A Study to Compare FKB327 Efficacy and Safety With Humira® in Rheumatoid Arthritis Patients
ARABESC
A Randomised, Blinded, Active-Controlled Study to Compare FKB327 Efficacy and Safety With the Comparator Humira® in Rheumatoid Arthritis Patients Inadequately Controlled on Methotrexate
1 other identifier
interventional
728
12 countries
100
Brief Summary
The purpose of the study is to compare the effectiveness and safety of FKB327 in comparison to Humira® in rheumatoid arthritis patients who have inadequate disease control on methotrexate.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Dec 2014
100 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 29, 2014
CompletedFirst Posted
Study publicly available on registry
October 9, 2014
CompletedStudy Start
First participant enrolled
December 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2016
CompletedResults Posted
Study results publicly available
September 20, 2017
CompletedNovember 28, 2017
October 1, 2017
1.6 years
July 29, 2014
July 5, 2017
October 23, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
American College of Rheumatology (ACR) 20 Response Rate
The primary efficacy endpoint was the ACR20 response rate at Week 24. An ACR20 response meant that the patient achieved a 20% improvement in Tender Joint Count and Swollen Joint Count and in at least 3 of the other 5 Core Data Set elements listed below. * Acute phase reactant (CRP) * Patient global assessment of disease activity * Physician global assessment of disease activity * Patient pain scale * Disability/functional questionnaire (patient completed Health Assessment Questionnaire Disability Index \[HAQ-DI\])
Week 24
Secondary Outcomes (13)
Disease Activity Score 28 (DAS28) Based on C-reactive Protein (DAS28-CRP) Score
Baseline, Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24
ACR20 Response Rates Over Time
Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24
ACR50 Response Rates Over Time
Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24
ACR70 Response Rates Over Time
Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24
Swollen Joint Count
Baseline and Week 24
- +8 more secondary outcomes
Other Outcomes (2)
Percentage of Patients Developing Anti-drug Antibodies (ADAs)
Baseline and last sampling day
Trough Adalimumab Concentration
Week 2, Week 4, Week 12, Week 20, and Week 24
Study Arms (2)
FKB327
EXPERIMENTALPatients will receive FKB327 40 mg every other week by subcutaneous injection. The treatment period will continue for 22 weeks.
Humira®
ACTIVE COMPARATORPatients will receive Humira® 40 mg every other week by subcutaneous injection. The treatment period will continue for 22 weeks.
Interventions
Eligibility Criteria
You may qualify if:
- Male or female aged 18 years or over
- Patients have been diagnosed with Rheumatoid Arthritis (RA) for at least 3 months
- Patient has active RA
- Patient has taken a stable dose of methotrexate for at least 3 months
You may not qualify if:
- Patient has been previously treated with adalimumab
- Patient has been previously treated or has ongoing treatment with prohibited medications
- Patient has been immunised with a live or attenuated vaccine in past 4 weeks
- Patient has positive result for HIV, HBV, HCV or TB infection
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (100)
Research Site
Peoria, Arizona, United States
Research Site
Palm Desert, California, United States
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Boca Raton, Florida, United States
Research Site
Brandon, Florida, United States
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Jacksonville, Florida, United States
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Miami, Florida, United States
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Miami Lakes, Florida, United States
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Sarasota, Florida, United States
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Shreveport, Louisiana, United States
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Lansing, Michigan, United States
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Durham, North Carolina, United States
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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
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Mesquite, Texas, United States
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Plovdiv, Bulgaria
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Sofia, Bulgaria
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Mississauga, Ontario, Canada
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Saint Catherines, Ontario, Canada
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Trois-Rivières, Quebec, Canada
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Osorno, Chile
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Puerto Varas, Chile
Research Site G
Santiago, Chile
Research Site M
Santiago, Chile
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Temuco, Chile
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Brno, Czechia
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Hlučín, Czechia
Research Site U
Prague, Czechia
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Prague, Czechia
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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
Research Site
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
Research Site
Torun, Poland
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Oradea, Bihor County, Romania
Research Site
Brasov, Romania
Research Site
Brăila, Romania
Research Site C
Bucharest, Romania
Research Site R
Bucharest, Romania
Research Site T
Bucharest, Romania
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Constanța, Romania
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Galati, Romania
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Sfântu Gheorghe, Romania
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Ufa, Bashkortostan Republic, Russia
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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
Related Publications (2)
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.
PMID: 33263165DERIVEDGenovese 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.
PMID: 31831079DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Clinical Trial Information
- Organization
- Fujifilm Kyowa Kirin Biologics Co., Ltd., EU Branch
Study Officials
- PRINCIPAL INVESTIGATOR
Josephine Glover, MD
Coephycient Pharmaceutical Consultancy
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 29, 2014
First Posted
October 9, 2014
Study Start
December 1, 2014
Primary Completion
July 1, 2016
Study Completion
July 1, 2016
Last Updated
November 28, 2017
Results First Posted
September 20, 2017
Record last verified: 2017-10