Arthritis, Rheumatoid Clinical Trial
Official title:
An Open-label Extension Study to Compare the Long-term Efficacy, Safety, Immunogenicity and Pharmacokinetics of FKB327 and Humira® in Patients With Rheumatoid Arthritis on Concomitant Methotrexate
The purpose of the study is to compare the long-term safety, effectiveness and immunogenicity of FKB327 in comparison to Humira® in rheumatoid arthritis patients who have completed study FKB327-002 and have inadequate disease control on methotrexate.
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.
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