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

Overview

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.

Full Title of Study: “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”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: April 2015

Detailed Description

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

Interventions

  • Drug: Humira (adalimumab)
  • Drug: SB5 (proposed biosimilar to adalimumab)

Arms, Groups and Cohorts

  • Experimental: SB5 (proposed biosimilar to adalimumab)
    • SB5 40 mg every other week via subcutaneous injection
  • Active Comparator: Humira (adalimumab)
    • Humira 40 mg every other week via subcutaneous injection

Clinical Trial Outcome Measures

Primary Measures

  • American College of Rheumatology 20% Response Criteria (ACR20)
    • Time Frame: Week 24

Secondary 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

Participating in This Clinical Trial

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).

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 75 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Samsung Bioepis Co., Ltd.
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Asta Baranauskaite, M.D., Ph.D., Principal Investigator, Hospital of Lithuanian University of Health Sciences

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.