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

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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.

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.

Condition or disease Intervention/treatment Phase
Rheumatoid Arthritis Drug: Enbrel (etanercept) Drug: SB4 (proposed biosimilar to etanercept) Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 596 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : June 2013
Primary Completion Date : April 2014
Study Completion Date : October 2015

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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)



Primary Outcome Measures :
  1. American College of Rheumatology 20% Response Criteria (ACR20) [ Time Frame: Week 24 ]

Secondary Outcome Measures :
  1. ACR20 [ Time Frame: Week 52 ]
  2. American College of Rheumatology 50% Response Criteria (ACR50) [ Time Frame: Week 24, Week 52 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01895309


Locations
Poland
Investigational Site
Kielce, Poland
United Kingdom
Investigational Site
Southampton, Hampshire, United Kingdom
Sponsors and Collaborators
Samsung Bioepis Co., Ltd.
Investigators
Principal Investigator: Jiri Vencovsky, M.D., Ph.D. Charles University, Czech Republic

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Samsung Bioepis Co., Ltd.
ClinicalTrials.gov Identifier: NCT01895309     History of Changes
Other Study ID Numbers: SB4-G31-RA
First Posted: July 10, 2013    Key Record Dates
Results First Posted: August 29, 2016
Last Update Posted: August 17, 2017
Last Verified: December 2015

Keywords provided by Samsung Bioepis Co., Ltd.:
Rheumatoid Arthritis
Etanercept
Biosimilar

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Methotrexate
Etanercept
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Physiological Effects of Drugs
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Dermatologic Agents
Enzyme Inhibitors
Folic Acid Antagonists
Immunosuppressive Agents
Immunologic Factors
Antirheumatic Agents
Nucleic Acid Synthesis Inhibitors
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents