Efficacy and Safety Study of ABP 501 Compared to Adalimumab in Subjects With Moderate to Severe Rheumatoid Arthritis
NCT ID: NCT01970475
Last Updated: 2016-12-13
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
526 participants
INTERVENTIONAL
2013-10-31
2014-11-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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ABP 501
Participants received ABP 501 40 mg subcutaneously on day 1 and every 2 weeks thereafter until week 22.
ABP 501
Solution for subcutaneous injection in pre-filled syringe
Adalimumab
Participants received adalimumab 40 mg subcutaneously on day 1 and every 2 weeks thereafter until week 22.
Adalimumab
Solution for subcutaneous injection in pre-filled syringe
Interventions
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ABP 501
Solution for subcutaneous injection in pre-filled syringe
Adalimumab
Solution for subcutaneous injection in pre-filled syringe
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Subjects must be diagnosed with rheumatoid arthritis for at least 3 months before baseline
3. Active RA defined as ≥ 6 swollen joints and ≥ 6 tender joints at screening and baseline
4. 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
5. Subject has no known history of active tuberculosis
Exclusion Criteria
2. Major chronic inflammatory disease or connective tissue disease other than RA, with the exception of secondary Sjögren's syndrome
3. Prior use of 2 or more biologic therapies for RA
4. Previous receipt of HUMIRA® (adalimumab) or a biosimilar of adalimumab
5. Ongoing use of prohibited treatments
18 Years
80 Years
ALL
No
Sponsors
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Amgen
INDUSTRY
Responsible Party
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Principal Investigators
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MD
Role: STUDY_DIRECTOR
Amgen
Locations
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Research Site
Victorville, California, United States
Research Site
Jupiter, Florida, United States
Research Site
Sandy Springs, Georgia, United States
Research Site
Lansing, Michigan, United States
Research Site
Middleburg Heights, Ohio, United States
Research Site
Winnipeg, Manitoba, Canada
Research Site
Hattingen, North Rhine-Westphalia, Germany
Research Site
Barnsley, England, United Kingdom
Research Site
North Shields, England, United Kingdom
Research Site
Suffolk, England, United Kingdom
Research Site
Cardiff, Wales, 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, 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.
Related Links
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AmgenTrials clinical trials website
Other Identifiers
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2013-000525-31
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
20120262
Identifier Type: -
Identifier Source: org_study_id