Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register allows you to search for protocol and results information on:
  • interventional clinical trials that are conducted in the European Union (EU) and the European Economic Area (EEA);
  • clinical trials conducted outside the EU / EEA that are linked to European paediatric-medicine development.
  • Learn   more about the EU Clinical Trials Register   including the source of the information and the legal basis.


    The EU Clinical Trials Register currently displays   41232   clinical trials with a EudraCT protocol, of which   6757   are clinical trials conducted with subjects less than 18 years old.
    The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).


    Phase 1 trials conducted solely in adults and that are not part of an agreed PIP are not public in the EU CTR (refer to European Guidance 2008/C 168/02   Art. 3 par. 2 and   Commission Guideline 2012/C 302/03,   Art. 5) .
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Download PDF

    Clinical Trial Results:
    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

    Summary
    EudraCT number
    2012-005733-37
    Trial protocol
    CZ   LT   BG   LV   GB  
    Global end of trial date
    25 Aug 2015

    Results information
    Results version number
    v1(current)
    This version publication date
    10 Feb 2019
    First version publication date
    10 Feb 2019
    Other versions

    Trial information

    Close Top of page
    Trial identification
    Sponsor protocol code
    SB2-G31-RA
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT01936181
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    Samsung Bioepis Co., Ltd.
    Sponsor organisation address
    107, Cheomdan-daero, Incheon, Korea, Republic of,
    Public contact
    Quintiles Contact Centre, Quintiles Limited, +1 862 261 3634,
    Scientific contact
    Quintiles Contact Centre, Quintiles Limited, +1 862 261 3634,
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    25 Aug 2015
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    25 Aug 2015
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    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.
    Protection of trial subjects
    The study and clinical study protocols were reviewed and approved by Independent Ethics Committee (IEC) or Institutional Review Board (IRB). This study was conducted in accordance with the ethical principles that have their origin in the Declaration of Helsinki (2008) and that are consistent with International Conference on Harmonisation (ICH) Good Clinical Practice (GCP) guidelines (ICH E6) and applicable local regulatory requirements and laws. The nature and purpose of the study was fully explained to each subject and written informed consent was obtained at Screening from each subject before any study related procedures were performed. The consent documents for the study was reviewed and approved by the appropriate IEC or IRB prior to use.
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    12 Aug 2013
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Poland: 122
    Country: Number of subjects enrolled
    United Kingdom: 2
    Country: Number of subjects enrolled
    Bulgaria: 61
    Country: Number of subjects enrolled
    Czech Republic: 63
    Country: Number of subjects enrolled
    Latvia: 17
    Country: Number of subjects enrolled
    Lithuania: 39
    Country: Number of subjects enrolled
    Korea, Republic of: 59
    Country: Number of subjects enrolled
    Philippines: 16
    Country: Number of subjects enrolled
    Ukraine: 110
    Country: Number of subjects enrolled
    Romania: 37
    Country: Number of subjects enrolled
    Bosnia and Herzegovina: 58
    Worldwide total number of subjects
    584
    EEA total number of subjects
    341
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    499
    From 65 to 84 years
    85
    85 years and over
    0

    Subject disposition

    Close Top of page
    Recruitment
    Recruitment details
    A total of 73 study centres were initiated in randomised, double-blind period. Among them, 57 study centres were participated for the transition-extension study period.

    Pre-assignment
    Screening details
    Participants who fulfilled the inclusion/exclusion criteria were randomly assigned to 1 of the 2 treatments of this study in randomised, double-blind period. At Week 54, subjects receiving Remicade® from the randomised, double-blind period were randomised again in a 1:1 ratio to either continue on Remicade (Remicade/Remicade).

