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Completed Phase 3 Interventional Results available

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

ClinicalTrials.gov ID: NCT02405780

Public ClinicalTrials.gov record NCT02405780. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Sep 15, 2026, 3:57 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

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

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID
NCT02405780
Recruitment status
Completed
Study type
Interventional
Phase
Phase 3
Enrollment
645 participants

Conditions and interventions

Interventions

Drug

Eligibility (public fields only)

Age range
18 Years and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Jun 9, 2015
Primary completion
Jan 17, 2018
Completion
Jan 17, 2018
Last update posted
Mar 25, 2019

2015 – 2018

United States locations

U.S. sites
15
U.S. states
9
U.S. cities
15
Facility City State ZIP Site status
Research Site Peoria Arizona 85381
Research Site Palm Desert California 92260
Research Site Boca Raton Florida 33486
Research Site Brandon Florida 33511
Research Site Jacksonville Florida 32207
Research Site Miami Florida 33135
Research Site Sarasota Florida 34239
Research Site Shreveport Louisiana 71101
Research Site Lansing Michigan 48910
Research Site Durham North Carolina 27704
Research Site Middleburg Heights Ohio 44130
Research Site Duncansville Pennsylvania 16635
Research Site Amarillo Texas 79124
Research Site Austin Texas 78745
Research Site Mesquite Texas 75150

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 77 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT02405780, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Mar 25, 2019 · Synced Sep 15, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT02405780 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →