Clinical trial NCT02405780: A Study to Compare FKB327 Long-term Safety, Efficacy and Immunogenicity With Humira® in Rheumatoid Arthritis Patients
Official title: An Open-label Extension Study to Compare the Long-term Efficacy, Safety, Immunogenicity and Pharmacokinetics of FKB327 and Humira® in Patients With Rheumatoid Arthritis on Concomitant 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: 2015-04-01
Enrollment: 645
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 long-term safety, effectiveness and immunogenicity of FKB327 in comparison to Humira® in rheumatoid arthritis patients who have completed study FKB327-002 and have inadequate disease control on methotrexate.

Detailed description: The first period of this extension study was an open label, randomised, comparative, multi centre, 2 arm extension Phase 3 study in patients with RA who were taking a stable dose of MTX and who had continued from the preceding Study FKB327-002 (NCT02260791). The transition from Study FKB327-002 was ideally to occur without interruption: the Week 24 visit of Study FKB327-002 was to be on the same day as the Week 0 visit of Study FKB327-003. Patients who had received FKB327 in Study FKB327-002 received FKB327 or Humira in a 2:1 ratio and patients who had received Humira in Study FKB327-002 received Humira or FKB327 in a 2:1 ratio (Period I). The second period of the study was an open label, single arm extension in which all patients received FKB327 treatment from Week 30 to Week 76 (Period II), followed by a 4 week Follow up period.

Clinic visits were scheduled for Weeks 0, 2, 4, 8, 12, 24, 30, 32, 34, 42, 54, 66, 76, and 80. The patient or carer was allowed to administer interim doses of study drug at home every other week (eow) between clinic visits.

Eligibility criteria: Inclusion Criteria:

1. Patient has completed the Week 24 visit procedures of Study FKB327-002 (NCT02260791) and are continuing with methotrexate
2. In the investigator's opinion, the patient showed a clinical response to treatment during Study FKB327-002 (NCT02260791)

Exclusion Criteria:

1. Patient has evidence of a serious adverse event (SAE) ongoing from Study FKB327-002
2. Patient has presence of active and/or untreated latent tuberculosis (TB)

Other Inclusion/Exclusion criteria may apply.

Primary outcomes:
measure: Number of Patients With Adverse Events as a Measure of Safety Per Treatment Group in Period I
timeFrame: Period I: from Week 0 up until Week 30;
measure: Number of Patients With Adverse Events as a Measure of Safety in Period II - Single Treatment Period
timeFrame: Period II: from Week 30 up to Week 80
measure: Number of Patients With Serious Adverse Events as a Measure of Safety Per Treatment Group in Period I
timeFrame: Period I: from Week 0 up until Week 30
measure: Number of Patients With Serious Adverse Events as a Measure of Safety in Period II - Single Treatment Period
timeFrame: Period II: from Week 30 up to Week 80
measure: Changes in Vital Signs as a Measure of Safety - Systolic Blood Pressure
timeFrame: From Week 0 to Week 80
measure: Changes in Vital Signs as a Measure of Safety - Diastolic Blood Pressure
timeFrame: From Week 0 to Week 80
measure: Changes in Vital Signs as a Measure of Safety - Pulse Rate
timeFrame: From Week 0 to Week 80
measure: Changes in Vital Signs as a Measure of Safety - Temperature Measurements
timeFrame: From Week 0 to Week 80
measure: Summary of Most Common Clinical Significant Laboratory Parameters Reported as Adverse Events (Reported by ≥1% of the Patients)
timeFrame: From Week 0 to Week 80
Secondary outcomes:
measure: Changes in Disease Activity Score 28 Based on C Reactive Protein (DAS28 CRP) Score Compared to Baseline as a Measure of Efficacy
timeFrame: From Week 0 of FKB327-002 to Week 80
measure: American College of Rheumatology 20 (ACR20) Response Rates From Baseline as a Measure of Efficacy
timeFrame: From Week 0 to Week 80
measure: American College of Rheumatology 50 (ACR50) Response Rates From Baseline as a Measure of Efficacy
timeFrame: From Week 0 to Week 80
measure: American College of Rheumatology 70 (ACR70) Response Rates From Baseline as a Measure of Efficacy
timeFrame: From Week 0 to Week 80
Other outcomes:
measure: Proportion of Patients Developing Anti-drug Antibodies (ADAs)
timeFrame: From Week 0 to Week 80
measure: Trough Adalimumab Concentration
timeFrame: From Week 0 to Week 80
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
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: 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: 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 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: Sfantu Gheorghe
country: Romania
facility: Research Site
state: Covasna
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: Galati
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 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.