week 72 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants With an American College of Rheumatology (ACR) 20 Response | A participant was a responder if the following 3 criteria for improvement from Baseline of the parent study 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. | Parent study baseline, extension study baseline and weeks 4, 24, 48, and 70 | 
| Change From Parent Study Baseline in Disease Activity Score 28-C-reactive Protein (DAS28-CRP) | The DAS28-CRP is a composite score to measure disease activity in patients with rheumatoid arthritis, derived from the following variables: The number of swollen and tender joints assessed using the 28-joint count; C-reactive protein (CRP) level Patient's global assessment of disease activity assessed on a score from 0 to 100 transformed from the result measured on a horizontal scale from 0 (no RA activity at all) to 10 (worst RA activity imaginable). The DAS28-CRP score ranges from approximately zero to ten. Higher DAS28-CRP scores indicate higher disease activity. | Parent study baseline, extension study baseline and weeks 4, 24, 48 and 70 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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arthritis, rheumatoid