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A Study to Compare FKB327 Efficacy and Safety With Humira® in Rheumatoid Arthritis Patients

NCT02260791 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 728

Last updated 2017-11-28

Study results available
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Summary

The purpose of the study is to compare the effectiveness and safety of FKB327 in comparison to Humira® in rheumatoid arthritis patients who 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 22 weeks.

DRUG

Humira®

Solution of Humira® for subcutaneous injection administered in a dose of 40 mg every 2 weeks for 22 weeks.

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
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-12-31
Primary Completion
2016-07-31
Completion
2016-07-31

Countries

  • United States
  • Bulgaria
  • 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 NCT02260791 on ClinicalTrials.gov