A Study to Compare FKB327 Efficacy and Safety With Humira® in Rheumatoid Arthritis Patients
NCT ID: NCT02260791
Last Updated: 2017-11-28
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
728 participants
INTERVENTIONAL
2014-12-31
2016-07-31
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
TRIPLE
Study Groups
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FKB327
Patients will receive FKB327 40 mg every other week by subcutaneous injection. The treatment period will continue for 22 weeks.
FKB327
Solution of FKB327 for subcutaneous injection administered in a dose of 40 mg every 2 weeks for 22 weeks.
Humira®
Patients will receive Humira® 40 mg every other week by subcutaneous injection. The treatment period will continue for 22 weeks.
Humira®
Solution of Humira® for subcutaneous injection administered in a dose of 40 mg every 2 weeks for 22 weeks.
Interventions
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FKB327
Solution of FKB327 for subcutaneous injection administered in a dose of 40 mg every 2 weeks for 22 weeks.
Humira®
Solution of Humira® for subcutaneous injection administered in a dose of 40 mg every 2 weeks for 22 weeks.
Eligibility Criteria
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Inclusion Criteria
2. Patients have been diagnosed with Rheumatoid Arthritis (RA) for at least 3 months
3. Patient has active RA
4. Patient has taken a stable dose of methotrexate for at least 3 months
Exclusion Criteria
2. Patient has been previously treated or has ongoing treatment with prohibited medications
3. Patient has been immunised with a live or attenuated vaccine in past 4 weeks
4. Patient has positive result for HIV, HBV, HCV or TB infection
18 Years
ALL
No
Sponsors
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Fujifilm Kyowa Kirin Biologics Co., Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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Josephine Glover, MD
Role: PRINCIPAL_INVESTIGATOR
Coephycient Pharmaceutical Consultancy
Locations
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Research Site
Peoria, Arizona, United States
Research Site
Palm Desert, California, United States
Research Site
Boca Raton, Florida, United States
Research Site
Brandon, Florida, United States
Research Site
Jacksonville, Florida, United States
Research Site
Miami, Florida, United States
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Miami Lakes, Florida, United States
Research Site
Sarasota, Florida, United States
Research Site
Shreveport, Louisiana, United States
Research Site
Lansing, Michigan, United States
Research Site
Durham, North Carolina, United States
Research Site
Middleburg Heights, Ohio, United States
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Duncansville, Pennsylvania, United States
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Amarillo, Texas, United States
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Austin, Texas, United States
Research Site
Mesquite, Texas, United States
Research Site
Plovdiv, , Bulgaria
Research Site
Sofia, , Bulgaria
Research Site
Mississauga, Ontario, Canada
Research Site
Saint Catherines, Ontario, Canada
Research Site
Trois-Rivières, Quebec, Canada
Research Site
Osorno, , Chile
Research Site
Puerto Varas, , Chile
Research Site G
Santiago, , Chile
Research Site M
Santiago, , Chile
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Temuco, , Chile
Research Site
Brno, , Czechia
Research Site
Hlučín, , Czechia
Research Site U
Prague, , Czechia
Research Site
Prague, , Czechia
Research Site
Uherské Hradiště, , Czechia
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Zlín, , Czechia
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Aachen, , Germany
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Berlin, , Germany
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Hamburg, , Germany
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Hildesheim, , Germany
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Munich, , Germany
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Ratingen, , Germany
Research Site B
Arequipa, , Peru
Research Site M
Arequipa, , Peru
Research Site CA
Lima, , Peru
Research Site CH
Lima, , Peru
Research Site PA
Lima, , Peru
Research Site PE
Lima, , Peru
Research Site S
Lima, , Peru
Research Site D
Bialystok, , Poland
Research Site R
Bialystok, , Poland
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Gdynia, , Poland
Research Site
Katowice, , Poland
Research Site KL
Krakow, , Poland
Research Site KR
Krakow, , Poland
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Lublin, , Poland
Research Site P
Poznan, , Poland
Research Site RH
Poznan, , Poland
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Torun, , Poland
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Oradea, Bihor County, Romania
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Brasov, , Romania
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Brăila, , Romania
Research Site C
Bucharest, , Romania
Research Site R
Bucharest, , Romania
Research Site T
Bucharest, , Romania
Research Site
Constanța, , Romania
Research Site
Galati, , Romania
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Sfântu Gheorghe, , Romania
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Ufa, Bashkortostan Republic, Russia
Research Site
Petrozavodsk, Karelia Republic, Russia
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Kazan', Tatarstan Republic, Russia
Research Site D
Moscow, , Russia
Research Site SM
Moscow, , Russia
Research Site ST
Moscow, , Russia
Research Site
Nizhny Novgorod, , Russia
Research Site
Penza, , Russia
Research Site
Perm, , Russia
Research Site
Ryazan, , Russia
Research Site B
Saint Petersburg, , Russia
Research Site Z
Saint Petersburg, , Russia
Research Site
Saratov, , Russia
Research Site
Smolensk, , Russia
Research Site
Vladimir, , Russia
Research Site E
Yaroslavl, , Russia
Research Site S
Yaroslavl, , Russia
Research Site
Santiago de Compostela, La Coruna, Spain
Research Site
Bilbao, Vizcaya, Spain
Research Site A
Barcelona, , Spain
Research Site G
Barcelona, , Spain
Research Site
Málaga, , Spain
Research Site
Chernivtsi, , Ukraine
Research Site
Ivano-Frankivsk, , Ukraine
Research Site A
Kyiv, , Ukraine
Research Site B
Kyiv, , Ukraine
Research Site P
Kyiv, , Ukraine
Research Site
Lutsk, , Ukraine
Research Site C
Lviv, , Ukraine
Research Site N
Lviv, , Ukraine
Research Site
Poltava, , Ukraine
Research Site
Ternopil, , Ukraine
Research Site
Uzhhorod, , Ukraine
Research Site G
Vinnytsia, , Ukraine
Research Site Sh
Vinnytsia, , Ukraine
Research Site St
Vinnytsia, , Ukraine
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.
Genovese MC, Glover J, Greenwald M, Porawska W, El Khouri EC, Dokoupilova E, Vargas JI, Stanislavchuk M, Kellner H, Baranova E, Matsunaga N, Alten R. FKB327, an adalimumab biosimilar, versus the reference product: results of a randomized, Phase III, double-blind study, and its open-label extension. Arthritis Res Ther. 2019 Dec 12;21(1):281. doi: 10.1186/s13075-019-2046-0.
Other Identifiers
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FKB327-002
Identifier Type: -
Identifier Source: org_study_id