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

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ClinicalTrials.gov Identifier: NCT02114931
Recruitment Status : Completed
First Posted : April 15, 2014
Results First Posted : April 24, 2017
Last Update Posted : April 24, 2017
Sponsor:
Information provided by (Responsible Party):
Amgen

Brief Summary:
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).

Condition or disease Intervention/treatment Phase
Arthritis, Rheumatoid Biological: ABP 501 Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 467 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : April 2014
Actual Primary Completion Date : April 2016
Actual Study Completion Date : April 2016

Resource links provided by the National Library of Medicine

Drug Information available for: Adalimumab

Arm Intervention/treatment
Experimental: ABP 501
Participants received ABP 501 40 mg subcutaneously (SC) every other week for up to 18 months.
Biological: ABP 501
Solution for subcutaneous injection in a syringe containing 40 mg/0.8 mL ABP 501
Other Names:
  • AMJEVITA™
  • Adalimumab-atto




Primary Outcome Measures :
  1. Number of Participants With Adverse Events [ Time Frame: From the first dose of study drug in the extension study to 28 days following the last dose; 72 weeks ]

    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.

  2. Number of Participants With Grade ≥ 3 Hematology and Chemistry Laboratory Results [ Time Frame: From the first dose of study drug in the extension study to 28 days following the last dose; 72 weeks ]

    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.


  3. Percentage of Participants Who Developed Antibodies to ABP 501 [ Time Frame: Up to week 72 ]

    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.



Secondary Outcome Measures :
  1. Percentage of Participants With an American College of Rheumatology (ACR) 20 Response [ Time Frame: Parent study baseline, extension study baseline and weeks 4, 24, 48, and 70 ]

    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.

  2. Change From Parent Study Baseline in Disease Activity Score 28-C-reactive Protein (DAS28-CRP) [ Time Frame: Parent study baseline, extension study baseline and weeks 4, 24, 48 and 70 ]

    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.




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Ages Eligible for Study:   18 Years to 81 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02114931


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Sponsors and Collaborators
Amgen
Investigators
Study Director: Amgen MD Amgen

Additional Information:
Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT02114931     History of Changes
Other Study ID Numbers: 20130258
2013-004654-13 ( EudraCT Number )
First Posted: April 15, 2014    Key Record Dates
Results First Posted: April 24, 2017
Last Update Posted: April 24, 2017
Last Verified: February 2017

Keywords provided by Amgen:
arthritis
rheumatoid

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Adalimumab
Anti-Inflammatory Agents
Antirheumatic Agents