CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 645 enrolled
Drug / intervention
FKB327 +1 moredrug
Likely dose
FKB327 40 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02405780
NCT02405780Phase 3Completed
CompareCT.gov

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

Fujifilm Kyowa Kirin Biologics Co., Ltd.·interventional·Posted Apr 1, 2015·Updated Mar 26, 2019

In Brief

A Phase 3 clinical trial evaluating FKB327 and Humira® for Arthritis, Rheumatoid. Completed, enrolled 645 participants across 92 sites in 11 countries.

Detailed Summary

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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsArthritis, Rheumatoid
CountriesCanada, Chile, Czechia, Germany, Peru, Poland, Romania, Russia, Spain, Ukraine, United States
Collaborators--

Timeline

Phase 3CompletedFinished
201520162017201820192020202120222023202420252026
First PostedApr 1, 2015
Enrollment StartJun 10, 2015
Primary CompletionJan 18, 2018
TodayJul 2, 2026
Enrollment to primary: 2.6 yearsPosted 11.3 years ago

Interventions

FKB327drug

Solution of FKB327 for subcutaneous injection administered in a dose of 40 mg every 2 weeks for 28 weeks. Patients may continue to receive FKB327 40 mg every other week by subcutaneous injection for up to 76 weeks.

Humira®drug

Solution of Humira® for subcutaneous injection administered in a dose of 40 mg every 2 weeks for 28 weeks. Patients may then receive FKB327 40 mg every other week by subcutaneous injection from week 30 to week 76.