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

The first period of this extension study was an open label, randomised, comparative, multi
centre, 2 arm extension Phase 3 study in patients with RA who were taking a stable dose of
MTX and who had continued from the preceding Study FKB327-002 (NCT02260791). The transition
from Study FKB327-002 was ideally to occur without interruption: the Week 24 visit of Study
FKB327-002 was to be on the same day as the Week 0 visit of Study FKB327-003. Patients who
had received FKB327 in Study FKB327-002 received FKB327 or Humira in a 2:1 ratio and patients
who had received Humira in Study FKB327-002 received Humira or FKB327 in a 2:1 ratio (Period
I). The second period of the study was an open label, single arm extension in which all
patients received FKB327 treatment from Week 30 to Week 76 (Period II), followed by a 4 week
Follow up period.

Clinic visits were scheduled for Weeks 0, 2, 4, 8, 12, 24, 30, 32, 34, 42, 54, 66, 76, and
80. The patient or carer was allowed to administer interim doses of study drug at home every
other week (eow) between clinic visits.

Inclusion Criteria:

1. Patient has completed the Week 24 visit procedures of Study FKB327-002 (NCT02260791)
and are continuing with methotrexate

2. In the investigator's opinion, the patient showed a clinical response to treatment
during Study FKB327-002 (NCT02260791)

Exclusion Criteria:

1. Patient has evidence of a serious adverse event (SAE) ongoing from Study FKB327-002

2. Patient has presence of active and/or untreated latent tuberculosis (TB)

Other Inclusion/Exclusion criteria may apply.