Long-term Safety and Efficacy of ABP 501 in Subjects With Moderate to Severe Rheumatoid Arthritis
NCT ID: NCT02114931
Last Updated: 2017-04-24
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
467 participants
INTERVENTIONAL
2014-04-30
2016-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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ABP 501
Participants received ABP 501 40 mg subcutaneously (SC) every other week for up to 18 months.
ABP 501
Solution for subcutaneous injection in a syringe containing 40 mg/0.8 mL ABP 501
Interventions
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ABP 501
Solution for subcutaneous injection in a syringe containing 40 mg/0.8 mL ABP 501
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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
18 Years
81 Years
ALL
No
Sponsors
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Amgen
INDUSTRY
Responsible Party
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Principal Investigators
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Amgen MD
Role: STUDY_DIRECTOR
Amgen
Locations
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Research Site
Huntsville, Alabama, United States
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Peoria, Arizona, United States
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Scottsdale, Arizona, United States
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Covina, California, United States
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El Cajon, California, United States
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Hemet, California, United States
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Palm Desert, California, United States
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Van Nuys, California, United States
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Whittier, California, United States
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Danbury, Connecticut, United States
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Miami, Florida, United States
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Orlando, Florida, United States
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Sarasota, Florida, United States
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Sandy Springs, Georgia, United States
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Lexington, Kentucky, United States
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Hagerstown, Maryland, United States
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Wheaton, Maryland, United States
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St Louis, Missouri, United States
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Omaha, Nebraska, United States
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Brooklyn, New York, United States
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Mineola, New York, United States
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Oklahoma City, Oklahoma, United States
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Bethlehem, Pennsylvania, United States
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Duncansville, Pennsylvania, United States
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Charleston, South Carolina, United States
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Memphis, Tennessee, United States
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Carrollton, Texas, United States
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Dallas, Texas, United States
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Spokane, Washington, United States
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Plovdiv, Plovdiv, Bulgaria
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Plovdiv, Plovdiv, Bulgaria
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Rousse, Ruse, Bulgaria
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Soifia, Sofia, Bulgaria
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Winnipeg, Manitoba, Canada
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St. John's, Newfoundland and Labrador, Canada
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Windsor, Ontario, Canada
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Prague, Prague, Czechia
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Prague, Prague, Czechia
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Hlučín, Severomoravsky Kraj, Czechia
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Ostrava, Severomoravsky Kraj, Czechia
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Zlín, Severomoravsky Kraj, Czechia
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Prague, , Czechia
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Prague, , Czechia
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Hamburg, City state of Hamburg, Germany
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Göttingen, Lower Saxony, Germany
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Ratingen, North Rhine-Westphalia, Germany
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Leipzig, Saxony, Germany
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Budapest, Budapest, Hungary
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Budapest, Budapest, Hungary
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Budapest, Budapest, Hungary
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Szentes, Csongrád megye, Hungary
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Balatonfüred, Veszprém megye, Hungary
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Veszprém, Veszprém megye, Hungary
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Kościan, Greater Poland Voivodeship, Poland
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Poznan, Greater Poland Voivodeship, Poland
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Poznan, Greater Poland Voivodeship, Poland
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Bydgoszcz, Kuyavian-Pomeranian Voivodeship, Poland
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Torun, Kuyavian-Pomeranian Voivodeship, Poland
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Wroclaw, Lower Silesian Voivodeship, Poland
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Wroclaw, Lower Silesian Voivodeship, Poland
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Lublin, Lublin Voivodeship, Poland
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Lublin, Lublin Voivodeship, Poland
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Warsaw, Masovian Voivodeship, Poland
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Warsaw, Masovian Voivodeship, Poland
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Bialystok, Podlaskie Voivodeship, Poland
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Bialystok, Podlaskie Voivodeship, Poland
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Gdansk, Pomeranian Voivodeship, Poland
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Gdynia, Pomeranian Voivodeship, Poland
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Działdowo, Warmian-Masurian Voivodeship, Poland
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Elblag, Warmian-Masurian Voivodeship, Poland
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Brăila, Brăila County, Romania
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Petrozavodsk, , Russia
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Santiago de Compostela, A Coruna, Spain
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A Coruña, La Coruna, Spain
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Madrid, Madrid, Spain
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Seville, Sevilla, Spain
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Suffolk, England, United Kingdom
Countries
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References
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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.
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.
Related Links
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AmgenTrials clinical trials website
Other Identifiers
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2013-004654-13
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
20130258
Identifier Type: -
Identifier Source: org_study_id
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