A Study Comparing SB5 to Humira® in Subjects With Moderate to Severe Rheumatoid Arthritis Despite Methotrexate Therapy
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|ClinicalTrials.gov Identifier: NCT02167139|
Recruitment Status : Completed
First Posted : June 18, 2014
Results First Posted : January 19, 2017
Last Update Posted : August 17, 2017
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|Condition or disease||Intervention/treatment||Phase|
|Rheumatoid Arthritis||Drug: Humira (adalimumab) Drug: SB5 (proposed biosimilar to adalimumab)||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||544 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|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|
|Study Start Date :||May 2014|
|Actual Primary Completion Date :||April 2015|
|Actual Study Completion Date :||October 2015|
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)
- American College of Rheumatology 20% Response Criteria (ACR20) [ Time Frame: Week 24 ]
- 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 ]
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, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- 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:
- 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.
- 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.
- 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:
- History of congestive heart failure (New York Heart Association Class III/IV).
- History of acute myocardial infarction or unstable angina within the previous 12 months prior to Screening.
- History of demyelinating disorders.
- History of any malignancy within the previous 5 years prior to Screening.
- History of lymphoproliferative disease including lymphoma.
- 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).
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
|Principal Investigator:||Asta Baranauskaite, M.D., Ph.D.||Hospital of Lithuanian University of Health Sciences|
|Responsible Party:||Samsung Bioepis Co., Ltd.|
|Other Study ID Numbers:||
|First Posted:||June 18, 2014 Key Record Dates|
|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|
Rheumatoid Arthritis, Adalimumab
Connective Tissue Diseases
Immune System Diseases
Tumor Necrosis Factor Inhibitors