A Study to Compare FKB327 Long-term Safety, Efficacy and Immunogenicity With Humira® in Rheumatoid Arthritis Patients

PHASE3CompletedINTERVENTIONAL
Enrollment

645

Participants

Timeline

Start Date

June 10, 2015

Primary Completion Date

January 18, 2018

Study Completion Date

January 18, 2018

Conditions
Arthritis, Rheumatoid
Interventions
DRUG

FKB327

Solution of FKB327 for subcutaneous injection administered in a dose of 40 mg every 2 weeks for 28 weeks. Patients may continue to receive FKB327 40 mg every other week by subcutaneous injection for up to 76 weeks.

DRUG

Humira®

Solution of Humira® for subcutaneous injection administered in a dose of 40 mg every 2 weeks for 28 weeks. Patients may then receive FKB327 40 mg every other week by subcutaneous injection from week 30 to week 76.

Trial Locations (92)

16635

Research Site, Duncansville

27704

Research Site, Durham

32207

Research Site, Jacksonville

33135

Research Site, Miami

33486

Research Site, Boca Raton

33511

Research Site, Brandon

34239

Research Site, Sarasota

44130

Research Site, Middleburg Heights

48910

Research Site, Lansing

71101

Research Site, Shreveport

75150

Research Site, Mesquite

78745

Research Site, Austin

79124

Research Site, Amarillo

85381

Research Site, Peoria

92260

Research Site, Palm Desert

Unknown

Research Site, Saint Catherines

Research Site, Trois-Rivières

Research Site, Osorno

Research Site, Puerto Varas

Research Site G, Santiago

Research Site M, Santiago

Research Site, Temuco

Research Site, Brno

Research Site, Hlučín

Research Site U, Prague

Research Site, Prague

Research Site, Uherské Hradiště

Research Site, Zlín

Research Site, Aachen

Research Site, Berlin

Research Site, Hamburg

Research Site, Munich

Research Site, Ratingen

Research Site B, Arequipa

Research Site M, Arequipa

Research Site CA, Lima

Research Site CH, Lima

Research Site PA, Lima

Research Site S, Lima

Research Site D, Bialystok

Research Site R, Bialystok

Research Site, Gdynia

Research Site, Katowice

Research Site KL, Krakow

Research Site KR, Krakow

Research Site, Lublin

Research Site P, Poznan

Research Site RH, Poznan

Research Site, Torun

Research Site, Oradea

Research Site, Sfântu Gheorghe

Research Site, Brasov

Research Site, Brăila

Research Site C, Bucharest

Research Site R, Bucharest

Research Site T, Bucharest

Research Site, Galati

Research Site, Ufa

Research Site, Petrozavodsk

Research Site, Kazan'

Research Site D, Moscow

Research Site SM, Moscow

Research Site ST, Moscow

Research Site, Nizhny Novgorod

Research Site, Penza

Research Site, Perm

Research Site, Ryazan

Research Site B, Saint Petersburg

Research Site Z, Saint Petersburg

Research Site, Saratov

Research Site, Smolensk

Research Site, Vladimir

Research Site E, Yaroslavl

Research Site S, Yaroslavl

Research Site, Santiago de Compostela

Research Site, Bilbao

Research Site G, Barcelona

Research Site, Málaga

Research Site, Chernivtsi

Research Site, Ivano-Frankivsk

Research Site A, Kyiv

Research Site B, Kyiv

Research Site P, Kyiv

Research Site, Lutsk

Research Site C, Lviv

Research Site N, Lviv

Research Site, Poltava

Research Site, Ternopil

Research Site, Uzhhorod

Research Site G, Vinnytsia

Research Site Sh, Vinnytsia

Research Site St, Vinnytsia

All Listed Sponsors
lead

Fujifilm Kyowa Kirin Biologics Co., Ltd.

INDUSTRY

NCT02405780 - A Study to Compare FKB327 Long-term Safety, Efficacy and Immunogenicity With Humira® in Rheumatoid Arthritis Patients | Biotech Hunter | Biotech Hunter