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    Clinical Trial Results:
    Randomized, Parallel, Double-Blind, Placebo-Controlled Trial to Evaluate the Efficacy and Safety of SBI-087 in Seropositive Subjects With Active Rheumatoid Arthritis on a Stable Background of Methotrexate

    Summary
    EudraCT number
    		 2009-010516-15
    Trial protocol
    		 HU   ES   PL   GR  
    Global end of trial date
    25 Jul 2013

    Results information
    Results version number
    		 v1(current)
    This version publication date
    23 May 2016
    First version publication date
    05 Aug 2015
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    3227K1-2000
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01008852
    WHO universal trial number (UTN)
    		 -
    Other trial identifiers
    		 Alias: B2261003
    Sponsors
    Sponsor organisation name
    Pfizer Inc.
    Sponsor organisation address
    235 E 42nd Street, New York, United States, NY 10017
    Public contact
    Pfizer ClinicalTrials.gov Call Center, Pfizer Inc., 001 8007181021, ClinicalTrials.gov_Inquiries@pfizer.com
    Scientific contact
    Pfizer ClinicalTrials.gov Call Center, Pfizer Inc., 001 8007181021, ClinicalTrials.gov_Inquiries@pfizer.com
    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
    03 Jul 2014
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    25 Jul 2013
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To evaluate clinical efficacy and safety of 4 SBI-087 subcutaneous (SC) dosing regimens versus placebo in seropositive subjects with active rheumatoid arthritis (RA) on a stable background of Methotrexate (MTX).
    Protection of trial subjects
    The study was in compliance with the ethical principles derived from the Declaration of Helsinki and in compliance with all International Conference on Harmonization (ICH) Good Clinical Practice (GCP) Guidelines. All the local regulatory requirements pertinent to safety of trial subjects were followed.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    08 Dec 2009
    Long term follow-up planned
    Yes
    Long term follow-up rationale
    		 Efficacy, Safety
    Long term follow-up duration
    		 2 Years
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Hungary: 11
    Country: Number of subjects enrolled
    Argentina: 7
    Country: Number of subjects enrolled
    Canada: 2
    Country: Number of subjects enrolled
    Chile: 6
    Country: Number of subjects enrolled
    Japan: 36
    Country: Number of subjects enrolled
    Mexico: 2
    Country: Number of subjects enrolled
    Serbia: 37
    Country: Number of subjects enrolled
    United States: 64
    Country: Number of subjects enrolled
    Poland: 35
    Country: Number of subjects enrolled
    Spain: 9
    Worldwide total number of subjects
    209
    EEA total number of subjects
    55
    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)
    169
    From 65 to 84 years
    40
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 A total of 210 subjects in 10 countries were enrolled in this study. Out of these 210 subjects, 209 subjects recieved the study treatment.

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Carer, Assessor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 SBI-087/ Placebo/ Placebo
    Arm description
    		 Subjects with active RA and on a on a stable background of MTX, received SBI-087 on Day 1 and placebo matched to SBI-087 on Day 15 and 84 during the initial phase of study. Subjects were followed up after day 168 of initial phase up to 2 years.
    Arm type
    		 Experimental

    Investigational medicinal product name
    SBI-087
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Subjects received 200 milligram (mg) SBI-087 SC injection on Day 1.

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Subjects received placebo matched to SBI-087 on Day 15 and 84.

    Arm title
    		 SBI-087/ SBI-087/ Placebo
    Arm description
    		 Subjects with active RA on a stable background of MTX, received SBI-087 on Day 1, 15 and placebo matched to SBI-087 on Day 84. Subjects were followed up after day 168 of initial phase up to 2 years.
    Arm type
    		 Experimental

    Investigational medicinal product name
    SBI-087
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Subjects received 200 mg SBI-087 SC injection on Day 1 and Day 15.

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Subjects received placebo matched to SBI-087on Day 84.

    Arm title
    		 SBI-087/ Placebo/ SBI-087
    Arm description
    		 Subjects with active RA on a stable background of MTX, received SBI-087 200 mg on Day 1, 84 and placebo matched to SBI-087 on Day 15. Subjects were followed up after day 168 of initial phase up to 2 years.
    Arm type
    		 Experimental

    Investigational medicinal product name
    SBI-087
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Subjects received 200 mg SBI-087 SC injection on Day 1 and Day 84.

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Subjects received placebo matched to SBI-087 on Day 15.

    Arm title
    		 SBI-087/ SBI-087/ SBI-087
    Arm description
    		 Subjects with active RA on a stable background of MTX, received SBI-087 200 mg on Day 1, 15 and 84. Subjects were followed up  after day 168 of initial phase up to 2 years.
    Arm type
    		 Experimental

    Investigational medicinal product name
    SBI-087
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Subjects received 200 mg SBI-087 SC injection on Day 1, 15 and 84.

    Arm title
    		 Placebo/ Placebo/ Placebo
    Arm description
    		 Subjects with active RA on a stable background of MTX, received placebo matched to SBI-087 on Day 1, 15 and 84. Subjects were followed up after day 168 of initial phase up to 2 years.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Subjects received placebo matched to SBI-087 SC injection on Day 1, 15 and 84.

    Number of subjects in period 1
    		SBI-087/ Placebo/ Placebo SBI-087/ SBI-087/ Placebo SBI-087/ Placebo/ SBI-087 SBI-087/ SBI-087/ SBI-087 Placebo/ Placebo/ Placebo
    Started
    43
    42
    43
    41
    40
    Initial Phase
    34
    36
    32
    37
    33
    Completed
    20
    29
    21
    26
    26
    Not completed
    23
    13
    22
    15
    14
         Consent withdrawn by subject
    10
    5
    10
    10
    2
         Physician decision
    1
    2
    1
    -
    2
         Adverse Event
    4
    2
    3
    -
    2
         Death
    -
    1
    2
    -
    -
         Protocol Violation
    2
    1
    1
    -
    -
         Lost to follow-up
    1
    -
    1
    -
    1
         Lack of efficacy
    5
    2
    4
    5
    7

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    SBI-087/ Placebo/ Placebo
    Reporting group description
    		 Subjects with active RA and on a on a stable background of MTX, received SBI-087 on Day 1 and placebo matched to SBI-087 on Day 15 and 84 during the initial phase of study. Subjects were followed up after day 168 of initial phase up to 2 years.

    Reporting group title
    SBI-087/ SBI-087/ Placebo
    Reporting group description
    		 Subjects with active RA on a stable background of MTX, received SBI-087 on Day 1, 15 and placebo matched to SBI-087 on Day 84. Subjects were followed up after day 168 of initial phase up to 2 years.

    Reporting group title
    SBI-087/ Placebo/ SBI-087
    Reporting group description
    		 Subjects with active RA on a stable background of MTX, received SBI-087 200 mg on Day 1, 84 and placebo matched to SBI-087 on Day 15. Subjects were followed up after day 168 of initial phase up to 2 years.

    Reporting group title
    SBI-087/ SBI-087/ SBI-087
    Reporting group description
    		 Subjects with active RA on a stable background of MTX, received SBI-087 200 mg on Day 1, 15 and 84. Subjects were followed up  after day 168 of initial phase up to 2 years.

    Reporting group title
    Placebo/ Placebo/ Placebo
    Reporting group description
    		 Subjects with active RA on a stable background of MTX, received placebo matched to SBI-087 on Day 1, 15 and 84. Subjects were followed up after day 168 of initial phase up to 2 years.

    Reporting group values
    		 SBI-087/ Placebo/ Placebo SBI-087/ SBI-087/ Placebo SBI-087/ Placebo/ SBI-087 SBI-087/ SBI-087/ SBI-087 Placebo/ Placebo/ Placebo Total
    Number of subjects
    		 43 42 43 41 40 209
    Age categorical
    Units: Subjects
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 56.77 ± 10.79 53.86 ± 10.83 52.88 ± 14.22 57.93 ± 10.62 52.03 ± 13.58 -
    Gender categorical
    Units: Subjects
        Female
    		 35 30 34 32 33 164
        Male
    		 8 12 9 9 7 45

    End points

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    End points reporting groups
    Reporting group title
    SBI-087/ Placebo/ Placebo
    Reporting group description
    		 Subjects with active RA and on a on a stable background of MTX, received SBI-087 on Day 1 and placebo matched to SBI-087 on Day 15 and 84 during the initial phase of study. Subjects were followed up after day 168 of initial phase up to 2 years.

