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Long-term Safety and Efficacy of ABP 501 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
Sponsored by
Amgen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Arthritis, Rheumatoid focused on measuring arthritis, rheumatoid

Eligibility Criteria

18 Years - 81 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

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Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

ABP 501

Arm Description

Participants received ABP 501 40 mg subcutaneously (SC) every other week for up to 18 months.

Outcomes

Primary Outcome Measures

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.
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.
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.

Secondary Outcome Measures

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.
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.

Full Information

First Posted
April 11, 2014
Last Updated
March 13, 2017
Sponsor
Amgen
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1. Study Identification

Unique Protocol Identification Number
NCT02114931
Brief Title
Long-term Safety and Efficacy of ABP 501 in Subjects With Moderate to Severe Rheumatoid Arthritis
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 Type
Interventional

2. Study Status

Record Verification Date
February 2017
Overall Recruitment Status
Completed
Study Start Date
April 2014 (undefined)
Primary Completion Date
April 2016 (Actual)
Study Completion Date
April 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Amgen

4. Oversight

Data Monitoring Committee
No

5. Study Description

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).

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
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
467 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ABP 501
Arm Type
Experimental
Arm Description
Participants received ABP 501 40 mg subcutaneously (SC) every other week for up to 18 months.
Intervention Type
Biological
Intervention Name(s)
ABP 501
Other Intervention Name(s)
AMJEVITA™, Adalimumab-atto
Intervention Description
Solution for subcutaneous injection in a syringe containing 40 mg/0.8 mL ABP 501
Primary Outcome Measure Information:
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 first dose of study drug in the extension study to 28 days following the last dose; 72 weeks
Title
Number of Participants With Grade ≥ 3 Hematology and Chemistry Laboratory Results
Description
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.
Time Frame
From the first dose of study drug in the extension study to 28 days following the last dose; 72 weeks
Title
Percentage of Participants Who Developed Antibodies to ABP 501
Description
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.
Time Frame
Up to week 72
Secondary Outcome Measure Information:
Title
Percentage of Participants With an American College of Rheumatology (ACR) 20 Response
Description
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.
Time Frame
Parent study baseline, extension study baseline and weeks 4, 24, 48, and 70
Title
Change From Parent Study 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.
Time Frame
Parent study baseline, extension study baseline and weeks 4, 24, 48 and 70