    Period 1
    Period 1 title
    Randomised, Double-blind Period
    Is this the baseline period?
    Yes
    Allocation method
    Randomised - controlled
    Blinding used
    Double blind
    Roles blinded
    Carer, Assessor, Subject, Investigator, Monitor, Data analyst

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    SB2 (proposed infliximab biosimilar)
    Arm description
    -
    Arm type
    Experimental

    Investigational medicinal product name
    SB2
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder for concentrate for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    3 mg/kg at Week 0, 2, 6 and then every 8 weeks until Week 46 (for the randomised, double-blind period) or Week 70 (for the transition-extension period); from Week 30 the dose level may have been increased step-wise by 1.5 mg/kg, up to a maximum of 7.5 mg/kg, every 8 weeks if the subject’s RA symptoms were not well controlled by existing dose. If adequate response was achieved, subjects continued on the selected dose.

    Arm title
    Remicade
    Arm description
    -
    Arm type
    Active comparator

    Investigational medicinal product name
    Infliximab
    Investigational medicinal product code
    Other name
    Remicade
    Pharmaceutical forms
    Powder for concentrate for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    3 mg/kg at Week 0, 2, 6 and then every 8 weeks until Week 46 (for the randomised, double-blind period) or Week 70 (for the transition-extension period); from Week 30 the dose level may have been increased step-wise by 1.5 mg/kg, up to a maximum of 7.5 mg/kg, every 8 weeks if the subject’s RA symptoms were not well controlled by existing dose. If adequate response was achieved, subjects continued on the selected dose.

    Number of subjects in period 1
    SB2 (proposed infliximab biosimilar) Remicade
    Started
    291
    293
    Completed
    227
    225
    Not completed
    64
    68
         Protocol deviation
    1
    5
         Physician decision
    4
    4
         Lack of efficacy
    5
    6
         Pregnancy
    -
    1
         Adverse event, non-fatal
    27
    21
         Consent withdrawn by subject
    23
    26
         Subjects from Eastern Ukraine sites
    4
    4
         Lost to follow-up
    -
    1
    Period 2
    Period 2 title
    Transition-extension period
    Is this the baseline period?
    No
    Allocation method
    Randomised - controlled
    Blinding used
    Double blind
    Roles blinded
    Carer, Assessor, Subject, Investigator, Monitor, Data analyst

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    SB2/SB2
    Arm description
    SB2 followed by SB2 from Week 54
    Arm type
    Experimental

    Investigational medicinal product name
    SB2
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder for concentrate for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    3 mg/kg at Week 0, 2, 6 and then every 8 weeks until Week 46 (for the randomised, double-blind period) or Week 70 (for the transition-extension period); from Week 30 the dose level may have been increased step-wise by 1.5 mg/kg, up to a maximum of 7.5 mg/kg, every 8 weeks if the subject’s RA symptoms were not well controlled by existing dose. If adequate response was achieved, subjects continued on the selected dose.

    Arm title
    Remicade/SB2
    Arm description
    Remicade followed by SB2 from Week 54
    Arm type
    Experimental

    Investigational medicinal product name
    Infliximab
    Investigational medicinal product code
    Other name
    Remicade
    Pharmaceutical forms
    Powder for concentrate for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    3 mg/kg at Week 0, 2, 6 and then every 8 weeks until Week 46 (for the randomised, double-blind period) or Week 70 (for the transition-extension period); from Week 30 the dose level may have been increased step-wise by 1.5 mg/kg, up to a maximum of 7.5 mg/kg, every 8 weeks if the subject’s RA symptoms were not well controlled by existing dose. If adequate response was achieved, subjects continued on the selected dose.

    Investigational medicinal product name
    SB2
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder for concentrate for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    3 mg/kg at Week 0, 2, 6 and then every 8 weeks until Week 46 (for the randomised, double-blind period) or Week 70 (for the transition-extension period); from Week 30 the dose level may have been increased step-wise by 1.5 mg/kg, up to a maximum of 7.5 mg/kg, every 8 weeks if the subject’s RA symptoms were not well controlled by existing dose. If adequate response was achieved, subjects continued on the selected dose.

    Arm title
    Remicade/Remicade
    Arm description
    Remicade followed by Remicade from Week 54
    Arm type
    Active comparator

    Investigational medicinal product name
    Infliximab
    Investigational medicinal product code
    Other name
    Remicade
    Pharmaceutical forms
    Powder for concentrate for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    3 mg/kg at Week 0, 2, 6 and then every 8 weeks until Week 46 (for the randomised, double-blind period) or Week 70 (for the transition-extension period); from Week 30 the dose level may have been increased step-wise by 1.5 mg/kg, up to a maximum of 7.5 mg/kg, every 8 weeks if the subject’s RA symptoms were not well controlled by existing dose. If adequate response was achieved, subjects continued on the selected dose.

