Overview

This trial is active, not recruiting.

Condition arthritis, rheumatoid
Treatments fkb327, humira®
Phase phase 3
Sponsor Fujifilm Kyowa Kirin Biologics Co., Ltd.
Start date June 2015
End date January 2018
Trial size 645 participants
Trial identifier NCT02405780, FKB327-003

Summary

The purpose of the study is to compare the 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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Patients will receive the drug 40 mg every other week by subcutaneous injection. The treatment period may continue for 76 weeks.
fkb327
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.
(Active Comparator)
Patients will receive the drug 40 mg every other week by subcutaneous injection. The treatment period may continue for 76 weeks.
humira®
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.

Primary Outcomes

Measure
Number of patients with Adverse Events as a measure of safety
time frame: Up to Week 80
Number of patients with Serious Adverse Events as a measure of safety
time frame: Up to Week 80
Number of patients with changes in Vital Signs as a measure of safety
time frame: Up to Week 80
Number of patients with changes in Clinical Laboratory Tests as a measure of safety
time frame: Up to Week 80

Secondary Outcomes

Measure
Changes in Disease Activity Score 28 based on C reactive protein (DAS28 CRP) score compared to baseline as a measure of efficacy
time frame: From Week 0 of FKB327-002 to Week 80
American College of Rheumatology 20 (ACR20) response rates from baseline as a measure of efficacy
time frame: From Week 0 of FKB327-002 to Week 80
American College of Rheumatology 50 (ACR50) response rates from baseline as a measure of efficacy
time frame: From Week 0 of FKB327-002 to Week 80
American College of Rheumatology 70 (ACR70) response rates from baseline as a measure of efficacy
time frame: From Week 0 of FKB327-002 to Week 80

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: 1. Patient has completed the Week 24 visit procedures of Study FKB327-002 and are continuing with methotrexate 2. In the investigator's opinion, the patient showed a clinical response to treatment during Study FKB327-002 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.

Additional Information

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
Principal investigator Josephine Glover, MD
Trial information was received from ClinicalTrials.gov and was last updated in July 2016.
Information provided to ClinicalTrials.gov by Fujifilm Kyowa Kirin Biologics Co., Ltd..