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A Study Comparing SB5 to Humira® in Subjects With Moderate to Severe Rheumatoid Arthritis Despite Methotrexate Therapy

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02167139
First Posted: June 18, 2014
Last Update Posted: August 17, 2017
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.
Information provided by (Responsible Party):
Samsung Bioepis Co., Ltd.
June 16, 2014
June 18, 2014
November 22, 2016
January 19, 2017
August 17, 2017
May 2014
April 2015   (Final data collection date for primary outcome measure)
American College of Rheumatology 20% Response Criteria (ACR20) [ Time Frame: Week 24 ]
Same as current
Complete list of historical versions of study NCT02167139 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
A Study Comparing SB5 to Humira® in Subjects With Moderate to Severe Rheumatoid Arthritis Despite Methotrexate Therapy
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.
Investigational product: SB5 40 mg (0.8 mL of 50 mg/mL) Indication studied: Rheumatoid arthritis
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Rheumatoid Arthritis
  • Drug: Humira (adalimumab)
  • Drug: SB5 (proposed biosimilar to adalimumab)
  • 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)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
544
October 2015
April 2015   (Final data collection date for primary outcome measure)

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).
Sexes Eligible for Study: All
18 Years to 75 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Lithuania,   Poland
 
 
NCT02167139
SB5-G31-RA
Yes
Not Provided
Plan to Share IPD: No
Samsung Bioepis Co., Ltd.
Samsung Bioepis Co., Ltd.
Not Provided
Principal Investigator: Asta Baranauskaite, M.D., Ph.D. Hospital of Lithuanian University of Health Sciences
Samsung Bioepis Co., Ltd.
November 2016

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