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A Study to Compare FKB327 Efficacy and Safety With Humira® in Rheumatoid Arthritis Patients

Information source: Fujifilm Kyowa Kirin Biologics Co., Ltd.
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Arthritis, Rheumatoid

Intervention: FKB327 (Drug); Humira® (Drug)

Phase: Phase 3

Status: Recruiting

Sponsored by: Fujifilm Kyowa Kirin Biologics Co., Ltd.

Official(s) and/or principal investigator(s):
Josephine Glover, MD, Principal Investigator, Affiliation: Coephycient Pharmaceutical Consultancy

Overall contact:
Clinical Trial Information, Email: clinical-trials@fujifilmkyowakirin-biologics.com

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.

Clinical Details

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 design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: American College of Rheumatology (ACR) 20 response rate

Secondary outcome:

Disease Activity Score 28 (DAS28) based on C-reactive protein (DAS28-CRP) score

ACR20 response rates over time

ACR50 response rates over time

ACR70 response rates over time

Values of the individual ACR core set variables (swollen joint count, tender joint count, CRP, patient's assessment of disease activity, physician's assessment of disease activity, patient's assessment of pain, HAQ-DI)

DAS28-CRP score and change in DAS28-CRP score over time

DAS28 score based on erythrocyte sedimentation rate (DAS28-ESR)

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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.

Locations and Contacts

Clinical Trial Information, Email: clinical-trials@fujifilmkyowakirin-biologics.com

Research Site, Plovdiv, Bulgaria; Recruiting

Research Site S, Plovdiv, Bulgaria; Not yet recruiting

Research Site, Ruse, Bulgaria; Not yet recruiting

Research Site, Sofia, Bulgaria; Not yet recruiting

Research Site, Stara Zagora, Bulgaria; Recruiting

Research Site, Osorno, Chile; Recruiting

Research Site, Puerto Varas, Chile; Not yet recruiting

Research Site G, Santiago, Chile; Recruiting

Research Site Gu, Santiago, Chile; Not yet recruiting

Research Site M, Santiago, Chile; Recruiting

Research Site R, Santiago, Chile; Not yet recruiting

Research Site, Temuco, Chile; Recruiting

Research Site, Brno, Czech Republic; Recruiting

Research Site, Hlucin, Czech Republic; Recruiting

Research Site, Prague, Czech Republic; Recruiting

Research Site, Uherske Hradiste, Czech Republic; Recruiting

Research Site, Zlin, Czech Republic; Recruiting

Research Site, Aachen, Germany; Recruiting

Research Site, Berlin, Germany; Recruiting

Research Site, Hamburg, Germany; Recruiting

Research Site, Herne, Germany; Recruiting

Research Site, Hildesheim, Germany; Not yet recruiting

Research Site, Munich, Germany; Recruiting

Research Site, Ratingen, Germany; Recruiting

Research Site D, Bialystok, Poland; Recruiting

Research Site R, Bialystok, Poland; Recruiting

Research Site, Katowice, Poland; Recruiting

Research Site KL, Krakow, Poland; Recruiting

Research Site KR, Krakow, Poland; Recruiting

Research Site, Lublin, Poland; Recruiting

Research Site P, Poznan, Poland; Recruiting

Research Site RH, Poznan, Poland; Recruiting

Research Site, Braila, Romania; Recruiting

Research Site, Brasov, Romania; Recruiting

Research Site C, Bucharest, Romania; Recruiting

Research Site R, Bucharest, Romania; Recruiting

Research Site T, Bucharest, Romania; Recruiting

Research Site, Constanta, Romania; Recruiting

Research Site, Galati, Romania; Recruiting

Research Site A, Moscow, Russian Federation; Recruiting

Research Site D, Moscow, Russian Federation; Recruiting

Research Site SM, Moscow, Russian Federation; Recruiting

Research Site ST, Moscow, Russian Federation; Recruiting

Research Site, Novosibirsk, Russian Federation; Recruiting

Research Site, Penza, Russian Federation; Recruiting

Research Site, Perm, Russian Federation; Recruiting

Research Site, Ryazan, Russian Federation; Recruiting

Research Site B, Saint-Petersburg, Russian Federation; Recruiting

Research Site Z, Saint-Petersburg, Russian Federation; Recruiting

Research Site, Saratov, Russian Federation; Recruiting

Research Site, Smolensk, Russian Federation; Recruiting

Research Site, Vladimir, Russian Federation; Recruiting

Research Site E, Yaroslavl, Russian Federation; Recruiting

Research Site S, Yaroslavl, Russian Federation; Recruiting

Research Site D, Belgrade, Serbia; Not yet recruiting

Research Site S, Belgrade, Serbia; Not yet recruiting

Research Site V, Belgrade, Serbia; Not yet recruiting

Research Site, Kragujevac, Serbia; Not yet recruiting

Research Site, Niska Banja, Serbia; Not yet recruiting

Research Site A, Barcelona, Spain; Recruiting

Research Site G, Barcelona, Spain; Recruiting

Research Site, Malaga, Spain; Recruiting

Research Site N, Sevilla, Spain; Recruiting

Research Site, Chernivtsi, Ukraine; Recruiting

Research Site, Ivano-Frankivsk, Ukraine; Recruiting

Research Site A, Kyiv, Ukraine; Recruiting

Research Site B, Kyiv, Ukraine; Recruiting

Research Site L, Kyiv, Ukraine; Recruiting

Research Site P, Kyiv, Ukraine; Recruiting

Research Site C, Lviv, Ukraine; Recruiting

Research Site N, Lviv, Ukraine; Recruiting

Research Site, Poltava, Ukraine; Recruiting

Research Site, Ternopil, Ukraine; Recruiting

Research Site, Uzhgorod, Ukraine; Recruiting

Research Site G, Vinnytsia, Ukraine; Recruiting

Research Site Sh, Vinnytsia, Ukraine; Recruiting

Research Site St, Vinnytsia, Ukraine; Recruiting

Research Site, Peoria, Arizona, United States; Recruiting

Research Site, Ufa, Bashkortostan Republic, Russian Federation; Recruiting

Research Site, Oradea, Bihor, Romania; Recruiting

Research Site, Palm Desert, California, United States; Recruiting

Research Site, Sf. Gheorghe, Covasna, Romania; Recruiting

Research Site, Boca Raton, Florida, United States; Recruiting

Research Site, Brandon, Florida, United States; Recruiting

Research Site, Jacksonville, Florida, United States; Recruiting

Research Site, Sarasota, Florida, United States; Recruiting

Research Site, Petrozavodsk, Karelia Republic, Russian Federation; Recruiting

Research Site, Santiago de Compostela, La Coruna, Spain; Recruiting

Research Site, Kalamazoo, Michigan, United States; Recruiting

Research Site, Lansing, Michigan, United States; Recruiting

Research Site, Middleburg Heights, Ohio, United States; Recruiting

Research Site, Mississauga, Ontario, Canada; Recruiting

Research Site, St. Catherines, Ontario, Canada; Recruiting

Research Site B, Toronto, Ontario, Canada; Not yet recruiting

Research Site, Duncansville, Pennsylvania, United States; Recruiting

Research Site, Trois-Rivieres, Quebec, Canada; Recruiting

Research Site, Kazan, Tatarstan Republic, Russian Federation; Recruiting

Research Site, Amarillo, Texas, United States; Recruiting

Research Site, Dallas, Texas, United States; Recruiting

Research Site, Bilbao, Vizcaya, Spain; Recruiting

Additional Information

Starting date: December 2014
Last updated: June 5, 2015

Page last updated: August 23, 2015

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