Long-term Safety and Efficacy of ABP 501 in Subjects With Moderate to Severe Rheumatoid Arthritis
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
2 other identifiers
interventional
467
11 countries
77
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Apr 2014
77 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2014
CompletedFirst Submitted
Initial submission to the registry
April 11, 2014
CompletedFirst Posted
Study publicly available on registry
April 15, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2016
CompletedResults Posted
Study results publicly available
April 24, 2017
CompletedApril 24, 2017
February 1, 2017
2 years
April 11, 2014
March 13, 2017
March 13, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
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.
From the first dose of study drug in the extension study to 28 days following the last dose; 72 weeks
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.
From the first dose of study drug in the extension study to 28 days following the last dose; 72 weeks
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.
Up to week 72
Secondary Outcomes (2)
Percentage of Participants With an American College of Rheumatology (ACR) 20 Response
Parent study baseline, extension study baseline and weeks 4, 24, 48, and 70
Change From Parent Study Baseline in Disease Activity Score 28-C-reactive Protein (DAS28-CRP)
Parent study baseline, extension study baseline and weeks 4, 24, 48 and 70
Study Arms (1)
ABP 501
EXPERIMENTALParticipants received ABP 501 40 mg subcutaneously (SC) every other week for up to 18 months.
Interventions
Solution for subcutaneous injection in a syringe containing 40 mg/0.8 mL ABP 501
Eligibility Criteria
You may qualify if:
- Subject was randomized into protocol 20120262 (NCT01970475) and completed the week 26 visit
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Amgenlead
Study Sites (77)
Research Site
Huntsville, Alabama, 35801, United States
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Peoria, Arizona, 85381, United States
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Scottsdale, Arizona, 85258, United States
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Covina, California, 91723, United States
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El Cajon, California, 92020, United States
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Hemet, California, 92543, United States
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Palm Desert, California, 92260, United States
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Van Nuys, California, 91405, United States
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Whittier, California, 90602, United States
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Danbury, Connecticut, 06810, United States
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Miami, Florida, 33015, United States
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Orlando, Florida, 32804, United States
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Sarasota, Florida, 34233, United States
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Sandy Springs, Georgia, 30328, United States
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Lexington, Kentucky, 40504, United States
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Hagerstown, Maryland, 21740, United States
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Wheaton, Maryland, 20902, United States
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St Louis, Missouri, 63141, United States
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Omaha, Nebraska, 68114, United States
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Brooklyn, New York, 11201, United States
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Mineola, New York, 11501, United States
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Oklahoma City, Oklahoma, 73103, United States
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Bethlehem, Pennsylvania, 18015, United States
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Duncansville, Pennsylvania, 16635, United States
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Charleston, South Carolina, 29406, United States
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Memphis, Tennessee, 38119, United States
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Carrollton, Texas, 75007, United States
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Dallas, Texas, 75231, United States
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Spokane, Washington, 99204, United States
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Plovdiv, Plovdiv, 4002, Bulgaria
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Plovdiv, Plovdiv, 4003, Bulgaria
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Rousse, Ruse, 7012, Bulgaria
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Soifia, Sofia, 1612, Bulgaria
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Winnipeg, Manitoba, R3N 0K6, Canada
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St. John's, Newfoundland and Labrador, A1A 5E8, Canada
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Windsor, Ontario, N8X 5A6, Canada
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Prague, Prague, 128 50, Czechia
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Prague, Prague, 140 00, Czechia
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Hlučín, Severomoravsky Kraj, 748 01, Czechia
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Ostrava, Severomoravsky Kraj, 702 00, Czechia
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Zlín, Severomoravsky Kraj, 760 01, Czechia
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Prague, 140 00, Czechia
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Prague, 140 59, Czechia
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Hamburg, Hamburg, 22391, Germany
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Göttingen, Lower Saxony, 37075, Germany
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Ratingen, North Rhine-Westphalia, 40882, Germany
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Leipzig, Saxony, 04103, Germany
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Budapest, Budapest, 1023, Hungary
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Budapest, Budapest, 1027, Hungary
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Budapest, Budapest, 1036, Hungary
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Szentes, Csongrád megye, 6600, Hungary
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Balatonfüred, Veszprém megye, 8230, Hungary
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Veszprém, Veszprém megye, 8200, Hungary
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Kościan, Greater Poland Voivodeship, 64-000, Poland
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Poznan, Greater Poland Voivodeship, 60-218, Poland
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Poznan, Greater Poland Voivodeship, 61-113, Poland
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Bydgoszcz, Kuyavian-Pomeranian Voivodeship, 85-168, Poland
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Torun, Kuyavian-Pomeranian Voivodeship, 87-100, Poland
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Wroclaw, Lower Silesian Voivodeship, 50-088, Poland
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Wroclaw, Lower Silesian Voivodeship, 52-416, Poland
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Lublin, Lublin Voivodeship, 20-022, Poland
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Lublin, Lublin Voivodeship, 20-582, Poland
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Warsaw, Masovian Voivodeship, 01-192, Poland
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Warsaw, Masovian Voivodeship, 01-518, Poland
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Bialystok, Podlaskie Voivodeship, 15-099, Poland
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Bialystok, Podlaskie Voivodeship, 15-351, Poland
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Gdansk, Pomeranian Voivodeship, 80-307, Poland
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Gdynia, Pomeranian Voivodeship, 81-338, Poland
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Działdowo, Warmian-Masurian Voivodeship, 13-200, Poland
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Elblag, Warmian-Masurian Voivodeship, 82-300, Poland
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Brăila, Brăila County, 810019, Romania
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Petrozavodsk, 185019, Russia
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Santiago de Compostela, A Coruna, 15705, Spain
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A Coruña, La Coruna, 15006, Spain
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Madrid, Madrid, 28041, Spain
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Seville, Sevilla, 41009, Spain
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Suffolk, England, IP33 2QZ, United Kingdom
Related Publications (2)
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.
PMID: 33263165DERIVEDCohen 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.
PMID: 30922373DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Study Director
- Organization
- Amgen Inc.
Study Officials
- STUDY DIRECTOR
Amgen MD
Amgen
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 11, 2014
First Posted
April 15, 2014
Study Start
April 1, 2014
Primary Completion
April 1, 2016
Study Completion
April 1, 2016
Last Updated
April 24, 2017
Results First Posted
April 24, 2017
Record last verified: 2017-02