    Number of subjects in period 2 [1]
    SB2/SB2 Remicade/SB2 Remicade/Remicade
    Started
    201
    94
    101
    Completed
    186
    88
    96
    Not completed
    15
    6
    5
         Physician decision
    2
    -
    1
         Adverse event, non-fatal
    3
    3
    1
         Consent withdrawn by subject
    7
    2
    1
         Lost to follow-up
    3
    1
    2
    Notes
    [1] - The number of subjects starting the period is not consistent with the number completing the preceding period. It is expected the number of subjects starting the subsequent period will be the same as the number completing the preceding period.
    Justification: 227 subjects in SB2 treatment group and 225 subjects in the Remicade treatment group completed Week 54 of treatment. Among them, 201 subjects from the SB2 treatment group and 195 subjects from the Remicade® treatment group were enrolled and re-randomised to the transition-extension period at Week 54.

    Baseline characteristics

    Close Top of page
    Baseline characteristics reporting groups
    Reporting group title
    SB2 (proposed infliximab biosimilar)
    Reporting group description
    -

    Reporting group title
    Remicade
    Reporting group description
    -

    Reporting group values
    SB2 (proposed infliximab biosimilar) Remicade Total
    Number of subjects
    291 293 584
    Age categorical
    Units: Subjects
        In utero
    0
        Preterm newborn infants (gestational age < 37 wks)
    0
        Newborns (0-27 days)
    0
        Infants and toddlers (28 days-23 months)
    0
        Children (2-11 years)
    0
        Adolescents (12-17 years)
    0
        Adults (18-64 years)
    0
        From 65-84 years
    0
        85 years and over
    0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    51.6 ± 11.92 52.6 ± 11.74 -
    Gender categorical
    Units: Subjects
        Female
    232 236 468
        Male
    59 57 116

    End points

    Close Top of page
    End points reporting groups
    Reporting group title
    SB2 (proposed infliximab biosimilar)
    Reporting group description
    -

    Reporting group title
    Remicade
    Reporting group description
    -
    Reporting group title
    SB2/SB2
    Reporting group description
    SB2 followed by SB2 from Week 54

    Reporting group title
    Remicade/SB2
    Reporting group description
    Remicade followed by SB2 from Week 54

    Reporting group title
    Remicade/Remicade
    Reporting group description
    Remicade followed by Remicade from Week 54

    Primary: American College of Rheumatology 20% Response Criteria (ACR20)

    Close Top of page
    End point title
    American College of Rheumatology 20% Response Criteria (ACR20)
    End point description
    Proportion of participants achieving clinical response according to the ACR20 criteria at Week 30
    End point type
    Primary
    End point timeframe
    Week 30
    End point values
    SB2 (proposed infliximab biosimilar) Remicade
    Number of subjects analysed
    231 [1]
    247 [2]
    Units: percentage
    148
    163
    Notes
    [1] - Per-protocol Set 1
    [2] - Per-protoco Set 1
    Statistical analysis title
    ACR20 Criteria at Week 30
    Comparison groups
    SB2 (proposed infliximab biosimilar) v Remicade
    Number of subjects included in analysis
    478
    Analysis specification
    Pre-specified
    Analysis type
    equivalence [3]
    Method
    Parameter type
    Difference in proportion
    Point estimate
    -1.88
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -10.26
         upper limit
    6.51
    Notes
    [3] - - Equivalence margin: [-15%, 15%]

    Adverse events

    Close Top of page
    Adverse events information
    Timeframe for reporting adverse events
    From Screening to Week 78
    Adverse event reporting additional description
    Remicade group includes subjects who were treated with SB2 in the transition-extension period.
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    16.0
    Reporting groups
    Reporting group title
    SB2 (overall study period)
    Reporting group description
    -

    Reporting group title
    Remicade (overall study period)
    Reporting group description
    - Remicade group includes subjects who are treated with SB2 in the transition-extension period.

