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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01895309
Recruitment Status : Completed
First Posted : July 10, 2013
Results First Posted : August 29, 2016
Last Update Posted : August 17, 2017
Sponsor:
Information provided by (Responsible Party):
Samsung Bioepis Co., Ltd.

Tracking Information
First Submitted Date  ICMJE July 3, 2013
First Posted Date  ICMJE July 10, 2013
Results First Submitted Date  ICMJE July 13, 2016
Results First Posted Date  ICMJE August 29, 2016
Last Update Posted Date August 17, 2017
Study Start Date  ICMJE June 2013
Actual Primary Completion Date April 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 10, 2013)
American College of Rheumatology 20% Response Criteria (ACR20) [ Time Frame: Week 24 ]
Original Primary Outcome Measures  ICMJE
 (submitted: July 3, 2013)
ACR20 [ Time Frame: Week 24 ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 13, 2016)
  • ACR20 [ Time Frame: Week 52 ]
  • American College of Rheumatology 50% Response Criteria (ACR50) [ Time Frame: Week 24, Week 52 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: July 3, 2013)
  • ACR20 [ Time Frame: Week 52 ]
  • ACR50 [ Time Frame: Week 24, Week 52 ]
  • DAS28 [ Time Frame: Week 24, Week 52 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study Comparing SB4 to Enbrel® in Subjects With Moderate to Severe Rheumatoid Arthritis Despite Methotrexate Therapy
Official Title  ICMJE 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
Brief Summary 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Rheumatoid Arthritis
Intervention  ICMJE
  • Drug: Enbrel (etanercept)
  • Drug: SB4 (proposed biosimilar to etanercept)
Study Arms  ICMJE
  • Experimental: SB4 (proposed biosimilar to etanercept)
    SB4 50 mg/week via subcutaneous injection
    Intervention: Drug: SB4 (proposed biosimilar to etanercept)
  • Active Comparator: Enbrel (etanercept)
    Enbrel 50 mg/week via subcutaneous injection
    Intervention: Drug: Enbrel (etanercept)
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 2, 2015)
596
Original Estimated Enrollment  ICMJE
 (submitted: July 3, 2013)
498
Actual Study Completion Date  ICMJE October 2015
Actual Primary Completion Date April 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Poland,   United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01895309
Other Study ID Numbers  ICMJE SB4-G31-RA
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Samsung Bioepis Co., Ltd.
Study Sponsor  ICMJE Samsung Bioepis Co., Ltd.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Jiri Vencovsky, M.D., Ph.D. Charles University, Czech Republic
PRS Account Samsung Bioepis Co., Ltd.
Verification Date December 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP