Clinical trial NCT02260791: A Study to Compare FKB327 Efficacy and Safety With Humira® in Rheumatoid Arthritis Patients
Official title: A Randomised, Blinded, Active-Controlled Study to Compare FKB327 Efficacy and Safety With the Comparator Humira® in Rheumatoid Arthritis Patients Inadequately Controlled on Methotrexate
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Arthritis, Rheumatoid
Keywords: Rheumatoid
Arthritis
Lead sponsor: Fujifilm Kyowa Kirin Biologics Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2014-10-09
Enrollment: 728
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

1. Male or female aged 18 years or over
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:

1. Patient has been previously treated with adalimumab
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

Other Inclusion/Exclusion criteria may apply.

Primary outcomes:
measure: American College of Rheumatology (ACR) 20 Response Rate
timeFrame: Week 24
Secondary outcomes:
measure: Disease Activity Score 28 (DAS28) Based on C-reactive Protein (DAS28-CRP) Score
timeFrame: Baseline, Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24
measure: ACR20 Response Rates Over Time
timeFrame: Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24
measure: ACR50 Response Rates Over Time
timeFrame: Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24
measure: ACR70 Response Rates Over Time
timeFrame: Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24
measure: Swollen Joint Count
timeFrame: Baseline and Week 24
measure: Tender Joint Count
timeFrame: Baseline and Week 24
measure: Analysis of Serum C-Reactive Protein (CRP) Concentration
timeFrame: Baseline and Week 24
measure: Patient Assessment of Disease Activity
timeFrame: Baseline and Week 24
measure: Physician Assessment of Disease Activity
timeFrame: Baseline and Week 24
measure: Patient's Assessment of Pain
timeFrame: Baseline and Week 24
measure: Health Assessment Questionnaire Disability Index (HAQ-DI)
timeFrame: Baseline and Week 24
measure: DAS28-CRP Score Over Time
timeFrame: Baseline and Week 24
measure: DAS28 Score Based on Erythrocyte Sedimentation Rate (DAS28-ESR)
timeFrame: Baseline, Week 12 and Week 24
Other outcomes:
measure: Percentage of Patients Developing Anti-drug Antibodies (ADAs)
timeFrame: Baseline and last sampling day
measure: Trough Adalimumab Concentration
timeFrame: Week 2, Week 4, Week 12, Week 20, and Week 24
Locations:
city: Peoria
country: United States
facility: Research Site
state: Arizona
city: Palm Desert
country: United States
facility: Research Site
state: California
city: Boca Raton
country: United States
facility: Research Site
state: Florida
city: Brandon
country: United States
facility: Research Site
state: Florida
city: Jacksonville
country: United States
facility: Research Site
state: Florida
city: Miami Lakes
country: United States
facility: Research Site
state: Florida
city: Miami
country: United States
facility: Research Site
state: Florida
city: Sarasota
country: United States
facility: Research Site
state: Florida
city: Shreveport
country: United States
facility: Research Site
state: Louisiana
city: Lansing
country: United States
facility: Research Site
state: Michigan
city: Durham
country: United States
facility: Research Site
state: North Carolina
city: Middleburg Heights
country: United States
facility: Research Site
state: Ohio
city: Duncansville
country: United States
facility: Research Site
state: Pennsylvania
city: Amarillo
country: United States
facility: Research Site
state: Texas
city: Austin
country: United States
facility: Research Site
state: Texas
city: Mesquite
country: United States
facility: Research Site
state: Texas
city: Plovdiv
country: Bulgaria
facility: Research Site
city: Sofia
country: Bulgaria
facility: Research Site
city: Mississauga
country: Canada
facility: Research Site
state: Ontario
city: St. Catherines
country: Canada
facility: Research Site
state: Ontario
city: Trois-Rivieres
country: Canada
facility: Research Site
state: Quebec
city: Osorno
country: Chile
facility: Research Site
city: Puerto Varas
country: Chile
facility: Research Site
city: Santiago
country: Chile
facility: Research Site G
city: Santiago
country: Chile
facility: Research Site M
city: Temuco
country: Chile
facility: Research Site
city: Brno
country: Czechia
facility: Research Site
city: Hlucin
country: Czechia
facility: Research Site
city: Prague
country: Czechia
facility: Research Site U