    Serious adverse events
    SB2 (overall study period) Remicade (overall study period)
    Total subjects affected by serious adverse events
         subjects affected / exposed
    36 / 290 (12.41%)
    38 / 293 (12.97%)
         number of deaths (all causes)
    0
    1
         number of deaths resulting from adverse events
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Benign Lung Neoplasm
         subjects affected / exposed
    1 / 290 (0.34%)
    0 / 293 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Brain Neoplasm
         subjects affected / exposed
    1 / 290 (0.34%)
    0 / 293 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Breast Cancer
         subjects affected / exposed
    1 / 290 (0.34%)
    0 / 293 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Prostate Cancer
         subjects affected / exposed
    1 / 290 (0.34%)
    0 / 293 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Basal Cell Carcinoma
         subjects affected / exposed
    0 / 290 (0.00%)
    1 / 293 (0.34%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Benign Salivary Gland Neoplasm
         subjects affected / exposed
    0 / 290 (0.00%)
    1 / 293 (0.34%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lip And/Or Oral Cavity Cancer
         subjects affected / exposed
    0 / 290 (0.00%)
    1 / 293 (0.34%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Immune system disorders
    Anaphylactic Reaction
         subjects affected / exposed
    2 / 290 (0.69%)
    0 / 293 (0.00%)
         occurrences causally related to treatment / all
    2 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypersensitivity
         subjects affected / exposed
    2 / 290 (0.69%)
    0 / 293 (0.00%)
         occurrences causally related to treatment / all
    2 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Anaphylactic Shock
         subjects affected / exposed
    0 / 290 (0.00%)
    1 / 293 (0.34%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Drug Hypersensitivity
         subjects affected / exposed
    0 / 290 (0.00%)
    1 / 293 (0.34%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Device Damage
         subjects affected / exposed
    1 / 290 (0.34%)
    0 / 293 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Psychiatric disorders
    Major Depression
         subjects affected / exposed
    0 / 290 (0.00%)
    1 / 293 (0.34%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Psychotic Disorder
         subjects affected / exposed
    0 / 290 (0.00%)
    1 / 293 (0.34%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Reproductive system and breast disorders
    Benign Prostatic Hyperplasia
         subjects affected / exposed
    1 / 290 (0.34%)
    0 / 293 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Endometriosis
         subjects affected / exposed
    1 / 290 (0.34%)
    0 / 293 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ovarian Cyst Torsion
         subjects affected / exposed
    0 / 290 (0.00%)
    1 / 293 (0.34%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Lower Limb Fracture
         subjects affected / exposed
    1 / 290 (0.34%)
    0 / 293 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lumbar Vertebral Fracture
         subjects affected / exposed
    0 / 290 (0.00%)
    1 / 293 (0.34%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Periprosthetic Fracture
         subjects affected / exposed
    0 / 290 (0.00%)
    1 / 293 (0.34%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Rib Fracture
         subjects affected / exposed
    0 / 290 (0.00%)
    1 / 293 (0.34%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Thoracic Vertebral Fracture
         subjects affected / exposed
    0 / 290 (0.00%)
    2 / 293 (0.68%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tibia Fracture
         subjects affected / exposed
    0 / 290 (0.00%)
    1 / 293 (0.34%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac disorders
    Angina Unstable
         subjects affected / exposed
    1 / 290 (0.34%)
    0 / 293 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Atrial Fibrillation
         subjects affected / exposed
    1 / 290 (0.34%)
    0 / 293 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Myocardial Infarction
         subjects affected / exposed
    1 / 290 (0.34%)
    1 / 293 (0.34%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Angina Pectoris
         subjects affected / exposed
    0 / 290 (0.00%)
    1 / 293 (0.34%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Left Ventricular Failure
         subjects affected / exposed
    0 / 290 (0.00%)
    1 / 293 (0.34%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Pericarditis
         subjects affected / exposed
    0 / 290 (0.00%)
    1 / 293 (0.34%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Asthma
         subjects affected / exposed
    0 / 290 (0.00%)
    1 / 293 (0.34%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pleurisy
         subjects affected / exposed
    0 / 290 (0.00%)
    1 / 293 (0.34%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Thrombocytosis
         subjects affected / exposed
    1 / 290 (0.34%)
    0 / 293 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nervous system disorders
    Sciatica
         subjects affected / exposed
    1 / 290 (0.34%)
    0 / 293 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vertebrobasilar Insufficiency
         subjects affected / exposed
    1 / 290 (0.34%)
    0 / 293 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Neuropathy Peripheral
         subjects affected / exposed
    0 / 290 (0.00%)
    1 / 293 (0.34%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Diverticulum
         subjects affected / exposed
    1 / 290 (0.34%)
    0 / 293 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ileus Paralytic
         subjects affected / exposed
    1 / 290 (0.34%)
    0 / 293 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Irritable Bowel Syndrome
         subjects affected / exposed