    Reporting group title
    SBI-087/ SBI-087/ Placebo
    Reporting group description
    		 Subjects with active RA on a stable background of MTX, received SBI-087 on Day 1, 15 and placebo matched to SBI-087 on Day 84. Subjects were followed up after day 168 of initial phase up to 2 years.

    Reporting group title
    SBI-087/ Placebo/ SBI-087
    Reporting group description
    		 Subjects with active RA on a stable background of MTX, received SBI-087 200 mg on Day 1, 84 and placebo matched to SBI-087 on Day 15. Subjects were followed up after day 168 of initial phase up to 2 years.

    Reporting group title
    SBI-087/ SBI-087/ SBI-087
    Reporting group description
    		 Subjects with active RA on a stable background of MTX, received SBI-087 200 mg on Day 1, 15 and 84. Subjects were followed up  after day 168 of initial phase up to 2 years.

    Reporting group title
    Placebo/ Placebo/ Placebo
    Reporting group description
    		 Subjects with active RA on a stable background of MTX, received placebo matched to SBI-087 on Day 1, 15 and 84. Subjects were followed up after day 168 of initial phase up to 2 years.

    Primary: Percentage of Subjects Achieving American College of Rheumatology 20% (ACR20) Response at Week 16

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    End point title
    		 Percentage of Subjects Achieving American College of Rheumatology 20% (ACR20) Response at Week 16 [1]
    End point description
    ACR20 response: greater than or equal to (>=) 20 percent (%) improvement in tender joints count with 28 joints (TJC28); >= 20% improvement in swollen joints count with 28 joints (SJC28); and >= 20% improvement in at least 3 of 5 remaining ACR core measures: subject assessment of pain; subject global assessment of disease activity; physician global assessment of disease activity; self­assessed disability (disability index of the Health Assessment Questionnaire [HAQ]); and C­Reactive Protein (CRP). Modified intent-to-treat (mITT) population included all randomized subjects who received any portion of investigational product. Missing values were imputed using the last observation carried forward (LOCF).
    End point type
    Primary
    End point timeframe
    Week 16
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Statistical analysis has been provided separately as an attachment.
    End point values
    		 SBI-087/ Placebo/ Placebo SBI-087/ SBI-087/ Placebo SBI-087/ Placebo/ SBI-087 SBI-087/ SBI-087/ SBI-087 Placebo/ Placebo/ Placebo
    Number of subjects analysed
    43
    42
    43
    41
    40
    Units: Percentage of subjects
        number (not applicable)
    55.81
    54.76
    51.16
    70.73
    50
    Attachments
    		 ACR20: SBI-087/ Placebo/ Placebo
    No statistical analyses for this end point

    Secondary: Change from Baseline in Swollen Joints Count (SJC) at Week 2, 4,8, 12, 16,20, 24 

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    End point title
    		 Change from Baseline in Swollen Joints Count (SJC) at Week 2, 4,8, 12, 16,20, 24 
    End point description
    Number of swollen joints was determined by examination of 28 joints and identifying when swelling was present. The number of swollen joints was recorded on the joint assessment form at each visit, no swelling = 0, swelling =1. A negative value in change from baseline indicates an improvement. Least square mean and standard error are estimated from an analysis of covariance (ANCOVA) model with treatment, prior anti-tumor necrosis factor (TNF) failure and geographic region as covariates. mITT population included all randomized subjects who received any portion of investigational product. Missing values were imputed using LOCF.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 2, 4, 8, 12, 16, 20, 24
    End point values
    		 SBI-087/ Placebo/ Placebo SBI-087/ SBI-087/ Placebo SBI-087/ Placebo/ SBI-087 SBI-087/ SBI-087/ SBI-087 Placebo/ Placebo/ Placebo
    Number of subjects analysed
    43
    42
    43
    41
    40
    Units: joints
    least squares mean (standard error)
        Baseline
    11.42 ± 4.62
    10.53 ± 4.83
    11.87 ± 6.04
    10.38 ± 5.22
    10.41 ± 5.34
        Change at Week 2
    -3.03 ± 0.63
    -2.42 ± 0.63
    -2.42 ± 0.63
    -3.09 ± 0.64
    -3.13 ± 0.64
        Change at Week 4
    -5.12 ± 0.63
    -5.37 ± 0.63
    -3.75 ± 0.63
    -5.77 ± 0.63
    -4.91 ± 0.64
        Change at Week 8
    -6.05 ± 0.67
    -5.56 ± 0.67
    -4.78 ± 0.67
    -5.83 ± 0.68
    -4.74 ± 0.69
        Change at Week 12
    -6.27 ± 0.65
    -5.69 ± 0.64
    -5.05 ± 0.64
    -6.42 ± 0.65
    -4.5 ± 0.66
        Change at Week 16
    -5.67 ± 0.69
    -5.69 ± 0.69
    -5.22 ± 0.69
    -6.95 ± 0.7
    -5.87 ± 0.7
        Change at Week 20
    -6.74 ± 0.68
    -6.72 ± 0.67
    -5.24 ± 0.67
    -7.48 ± 0.68
    -5.75 ± 0.69
        Change at Week 24
    -5.58 ± 0.74
    -7.16 ± 0.74
    -5.74 ± 0.74
    -7.64 ± 0.75
    -6.37 ± 0.75
    No statistical analyses for this end point

    Secondary: Change From Baseline in Tender Joints Count (TJC) at Week 2, 4, 8, 12, 16, 20, 24

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    End point title
    		 Change From Baseline in Tender Joints Count (TJC) at Week 2, 4, 8, 12, 16, 20, 24
    End point description
    Number of tender joints was determined by examining 28 joints and identified the joints that were painful under pressure or to passive motion. The number of tender joints was recorded on the joint assessment form at each visit, no tenderness = 0, tenderness = 1. A negative value in change from baseline indicates an improvement. Least square mean and standard error are estimated from an ANCOVA model with treatment, prior anti-TNF failure and geographic region as covariates. mITT population included all randomized subjects who received any portion of investigational product. Missing values were imputed using LOCF.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 2, 4, 8, 12, 16, 20, 24
    End point values
    		 SBI-087/ Placebo/ Placebo SBI-087/ SBI-087/ Placebo SBI-087/ Placebo/ SBI-087 SBI-087/ SBI-087/ SBI-087 Placebo/ Placebo/ Placebo
    Number of subjects analysed
    43
    42
    43
    41
    40
    Units: joints
    least squares mean (standard error)
        Baseline
    15.1 ± 6.32
    13.02 ± 6.04
    14.17 ± 5.88
    13.39 ± 6.37
    13.43 ± 7.34
        Change at Week 2
    -3.47 ± 0.76
    -2.66 ± 0.76
    -2.19 ± 0.76
    -3.01 ± 0.77
    -3.43 ± 0.78
        Change at Week 4
    -5.85 ± 0.85
    -6.94 ± 0.84
    -3.96 ± 0.84
    -6.08 ± 0.85
    -4.98 ± 0.86
        Change at Week 8
    -6.32 ± 0.9
    -7.55 ± 0.9
    -5.75 ± 0.89
    -7.61 ± 0.91
    -5.43 ± 0.92
        Change at Week 12
    -7.06 ± 0.9
    -7.67 ± 0.9
    -5.89 ± 0.9
    -7.38 ± 0.91
    -4.65 ± 0.92
        Change at Week 16
    -7.39 ± 0.92
    -7.9 ± 0.91
    -6.13 ± 0.91
    -8.08 ± 0.92
    -6.79 ± 0.93
        Change at Week 20
    -7.48 ± 0.94
    -7.73 ± 0.94
    -6.04 ± 0.63
    -9.01 ± 0.95
    -5.26 ± 0.96
        Change at Week 24
    -6.38 ± 0.95
    -7.88 ± 0.95
    -7.06 ± 0.96
    -9.61 ± 0.956
    -6.07 ± 0.97
    No statistical analyses for this end point