city: Prague
country: Czechia
facility: Research Site
city: Uherske Hradiste
country: Czechia
facility: Research Site
city: Zlin
country: Czechia
facility: Research Site
city: Aachen
country: Germany
facility: Research Site
city: Berlin
country: Germany
facility: Research Site
city: Hamburg
country: Germany
facility: Research Site
city: Hildesheim
country: Germany
facility: Research Site
city: Munich
country: Germany
facility: Research Site
city: Ratingen
country: Germany
facility: Research Site
city: Arequipa
country: Peru
facility: Research Site B
city: Arequipa
country: Peru
facility: Research Site M
city: Lima
country: Peru
facility: Research Site CA
city: Lima
country: Peru
facility: Research Site CH
city: Lima
country: Peru
facility: Research Site PA
city: Lima
country: Peru
facility: Research Site PE
city: Lima
country: Peru
facility: Research Site S
city: Bialystok
country: Poland
facility: Research Site D
city: Bialystok
country: Poland
facility: Research Site R
city: Gdynia
country: Poland
facility: Research Site
city: Katowice
country: Poland
facility: Research Site
city: Krakow
country: Poland
facility: Research Site KL
city: Krakow
country: Poland
facility: Research Site KR
city: Lublin
country: Poland
facility: Research Site
city: Poznan
country: Poland
facility: Research Site P
city: Poznan
country: Poland
facility: Research Site RH
city: Torun
country: Poland
facility: Research Site
city: Oradea
country: Romania
facility: Research Site
state: Bihor
city: Braila
country: Romania
facility: Research Site
city: Brasov
country: Romania
facility: Research Site
city: Bucharest
country: Romania
facility: Research Site C
city: Bucharest
country: Romania
facility: Research Site R
city: Bucharest
country: Romania
facility: Research Site T
city: Constanta
country: Romania
facility: Research Site
city: Galati
country: Romania
facility: Research Site
city: Sfântu Gheorghe
country: Romania
facility: Research Site
city: Ufa
country: Russian Federation
facility: Research Site
state: Bashkortostan Republic
city: Petrozavodsk
country: Russian Federation
facility: Research Site
state: Karelia Republic
city: Kazan
country: Russian Federation
facility: Research Site
state: Tatarstan Republic
city: Moscow
country: Russian Federation
facility: Research Site D
city: Moscow
country: Russian Federation
facility: Research Site SM
city: Moscow
country: Russian Federation
facility: Research Site ST
city: Nizhny Novgorod
country: Russian Federation
facility: Research Site
city: Penza
country: Russian Federation
facility: Research Site
city: Perm
country: Russian Federation
facility: Research Site
city: Ryazan
country: Russian Federation
facility: Research Site
city: Saint-Petersburg
country: Russian Federation
facility: Research Site B
city: Saint-Petersburg
country: Russian Federation
facility: Research Site Z
city: Saratov
country: Russian Federation
facility: Research Site
city: Smolensk
country: Russian Federation
facility: Research Site
city: Vladimir
country: Russian Federation
facility: Research Site
city: Yaroslavl
country: Russian Federation
facility: Research Site E
city: Yaroslavl
country: Russian Federation
facility: Research Site S
city: Santiago de Compostela
country: Spain
facility: Research Site
state: La Coruna
city: Bilbao
country: Spain
facility: Research Site
state: Vizcaya
city: Barcelona
country: Spain
facility: Research Site A
city: Barcelona
country: Spain
facility: Research Site G
city: Malaga
country: Spain
facility: Research Site
city: Chernivtsi
country: Ukraine
facility: Research Site
city: Ivano-Frankivsk
country: Ukraine
facility: Research Site
city: Kyiv
country: Ukraine
facility: Research Site A
city: Kyiv
country: Ukraine
facility: Research Site B
city: Kyiv
country: Ukraine
facility: Research Site P
city: Lutsk
country: Ukraine
facility: Research Site
city: Lviv
country: Ukraine
facility: Research Site C
city: Lviv
country: Ukraine
facility: Research Site N
city: Poltava
country: Ukraine
facility: Research Site
city: Ternopil
country: Ukraine
facility: Research Site
city: Uzhgorod
country: Ukraine
facility: Research Site
city: Vinnytsia
country: Ukraine
facility: Research Site G
city: Vinnytsia
country: Ukraine
facility: Research Site Sh
city: Vinnytsia
country: Ukraine
facility: Research Site St
Study officials:
affiliation: Coephycient Pharmaceutical Consultancy
name: Josephine Glover, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.