    1 / 290 (0.34%)
    0 / 293 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Abdominal wall haemorrhage
         subjects affected / exposed
    0 / 290 (0.00%)
    1 / 293 (0.34%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ileal Perforation
         subjects affected / exposed
    0 / 290 (0.00%)
    1 / 293 (0.34%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peptic ulcer haemorrhage
         subjects affected / exposed
    0 / 290 (0.00%)
    1 / 293 (0.34%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Salivary Gland Calculus
         subjects affected / exposed
    0 / 290 (0.00%)
    1 / 293 (0.34%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Bile Duct Stone
         subjects affected / exposed
    1 / 290 (0.34%)
    0 / 293 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cholecystitis Acute
         subjects affected / exposed
    1 / 290 (0.34%)
    0 / 293 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    Urticaria
         subjects affected / exposed
    0 / 290 (0.00%)
    1 / 293 (0.34%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Rheumatoid Arthritis
         subjects affected / exposed
    4 / 290 (1.38%)
    4 / 293 (1.37%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Foot Deformity
         subjects affected / exposed
    1 / 290 (0.34%)
    0 / 293 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Fistula
         subjects affected / exposed
    0 / 290 (0.00%)
    1 / 293 (0.34%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intervertebral Disc Protrusion
         subjects affected / exposed
    0 / 290 (0.00%)
    1 / 293 (0.34%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Joint Swelling
         subjects affected / exposed
    0 / 290 (0.00%)
    1 / 293 (0.34%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Osteoarthritis
         subjects affected / exposed
    0 / 290 (0.00%)
    1 / 293 (0.34%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Synovitis
         subjects affected / exposed
    0 / 290 (0.00%)
    1 / 293 (0.34%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Pneumonia
         subjects affected / exposed
    3 / 290 (1.03%)
    2 / 293 (0.68%)
         occurrences causally related to treatment / all
    3 / 3
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Appendicitis
         subjects affected / exposed
    1 / 290 (0.34%)
    0 / 293 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bronchitis
         subjects affected / exposed
    1 / 290 (0.34%)
    1 / 293 (0.34%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Clostridium Difficile Colitis
         subjects affected / exposed
    1 / 290 (0.34%)
    0 / 293 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia Bacterial
         subjects affected / exposed
    1 / 290 (0.34%)
    0 / 293 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pseudomembranous Colitis
         subjects affected / exposed
    1 / 290 (0.34%)
    0 / 293 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pyelonephritis
         subjects affected / exposed
    1 / 290 (0.34%)
    0 / 293 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Soft Tissue Infection
         subjects affected / exposed
    1 / 290 (0.34%)
    0 / 293 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tuberculous Pleurisy
         subjects affected / exposed
    1 / 290 (0.34%)
    0 / 293 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urinary Tract Infection
         subjects affected / exposed
    1 / 290 (0.34%)
    0 / 293 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urosepsis
         subjects affected / exposed
    1 / 290 (0.34%)
    0 / 293 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Arthritis Bacterial
         subjects affected / exposed
    0 / 290 (0.00%)
    1 / 293 (0.34%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cellulitis
         subjects affected / exposed
    0 / 290 (0.00%)
    1 / 293 (0.34%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diabetic Foot Infection
         subjects affected / exposed
    0 / 290 (0.00%)
    1 / 293 (0.34%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Erysipelas
         subjects affected / exposed
    0 / 290 (0.00%)
    1 / 293 (0.34%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haematoma Infection
         subjects affected / exposed
    0 / 290 (0.00%)
    1 / 293 (0.34%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory Tract Infection
         subjects affected / exposed
    0 / 290 (0.00%)
    1 / 293 (0.34%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Wound Infection
         subjects affected / exposed
    0 / 290 (0.00%)
    1 / 293 (0.34%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    SB2 (overall study period) Remicade (overall study period)
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    108 / 290 (37.24%)
    104 / 293 (35.49%)
    Investigations
    Alanine Aminotransferase Increased
         subjects affected / exposed
    27 / 290 (9.31%)
    14 / 293 (4.78%)
         occurrences all number
    32
    15
    Aspartate Aminotransferase Increased
         subjects affected / exposed
    16 / 290 (5.52%)
    15 / 293 (5.12%)
         occurrences all number
    18
    15
    Nervous system disorders
    Headache
         subjects affected / exposed
    16 / 290 (5.52%)
    15 / 293 (5.12%)
         occurrences all number
    30
    16
    Musculoskeletal and connective tissue disorders
    Rheumatoid Arthritis
         subjects affected / exposed
    20 / 290 (6.90%)
    12 / 293 (4.10%)
         occurrences all number
    26
    16
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    26 / 290 (8.97%)
    25 / 293 (8.53%)
         occurrences all number
    34
    34
    Latent Tuberculosis
         subjects affected / exposed
    24 / 290 (8.28%)
    27 / 293 (9.22%)
         occurrences all number
    31
    33
    Upper Respiratory Tract Infection
         subjects affected / exposed
    13 / 290 (4.48%)
    18 / 293 (6.14%)
         occurrences all number
    32
    31

