A Study Comparing SB4 to Enbrel® in Subjects With Moderate to Severe Rheumatoid Arthritis Despite Methotrexate Therapy

July 10, 2017 updated by: Samsung Bioepis Co., Ltd.

A Randomised, Double-blind, Parallel Group, Multicentre Clinical Study to Evaluate the Efficacy, Safety, Pharmacokinetics and Immunogenicity of SB4 Compared to Enbrel® in Subjects With Moderate to Severe Rheumatoid Arthritis Despite Methotrexate Therapy

This is a randomized, double-blind, parallel group, multicentre clinical study to evaluate the efficacy, safety, pharmacokinetics and immunogenicity of SB4 compared to Enbrel in subjects with moderate to severe Rheumatoid Arthritis (RA) despite Methotrexate (MTX) therapy. In some countries, after 52 weeks of treatment with either SB4 or Enbrel, subjects will be enrolled into an open label extension period. Subjects will receive SB4 for an additional 48 weeks.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

596

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Poland
      • Kielce, Poland
        • Investigational Site
  • United Kingdom
    • Hampshire
      • Southampton, Hampshire, United Kingdom
        • Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Diagnosed as having RA according to the revised 1987 ACR criteria for at least 6 months but not exceeding 15 years prior to Screening
  • Have moderate to severe active disease despite MTX therapy defined as having more than or equal to six swollen joints and more than or equal to six tender joints and either erythrocyte sedimentation rate (ESR, Westergren) ≥ 28 mm/h or serum C-reactive protein ≥ 1.0 mg/dL
  • Must have been treated with MTX for at least 6 months prior to Randomisation and on a stable dose of MTX 10-25 mg/week given at least 4 weeks prior to Screening
  • Female subjects who are not pregnant or nursing at Screening and who are not planning to become pregnant from Screening until 2 months after the last dose of investigational product

Exclusion Criteria:

  • Have been treated previously with any biological agents including any tumour necrosis factor inhibitor
  • Have a known hypersensitivity to human immunoglobulin proteins or other components of Enbrel or SB4
  • Have a positive serological test for hepatitis B or hepatitis C or have a known history of infection with human immunodeficiency virus
  • Have a current diagnosis of active tuberculosis
  • Have had a serious infection or have been treated with intravenous antibiotics for an infection within 8 weeks or oral antibiotics within 2 weeks prior to Randomisation.

  • Have any of the following conditions

    1. Other inflammatory or rheumatic diseases.
    2. History of any malignancy within the previous 5 years prior to Screening
    3. History of lymphoproliferative disease including lymphoma.
    4. History of congestive heart failure
    5. Physical incapacitation (ACR functional Class IV or wheelchair-/bed-bound).
    6. History of demyelinating disorders.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: SB4 (proposed biosimilar to etanercept)
SB4 50 mg/week via subcutaneous injection
Drug: SB4 (proposed biosimilar to etanercept)
Active Comparator: Enbrel (etanercept)
Enbrel 50 mg/week via subcutaneous injection
Drug: Enbrel (etanercept)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
American College of Rheumatology 20% Response Criteria (ACR20)
Time Frame: Week 24
Week 24

Secondary Outcome Measures

Outcome Measure
Time Frame
ACR20
Time Frame: Week 52
Week 52
American College of Rheumatology 50% Response Criteria (ACR50)
Time Frame: Week 24, Week 52
Week 24, Week 52

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Samsung Bioepis Co., Ltd.

Investigators

  • Principal Investigator: Jiri Vencovsky, M.D., Ph.D., Charles University, Czech Republic

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2013

Primary Completion (Actual)

April 1, 2014

Study Completion (Actual)

October 1, 2015

Study Registration Dates

First Submitted

July 3, 2013

First Submitted That Met QC Criteria

July 3, 2013

First Posted (Estimate)

July 10, 2013

Study Record Updates

Last Update Posted (Actual)

August 17, 2017

Last Update Submitted That Met QC Criteria

July 10, 2017

Last Verified

December 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SB4-G31-RA

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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