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

Completed · Phase 3

Conditions studied: Arthritis, Rheumatoid

In brief

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.

Key facts

Study ID

NCT02260791

Run by

Fujifilm Kyowa Kirin Biologics Co., Ltd.

People needed

728

Starts

2014-12-01

Expected to finish

2016-07-01

Last updated by the study team

2017-11-28

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Male or female aged 18 years or over
• Patients have been diagnosed with Rheumatoid Arthritis (RA) for at least 3 months
• Patient has active RA
• Patient has taken a stable dose of methotrexate for at least 3 months

You may not qualify if…

• Patient has been previously treated with adalimumab
• Patient has been previously treated or has ongoing treatment with prohibited medications
• Patient has been immunised with a live or attenuated vaccine in past 4 weeks
• Patient has positive result for HIV, HBV, HCV or TB infection
• Other Inclusion/Exclusion criteria may apply.

Where it is running

• Research Site — Palm Desert, California, United States
• Research Site — Boca Raton, Florida, United States
• Research Site — Brandon, Florida, United States
• Research Site — Jacksonville, Florida, United States
• Research Site — Miami, Florida, United States
• Research Site — Miami Lakes, Florida, United States
• Research Site — Sarasota, Florida, United States
• Research Site — Shreveport, Louisiana, United States
• Research Site — Lansing, Michigan, United States
• Research Site — Durham, North Carolina, United States
• Research Site — Middleburg Heights, Ohio, United States
• Research Site — Duncansville, Pennsylvania, United States
• Research Site — Amarillo, Texas, United States
• Research Site — Austin, Texas, United States
• Research Site — Mesquite, Texas, United States
• Research Site — Plovdiv, Bulgaria
• Research Site — Sofia, Bulgaria
• Research Site — Mississauga, Ontario, Canada
• Research Site — Saint Catherines, Ontario, Canada
• Research Site — Trois-Rivières, Quebec, Canada
• Research Site — Osorno, Chile
• Research Site — Puerto Varas, Chile
• Research Site G — Santiago, Chile
• Research Site M — Santiago, Chile
• Research Site — Peoria, Arizona, United States

Full record on ClinicalTrials.gov

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