    More information

    Close Top of page

    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    08 Mar 2013
    • The PK population was clarified as the first 50% of the enrolled subjects. • The end of study was defined. • An assumption for sample size calculation was revised. • Details on IP preparation were added. • Blood volume to be collected and sample handling process for PK assessment was changed based on final decision of required blood volume and sample handling procedures. • Interim analyses for DSMB review were added. • Other administrative changes
    28 Jun 2013
    • The period of contraception after the last dose of IP was increased from 2 months to 6 months based on SmPC of Remicade® and MTX. • The sentence “If adequate response is achieved, subjects should be continued on the selected dose” was added in accordance with the SmPC of Remicade®. • The clinical chemistry parameters were updated. • Other administrative changes
    22 Aug 2013
    • The observation period for acute infusion-related reaction was added based on the SmPC of Remicade®. • The follow up action for IP discontinuation criteria was changed according to the SmPC of Remicade®.
    11 Apr 2014
    * Not submitted to the Philippines and the United Kingdom • The transition-extension period of SB2-G31-RA study was added to evaluate the safety and tolerability in subjects who transitioned to SB2 from Remicade® compared to subjects who maintained Remicade®. • Other administrative changes

    Interruptions (globally)

    Were there any global interruptions to the trial? No

    Limitations and caveats

    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported

    Online references

    http://www.ncbi.nlm.nih.gov/pubmed/29042358
    http://www.ncbi.nlm.nih.gov/pubmed/28957563
    http://www.ncbi.nlm.nih.gov/pubmed/26318384
    For support, visit the EMA Service Desk , log in using your EMA account and open a ticket specifying "EU CTR" in your request.
    If you do not have an account, please visit the EMA Account management page page click on "Create an EMA account" and follow the instructions.
    The status of studies in GB is no longer updated from 1.1.2021
    For the UK, as from 1.1.2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI
    EU Clinical Trials Register Service Desk: https://servicedesk.ema.europa.eu
    European Medicines Agency © 1995-2021 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    Legal notice
    EMA HMA