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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.
  Purpose
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.

Condition Intervention Phase
Rheumatoid Arthritis Drug: Humira (adalimumab) Drug: SB5 (proposed biosimilar to adalimumab) Phase 3

Study Type: Interventional
Study Design: 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, Tolerability, Pharmacokinetics and Immunogenicity of SB5 Compared to Humira® in Subjects With Moderate to Severe Rheumatoid Arthritis

Resource links provided by NLM:


Further study details as provided by Samsung Bioepis Co., Ltd.:

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

Secondary Outcome Measures:
  • 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 ]

Enrollment: 544
Study Start Date: May 2014
Study Completion Date: October 2015
Primary Completion Date: April 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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: Humira (adalimumab) Drug: SB5 (proposed biosimilar to adalimumab)

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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

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).
  Contacts and Locations
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): NCT02167139


Locations
Lithuania
Investigational Site
Kaunas, Lithuania
Poland
Investigational site
Katowice, Poland
Sponsors and Collaborators
Samsung Bioepis Co., Ltd.
Investigators
Principal Investigator: Asta Baranauskaite, M.D., Ph.D. Hospital of Lithuanian University of Health Sciences
  More Information

Responsible Party: Samsung Bioepis Co., Ltd.
ClinicalTrials.gov Identifier: NCT02167139     History of Changes
Other Study ID Numbers: SB5-G31-RA
First Submitted: June 16, 2014
First Posted: June 18, 2014
Results First Submitted: November 22, 2016
Results First Posted: January 19, 2017
Last Update Posted: August 17, 2017
Last Verified: November 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Adalimumab
Anti-Inflammatory Agents
Antirheumatic Agents