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A Study to Compare FKB327 Long-term Safety, Efficacy and Immunogenicity 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 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.

Clinical Details

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 design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome:

Number of patients with Adverse Events as a measure of safety

Number of patients with Serious Adverse Events as a measure of safety

Number of patients with changes in Vital Signs as a measure of safety

Number of patients with changes in Clinical Laboratory Tests as a measure of safety

Secondary outcome:

Changes in Disease Activity Score 28 based on C reactive protein (DAS28 CRP) score compared to baseline as a measure of efficacy

American College of Rheumatology 20 (ACR20) response rates from baseline as a measure of efficacy

American College of Rheumatology 50 (ACR50) response rates from baseline as a measure of efficacy

American College of Rheumatology 70 (ACR70) response rates from baseline as a measure of efficacy

Eligibility

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

Criteria:

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

Locations and Contacts

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

Research Site, Brno, Czech Republic; Not yet recruiting

Research Site, Hlucin, Czech Republic; Not yet recruiting

Research Site, Prague, Czech Republic; Not yet recruiting

Research Site, Uherske Hradiste, Czech Republic; Not yet recruiting

Research Site, Zlin, Czech Republic; Not yet recruiting

Research Site A, Moscow, Russian Federation; Not yet recruiting

Research Site D, Moscow, Russian Federation; Not yet recruiting

Research Site SM, Moscow, Russian Federation; Not yet recruiting

Research Site ST, Moscow, Russian Federation; Not yet recruiting

Research Site, Novosibirsk, Russian Federation; Not yet recruiting

Research Site, Penza, Russian Federation; Not yet recruiting

Research Site, Perm, Russian Federation; Not yet recruiting

Research Site, Ryazan, Russian Federation; Not yet recruiting

Research Site B, Saint-Petersburg, Russian Federation; Not yet recruiting

Research Site Z, Saint-Petersburg, Russian Federation; Not yet recruiting

Research Site, Saratov, Russian Federation; Not yet recruiting

Research Site, Smolensk, Russian Federation; Not yet recruiting

Research Site, Vladimir, Russian Federation; Not yet recruiting

Research Site E, Yaroslavl, Russian Federation; Not yet recruiting

Research Site S, Yaroslavl, Russian Federation; Not yet recruiting

Research Site A, Barcelona, Spain; Not yet recruiting

Research Site G, Barcelona, Spain; Not yet recruiting

Research Site, Malaga, Spain; Not yet recruiting

Research Site N, Sevilla, Spain; Not yet recruiting

Research Site, Peoria, Arizona, United States; Recruiting

Research Site, Ufa, Bashkortostan Republic, Russian Federation; Not yet recruiting

Research Site, Palm Desert, California, United States; Not yet recruiting

Research Site, Boca Raton, Florida, United States; Not yet recruiting

Research Site, Brandon, Florida, United States; Not yet recruiting

Research Site, Jacksonville, Florida, United States; Not yet recruiting

Research Site, Sarasota, Florida, United States; Recruiting

Research Site, Petrozavodsk, Karelia Republic, Russian Federation; Not yet recruiting

Research Site, Santiago de Compostela, La Coruna, Spain; Not yet recruiting

Research Site, Kalamazoo, Michigan, United States; Not yet recruiting

Research Site, Lansing, Michigan, United States; Recruiting

Research Site, Middleburg Heights, Ohio, United States; Not yet recruiting

Research Site, Mississauga, Ontario, Canada; Not yet recruiting

Research Site, St. Catherines, Ontario, Canada; Not yet recruiting

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

Research Site, Duncansville, Pennsylvania, United States; Recruiting

Research Site, Trois-Rivieres, Quebec, Canada; Not yet recruiting

Research Site, Kazan, Tatarstan Republic, Russian Federation; Not yet recruiting

Research Site, Amarillo, Texas, United States; Not yet recruiting

Research Site, Dallas, Texas, United States; Not yet recruiting

Research Site, Bilbao, Vizcaya, Spain; Not yet recruiting

Additional Information

Starting date: June 2015
Last updated: June 13, 2015

Page last updated: August 23, 2015

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