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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: EUCTR
Last refreshed on: 1 February 2016
Main ID:  EUCTR2013-005013-13-PL
Date of registration: 31/03/2014
Prospective Registration: Yes
Primary sponsor: Samsung Bioepis Co., Ltd.
Public title: A Study Comparing SB5 to Humira® in Subjects with Moderate to Severe Rheumatoid Arthritis despite Methotrexate Therapy
Scientific 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
Date of first enrolment: 25/06/2014
Target sample size: 490
Recruitment status: Not Recruiting
URL:  https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2013-005013-13
Study type:  Interventional clinical trial of medicinal product
Study design:  Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: yes Cross over: no Other: yes Other trial design description: Transition If controlled, specify comparator, Other Medicinial Product: yes Placebo: no Other: no Number of treatment arms in the trial: 2  
Phase: 
Countries of recruitment
Bosnia and Herzegovina Bulgaria Czech Republic Korea, Republic of Latvia Lithuania Mexico Poland
Russian Federation Ukraine United Kingdom
Contacts
Name: Information Desk   
Address:  107, Cheomdan-daero, Yeonsu-gu 406-840 Incheon Korea, Republic of
Telephone: +82324553114
Email: bioepisinfo@samsung.com
Affiliation:  Samsung Bioepis Co., Ltd.
Name: Information Desk   
Address:  107, Cheomdan-daero, Yeonsu-gu 406-840 Incheon Korea, Republic of
Telephone: +82324553114
Email: bioepisinfo@samsung.com
Affiliation:  Samsung Bioepis Co., Ltd.
Key inclusion & exclusion criteria
Inclusion criteria:
1. Are male or female aged 18-75 years at the time of signing the informed consent form.
2. 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.
3. Have moderate to severe active disease despite MTX therapy defined as:
a. 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.
b. Either erythrocyte sedimentation rate (Westergren) = 28 mm/h or serum C-reactive protein = 1.0 mg/dL at Screening.
4. 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.
5. 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.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 430
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 60

Exclusion criteria:
1. Have been treated previously with any biological agents including any tumour necrosis factor inhibitor.
2. Have a known hypersensitivity to human immunoglobulin proteins or other components of Humira® or SB5.
3. Have a positive serological test for hepatitis B or hepatitis C or have a known history of infection with human immunodeficiency virus.
4. 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.
5. 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.
6. Have a history of chronic or recurrent infection.
7. Have any of the following conditions:
a. History of congestive heart failure (New York Heart Association Class III/IV).
b. History of acute myocardial infarction or unstable angina within the previous 12 months prior to Screening.
c. History of demyelinating disorders.
d. History of any malignancy within the previous 5 years prior to Screening.
e. History of lymphoproliferative disease including lymphoma.
f. Any other disease or disorder which, in the opinion of the Investigator, will put the subject at risk if they are enrolled.
8. Have physical incapacitation (ACR functional Class IV or wheelchair-/bed-bound).


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes
Health Condition(s) or Problem(s) studied
Subjects with Moderate to Severe Rheumatoid Arthritis despite Methotrexate Therapy. The intended use of SB5 is rheumatoid arthritis (RA), polyarticular juvenile idiopathic arthritis (JIA), adult Crohn's disease (CD), paediatric CD, ankylosing spondylitis (AS), psoriasis (Ps), psoriatic arthritis (PsA), ulcerative colitis (UC), and psoriasis.
MedDRA version: 16.1 Level: PT Classification code 10039073 Term: Rheumatoid arthritis System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Intervention(s)

Product Name: SB5
Pharmaceutical Form: Solution for injection in pre-filled syringe
INN or Proposed INN: ADALIMUMAB
CAS Number: 331731-18-1
Current Sponsor code: SB5
Other descriptive name: SB5
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 50-

Trade Name: Humira®
Product Name: Humira®
Pharmaceutical Form: Solution for injection in pre-filled syringe
INN or Proposed INN: ADALIMUMAB
CAS Number: 331731-18-1
Current Sponsor code: not applicable
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 50-

Primary Outcome(s)
Main Objective: The primary objective of this study is to demonstrate the equivalence of SB5 to Humira® atWeek 24, in terms of American College of Rheumatology 20% response criteria (ACR20) response rate in subjects with moderate to severe rheumatoid arthritis (RA) despite methotrexate (MTX) therapy.
Primary end point(s): The primary endpoint for the study is the ACR20 response at Week 24
Secondary Objective: • To evaluate efficacy of SB5 compared to Humira® using relevant efficacy endpoints other than ACR20 at Week 24 in subjects with moderate to severe RA despite MTX therapy
• To evaluate safety and tolerability of SB5 compared to Humira® in subjects with moderate to severe RA despite MTX therapy
• To evaluate pharmacokinetics of SB5 compared to Humira® in subjects with moderate to severe RA despite MTX therapy
• To evaluate immunogenicity of SB5 compared to Humira® in subjects with moderate to severe RA despite MTX therapy
• To evaluate safety and immunogenicity in subjects who transitioned to SB5 and who maintained Humira® at Week 24 for transition sub-study
Timepoint(s) of evaluation of this end point: Week 24
Secondary Outcome(s)
Secondary end point(s): • The ACR20 response at Week 52
• The ACR 50% response criteria (ACR50) response and ACR 70% response criteria (ACR70) response at Week 24 and Week 52
• The numeric index of the ACR response (ACR-N) at Week 24 and Week 52
• The area under the curve (AUC) of ACR-N up to Week 24
• The change in disease activity score based on a 28 joint count (DAS28 score) from Week 0 at Week 24 and Week 52
• The European League Against Rheumatism response at Week 24 and Week 52
• The AUC of the change in DAS28 from Week 0 up to Week 24
• Major clinical response (ACR70 response for 6 consecutive months) at Week 52
• Change in modified Total Sharp Score from Week 0 at Week 52
Timepoint(s) of evaluation of this end point: • The ACR20 response at Week 52
• The ACR50 response and ACR70 response at Week 24 and Week 52
• The ACR-N at Week 24 and Week 52
• The AUC of ACR-N up to Week 24
• The change in DAS28 score from Week 0 at Week 24 and Week 52
• The European League Against Rheumatism response at Week 24 and Week 52
• The AUC of the change in DAS28 from Week 0 up to Week 24
• Major clinical response (ACR70 response for 6 consecutive months) at Week 52
• Change in modified Total Sharp Score from Week 0 at Week 52
Secondary ID(s)
2013-005013-13-CZ
SB5-G31-RA
Source(s) of Monetary Support
Samsung Bioepis Co., Ltd.
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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