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
81 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Amgen MD
Organizational Affiliation
Amgen
Official's Role
Study Director
Facility Information:
Facility Name
Research Site
City
Huntsville
State/Province
Alabama
ZIP/Postal Code
35801
Country
United States
Facility Name
Research Site
City
Peoria
State/Province
Arizona
ZIP/Postal Code
85381
Country
United States
Facility Name
Research Site
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85258
Country
United States
Facility Name
Research Site
City
Covina
State/Province
California
ZIP/Postal Code
91723
Country
United States
Facility Name
Research Site
City
El Cajon
State/Province
California
ZIP/Postal Code
92020
Country
United States
Facility Name
Research Site
City
Hemet
State/Province
California
ZIP/Postal Code
92543
Country
United States
Facility Name
Research Site
City
Palm Desert
State/Province
California
ZIP/Postal Code
92260
Country
United States
Facility Name
Research Site
City
Van Nuys
State/Province
California
ZIP/Postal Code
91405
Country
United States
Facility Name
Research Site
City
Whittier
State/Province
California
ZIP/Postal Code
90602
Country
United States
Facility Name
Research Site
City
Danbury
State/Province
Connecticut
ZIP/Postal Code
06810
Country
United States
Facility Name
Research Site
City
Miami
State/Province
Florida
ZIP/Postal Code
33015
Country
United States
Facility Name
Research Site
City
Orlando
State/Province
Florida
ZIP/Postal Code
32804
Country
United States
Facility Name
Research Site
City
Sarasota
State/Province
Florida
ZIP/Postal Code
34233
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
Lexington
State/Province
Kentucky
ZIP/Postal Code
40504
Country
United States
Facility Name
Research Site
City
Hagerstown
State/Province
Maryland
ZIP/Postal Code
21740
Country
United States
Facility Name
Research Site
City
Wheaton
State/Province
Maryland
ZIP/Postal Code
20902
Country
United States
Facility Name
Research Site
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63141
Country
United States
Facility Name
Research Site
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68114
Country
United States
Facility Name
Research Site
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11201
Country
United States
Facility Name
Research Site
City
Mineola
State/Province
New York
ZIP/Postal Code
11501
Country
United States
Facility Name
Research Site
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73103
Country
United States
Facility Name
Research Site
City
Bethlehem
State/Province
Pennsylvania
ZIP/Postal Code
18015
Country
United States
Facility Name
Research Site
City
Duncansville
State/Province
Pennsylvania
ZIP/Postal Code
16635
Country
United States
Facility Name
Research Site
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29406
Country
United States
Facility Name
Research Site
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38119
Country
United States
Facility Name
Research Site
City
Carrollton
State/Province
Texas
ZIP/Postal Code
75007
Country
United States
Facility Name
Research Site
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
Facility Name
Research Site
City
Spokane
State/Province
Washington
ZIP/Postal Code
99204
Country
United States
Facility Name
Research Site
City
Soifia
State/Province
Sofiya
ZIP/Postal Code
1612
Country
Bulgaria
Facility Name
Research Site
City
Plovdiv
ZIP/Postal Code
4002
Country
Bulgaria
Facility Name
Research Site
City
Plovdiv
ZIP/Postal Code
4003
Country
Bulgaria
Facility Name
Research Site
City
Ruse
ZIP/Postal Code
7012
Country
Bulgaria
Facility Name
Research Site
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R3N 0K6
Country
Canada
Facility Name
Research Site
City
St. John's
State/Province
Newfoundland and Labrador
ZIP/Postal Code
A1A 5E8
Country
Canada
Facility Name
Research Site
City
Windsor
State/Province
Ontario
ZIP/Postal Code
N8X 5A6
Country
Canada
Facility Name
Research Site
City
Praha 2
State/Province
Praha
ZIP/Postal Code
128 50
Country
Czech Republic
Facility Name
Research Site
City
Praha 4
State/Province
Praha
ZIP/Postal Code
140 00
Country
Czech Republic
Facility Name
Research Site
City
Hlučín
State/Province
Severomoravsky Kraj
ZIP/Postal Code
748 01
Country
Czech Republic
Facility Name
Research Site
City
Ostrava
State/Province
Severomoravsky Kraj
ZIP/Postal Code
702 00
Country
Czech Republic
Facility Name
Research Site
City
Zlín
State/Province
Severomoravsky Kraj
ZIP/Postal Code
760 01
Country
Czech Republic
Facility Name
Research Site
City
Praha 4
ZIP/Postal Code
140 00
Country
Czech Republic
Facility Name
Research Site
City
Praha
ZIP/Postal Code
140 59
Country
Czech Republic
Facility Name
Research Site
City
Göttingen
State/Province
Niedersachsen
ZIP/Postal Code
37075
Country
Germany
Facility Name
Research Site
City
Ratingen
State/Province
Nordrhein-westfalen
ZIP/Postal Code
40882
Country
Germany
Facility Name
Research Site
City
Leipzig
State/Province
Sachsen
ZIP/Postal Code
04103
Country
Germany
Facility Name
Research Site
City
Hamburg
ZIP/Postal Code
22391
Country
Germany
Facility Name
Research Site
City
Szentes
State/Province
Csongrad
ZIP/Postal Code
6600
Country
Hungary
Facility Name
Research Site
City
Balatonfüred
State/Province
Veszprem
ZIP/Postal Code
8230
Country
Hungary
Facility Name
Research Site
City
Veszprém
State/Province
Veszprem
ZIP/Postal Code
8200
Country
Hungary
Facility Name
Research Site
City
Budapest
ZIP/Postal Code
1023
Country
Hungary
Facility Name
Research Site
City
Budapest
ZIP/Postal Code
1027
Country
Hungary
Facility Name
Research Site
City
Budapest
ZIP/Postal Code
1036
Country
Hungary
Facility Name
Research Site
City
Wrocław
State/Province
Dolnoslaskie
ZIP/Postal Code
50-088
Country
Poland
Facility Name
Research Site
City
Wrocław
State/Province
Dolnoslaskie
ZIP/Postal Code
52-416
Country
Poland
Facility Name
Research Site
City
Bydgoszcz
State/Province
Kujawsko-pomorskie
ZIP/Postal Code
85-168
Country
Poland
Facility Name
Research Site
City
Toruń
State/Province
Kujawsko-pomorskie
ZIP/Postal Code
87-100
Country
Poland
Facility Name
Research Site
City
Lublin
State/Province
Lubelskie
ZIP/Postal Code
20-022
Country
Poland
Facility Name
Research Site
City
Lublin
State/Province
Lubelskie
ZIP/Postal Code
20-582
Country
Poland
Facility Name
Research Site
City
Warszawa
State/Province
Mazowieckie
ZIP/Postal Code
01-192
Country
Poland
Facility Name
Research Site
City
Warszawa
State/Province
Mazowieckie
ZIP/Postal Code
01-518
Country
Poland
Facility Name
Research Site
City
Białystok
State/Province
Podlaskie
ZIP/Postal Code
15-099
Country
Poland
Facility Name
Research Site
City
Białystok
State/Province
Podlaskie
ZIP/Postal Code
15-351
Country
Poland
Facility Name
Research Site
City
Gdańsk
State/Province
Pomorskie
ZIP/Postal Code
80-307
Country
Poland
Facility Name
Research Site
City
Gdynia
State/Province
Pomorskie
ZIP/Postal Code
81-338
Country
Poland
Facility Name
Research Site
City
Działdowo
State/Province
Warminsko-mazurskie
ZIP/Postal Code
13-200
Country
Poland
Facility Name
Research Site
City
Elbląg
State/Province
Warminsko-mazurskie
ZIP/Postal Code
82-300
Country
Poland
Facility Name
Research Site
City
Kościan
State/Province
Wielkopolskie
ZIP/Postal Code
64-000
Country
Poland
Facility Name
Research Site
City
Poznań
State/Province
Wielkopolskie
ZIP/Postal Code
60-218
Country
Poland
Facility Name
Research Site
City
Poznań
State/Province
Wielkopolskie
ZIP/Postal Code
61-113
Country
Poland
Facility Name
Research Site
City
Braila
ZIP/Postal Code
810019
Country
Romania
Facility Name
Research Site
City
Petrozavodsk
ZIP/Postal Code
185019
Country
Russian Federation
Facility Name
Research Site
City
Santiago de Compostela
State/Province
A Coruna
ZIP/Postal Code
15705
Country
Spain
Facility Name
Research Site
City
La Coruña
State/Province
La Coruna
ZIP/Postal Code
15006
Country
Spain
Facility Name
Research Site
City
Madrid
ZIP/Postal Code
28041
Country
Spain
Facility Name
Research Site
City
Sevilla
ZIP/Postal Code
41009
Country
Spain
Facility Name
Research Site
City
Suffolk
State/Province
England
ZIP/Postal Code
IP33 2QZ
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
30922373
Citation
Cohen S, Pablos JL, Pavelka K, Muller 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.
Results Reference
derived
Links:
URL
http://www.amgentrials.com
Description
AmgenTrials clinical trials website

Learn more about this trial

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

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