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

• Status: Completed
• Trial end date: 2016-07-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Fujifilm Kyowa Kirin Biologics Co., Ltd.
• Treatments: Adalimumab

Criteria

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.