    Secondary: Percentage of Subjects Achieving American College of Rheumatology 20% (ACR20) Response at Week 2, 8, 12 and 24

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    End point title
    		 Percentage of Subjects Achieving American College of Rheumatology 20% (ACR20) Response at Week 2, 8, 12 and 24
    End point description
    ACR20 response: greater than or equal to (>=) 20 percent (%) improvement in tender joints count (TJC); >= 20% improvement in swollen joints count (SJC); and >= 20% improvement in at least 3 of 5 remaining ACR core measures: subject assessment of pain; subject global assessment of disease activity; physician global assessment of disease activity; self­assessed disability (disability index of the Health Assessment Questionnaire [HAQ]); and C­Reactive Protein (CRP). mITT population included all randomized subjects who received any portion of investigational product. Missing values were imputed using LOCF. Here ‘n’ signifies subjects who were evaluable at specified time points for each arm group, respectively.
    End point type
    Secondary
    End point timeframe
    Week 2, 8, 12, 24
    End point values
    		 SBI-087/ Placebo/ Placebo SBI-087/ SBI-087/ Placebo SBI-087/ Placebo/ SBI-087 SBI-087/ SBI-087/ SBI-087 Placebo/ Placebo/ Placebo
    Number of subjects analysed
    43
    42
    43
    41
    40
    Units: Percentage of subjects
    number (not applicable)
        Week 2 (n=43, 42, 43, 41, 40)
    18.6
    14.29
    13.95
    14.63
    12.5
        Week 8 (n=43, 42, 43, 41, 40)
    48.84
    52.38
    41.86
    56.1
    30
        Week 12 (n=43, 41, 43, 41, 40)
    53.49
    53.66
    44.19
    58.54
    42.5
        Week 24 (n=43, 42, 43, 41, 40)
    55.81
    54.76
    60.47
    70.73
    50
    Attachments
    		 ACR20 Week 2: SBI-087/ Placebo/ Placebo
    No statistical analyses for this end point

    Secondary: Percentage of Subjects Achieving American College of Rheumatology 50% (ACR50) Response at Week 2, 8, 12, 16 and 24

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    End point title
    		 Percentage of Subjects Achieving American College of Rheumatology 50% (ACR50) Response at Week 2, 8, 12, 16 and 24
    End point description
    ACR50 response: >= 50 percent (%) improvement in TJC; >= 50% improvement in SJC; and >= 50% improvement in at least 3 of 5 remaining ACR core measures: subject assessment of pain; subject global assessment of disease activity; physician global assessment of disease activity; self­assessed disability (disability index of the HAQ); and CRP. mITT population included all randomized subjects who received any portion of investigational product. Missing values were imputed using LOCF.
    End point type
    Secondary
    End point timeframe
    Week 2, 8, 12, 16, 24
    End point values
    		 SBI-087/ Placebo/ Placebo SBI-087/ SBI-087/ Placebo SBI-087/ Placebo/ SBI-087 SBI-087/ SBI-087/ SBI-087 Placebo/ Placebo/ Placebo
    Number of subjects analysed
    43
    42
    43
    41
    40
    Units: Percentage of subjects
    number (not applicable)
        Week 2
    4.65
    0
    2.33
    2.44
    5
        Week 8
    18.6
    14.29
    25.58
    29.27
    20
        Week 12
    20.93
    33.33
    23.26
    17.07
    7.5
        Week 16
    23.26
    33.33
    23.26
    39.02
    25.64
        Week 24
    27.91
    38.1
    34.88
    43.9
    30
    Attachments
    		 ACR50 Week 2: SBI-087/ Placebo/ Placebo
    No statistical analyses for this end point

    Secondary:  Percentage of Subjects Achieving American College of Rheumatology 70% (ACR70) Response at Week 2, 8, 12, 16 and 24

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    End point title
    		  Percentage of Subjects Achieving American College of Rheumatology 70% (ACR70) Response at Week 2, 8, 12, 16 and 24
    End point description
    ACR70 response: >= 70 % improvement in TJC; >= 70% improvement in SJC; and >= 70% improvement in at least 3 of 5 remaining ACR core measures: subject assessment of pain; subject global assessment of disease activity; physician global assessment of disease activity; self­assessed disability (disability index of the HAQ); and CRP. mITT population included all randomized subjects who received any portion of investigational product. Missing values were imputed using LOCF.
    End point type
    Secondary
    End point timeframe
    Week 2, 8, 12, 16, 24
    End point values
    		 SBI-087/ Placebo/ Placebo SBI-087/ SBI-087/ Placebo SBI-087/ Placebo/ SBI-087 SBI-087/ SBI-087/ SBI-087 Placebo/ Placebo/ Placebo
    Number of subjects analysed
    43
    42
    43
    41
    40
    Units: Percentage of subjects
    number (not applicable)
        Week 2
    0
    0
    0
    0
    0
        Week 8
    9.3
    0
    4.65
    2.44
    10
        Week 12
    6.98
    2.38
    2.33
    7.32
    2.5
        Week 16
    6.98
    11.9
    16.28
    12.2
    7.5
        Week 24
    11.63
    11.9
    20.93
    24.39
    5
    Attachments
    		 ACR70 Week 2: SBI-087/ Placebo/ Placebo
    No statistical analyses for this end point

    Secondary: Percentage of Subjects With Hybrid Measure of American College of Rheumatology (ACR) 

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    End point title
    		 Percentage of Subjects With Hybrid Measure of American College of Rheumatology (ACR) 
    End point description
    Average percentage improvement in ACR core set measures of subjects were calculated. If a core set measure worsened by 100%, that percentage improvement was limited to ­-100%. This measure was used to determine whether subject had achieved: ACR20, 50, or 70. ACR20, 50 or 70 responses: >=20 or 50 or 70% (respective) improvement in tender joint count or in swollen joint count; and >= 20 or 50 or 70% (respective) improvement in at least 3 of 5 remaining ACR core measures: subject assessment of pain; subject global assessment of disease activity; physician global assessment of disease activity; self ­assessed disability (disability index of the HAQ); and CRP. A table was used to obtain the Hybrid ACR response measure, where, ACR status of the subject (left column) and the mean percentage improvement in core set items was taken, the Hybrid ACR score is where they intersect in the table.
    End point type
    Secondary
    End point timeframe
    Week 2, 8, 12, 16, 24
    End point values
    		 SBI-087/ Placebo/ Placebo SBI-087/ SBI-087/ Placebo SBI-087/ Placebo/ SBI-087 SBI-087/ SBI-087/ SBI-087 Placebo/ Placebo/ Placebo
    Number of subjects analysed
    0 [2]
    0 [3]
    0 [4]
    0 [5]
    0 [6]
    Units: Percentage of subjects
        number (not applicable)
    Notes
    [2] - Data is not reported because analysis was not performed for this endpoint due to Sponsor’s decision.
    [3] - Data is not reported because analysis was not performed for this endpoint due to Sponsor’s decision.
    [4] - Data is not reported because analysis was not performed for this endpoint due to Sponsor’s decision.
    [5] - Data is not reported because analysis was not performed for this endpoint due to Sponsor’s decision.
    [6] - Data is not reported because analysis was not performed for this endpoint due to Sponsor’s decision.
    No statistical analyses for this end point

    Secondary: American College of Rheumatology Numeric Response (ACR-N)

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    End point title
    		 American College of Rheumatology Numeric Response (ACR-N)
    End point description
    ACR-­N was calculated by taking the (1) lowest percentage improvement in swollen joint count or (2) lowest percentage improvement in tender joint count or (3) the median of the remaining 5 components of the ACR response (subject’s assessment of disease activity; subject’s global assessment of pain; physician’s assessment of disease activity; subject’s assessment of physical function; an acute phase reactant value ­C-reactive protein [CRP]). Negative numbers indicate worsening.
    End point type
    Secondary
    End point timeframe
    Week 2, 8, 12, 16, 24
    End point values
    		 SBI-087/ Placebo/ Placebo SBI-087/ SBI-087/ Placebo SBI-087/ Placebo/ SBI-087 SBI-087/ SBI-087/ SBI-087 Placebo/ Placebo/ Placebo
    Number of subjects analysed
    0 [7]
    0 [8]
    0 [9]
    0 [10]
    0 [11]
    Units: Units on scale
        number (not applicable)
    Notes
    [7] - Data is not reported because analysis was not performed for this endpoint due to Sponsor’s decision.
    [8] - Data is not reported because analysis was not performed for this endpoint due to Sponsor’s decision.
    [9] - Data is not reported because analysis was not performed for this endpoint due to Sponsor’s decision.
    [10] - Data is not reported because analysis was not performed for this endpoint due to Sponsor’s decision.
    [11] - Data is not reported because analysis was not performed for this endpoint due to Sponsor’s decision.
    No statistical analyses for this end point

    Secondary: Area Under the Numeric Index of American College of Rheumatology Response (ACR-­n) Curve

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    End point title
    		 Area Under the Numeric Index of American College of Rheumatology Response (ACR-­n) Curve
    End point description
    ACR-n: calculated by taking the (1) lowest percentage improvement in swollen joint count or (2) lowest percentage improvement in tender joint count or (3) the median of the remaining 5 components of the ACR response (subject’s assessment of disease activity; subject’s global assessment of pain; physician’s assessment of disease activity; subject’s assessment of physical function; an acute phase reactant value ­C-reactive protein [CRP]). Negative numbers indicate worsening. The area under the curve (AUC) for ACR-­n is the measure of the AUC of the mean change from baseline in ACR-­n.
    End point type
    Secondary
    End point timeframe
    Baseline up to Week 16, 24
    End point values
    		 SBI-087/ Placebo/ Placebo SBI-087/ SBI-087/ Placebo SBI-087/ Placebo/ SBI-087 SBI-087/ SBI-087/ SBI-087 Placebo/ Placebo/ Placebo
    Number of subjects analysed
    0 [12]
    0 [13]
    0 [14]
    0 [15]
    0 [16]
    Units: Units on scale*weeks
        number (not applicable)
    Notes
    [12] - Data is not reported because analysis was not performed for this endpoint due to Sponsor’s decision.
    [13] - Data is not reported because analysis was not performed for this endpoint due to Sponsor’s decision.
    [14] - Data is not reported because analysis was not performed for this endpoint due to Sponsor’s decision.
    [15] - Data is not reported because analysis was not performed for this endpoint due to Sponsor’s decision.
    [16] - Data is not reported because analysis was not performed for this endpoint due to Sponsor’s decision.
    No statistical analyses for this end point

    Secondary: Change From Baseline in C­-Reactive Protein (CRP) at Week 2, 8, 12, 16, 24

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    End point title
    		 Change From Baseline in C­-Reactive Protein (CRP) at Week 2, 8, 12, 16, 24
    End point description
    The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay. Normal range of CRP is 0 milligram per liter (mg/L) to 100 mg/L. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement. Least square mean and standard error are estimated from an ANCOVA model with treatment, prior anti-TNF failure and geographic region as covariates. mITT population included all randomized subjects who received any portion of investigational product. Missing values were imputed using LOCF.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 2, 8, 12, 16, 24
    End point values
    		 SBI-087/ Placebo/ Placebo SBI-087/ SBI-087/ Placebo SBI-087/ Placebo/ SBI-087 SBI-087/ SBI-087/ SBI-087 Placebo/ Placebo/ Placebo
    Number of subjects analysed
    43
    42
    43
    41
    40
    Units: milligram per deciliter (mg/dL)
    least squares mean (standard error)
        Baseline
    15.89 ± 16.22
    15.78 ± 20.23
    22.23 ± 22.36
    14.13 ± 16.26
    21.79 ± 34
        Change at Week 2
    -1.19 ± 1.91
    -1.28 ± 1.9
    -0.25 ± 1.91
    0.53 ± 1.93
    0.09 ± 1.96
        Change at Week 8
    -5.86 ± 2.83
    -1.97 ± 2.83
    -0.25 ± 2.84
    -4.1 ± 2.86
    -1.89 ± 2.91
        Change at Week 12
    -7.48 ± 2.13
    -7.9 ± 2.13
    -4.48 ± 2.14
    -8.83 ± 2.16
    1.17 ± 2.19
        Change at Week 16
    -7.71 ± 2.06
    -8.44 ± 2.06
    -5.25 ± 2.07
    -9.17 ± 2.09
    -1.51 ± 2.12
        Change at Week 24
    -6.81 ± 2.38
    -6.56 ± 2.37
    -6.07 ± 2.38
    -8.78 ± 2.4
    -0.77 ± 2.44
    No statistical analyses for this end point

    Secondary: Change From Baseline in Pain Using Visual Analogue Scale (VAS) at Week 2, 4, 8, 12, 16, 20, 24

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    End point title
    		 Change From Baseline in Pain Using Visual Analogue Scale (VAS) at Week 2, 4, 8, 12, 16, 20, 24
    End point description
    VAS consists of a line 0 to 100 millimeters (mm) in length; range is (no pain) to 100 mm (worst possible pain). Subjects placed a mark indicating the intensity of their pain. Higher score indicates greater level of pain. Change = observation minus baseline. Least square mean and standard error are estimated from an ANCOVA model with treatment, prior anti-TNF failure and geographic region as covariates. mITT population included all randomized subjects who received any portion of investigational product. Missing values were imputed using the LOCF.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 2, 4, 8, 12, 16, 20, 24
    End point values
    		 SBI-087/ Placebo/ Placebo SBI-087/ SBI-087/ Placebo SBI-087/ Placebo/ SBI-087 SBI-087/ SBI-087/ SBI-087 Placebo/ Placebo/ Placebo
    Number of subjects analysed
    43
    42
    43
    41
    40
    Units: mm
    least squares mean (standard error)
        Baseline
    49.48 ± 21.04
    58.81 ± 20.52
    61.42 ± 19.11
    54.22 ± 21.38
    59.33 ± 20
        Change at Week 2
    -7.92 ± 2.73
    -2.83 ± 2.7
    -5.42 ± 2.7
    -6.51 ± 2.73
    -1.71 ± 2.76
        Change at Week 4
    -8.43 ± 3.06
    -13.86 ± 3.02
    -8.82 ± 3.02
    -12.23 ± 3.06
    -9.33 ± 3.09
        Change at Week 8
    -12.82 ± 3.38
    -10.98 ± 3.33
    -10.15 ± 3.33
    -19.46 ± 3.38
    -10.25 ± 3.41
        Change at Week 12
    -13.4 ± 3.47
    -12.91 ± 3.43
    -13.18 ± 3.43
    -12.26 ± 3.48
    -9.94 ± 3.51
        Change at Week 16
    -14.71 ± 3.68
    -15.67 ± 3.63
    -14.55 ± 3.64
    -23.72 ± 3.68
    -13.05 ± 3.72
        Change at Week 20
    -18.41 ± 3.5
    -14.48 ± 3.46
    -15.95 ± 3.46
    -23.68 ± 3.51
    -14.26 ± 3.54
        Change at Week 24
    -16.5 ± 3.6
    -15.87 ± 3.55
    -21.59 ± 3.55
    -22.68 ± 3.6
    -15.83 ± 3.63
    No statistical analyses for this end point

    Secondary: Change From Baseline in Physician Global Assessment (PGA) of Disease Activity at Week 2, 4, 8, 12, 16, 20, 24

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    End point title
    		 Change From Baseline in Physician Global Assessment (PGA) of Disease Activity at Week 2, 4, 8, 12, 16, 20, 24
    End point description
    Physicians were asked to assess the disease activity of subjects within the past 3 days. Disease activity was evaluated on an 11­point scale: min = 0 (no disease activity), max = 10 (extreme disease activity). Least square mean and standard error are estimated from an ANCOVA model with treatment, prior anti-TNF failure and geographic region as covariates. mITT population included all randomized subjects who received any portion of investigational product. Missing values were imputed using LOCF.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 2, 4, 8, 12, 16, 20, 24
    End point values
    		 SBI-087/ Placebo/ Placebo SBI-087/ SBI-087/ Placebo SBI-087/ Placebo/ SBI-087 SBI-087/ SBI-087/ SBI-087 Placebo/ Placebo/ Placebo
    Number of subjects analysed
    43
    42
    43
    41
    40
    Units: Units on scale
    least squares mean (standard error)
        Baseline
    6.4 ± 1.61
    6.69 ± 1.57
    6.67 ± 1.46
    6.41 ± 1.38
    6.53 ± 1.96
        Change at Week 2
    -1.59 ± 0.28
    -1.34 ± 0.28
    -0.7 ± 0.28
    -0.84 ± 0.29
    -1.5 ± 0.29
        Change at Week 4
    -2.38 ± 0.31
    -2.47 ± 0.3
    -1.95 ± 0.3
    -2.2 ± 0.3
    -1.83 ± 0.3
        Change at Week 8
    -2.74 ± 0.32
    -2.62 ± 0.32
    -2.51 ± 0.31
    -2.95 ± 0.32
    -2.48 ± 0.32
        Change at Week 12
    -2.82 ± 0.31
    -2.92 ± 0.31
    -2.35 ± 0.32
    -2.76 ± 0.31
    -2.09 ± 0.31
        Change at Week 16
    -2.77 ± 0.34
    -2.9 ± 0.34
    -2.64 ± 0.33
    -3.32 ± 0.34
    -2.51 ± 0.34
        Change at Week 20
    -3.21 ± 0.37
    -3.13 ± 0.35
    -3.03 ± 0.37
    -3.45 ± 0.34
    -2.83 ± 0.36
        Change at Week 24
    -2.82 ± 0.36
    -3.28 ± 0.36
    -2.64 ± 0.36
    -3.67 ± 0.37
    -2.8 ± 0.37
    No statistical analyses for this end point

    Secondary: Change From Baseline in Patient Global Assessment (PtGA) of Disease Activity at Week 2, 4, 8, 12, 16, 20, 24

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    End point title
    		 Change From Baseline in Patient Global Assessment (PtGA) of Disease Activity at Week 2, 4, 8, 12, 16, 20, 24
    End point description
    Subjects were asked for the assessment of the overall activity of arthritis. Disease activity was evaluated on an 11­point scale: min = 0 (no disease activity), max = 10 (extreme disease activity). Least square mean and standard error are estimated from an ANCOVA model with treatment, prior anti-TNF failure and geographic region as covariates. mITT population included all randomized subjects who received any portion of investigational product. Missing values were imputed using LOCF.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 2, 4, 8, 12, 16, 20, 24
    End point values
    		 SBI-087/ Placebo/ Placebo SBI-087/ SBI-087/ Placebo SBI-087/ Placebo/ SBI-087 SBI-087/ SBI-087/ SBI-087 Placebo/ Placebo/ Placebo
    Number of subjects analysed
    43
    42
    43
    41
    40
    Units: Units on scale
    least squares mean (standard error)
        Baseline
    5.93 ± 2.2
    6.4 ± 1.87
    6.72 ± 1.83
    6.59 ± 1.83
    6.9 ± 2
        Change at Week 2
    -0.83 ± 0.26
    -0.32 ± 0.26
    -0.41 ± 0.26
    -0.86 ± 0.26
    -0.57 ± 0.27
        Change at Week 4
    -1.2 ± 0.28
    -1.38 ± 0.28
    -1 ± 0.28
    -1.41 ± 0.28
    -1.16 ± 0.29
        Change at Week 8
    -1.4 ± 0.33
    -1.28 ± 0.33
    -1.2 ± 0.33
    -1.92 ± 0.33
    -1.3 ± 0.33
        Change at Week 12
    -1.66 ± 0.32
    -1.55 ± 0.32
    -1.35 ± 0.32
    -1.43 ± 0.32
    -1.03 ± 0.33
        Change at Week 16
    -1.72 ± 0.34
    -1.64 ± 0.34
    -1.44 ± 0.34
    -2.25 ± 0.34
    -1.4 ± 0.35
        Change at Week 20
    -2.04 ± 0.35
    -1.53 ± 0.34
    -1.79 ± 0.34
    -2.51 ± 0.35
    -1.61 ± 0.35
        Change at Week 24
    -1.95 ± 0.36
    -1.66 ± 0.36
    -2.17 ± 0.36
    -2.49 ± 0.36
    -1.32 ± 0.36
    No statistical analyses for this end point

    Secondary: Change From Baseline in Duration of Morning Stiffness at Week 2, 4, 8, 12, 16, 20, 24

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    End point title
    		 Change From Baseline in Duration of Morning Stiffness at Week 2, 4, 8, 12, 16, 20, 24
    End point description
    Duration of morning stiffness is defined as the time elapsed when subject woke up in the morning and was able to resume normal activities without stiffness in minutes. Least square mean and standard error are estimated from an ANCOVA model with treatment, prior anti-TNF failure and geographic region as covariates. mITT population included all randomized subjects who received any portion of investigational product. Missing values were imputed using LOCF. Here "99999" in change from baseline in Duration of morning stiffness signifies not available (NA).
    End point type
    Secondary
    End point timeframe
    Baseline, Week 2, 4, 8, 12, 16, 20, 24
    End point values
    		 SBI-087/ Placebo/ Placebo SBI-087/ SBI-087/ Placebo SBI-087/ Placebo/ SBI-087 SBI-087/ SBI-087/ SBI-087 Placebo/ Placebo/ Placebo
    Number of subjects analysed
    43
    42
    43
    41
    40
    Units: Minutes
    least squares mean (standard error)
        Baseline
    5.93 ± 99999
    6.4 ± 99999
    6.72 ± 99999
    6.59 ± 99999
    6.9 ± 99999
        Change at Week 2
    -46.18 ± 17.03
    -32.26 ± 17.02
    -22.14 ± 17.12
    -27.61 ± 17.22
    -10.58 ± 17.38
        Change at Week 4
    -45.72 ± 22.75
    -43.58 ± 22.73
    -17.59 ± 22.86
    -45.29 ± 23
    -8.63 ± 23.21
        Change at Week 8
    -69.88 ± 16.35
    -71.98 ± 16.34
    -76.89 ± 16.43
    -79.87 ± 16.53
    26.07 ± 16.68
        Change at Week 12
    -49.27 ± 24.52
    -54.47 ± 24.5
    -16.4 ± 24.64
    -20.64 ± 24.8
    -5.65 ± 25.02
        Change at Week 16
    -62.82 ± 18.28
    -58.66 ± 18.27
    -23.98 ± 18.37
    -81.56 ± 18.49
    -25.26 ± 18.65
        Change at Week 20
    -24.34 ± 29.05
    -49 ± 29.03
    -7.6 ± 29.19
    -46.7 ± 29.38
    -18.87 ± 29.64
        Change at Week 24
    2.74 ± 32.91
    -69.34 ± 32.89
    -49.06 ± 33.07
    -54.02 ± 33.28
    -24.1 ± 33.58
    No statistical analyses for this end point

    Secondary: Change From Baseline in Subjects General Health Visual Analog Scale (VAS) at Week 2, 4, 8, 12, 16, 20, 24

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    End point title
    		 Change From Baseline in Subjects General Health Visual Analog Scale (VAS) at Week 2, 4, 8, 12, 16, 20, 24
    End point description
    Subjects were simply asked to rate their feelings concerning their arthritis and this assessment was performed more often than prior to administration of study drug. Subjects responded by using a 0 to 100 mm VAS Scale, range is 0 mm (very well) to 100 mm (extremely bad). Change = observation minus baseline. Least square mean and standard error are estimated from an ANCOVA model with treatment, prior anti-TNF failure and geographic region as covariates. mITT population included all randomized subjects who received any portion of investigational product. Missing values were imputed using LOCF.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 2, 4, 8, 12, 16, 20, 24
    End point values
    		 SBI-087/ Placebo/ Placebo SBI-087/ SBI-087/ Placebo SBI-087/ Placebo/ SBI-087 SBI-087/ SBI-087/ SBI-087 Placebo/ Placebo/ Placebo
    Number of subjects analysed
    43
    42
    43
    41
    40
    Units: mm
    least squares mean (standard error)
        Baseline
    54.72 ± 19.53
    62.1 ± 20
    65.19 ± 17.77
    63.59 ± 17.41
    60.25 ± 22.59
        Change at Week 2
    -8.53 ± 2.92
    -4.44 ± 2.88
    -7.61 ± 2.88
    -7.48 ± 2.92
    -4.43 ± 2.95
        Change at Week 4
    -13.78 ± 2.88
    -13.48 ± 2.83
    -13.09 ± 2.83
    -15.88 ± 2.87
    -7.84 ± 2.9
        Change at Week 8
    -13.84 ± 3.36
    -10.54 ± 3.31
    -13.04 ± 3.31
    -22.29 ± 3.36
    -9.26 ± 3.39
        Change at Week 12
    -14.85 ± 3.47
    -15.68 ± 3.41
    -12.51 ± 3.41
    -17.23 ± 3.46
    -7.82 ± 3.49
        Change at Week 16
    -14.94 ± 3.65
    -16.36 ± 3.59
    -18.03 ± 3.59
    -25.4 ± 3.64
    -12.03 ± 3.68
        Change at Week 20
    -18.45 ± 3.64
    -15.02 ± 3.59
    -18.48 ± 3.58
    -22.55 ± 3.64
    -13.96 ± 3.67
        Change at Week 24
    -17.66 ± 3.82
    -16.72 ± 3.76
    -21.4 ± 3.76
    -21.31 ± 3.82
    -11.73 ± 3.85
    No statistical analyses for this end point

    Secondary: Change From Baseline in Disease Activity Score Based on 28 Joints Count, General Health Score and C-­Reactive Protein (DAS28­-4 [CRP]) at Week 2, 8, 12, 16, 24

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    End point title
    		 Change From Baseline in Disease Activity Score Based on 28 Joints Count, General Health Score and C-­Reactive Protein (DAS28­-4 [CRP]) at Week 2, 8, 12, 16, 24
    End point description
    DAS28­-4 (CRP) was calculated from SJC and TJC using 28 joints count, CRP (mg/dL) and general health score using 100 mm VAS scale. Total score range: 0­9.4, higher score=more disease activity. DAS28­-4 (CRP) less than or equal to (<=) 3.2 implied low disease activity and greater than (>) 3.2 to 5.1 implied moderate to high disease activity, and DAS28­-4 (CRP) less than (<) 2.6 = remission. Least square mean and standard error are estimated from an ANCOVA model with treatment, prior anti-TNF failure and geographic region as covariates. mITT population included all randomized subjects who received any portion of investigational product. Missing values were imputed using LOCF.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 2, 8, 12, 16, 24
    End point values
    		 SBI-087/ Placebo/ Placebo SBI-087/ SBI-087/ Placebo SBI-087/ Placebo/ SBI-087 SBI-087/ SBI-087/ SBI-087 Placebo/ Placebo/ Placebo
    Number of subjects analysed
    43
    42
    43
    41
    40
    Units: Units on scale
    least squares mean (standard error)
        Baseline
    5.65 ± 0.8
    5.52 ± 0.78
    5.83 ± 0.96
    5.51 ± 0.9
    5.52 ± 1.11
        Change at Week 2
    -0.66 ± 0.14
    -0.52 ± 0.14
    -0.52 ± 0.14
    -0.62 ± 0.14
    -0.64 ± 0.14
        Change at Week 8
    -1.41 ± 0.18
    -1.37 ± 0.18
    -1.24 ± 0.18
    -1.68 ± 0.19
    -1.19 ± 0.19
        Change at Week 12
    -1.5 ± 0.18
    -1.57 ± 0.17
    -1.27 ± 0.18
    -1.67 ± 0.18
    -0.96 ± 0.18
        Change at Week 16
    -1.63 ± 0.2
    -1.67 ± 0.2
    -1.44 ± 0.2
    -2.05 ± 0.2
    -1.45 ± 0.2
        Change at Week 24
    -1.54 ± 0.21
    -1.78 ± 0.21
    -1.71 ± 0.21
    -2.14 ± 0.21
    -1.34 ± 0.21
    No statistical analyses for this end point

    Secondary: Percentage of Subjects With European League Against Rheumatism (EULAR) Response Based on DAS28

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    End point title
    		 Percentage of Subjects With European League Against Rheumatism (EULAR) Response Based on DAS28
    End point description
    The Disease Activity Score Based on 28­ joints Count based (DAS28 ­based) EULAR response criteria were used to measure individual response as none, good, and moderate, depending on the extent of change from baseline and the level of disease activity reached. Good responders: change from baseline >1.2 with DAS28 =< 3.2; moderate responders: change from baseline >1.2 with DAS28 >3.2 or change from baseline >0.6 to =<1.2 with DAS28 >5.1; non­responders: change from baseline =< 0.6 or change from baseline >0.6 and =<1.2 with DAS28 >5.1.
    End point type
    Secondary
    End point timeframe
    Week 2, 8, 12, 16, 24
    End point values
    		 SBI-087/ Placebo/ Placebo SBI-087/ SBI-087/ Placebo SBI-087/ Placebo/ SBI-087 SBI-087/ SBI-087/ SBI-087 Placebo/ Placebo/ Placebo
    Number of subjects analysed
    0 [17]
    0 [18]
    0 [19]
    0 [20]
    0 [21]
    Units: Percentage of subjects
        number (not applicable)
    Notes
    [17] - Data is not reported because analysis was not performed for this endpoint due to Sponsor’s decision.
    [18] - Data is not reported because analysis was not performed for this endpoint due to Sponsor’s decision.
    [19] - Data is not reported because analysis was not performed for this endpoint due to Sponsor’s decision.
    [20] - Data is not reported because analysis was not performed for this endpoint due to Sponsor’s decision.
    [21] - Data is not reported because analysis was not performed for this endpoint due to Sponsor’s decision.
    No statistical analyses for this end point

    Secondary: Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ­-DI) at Week 2, 4, 8, 12, 16, 20, 24

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    End point title
    		 Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ­-DI) at Week 2, 4, 8, 12, 16, 20, 24
    End point description
    HAQ-­DI: subject-reported assessment of ability to perform tasks in 8 functional categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; and common activities over past week. Each item scored on 4-­point scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0-­3, 0=least functional difficulty and 3=extreme functional difficulty. Change = observation overall score minus baseline overall score. Least square mean and standard error are estimated from an ANCOVA model with treatment, prior anti-TNF failure and geographic region as covariates. mITT population included all randomized subjects who received any portion of investigational product. Missing values were imputed using LOCF.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 2, 4, 8, 12, 16, 20, 24
    End point values
    		 SBI-087/ Placebo/ Placebo SBI-087/ SBI-087/ Placebo SBI-087/ Placebo/ SBI-087 SBI-087/ SBI-087/ SBI-087 Placebo/ Placebo/ Placebo
    Number of subjects analysed
    43
    42
    43
    41
    40
    Units: Units on scale
    least squares mean (standard error)
        Baseline
    1.46 ± 0.57
    1.46 ± 0.58
    1.54 ± 0.58
    1.36 ± 0.68
    1.43 ± 0.8
        Change at Week 2
    -0.16 ± 0.05
    -0.06 ± 0.05
    -0.08 ± 0.05
    -0.1 ± 0.05
    -0.17 ± 0.05
        Change at Week 4
    -0.16 ± 0.05
    -0.26 ± 0.06
    -0.16 ± 0.06
    -0.29 ± 0.06
    -0.19 ± 0.06
        Change at Week 8
    -0.22 ± 0.06
    -0.26 ± 0.07
    -0.18 ± 0.07
    -0.3 ± 0.07
    -0.21 ± 0.07
        Change at Week 12
    -0.21 ± 0.07
    -0.25 ± 0.07
    -0.15 ± 0.07
    -0.34 ± 0.07
    -0.28 ± 0.07
        Change at Week 16
    -0.36 ± 0.07
    -0.27 ± 0.07
    -0.23 ± 0.07
    -0.43 ± 0.07
    -0.28 ± 0.08
        Change at Week 20
    -0.32 ± 0.08
    -0.25 ± 0.08
    -0.35 ± 0.09
    -0.42 ± 0.08
    -0.35 ± 0.08
        Change at Week 24
    -0.3 ± 0.08
    -0.28 ± 0.08
    -0.31 ± 0.08
    -0.44 ± 0.08
    -0.24 ± 0.08
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Baseline up to 999 days after last dose of study drug
    Adverse event reporting additional description
    The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    18.0
    Reporting groups
    Reporting group title
    SBI-087/ Placebo/ Placebo
    Reporting group description
    		 Subjects with active RA and on a on a stable background of MTX, received SBI-087 on Day 1 and placebo matched to SBI-087 on Day 15 and 84 during the initial phase of study. Subjects were followed up after day 168 of initial phase up to 2 years.

    Reporting group title
    SBI-087/ SBI-087/ Placebo
    Reporting group description
    		 Subjects with active RA on a stable background of MTX, received SBI-087 on Day 1, 15 and placebo matched to SBI-087 on Day 84. Subjects were followed up after day 168 of initial phase up to 2 years.

    Reporting group title
    SBI-087/ Placebo/ SBI-087
    Reporting group description
    		 Subjects with active RA on a stable background of MTX, received SBI-087 200 mg on Day 1, 84 and placebo matched to SBI-087 on Day 15. Subjects were followed up after day 168 of initial phase up to 2 years.

    Reporting group title
    SBI-087/ SBI-087/ SBI-087
    Reporting group description
    		 Subjects with active RA on a stable background of MTX, received SBI-087 200 mg on Day 1, 15 and 84. Subjects were followed up  after day 168 of initial phase up to 2 years.

    Reporting group title
    Placebo/ Placebo/ Placebo
    Reporting group description
    		 Subjects with active RA on a stable background of MTX, received placebo matched to SBI-087 on Day 1, 15 and 84. Subjects were followed up after day 168 of initial phase up to 2 years.

