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

Completed · Phase 3

Conditions studied: Arthritis, Rheumatoid

In brief

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.

Key facts

Study ID

NCT02405780

Run by

Fujifilm Kyowa Kirin Biologics Co., Ltd.

People needed

645

Starts

2015-06-10

Expected to finish

2018-01-18

Last updated by the study team

2019-03-26

Who can join

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

You may qualify if…

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

You may not qualify if…

• Patient has evidence of a serious adverse event (SAE) ongoing from Study FKB327-002
• Patient has presence of active and/or untreated latent tuberculosis (TB)
• 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 — 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 — 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 — Temuco, Chile
• Research Site — Brno, Czechia
• Research Site — Hlučín, Czechia
• Research Site U — Prague, Czechia
• Research Site — Peoria, Arizona, United States

Full record on ClinicalTrials.gov

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