Working…
Help guide our efforts to modernize ClinicalTrials.gov.
Send us your comments by March 14, 2020.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE April 11, 2014
First Posted Date  ICMJE April 15, 2014
Results First Submitted Date  ICMJE March 13, 2017
Results First Posted Date  ICMJE April 24, 2017
Last Update Posted Date April 24, 2017
Study Start Date  ICMJE April 2014
Actual Primary Completion Date April 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 13, 2017)
  • 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.
  • 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.
  • 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.
Original Primary Outcome Measures  ICMJE
 (submitted: April 11, 2014)
  • Subject incidence of adverse events and serious adverse events [ Time Frame: Up to week 72 ]
  • Clinically significant changes in laboratory values and vital signs [ Time Frame: Up to week 72 ]
  • Incidence of anti-drug antibodies [ Time Frame: Up to week 72 ]
Change History Complete list of historical versions of study NCT02114931 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: March 13, 2017)
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: April 11, 2014)
  • ACR 20 (20% improvement in American College of Rheumatology (ACR) core set measurements at all measured time points) [ Time Frame: Up to week 70 ]
  • Disease Activity Score (DAS) 28-CRP at all timepoints [ Time Frame: Up to week 70 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Long-term Safety and Efficacy of ABP 501 in Subjects With Moderate to Severe Rheumatoid Arthritis
Official Title  ICMJE 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
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).
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Arthritis, Rheumatoid
Intervention  ICMJE Biological: ABP 501
Solution for subcutaneous injection in a syringe containing 40 mg/0.8 mL ABP 501
Other Names:
  • AMJEVITA™
  • Adalimumab-atto
Study Arms  ICMJE Experimental: ABP 501
Participants received ABP 501 40 mg subcutaneously (SC) every other week for up to 18 months.
Intervention: Biological: ABP 501
Publications * Cohen S, Pablos JL, Pavelka K, Müller GA, Matsumoto A, Kivitz A, Wang H, Krishnan E. An open-label extension study to demonstrate long-term safety and efficacy of ABP 501 in patients with rheumatoid arthritis. Arthritis Res Ther. 2019 Mar 29;21(1):84. doi: 10.1186/s13075-019-1857-3.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 14, 2015)
467
Original Estimated Enrollment  ICMJE
 (submitted: April 11, 2014)
425
Actual Study Completion Date  ICMJE April 2016
Actual Primary Completion Date April 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 81 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Bulgaria,   Canada,   Czech Republic,   Germany,   Hungary,   Poland,   Romania,   Russian Federation,   Spain,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02114931
Other Study ID Numbers  ICMJE 20130258
2013-004654-13 ( EudraCT Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Amgen
Study Sponsor  ICMJE Amgen
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Amgen MD Amgen
PRS Account Amgen
Verification Date February 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP