A Study Comparing SB5 to Humira® in Subjects With Moderate to Severe Rheumatoid Arthritis Despite Methotrexate Therapy
Information source: Samsung Bioepis Co., Ltd.
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Rheumatoid Arthritis
Intervention: Humira (adalimumab) (Drug); SB5 (proposed biosimilar to adalimumab) (Drug)
Phase: Phase 3
Status: Active, not recruiting
Sponsored by: Samsung Bioepis Co., Ltd. Official(s) and/or principal investigator(s): Asta Baranauskaite, M.D., Ph.D., Principal Investigator, Affiliation: Hospital of Lithuanian University of Health Sciences
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.
Clinical Details
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 Despite Methotrexate Therapy
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: American College of Rheumatology 20% response criteria (ACR20)
Secondary outcome: ACR20American College of Rheumatology 50% response criteria (ACR50) Disease activity score based on a 28 joint count (DAS28)
Eligibility
Minimum age: 18 Years.
Maximum age: 75 Years.
Gender(s): Both.
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 ≥ 1. 0 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).
Locations and Contacts
Investigational Site, Kaunas, Lithuania
Investigational site, Katowice, Poland
Additional Information
Starting date: May 2014
Last updated: May 13, 2015
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