A Study Comparing SB5 to Humira® 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, Tolerability, Pharmacokinetics and Immunogenicity of SB5 Compared to Humira® in Subjects With Moderate to Severe Rheumatoid Arthritis

This is a randomised, double-blind, parallel group, multicentre clinical study to evaluate the efficacy, safety, tolerability, pharmacokinetics and immunogenicity of SB5 compared to Humira® in subjects with moderate to severe RA despite MTX therapy.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Investigational product: SB5 40 mg (0.8 mL of 50 mg/mL) Indication studied: Rheumatoid arthritis

Study Type

Interventional

Enrollment (Actual)

544

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

  • Lithuania
      • Kaunas, Lithuania
        • Investigational Site
  • Poland
      • Katowice, Poland
        • 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:

  • Are male or female aged 18-75 years at the time of signing the informed consent form.
  • Have been diagnosed as having RA according to the revised 1987 American College of Rheumatology (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:

    1. More than or equal to six swollen joints and more than or equal to six tender joints (from the 66/68 joint count system) at Screening and Randomisation.
    2. Either erythrocyte sedimentation rate (Westergren) ≥ 28 mm/h or serum C-reactive protein ≥ 10 mg/dL at Screening.
  • Must have been treated with MTX for a total of at least 6 months prior to Randomisation and must have been on both: a stable route of administration (oral or parenteral) and stable dose of MTX (10-25 mg/week) for at least 4 weeks prior to Screening.
  • Female subjects who are not pregnant or nursing at Screening and Randomisation and who are not planning to become pregnant from Screening until 5 months after the last dose of IP.

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 Humira or SB5.
  • 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 (TB), have been recently exposed to a person with active TB, or are considered to have latent TB.
  • 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 a history of chronic or recurrent infection.

  • Have any of the following conditions:

    1. History of congestive heart failure (New York Heart Association Class III/IV).
    2. History of acute myocardial infarction or unstable angina within the previous 12 months prior to Screening.
    3. History of demyelinating disorders.
    4. History of any malignancy within the previous 5 years prior to Screening.
    5. History of lymphoproliferative disease including lymphoma.
    6. Any other disease or disorder which, in the opinion of the Investigator, will put the subject at risk if they are enrolled.
  • Have physical incapacitation (ACR functional Class IV or wheelchair-/bed-bound).

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: SB5 (proposed biosimilar to adalimumab)
SB5 40 mg every other week via subcutaneous injection
Drug: SB5 (proposed biosimilar to adalimumab)
Active Comparator: Humira (adalimumab)
Humira 40 mg every other week via subcutaneous injection
Drug: SB5 (proposed biosimilar to adalimumab)
Drug: Humira (adalimumab)

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
Disease Activity Score Based on a 28 Joint Count (DAS28)
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: Asta Baranauskaite, M.D., Ph.D., Hospital of Lithuanian University of Health Sciences

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

May 1, 2014

Primary Completion (Actual)

April 1, 2015

Study Completion (Actual)

October 1, 2015

Study Registration Dates

First Submitted

June 16, 2014

First Submitted That Met QC Criteria

June 16, 2014

First Posted (Estimate)

June 18, 2014

Study Record Updates

Last Update Posted (Actual)

August 17, 2017

Last Update Submitted That Met QC Criteria

July 10, 2017

Last Verified

November 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SB5-G31-RA

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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.

Clinical Trials on Rheumatoid Arthritis

Clinical Trials on SB5 (proposed biosimilar to adalimumab)

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Vietnam

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe