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

Status:	Completed
Conditions:	Arthritis, Rheumatoid Arthritis
Therapuetic Areas:	Rheumatology
Healthy:	No
Age Range:	18 - Any
Updated:	11/30/2017
Start Date:	December 2014
End Date:	July 2016

A Randomised, Blinded, Active-Controlled Study to Compare FKB327 Efficacy and Safety With the Comparator Humira® in Rheumatoid Arthritis Patients Inadequately Controlled on Methotrexate

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.

Inclusion Criteria:

1. Male or female aged 18 years or over

2. Patients have been diagnosed with Rheumatoid Arthritis (RA) for at least 3 months

3. Patient has active RA

4. Patient has taken a stable dose of methotrexate for at least 3 months

Exclusion Criteria:

1. Patient has been previously treated with adalimumab

2. Patient has been previously treated or has ongoing treatment with prohibited
medications

3. Patient has been immunised with a live or attenuated vaccine in past 4 weeks

4. Patient has positive result for HIV, HBV, HCV or TB infection

Other Inclusion/Exclusion criteria may apply.

We found this trial at

sites

Clinical Trial Facility in Miami Florida

Miami, Florida 33136

from

Miami, FL