Conditions: Arthritis, Rheumatoid
Keywords: Rheumatoid Arthritis
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 728
Healthy volunteers: no

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.

Detailed description:

Arms:
arm 1: Patients will receive FKB327 40 mg every other week by subcutaneous injection. The treatment period will continue for 22 weeks. arm 2: Patients will receive Humira® 40 mg every other week by subcutaneous injection. The treatment period will continue for 22 weeks.

Interventions: intervention 1: FKB327 intervention 2: Humira®
Intervention descriptions: intervention 1: Solution of FKB327 for subcutaneous injection administered in a dose of 40 mg every 2 weeks for 22 weeks. intervention 2: Solution of Humira® for subcutaneous injection administered in a dose of 40 mg every 2 weeks for 22 weeks.

Protocol document: