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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: 8 August 2016
Main ID:  EUCTR2012-005733-37-CZ
Date of registration: 15/05/2013
Prospective Registration: Yes
Primary sponsor: Samsung Bioepis Co., Ltd.
Public title: A Study Comparing SB2 to Remicade® in Subjects with Moderate to Severe Rheumatoid Arthritis
Scientific title: A Randomised, Double-blind, Parallel Group, Multicentre Clinical Study to Evaluate the Efficacy, Safety, Pharmacokinetics and Immunogenicity of SB2 Compared to Remicade® in Subjects with Moderate to Severe Rheumatoid Arthritis despite Methotrexate Therapy
Date of first enrolment: 16/08/2013
Target sample size: 584
Recruitment status: Not Recruiting
URL:  https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2012-005733-37
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: no If controlled, specify comparator, Other Medicinial Product: no Placebo: no Other: yes Other specify the comparator: Remicade Number of treatment arms in the trial: 2  
Phase:  Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): yes Therapeutic use (Phase IV): no
Countries of recruitment
Bosnia and Herzegovina Bulgaria Czech Republic India Korea, Republic of Latvia Lithuania Mexico
Philippines Poland Romania Ukraine United Kingdom
Contacts
Name: Quintiles Contact Centre   
Address:  The Alba Campus, Rosebank EH54 7EG Livingston United Kingdom
Telephone: +1 862 261 3634
Email:
Affiliation:  Quintiles Limited
Name: Quintiles Contact Centre   
Address:  The Alba Campus, Rosebank EH54 7EG Livingston United Kingdom
Telephone: +1 862 261 3634
Email:
Affiliation:  Quintiles Limited
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 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 at least 6 months prior to Randomisation and on a stable dose of MTX 10–25 mg/week given orally or parenterally for at least 4 weeks prior to Screening.
5. Female subjects who are not pregnant or nursing at Screening and who are not planning to become pregnant from Screening until 2 months after the last dose of investigational product (IP)
Subjects must meet all of the following criteria to be enrolled in the
transition-extension period:
1. Have been enrolled and completed the scheduled Week 54 visit of the
randomised, double-blind period of the SB2-G31-RA study.
2. In the opinion of the Investigator, subjects who may benefit from
continuing IP treatment (either SB2 or Remicade), understand the
implications of taking part in the study and willing to participate in the
transition-extension period.
3. Female subjects who are not pregnant or nursing and who are not
planning to become pregnant until 6 months after the last dose of IP.
4. Subjects of child-bearing potential (female or male) who agree to use
at least two forms of appropriate contraception (e.g., established use of
oral, injected or implanted hormonal contraceptive, placement of an
intrauterine device or intrauterine system, physical barrier, male
sterilisation or true abstinence) until 6 months after the last dose of IP.
5. Must be able to provide informed consent, which must be obtained
prior to the procedures related to the transition-extension period.
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 514
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 70

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 Remicade or SB2
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
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 any of the following conditions
a. Other inflammatory or rheumatic diseases.
b. History of any malignancy within the previous 5 years prior to
Screening
c. History of lymphoproliferative disease including lymphoma.
d. History of congestive heart failure
e. Physical incapacitation (ACR functional Class IV or wheelchair-
/bedbound).
f. History of demyelinating disorders.
Subjects meeting any of the following criteria must not be enrolled in the
transition-extension period:
1. Have been withdrawn from the SB2-G31-RA study for any reason.
2. Have had any significant medical conditions, such as an occurrence of
a serious AE (SAE) or intolerance of SB2 or Remicade during the
randomised, double-blind period of the SB2-G31-RA study which may
render the subject unsuitable to participate in the transition-extension
period, at the discretion of the Investigator.
3. Plan to participate in another study with an investigational product
during the transition-extension period.
4. Have been taking or plan to take any biological agents except SB2 and
Remicade during the transition-extension period.
5. Are taking or plan to take any of the following concomitant
medications during the transition-extension period:
a. Corticosteroids above levels equivalent to 10 mg prednisolone daily,
for RA treatment.
b. Any DMARDs/systemic immunosuppressive agents, other than MTX,
including hydroxy-chloroquine, chloroquine, sulfasalazine, azathioprine,
cyclosporine, mycophenolate mofetil, or leflunomide.
c. Alkylating agents.
d. Live or live-attenuated vaccine.


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes
Health Condition(s) or Problem(s) studied
Rheumatoid Arthritis
MedDRA version: 17.0 Level: PT Classification code 10039073 Term: Rheumatoid arthritis System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Intervention(s)

Product Name: SB2 (infliximab biosimilar)
Product Code: SB2
Pharmaceutical Form: Powder for concentrate for solution for infusion
INN or Proposed INN: INFLIXIMAB
CAS Number: 170277-31-3
Current Sponsor code: SB2
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 100-

Trade Name: Remicade®
Product Name: Remicade
Pharmaceutical Form: Powder for concentrate for solution for infusion
INN or Proposed INN: INFLIXIMAB
CAS Number: 170277-31-3
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 100-

Primary Outcome(s)
Main Objective: The primary objective of this study is to demonstrate the equivalence of SB2 to Remicade at Week 30, in terms of the 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 30
Secondary Objective: The secondary objectives are:
1. To evaluate the efficacy of SB2 compared to Remicade using relevant
efficacy endpoints other than ACR20 at Week 30 in subjects with
moderate to severe RA despite MTX therapy
2. To evaluate the safety and tolerability of SB2 compared to Remicade
in subjects with moderate to severe RA despite MTX therapy
3. To evaluate the pharmacokinetics of SB2 compared to Remicade in
subjects with moderate to severe RA despite MTX therapy
4. To evaluate the immunogenicity of SB2 compared to Remicade in
subjects with moderate to severe RA despite MTX therapy
The secondary objectives for the transition extension period are:
To evaluate the safety, tolerability, immunogenicity and efficacy in
subjects with RA who transitioned to SB2 from Remicade compared to
subjects who maintained Remicade from the randomised, double-blind
period.
Timepoint(s) of evaluation of this end point: Week 30
Secondary Outcome(s)
Secondary end point(s): The secondary efficacy endpoints are:
1. The ACR20 response at Week 54
2. The ACR 50% response criteria (ACR50) and ACR 70% response criteria (ACR70) response at Week 30 and Week 54
3. The numeric index of the ACR response (ACR-N) at Week 30 and Week 54
4. The area under the curve (AUC) of ACR-N up to Week 30
5. The disease activity score based on a 28 joint count (DAS28 score) at Week 30 and Week 54
6. The European League Against Rheumatism response at Week30 and Week 54
7. The AUC of the change in DAS28 from Baseline up to Week 30
8. Major clinical response (ACR70 response for 6 consecutive months) at Week 54
9. Change from Baseline in modified Total Sharp Score (mTSS) at Week 54
Secondary endpoints for the transition-extension period:
The safety endpoints are:
• Incidence of SAEs
• Incidence of AEs (graded as mild, moderate, severe)
• Incidence of clinical laboratory abnormalities
• Vital signs abnormalities
The immunogenicity endpoints are:
• Incidence of anti-drug antibodies
• Incidence of neutralising antibodies
The efficacy endpoints are:
• The ACR20, ACR50 and ACR70 response
• Continuous ACR-N
• The change in DAS28 score from Week 0
• The EULAR response
Timepoint(s) of evaluation of this end point: Weeks 30 and 54
For the transition-extension period week 78.
Secondary ID(s)
SB2-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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