Back to resultsEfficacy and Safety Study of ABP 501 Compared to Adalimumab in Subjects With Moderate to Severe Rheumatoid Arthritis
Primary Purpose
Arthritis, Rheumatoid
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
ABP 501
Adalimumab
Sponsored by
About this trial
This is an interventional treatment trial for Arthritis, Rheumatoid focused on measuring Arthritis, Rheumatoid
Eligibility Criteria
Inclusion Criteria:
- Men or women ≥ 18 and ≤ 80 years old
- Subjects must be diagnosed with rheumatoid arthritis for at least 3 months before baseline
- Active RA defined as ≥ 6 swollen joints and ≥ 6 tender joints at screening and baseline
- 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
- Subject has no known history of active tuberculosis
Exclusion Criteria:
- Class IV RA, Felty's syndrome or history of prosthetic or native joint infection
- Major chronic inflammatory disease or connective tissue disease other than RA, with the exception of secondary Sjögren's syndrome
- Prior use of 2 or more biologic therapies for RA
- Previous receipt of HUMIRA® (adalimumab) or a biosimilar of adalimumab
- Ongoing use of prohibited treatments
Other Inclusion/Exclusion criteria may apply
Sites / Locations
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
ABP 501
Adalimumab
Arm Description
Participants received ABP 501 40 mg subcutaneously on day 1 and every 2 weeks thereafter until week 22.
Participants received adalimumab 40 mg subcutaneously on day 1 and every 2 weeks thereafter until week 22.
Outcomes
Primary Outcome Measures
Percentage of Participants With an American College of Rheumatology (ACR) 20 Response at 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)
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
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
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
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
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
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01970475
Brief Title
Efficacy and Safety Study of ABP 501 Compared to Adalimumab in Subjects With Moderate to Severe Rheumatoid Arthritis
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
Study Type
Interventional
2. Study Status
Record Verification Date
October 2016
Overall Recruitment Status
Completed
Study Start Date
October 2013 (undefined)
Primary Completion Date
November 2014 (Actual)
Study Completion Date
November 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Amgen
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Arthritis, Rheumatoid
Keywords
Arthritis, Rheumatoid
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
526 (Actual)
8. Arms, Groups, and Interventions
Arm Title
ABP 501
Arm Type
Experimental
Arm Description
Participants received ABP 501 40 mg subcutaneously on day 1 and every 2 weeks thereafter until week 22.
Arm Title
Adalimumab
Arm Type
Active Comparator
Arm Description
Participants received adalimumab 40 mg subcutaneously on day 1 and every 2 weeks thereafter until week 22.
Intervention Type
Biological
Intervention Name(s)
ABP 501
Other Intervention Name(s)
AMJEVITA™, Adalimumab-atto
Intervention Description
Solution for subcutaneous injection in pre-filled syringe
Intervention Type
Biological
Intervention Name(s)
Adalimumab
Other Intervention Name(s)
HUMIRA®
Intervention Description
Solution for subcutaneous injection in pre-filled syringe
Primary Outcome Measure Information:
Title
Percentage of Participants With an American College of Rheumatology (ACR) 20 Response at Week 24
Description
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.
Time Frame
Baseline and Week 24
Secondary Outcome Measure Information:
Title
Change From Baseline in Disease Activity Score 28-C-reactive Protein (DAS28-CRP)
Description
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.
Time Frame
Baseline and weeks 2, 4, 8, 12, 18, and 24
Title
Percentage of Participants With an ACR20 Response at Week 2 and Week 8
Description
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.
Time Frame
Baseline, week 2 and week 8
Title
Percentage of Participants With an ACR50 Response at Week 24
Description
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.
Time Frame
Baseline and week 24
Title
Percentage of Participants With an ACR70 Response at Week 24
Description
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.
Time Frame
Baseline and Week 24
Title
Number of Participants With Adverse Events
Description
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.
Time Frame
From the time of first treatment up to 28 days following the last dose of study treatment; 26 weeks.
Title
Percentage of Participants Who Developed Antibodies to ABP 501 or Adalimumab
Description
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.
Time Frame
Up to week 26
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Men or women ≥ 18 and ≤ 80 years old
Subjects must be diagnosed with rheumatoid arthritis for at least 3 months before baseline
Active RA defined as ≥ 6 swollen joints and ≥ 6 tender joints at screening and baseline
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
Subject has no known history of active tuberculosis
Exclusion Criteria:
Class IV RA, Felty's syndrome or history of prosthetic or native joint infection
Major chronic inflammatory disease or connective tissue disease other than RA, with the exception of secondary Sjögren's syndrome
Prior use of 2 or more biologic therapies for RA
Previous receipt of HUMIRA® (adalimumab) or a biosimilar of adalimumab
Ongoing use of prohibited treatments
Other Inclusion/Exclusion criteria may apply
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
MD
Organizational Affiliation
Amgen
Official's Role
Study Director
Facility Information:
Facility Name
Research Site
City
Victorville
State/Province
California
ZIP/Postal Code
92395
Country
United States
Facility Name
Research Site
City
Jupiter
State/Province
Florida
ZIP/Postal Code
33458
Country
United States
Facility Name
Research Site
City
Sandy Springs
State/Province
Georgia
ZIP/Postal Code
30328
Country
United States
Facility Name
Research Site
City
Lansing
State/Province
Michigan
ZIP/Postal Code
48910
Country
United States
Facility Name
Research Site
City
Middleburg Heights
State/Province
Ohio
ZIP/Postal Code
44130
Country
United States
Facility Name
Research Site
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R3A 1M3
Country
Canada
Facility Name
Research Site
City
Hattingen
State/Province
Nordrhein-westfalen
ZIP/Postal Code
45525
Country
Germany
Facility Name
Research Site
City
Barnsley
State/Province
England
ZIP/Postal Code
S75 2EP
Country
United Kingdom
Facility Name
Research Site
City
North Shields
State/Province
England
ZIP/Postal Code
NE29 8NH
Country
United Kingdom
Facility Name
Research Site
City
Suffolk
State/Province
England
ZIP/Postal Code
IP4 5PD
Country
United Kingdom
Facility Name
Research Site
City
Cardiff
State/Province
Wales
ZIP/Postal Code
CF14 4XN
Country
United Kingdom
12. IPD Sharing Statement
Citations:
PubMed Identifier
33263165
Citation
Huizinga TWJ, Torii Y, Muniz R. Adalimumab Biosimilars in the Treatment of Rheumatoid Arthritis: A Systematic Review of the Evidence for Biosimilarity. Rheumatol Ther. 2021 Mar;8(1):41-61. doi: 10.1007/s40744-020-00259-8. Epub 2020 Dec 1.
Results Reference
derived
PubMed Identifier
28584187
Citation
Cohen S, Genovese MC, Choy E, Perez-Ruiz F, Matsumoto A, Pavelka K, Pablos JL, Rizzo W, Hrycaj P, Zhang N, Shergy W, Kaur P. Efficacy and safety of the biosimilar ABP 501 compared with adalimumab in patients with moderate to severe rheumatoid arthritis: a randomised, double-blind, phase III equivalence study. Ann Rheum Dis. 2017 Oct;76(10):1679-1687. doi: 10.1136/annrheumdis-2016-210459. Epub 2017 Jun 5.
Results Reference
derived
Links:
URL
http://www.amgentrials.com
Description
AmgenTrials clinical trials website
Learn more about this trial
Efficacy and Safety Study of ABP 501 Compared to Adalimumab in Subjects With Moderate to Severe Rheumatoid Arthritis
We'll reach out to this number within 24 hrs