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Efficacy and Safety Study of ABP 501 Compared to Adalimumab in Subjects With Moderate to Severe Rheumatoid Arthritis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Amgen
ClinicalTrials.gov Identifier:
NCT01970475
First received: October 23, 2013
Last updated: October 20, 2016
Last verified: October 2016
  Purpose
The purpose of this study is to compare the effectiveness and safety of ABP 501 against adalimumab (HUMIRA®) in adults with moderate to severe rheumatoid arthritis (RA) who have an inadequate response to methotrexate (MTX).

Condition Intervention Phase
Arthritis, Rheumatoid
Biological: ABP 501
Biological: Adalimumab
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Double-blind, Phase 3 Study of ABP 501 Efficacy and Safety Compared to Adalimumab in Subjects With Moderate to Severe Rheumatoid Arthritis

Resource links provided by NLM:


Further study details as provided by Amgen:

Primary Outcome Measures:
  • Percentage of Participants With an American College of Rheumatology (ACR) 20 Response at Week 24 [ Time Frame: Baseline and Week 24 ]

    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.


Secondary Outcome Measures:
  • Change From Baseline in Disease Activity Score 28-C-reactive Protein (DAS28-CRP) [ Time Frame: Baseline and weeks 2, 4, 8, 12, 18, and 24 ]

    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.

    A repeated measures analysis with the DAS28-CRP change from baseline as the response and the stratification variables, visit, treatment, treatment-by-visit interaction and the baseline DAS28-CRP measurement as predictors in the model was performed.


  • Percentage of Participants With an ACR20 Response at Week 2 and Week 8 [ Time Frame: Baseline, week 2 and week 8 ]

    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.

  • Percentage of Participants With an ACR50 Response at Week 24 [ Time Frame: Baseline and week 24 ]

    A participant was a responder if the following 3 criteria for improvement from Baseline were met:

    • ≥ 50% improvement in tender joint count;
    • ≥ 50% improvement in swollen joint count; and
    • ≥ 50% 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.

  • Percentage of Participants With an ACR70 Response at Week 24 [ Time Frame: Baseline and Week 24 ]

    A participant was a responder if the following 3 criteria for improvement from Baseline were met:

    • ≥ 70% improvement in tender joint count;
    • ≥ 70% improvement in swollen joint count; and
    • ≥ 70% 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.

  • Number of Participants With Adverse Events [ Time Frame: From the time of first treatment up to 28 days following the last dose of study treatment; 26 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.

  • Percentage of Participants Who Developed Antibodies to ABP 501 or Adalimumab [ Time Frame: Up to week 26 ]

    Two validated assays were used to detect the presence of anti-drug antibodies. Samples were first tested in an electrochemiluminescence (ECL)-based bridging immunoassay to detect anti-drug antibodies (ADA) against ABP 501 and adalimumab (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 or adalimumab (Neutralizing Antibody Assay).

    Developing antibody incidence is defined as a negative or no antibody result at baseline and a positive antibody result at a post-baseline time point.



Enrollment: 526
Study Start Date: October 2013
Study Completion Date: November 2014
Primary Completion Date: November 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ABP 501
Participants received ABP 501 40 mg subcutaneously on day 1 and every 2 weeks thereafter until week 22.
Biological: ABP 501
Solution for subcutaneous injection in pre-filled syringe
Other Names:
  • AMJEVITA™
  • Adalimumab-atto
Active Comparator: Adalimumab
Participants received adalimumab 40 mg subcutaneously on day 1 and every 2 weeks thereafter until week 22.
Biological: Adalimumab
Solution for subcutaneous injection in pre-filled syringe
Other Name: HUMIRA®

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Men or women ≥ 18 and ≤ 80 years old
  2. Subjects must be diagnosed with rheumatoid arthritis for at least 3 months before baseline
  3. Active RA defined as ≥ 6 swollen joints and ≥ 6 tender joints at screening and baseline
  4. Subjects must be taking MTX for ≥ 12 consecutive weeks and on a stable dose of 7.5 to 25 mg/week for > 8 weeks prior to receiving the study drug and be willing to remain on stable dose throughout the study
  5. Subject has no known history of active tuberculosis

Exclusion Criteria:

  1. Class IV RA, Felty's syndrome or history of prosthetic or native joint infection
  2. Major chronic inflammatory disease or connective tissue disease other than RA, with the exception of secondary Sjögren's syndrome
  3. Prior use of 2 or more biologic therapies for RA
  4. Previous receipt of HUMIRA® (adalimumab) or a biosimilar of adalimumab
  5. Ongoing use of prohibited treatments

Other Inclusion/Exclusion criteria may apply

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01970475

Locations
United States, California
Research Site
Victorville, California, United States, 92395
United States, Florida
Research Site
Jupiter, Florida, United States, 33458
United States, Georgia
Research Site
Sandy Springs, Georgia, United States, 30328
United States, Michigan
Research Site
Lansing, Michigan, United States, 48910
United States, Ohio
Research Site
Middleburg Heights, Ohio, United States, 44130
Canada, Manitoba
Research Site
Winnipeg, Manitoba, Canada, R3A 1M3
Germany
Research Site
Hattingen, Nordrhein-westfalen, Germany, 45525
United Kingdom
Research Site
Barnsley, England, United Kingdom, S75 2EP
Research Site
North Shields, England, United Kingdom, NE29 8NH
Research Site
Suffolk, England, United Kingdom, IP4 5PD
Research Site
Cardiff, Wales, United Kingdom, CF14 4XN
Sponsors and Collaborators
Amgen
Investigators
Study Director: MD Amgen
  More Information

Additional Information:
Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT01970475     History of Changes
Other Study ID Numbers: 20120262
2013-000525-31 ( EudraCT Number )
Study First Received: October 23, 2013
Results First Received: October 20, 2016
Last Updated: October 20, 2016

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

ClinicalTrials.gov processed this record on May 22, 2017