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

NCT02405780 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 645

Last updated 2019-03-26

Study results available
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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.

Conditions

  • Arthritis, Rheumatoid

Interventions

DRUG

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.

DRUG

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.

Sponsors & Collaborators

  • Fujifilm Kyowa Kirin Biologics Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Josephine Glover, MD · Coephycient Pharmaceutical Consultancy

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-06-10
Primary Completion
2018-01-18
Completion
2018-01-18

Countries

  • United States
  • Canada
  • Chile
  • Czechia
  • Germany
  • Peru
  • Poland
  • Romania
  • Russia
  • Spain
  • Ukraine

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02405780 on ClinicalTrials.gov