Clinical trial NCT02114931: 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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Arthritis, Rheumatoid
Keywords: arthritis
rheumatoid
Lead sponsor: Amgen
Sponsor class: INDUSTRY
First posted: 2014-04-15
Enrollment: 467
Sex: ALL
Minimum age (years): 18
Maximum age (years): 81
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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).


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

Primary outcomes:
measure: Number of Participants With Adverse Events
timeFrame: From the first dose of study drug in the extension study to 28 days following the last dose; 72 weeks
measure: Number of Participants With Grade ≥ 3 Hematology and Chemistry Laboratory Results
timeFrame: From the first dose of study drug in the extension study to 28 days following the last dose; 72 weeks
measure: Percentage of Participants Who Developed Antibodies to ABP 501
timeFrame: Up to week 72
Secondary outcomes:
measure: Percentage of Participants With an American College of Rheumatology (ACR) 20 Response
timeFrame: Parent study baseline, extension study baseline and weeks 4, 24, 48, and 70
measure: Change From Parent Study Baseline in Disease Activity Score 28-C-reactive Protein (DAS28-CRP)
timeFrame: Parent study baseline, extension study baseline and weeks 4, 24, 48 and 70
Other outcomes:
Locations:
city: Huntsville
country: United States
facility: Research Site
state: Alabama
city: Peoria
country: United States
facility: Research Site
state: Arizona
city: Scottsdale
country: United States
facility: Research Site
state: Arizona
city: Covina
country: United States
facility: Research Site
state: California
city: El Cajon
country: United States
facility: Research Site
state: California
city: Hemet
country: United States
facility: Research Site
state: California
city: Palm Desert
country: United States
facility: Research Site
state: California
city: Van Nuys
country: United States
facility: Research Site
state: California
city: Whittier
country: United States
facility: Research Site
state: California
city: Danbury
country: United States
facility: Research Site
state: Connecticut
city: Miami
country: United States
facility: Research Site
state: Florida
city: Orlando
country: United States
facility: Research Site
state: Florida
city: Sarasota
country: United States
facility: Research Site
state: Florida
city: Sandy Springs
country: United States
facility: Research Site
state: Georgia
city: Lexington
country: United States
facility: Research Site
state: Kentucky
city: Hagerstown
country: United States
facility: Research Site
state: Maryland
city: Wheaton
country: United States
facility: Research Site
state: Maryland
city: Saint Louis
country: United States
facility: Research Site
state: Missouri
city: Omaha
country: United States
facility: Research Site
state: Nebraska
city: Brooklyn
country: United States
facility: Research Site
state: New York
city: Mineola
country: United States
facility: Research Site
state: New York
city: Oklahoma City
country: United States
facility: Research Site
state: Oklahoma
city: Bethlehem
country: United States
facility: Research Site
state: Pennsylvania
city: Duncansville
country: United States
facility: Research Site
state: Pennsylvania
city: Charleston
country: United States
facility: Research Site
state: South Carolina
city: Memphis
country: United States
facility: Research Site
state: Tennessee
city: Carrollton
country: United States
facility: Research Site
state: Texas
city: Dallas
country: United States
facility: Research Site
state: Texas
city: Spokane
country: United States
facility: Research Site
state: Washington
city: Soifia
country: Bulgaria
facility: Research Site
state: Sofiya
city: Plovdiv
country: Bulgaria
facility: Research Site
city: Plovdiv
country: Bulgaria
facility: Research Site
city: Ruse
country: Bulgaria
facility: Research Site
city: Winnipeg
country: Canada
facility: Research Site
state: Manitoba
city: St. John's
country: Canada
facility: Research Site
state: Newfoundland and Labrador
city: Windsor
country: Canada
facility: Research Site
state: Ontario
city: Praha 2
country: Czech Republic
facility: Research Site
state: Praha
city: Praha 4
country: Czech Republic
facility: Research Site
state: Praha
city: Hlučín
country: Czech Republic
facility: Research Site
state: Severomoravsky Kraj
city: Ostrava
country: Czech Republic
facility: Research Site
state: Severomoravsky Kraj
city: Zlín
country: Czech Republic
facility: Research Site
state: Severomoravsky Kraj
city: Praha 4
country: Czech Republic
facility: Research Site
city: Praha
country: Czech Republic
facility: Research Site
city: Göttingen
country: Germany
facility: Research Site
state: Niedersachsen
city: Ratingen
country: Germany
facility: Research Site
state: Nordrhein-westfalen
city: Leipzig
country: Germany
facility: Research Site
state: Sachsen
city: Hamburg
country: Germany
facility: Research Site
city: Szentes
country: Hungary
facility: Research Site
state: Csongrad
city: Balatonfüred
country: Hungary
facility: Research Site
state: Veszprem
city: Veszprém
country: Hungary
facility: Research Site
state: Veszprem
city: Budapest
country: Hungary
facility: Research Site
city: Budapest
country: Hungary
facility: Research Site
city: Budapest
country: Hungary
facility: Research Site
city: Wrocław
country: Poland
facility: Research Site
state: Dolnoslaskie
city: Wrocław
country: Poland
facility: Research Site
state: Dolnoslaskie
city: Bydgoszcz
country: Poland
facility: Research Site
state: Kujawsko-pomorskie
city: Toruń
country: Poland
facility: Research Site
state: Kujawsko-pomorskie
city: Lublin
country: Poland
facility: Research Site
state: Lubelskie
city: Lublin
country: Poland
facility: Research Site
state: Lubelskie
city: Warszawa
country: Poland
facility: Research Site
state: Mazowieckie
city: Warszawa
country: Poland
facility: Research Site
state: Mazowieckie
city: Białystok
country: Poland
facility: Research Site
state: Podlaskie
city: Białystok
country: Poland
facility: Research Site
state: Podlaskie
city: Gdańsk
country: Poland
facility: Research Site
state: Pomorskie
city: Gdynia
country: Poland
facility: Research Site
state: Pomorskie
city: Działdowo
country: Poland
facility: Research Site
state: Warminsko-mazurskie
city: Elbląg
country: Poland
facility: Research Site
state: Warminsko-mazurskie
city: Kościan
country: Poland
facility: Research Site
state: Wielkopolskie
city: Poznań
country: Poland
facility: Research Site
state: Wielkopolskie
city: Poznań
country: Poland
facility: Research Site
state: Wielkopolskie
city: Braila
country: Romania
facility: Research Site
city: Petrozavodsk
country: Russian Federation
facility: Research Site
city: Santiago de Compostela
country: Spain
facility: Research Site
state: A Coruna
city: La Coruña
country: Spain
facility: Research Site
state: La Coruna
city: Madrid
country: Spain
facility: Research Site
city: Sevilla
country: Spain
facility: Research Site
city: Suffolk
country: United Kingdom
facility: Research Site
state: England
Study officials:
affiliation: Amgen
name: Amgen MD
role: STUDY_DIRECTOR
References:
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.
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.