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A Study Comparing SB5 to Humira® 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: NCT02167139
Recruitment Status : Completed
First Posted : June 18, 2014
Results First Posted : January 19, 2017
Last Update Posted : August 17, 2017
Sponsor:
Information provided by (Responsible Party):
Samsung Bioepis Co., Ltd.

Tracking Information
First Submitted Date  ICMJE June 16, 2014
First Posted Date  ICMJE June 18, 2014
Results First Submitted Date  ICMJE November 22, 2016
Results First Posted Date  ICMJE January 19, 2017
Last Update Posted Date August 17, 2017
Study Start Date  ICMJE May 2014
Actual Primary Completion Date April 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 22, 2016)		 American College of Rheumatology 20% Response Criteria (ACR20) [ Time Frame: Week 24 ]
Original Primary Outcome Measures  ICMJE
 (submitted: June 16, 2014)		 American College of Rheumatology 20% response criteria (ACR20) [ Time Frame: Week 24 ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 22, 2016)
  • ACR20 [ Time Frame: Week 52 ]
  • American College of Rheumatology 50% Response Criteria (ACR50) [ Time Frame: Week 24, Week 52 ]
  • Disease Activity Score Based on a 28 Joint Count (DAS28) [ Time Frame: Week 24, Week 52 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: June 16, 2014)
  • ACR20 [ Time Frame: Week 52 ]
  • American College of Rheumatology 50% response criteria (ACR50) [ Time Frame: Week 24, Week 52 ]
  • Disease activity score based on a 28 joint count (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 SB5 to Humira® 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, Tolerability, Pharmacokinetics and Immunogenicity of SB5 Compared to Humira® in Subjects With Moderate to Severe Rheumatoid Arthritis
Brief Summary 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.
Detailed Description Investigational product: SB5 40 mg (0.8 mL of 50 mg/mL) Indication studied: Rheumatoid arthritis
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: Humira (adalimumab)
  • Drug: SB5 (proposed biosimilar to adalimumab)
Study Arms  ICMJE
  • Experimental: SB5 (proposed biosimilar to adalimumab)
    SB5 40 mg every other week via subcutaneous injection
    Intervention: Drug: SB5 (proposed biosimilar to adalimumab)
  • Active Comparator: Humira (adalimumab)
    Humira 40 mg every other week via subcutaneous injection
    Interventions:
    • Drug: Humira (adalimumab)
    • Drug: SB5 (proposed biosimilar to adalimumab)
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)		 544
Original Estimated Enrollment  ICMJE
 (submitted: June 16, 2014)		 490
Actual Study Completion Date  ICMJE October 2015
Actual Primary Completion Date April 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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).
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 Lithuania,   Poland
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02167139
Other Study ID Numbers  ICMJE SB5-G31-RA
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party Samsung Bioepis Co., Ltd.
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Samsung Bioepis Co., Ltd.
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Asta Baranauskaite, M.D., Ph.D. Hospital of Lithuanian University of Health Sciences
PRS Account Samsung Bioepis Co., Ltd.
Verification Date November 2016

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