Status:
COMPLETED
A Study to Compare FKB327 Efficacy and Safety With Humira® in Rheumatoid Arthritis Patients
Lead Sponsor:
Fujifilm Kyowa Kirin Biologics Co., Ltd.
Conditions:
Arthritis, Rheumatoid
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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.
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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.
Key Trial Info
Start Date :
December 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2016
Estimated Enrollment :
728 Patients enrolled
Trial Details
Trial ID
NCT02260791
Start Date
December 1 2014
End Date
July 1 2016
Last Update
November 28 2017
Active Locations (100)
Enter a location and click search to find clinical trials sorted by distance.
1
Research Site
Peoria, Arizona, United States
2
Research Site
Palm Desert, California, United States
3
Research Site
Boca Raton, Florida, United States
4
Research Site
Brandon, Florida, United States