Study to Assess if ABP 798 is Safe & Effective in Treating Moderate to Severe Rheumatoid Arthritis (RA) Compared to Rituximab
NCT ID: NCT02792699
Last Updated: 2020-10-06
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
311 participants
INTERVENTIONAL
2016-05-17
2018-10-08
Brief Summary
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This study will also assess if the investigational medicine is safe and effective in treating moderate or severe RA compared to the licensed medicine.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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ABP 798 / ABP 798
Participants received ABP 798 on days 1 and 15 (dose 1) and a second dose of ABP 798 at weeks 24 and 26 (dose 2). Each dose consisted of two 1000 mg intravenous infusions 2 weeks apart.
ABP 798
Supplied as a 10 mg/mL liquid concentrate for intravenous (IV) administration.
Rituximab (US) / ABP 798
Participants received rituximab (United States \[US\] formulation) on days 1 and 15 (dose 1) and transitioned to receive ABP 798 at weeks 24 and 26 (dose 2). Each dose consisted of two 1000 mg intravenous infusions 2 weeks apart.
ABP 798
Supplied as a 10 mg/mL liquid concentrate for intravenous (IV) administration.
Rituximab (US)
Supplied as a 10 mg/mL liquid concentrate for IV administration.
Rituximab (EU) / Rituximab (EU)
Participants received rituximab (European Union \[EU\] formulation) on days 1 and 15 (dose 1) and a second dose of rituximab (EU formulation) at weeks 24 and 26 (dose 2). Each dose consisted of two 1000 mg intravenous infusions 2 weeks apart.
Rituximab (EU)
Supplied as a 10 mg/mL liquid concentrate for IV administration.
Interventions
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ABP 798
Supplied as a 10 mg/mL liquid concentrate for intravenous (IV) administration.
Rituximab (US)
Supplied as a 10 mg/mL liquid concentrate for IV administration.
Rituximab (EU)
Supplied as a 10 mg/mL liquid concentrate for IV administration.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Subjects must be diagnosed with rheumatoid arthritis for at least 6 months before baseline
* Active RA defined as ≥ 6 swollen joints and ≥ 6 tender joints at screening and baseline and at least one of the following at screening:
* erythrocyte sedimentation rate (ESR) ≥ 28 mm/hr
* serum C-reactive protein (CRP) \> 1.0 mg/dL
* Subjects must be taking methotrexate (MTX) for ≥ 12 consecutive weeks and on a stable dose of MTX 7.5 to 25 mg/week for ≥ 8 weeks prior to receiving the investigational product (IP), and be willing to remain on a stable dose throughout the study
* Subject has no known history of active tuberculosis
Exclusion Criteria
* Major chronic inflammatory disease or connective tissue disease other than RA, with the exception of secondary Sjögren's syndrome
* Use of commercially available or investigational biologic therapies for RA as follows:
* anakinra, etanercept within 1 month prior to first dose of IP
* infliximab, abatacept, tocilizumab, golimumab, certolizumab within 3 months prior to first dose of IP
* other experimental or commercially available biologic therapies for RA within 3 months or 5 half-lives (whichever is longer) prior to first dose of IP
* Previous receipt of rituximab or a biosimilar of rituximab
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
Tuscaloosa, Alabama, United States
Research Site
Los Angeles, California, United States
Research Site
Thousand Oaks, California, United States
Research Site
Upland, California, United States
Research Site
Aventura, Florida, United States
Research Site
Edgewater, Florida, United States
Research Site
Hialeah, Florida, United States
Research Site
Orlando, Florida, United States
Research Site
Vero Beach, Florida, United States
Research Site
Idaho Falls, Idaho, United States
Research Site
Lexington, Kentucky, United States
Research Site
Lansing, Michigan, United States
Research Site
Flowood, Mississippi, United States
Research Site
Las Vegas, Nevada, United States
Research Site
Charlotte, North Carolina, United States
Research Site
Oklahoma City, Oklahoma, United States
Research Site
Duncansville, Pennsylvania, United States
Research Site
Orangeburg, South Carolina, United States
Research Site
Summerville, South Carolina, United States
Research Site
Memphis, Tennessee, United States
Research Site
Carrollton, Texas, United States
Research Site
Dallas, Texas, United States
Research Site
League City, Texas, United States
Research Site
Mesquite, Texas, United States
Research Site
Plano, Texas, United States
Research Site
Olympia, Washington, United States
Research Site
Spokane, Washington, United States
Research Site
Sofia, Sofia, Bulgaria
Research Site
Sofia, Sofia, Bulgaria
Research Site
Plovdiv, , Bulgaria
Research Site
Tallinn, Harjuma, Estonia
Research Site
Tartu, , Estonia
Research Site
Bad Nauheim, Hesse, Germany
Research Site
Magdeburg, Saxony-Anhalt, Germany
Research Site
Berlin, , Germany
Research Site
Berlin, , Germany
Research Site
Gyula, Bekes County, Hungary
Research Site
Szentes, Csongrád megye, Hungary
Research Site
Budapest, Pest County, Hungary
Research Site
Szombathely, Vas County, Hungary
Research Site
Veszprém, Veszprém megye, Hungary
Research Site
Poznan, Greater Poland Voivodeship, Poland
Research Site
Poznan, Greater Poland Voivodeship, Poland
Research Site
Poznan, Greater Poland Voivodeship, Poland
Research Site
Bydgoszcz, Kuyavian-Pomeranian Voivodeship, Poland
Research Site
Krakow, Lesser Poland Voivodeship, Poland
Research Site
Wroclaw, Lower Silesian Voivodeship, Poland
Research Site
Lublin, Lublin Voivodeship, Poland
Research Site
Warsaw, Masovian Voivodeship, Poland
Research Site
Stalowa Wola, Podkarpackie Voivodeship, Poland
Research Site
Bialystok, Podlaskie Voivodeship, Poland
Research Site
Gdansk, Pomeranian Voivodeship, Poland
Research Site
Katowice, Silesian Voivodeship, Poland
Research Site
Elblag, Warmian-Masurian Voivodeship, Poland
Research Site
Lodz, Łódź Voivodeship, Poland
Countries
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References
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Burmester G, Chien D, Chow V, Gessner M, Pan J, Cohen S. A Randomized, Double-Blind Study Comparing Pharmacokinetics and Pharmacodynamics of Proposed Biosimilar ABP 798 With Rituximab Reference Product in Subjects With Moderate to Severe Rheumatoid Arthritis. Clin Pharmacol Drug Dev. 2020 Nov;9(8):1003-1014. doi: 10.1002/cpdd.845. Epub 2020 Jul 5.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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AmgenTrials clinical trials website
Other Identifiers
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2013-005543-90
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
20130108
Identifier Type: -
Identifier Source: org_study_id
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