    Serious adverse events
    		 SBI-087/ Placebo/ Placebo SBI-087/ SBI-087/ Placebo SBI-087/ Placebo/ SBI-087 SBI-087/ SBI-087/ SBI-087 Placebo/ Placebo/ Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    5 / 43 (11.63%)
    7 / 42 (16.67%)
    7 / 43 (16.28%)
    7 / 41 (17.07%)
    5 / 40 (12.50%)
         number of deaths (all causes)
    0
    1
    2
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    0
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Ovarian neoplasm
         subjects affected / exposed
    0 / 43 (0.00%)
    0 / 42 (0.00%)
    0 / 43 (0.00%)
    1 / 41 (2.44%)
    0 / 40 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Small cell lung cancer
         subjects affected / exposed
    0 / 43 (0.00%)
    0 / 42 (0.00%)
    1 / 43 (2.33%)
    0 / 41 (0.00%)
    0 / 40 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    Reproductive system and breast disorders
    Prostatitis
         subjects affected / exposed
    0 / 43 (0.00%)
    0 / 42 (0.00%)
    1 / 43 (2.33%)
    0 / 41 (0.00%)
    0 / 40 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    2 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Chronic obstructive pulmonary disease
         subjects affected / exposed
    0 / 43 (0.00%)
    2 / 42 (4.76%)
    1 / 43 (2.33%)
    0 / 41 (0.00%)
    0 / 40 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 2
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    Respiratory failure
         subjects affected / exposed
    0 / 43 (0.00%)
    1 / 42 (2.38%)
    1 / 43 (2.33%)
    0 / 41 (0.00%)
    0 / 40 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Psychiatric disorders
    Bipolar disorder
         subjects affected / exposed
    0 / 43 (0.00%)
    0 / 42 (0.00%)
    0 / 43 (0.00%)
    0 / 41 (0.00%)
    1 / 40 (2.50%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Investigations
    Blood creatinine increased
         subjects affected / exposed
    0 / 43 (0.00%)
    0 / 42 (0.00%)
    0 / 43 (0.00%)
    1 / 41 (2.44%)
    0 / 40 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hepatic enzyme increased
         subjects affected / exposed
    0 / 43 (0.00%)
    0 / 42 (0.00%)
    0 / 43 (0.00%)
    0 / 41 (0.00%)
    1 / 40 (2.50%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Femur fracture
         subjects affected / exposed
    1 / 43 (2.33%)
    0 / 42 (0.00%)
    0 / 43 (0.00%)
    0 / 41 (0.00%)
    1 / 40 (2.50%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pelvic fracture
         subjects affected / exposed
    0 / 43 (0.00%)
    0 / 42 (0.00%)
    0 / 43 (0.00%)
    0 / 41 (0.00%)
    1 / 40 (2.50%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Thoracic vertebral fracture
         subjects affected / exposed
    0 / 43 (0.00%)
    1 / 42 (2.38%)
    0 / 43 (0.00%)
    0 / 41 (0.00%)
    0 / 40 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Wound decomposition
         subjects affected / exposed
    0 / 43 (0.00%)
    1 / 42 (2.38%)
    0 / 43 (0.00%)
    0 / 41 (0.00%)
    0 / 40 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Congenital, familial and genetic disorders
    Hamartoma
         subjects affected / exposed
    0 / 43 (0.00%)
    1 / 42 (2.38%)
    0 / 43 (0.00%)
    0 / 41 (0.00%)
    0 / 40 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cardiac disorders
    Cardiac failure
         subjects affected / exposed
    0 / 43 (0.00%)
    1 / 42 (2.38%)
    0 / 43 (0.00%)
    0 / 41 (0.00%)
    0 / 40 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    Atrial fibrillation
         subjects affected / exposed
    0 / 43 (0.00%)
    0 / 42 (0.00%)
    0 / 43 (0.00%)
    1 / 41 (2.44%)
    0 / 40 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    Cerebral infarction
         subjects affected / exposed
    0 / 43 (0.00%)
    1 / 42 (2.38%)
    0 / 43 (0.00%)
    0 / 41 (0.00%)
    0 / 40 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cerebrovascular accident
         subjects affected / exposed
    0 / 43 (0.00%)
    1 / 42 (2.38%)
    0 / 43 (0.00%)
    0 / 41 (0.00%)
    0 / 40 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hemiparesis
         subjects affected / exposed
    1 / 43 (2.33%)
    0 / 42 (0.00%)
    0 / 43 (0.00%)
    0 / 41 (0.00%)
    0 / 40 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Vascular encephalopathy
         subjects affected / exposed
    0 / 43 (0.00%)
    0 / 42 (0.00%)
    1 / 43 (2.33%)
    0 / 41 (0.00%)
    0 / 40 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Vertebrobasilar insufficiency
         subjects affected / exposed
    0 / 43 (0.00%)
    0 / 42 (0.00%)
    1 / 43 (2.33%)
    0 / 41 (0.00%)
    0 / 40 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Leukopenia
         subjects affected / exposed
    1 / 43 (2.33%)
    0 / 42 (0.00%)
    0 / 43 (0.00%)
    0 / 41 (0.00%)
    0 / 40 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pancytopenia
         subjects affected / exposed
    0 / 43 (0.00%)
    0 / 42 (0.00%)
    1 / 43 (2.33%)
    0 / 41 (0.00%)
    0 / 40 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Eye disorders
    Visual impairment
         subjects affected / exposed
    1 / 43 (2.33%)
    0 / 42 (0.00%)
    0 / 43 (0.00%)
    0 / 41 (0.00%)
    0 / 40 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Peptic ulcer
         subjects affected / exposed
    0 / 43 (0.00%)
    0 / 42 (0.00%)
    0 / 43 (0.00%)
    1 / 41 (2.44%)
    0 / 40 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Small intestinal obstruction
         subjects affected / exposed
    1 / 43 (2.33%)
    0 / 42 (0.00%)
    0 / 43 (0.00%)
    0 / 41 (0.00%)
    0 / 40 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Umbilical hernia
         subjects affected / exposed
    0 / 43 (0.00%)
    0 / 42 (0.00%)
    0 / 43 (0.00%)
    0 / 41 (0.00%)
    1 / 40 (2.50%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Cholecystitis chronic
         subjects affected / exposed
    0 / 43 (0.00%)
    0 / 42 (0.00%)
    0 / 43 (0.00%)
    1 / 41 (2.44%)
    0 / 40 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cholelithiasis
         subjects affected / exposed
    0 / 43 (0.00%)
    0 / 42 (0.00%)
    0 / 43 (0.00%)
    1 / 41 (2.44%)
    0 / 40 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    Rash generalised
         subjects affected / exposed
    1 / 43 (2.33%)
    0 / 42 (0.00%)
    0 / 43 (0.00%)
    0 / 41 (0.00%)
    0 / 40 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Renal and urinary disorders
    Renal colic
         subjects affected / exposed
    0 / 43 (0.00%)
    0 / 42 (0.00%)
    1 / 43 (2.33%)
    0 / 41 (0.00%)
    0 / 40 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Endocrine disorders
    Adrenal insufficiency
         subjects affected / exposed
    0 / 43 (0.00%)
    1 / 42 (2.38%)
    0 / 43 (0.00%)
    0 / 41 (0.00%)
    0 / 40 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Chronic recurrent multifocal osteomyelitis
         subjects affected / exposed
    0 / 43 (0.00%)
    0 / 42 (0.00%)
    1 / 43 (2.33%)
    0 / 41 (0.00%)
    0 / 40 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    Rheumatoid arthritis
         subjects affected / exposed
    0 / 43 (0.00%)
    0 / 42 (0.00%)
    0 / 43 (0.00%)
    1 / 41 (2.44%)
    0 / 40 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Acute sinusitis
         subjects affected / exposed
    0 / 43 (0.00%)
    0 / 42 (0.00%)
    1 / 43 (2.33%)
    0 / 41 (0.00%)
    0 / 40 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    1 / 43 (2.33%)
    0 / 42 (0.00%)
    0 / 43 (0.00%)
    1 / 41 (2.44%)
    1 / 40 (2.50%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pneumonia necrotising
         subjects affected / exposed
    0 / 43 (0.00%)
    0 / 42 (0.00%)
    1 / 43 (2.33%)
    0 / 41 (0.00%)
    0 / 40 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Wound infection
         subjects affected / exposed
    1 / 43 (2.33%)
    0 / 42 (0.00%)
    0 / 43 (0.00%)
    0 / 41 (0.00%)
    0 / 40 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 SBI-087/ Placebo/ Placebo SBI-087/ SBI-087/ Placebo SBI-087/ Placebo/ SBI-087 SBI-087/ SBI-087/ SBI-087 Placebo/ Placebo/ Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    26 / 43 (60.47%)
    26 / 42 (61.90%)
    29 / 43 (67.44%)
    22 / 41 (53.66%)
    19 / 40 (47.50%)
    Investigations
    Alanine aminotransferase increased
         subjects affected / exposed
    3 / 43 (6.98%)
    2 / 42 (4.76%)
    2 / 43 (4.65%)
    3 / 41 (7.32%)
    0 / 40 (0.00%)
         occurrences all number
    3
    2
    7
    4
    0
    Vascular disorders
    Hypertension
         subjects affected / exposed
    3 / 43 (6.98%)
    0 / 42 (0.00%)
    5 / 43 (11.63%)
    0 / 41 (0.00%)
    1 / 40 (2.50%)
         occurrences all number
    5
    0
    6
    0
    1
    Nervous system disorders
    Headache
         subjects affected / exposed
    2 / 43 (4.65%)
    1 / 42 (2.38%)
    4 / 43 (9.30%)
    5 / 41 (12.20%)
    1 / 40 (2.50%)
         occurrences all number
    2
    1
    6
    13
    3
    Blood and lymphatic system disorders
    Leukopenia
         subjects affected / exposed
    3 / 43 (6.98%)
    0 / 42 (0.00%)
    7 / 43 (16.28%)
    3 / 41 (7.32%)
    0 / 40 (0.00%)
         occurrences all number
    5
    0
    9
    3
    0
    General disorders and administration site conditions
    Pyrexia
         subjects affected / exposed
    1 / 43 (2.33%)
    4 / 42 (9.52%)
    1 / 43 (2.33%)
    4 / 41 (9.76%)
    1 / 40 (2.50%)
         occurrences all number
    1
    6
    1
    4
    1
    Gastrointestinal disorders
    Abdominal discomfort
         subjects affected / exposed
    1 / 43 (2.33%)
    3 / 42 (7.14%)
    0 / 43 (0.00%)
    1 / 41 (2.44%)
    0 / 40 (0.00%)
         occurrences all number
    2
    4
    0
    1
    0
    Constipation
         subjects affected / exposed
    2 / 43 (4.65%)
    1 / 42 (2.38%)
    2 / 43 (4.65%)
    3 / 41 (7.32%)
    0 / 40 (0.00%)
         occurrences all number
    2
    1
    2
    4
    0
    Diarrhoea
         subjects affected / exposed
    1 / 43 (2.33%)
    2 / 42 (4.76%)
    1 / 43 (2.33%)
    4 / 41 (9.76%)
    4 / 40 (10.00%)
         occurrences all number
    1
    3
    1
    5
    5
    Nausea
         subjects affected / exposed
    2 / 43 (4.65%)
    1 / 42 (2.38%)
    4 / 43 (9.30%)
    2 / 41 (4.88%)
    1 / 40 (2.50%)
         occurrences all number
    2
    1
    4
    2
    1
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    0 / 43 (0.00%)
    4 / 42 (9.52%)
    2 / 43 (4.65%)
    1 / 41 (2.44%)
    2 / 40 (5.00%)
         occurrences all number
    0
    4
    2
    1
    2
    Skin and subcutaneous tissue disorders
    Dermatitis
         subjects affected / exposed
    3 / 43 (6.98%)
    0 / 42 (0.00%)
    0 / 43 (0.00%)
    0 / 41 (0.00%)
    1 / 40 (2.50%)
         occurrences all number
    3
    0
    0
    0
    1
    Dry skin
         subjects affected / exposed
    0 / 43 (0.00%)
    0 / 42 (0.00%)
    0 / 43 (0.00%)
    0 / 41 (0.00%)
    3 / 40 (7.50%)
         occurrences all number
    0
    0
    0
    0
    4
    Rash
         subjects affected / exposed
    3 / 43 (6.98%)
    0 / 42 (0.00%)
    1 / 43 (2.33%)
    1 / 41 (2.44%)
    1 / 40 (2.50%)
         occurrences all number
    5
    0
    1
    1
    1
    Psychiatric disorders
    Insomnia
         subjects affected / exposed
    1 / 43 (2.33%)
    3 / 42 (7.14%)
    1 / 43 (2.33%)
    1 / 41 (2.44%)
    0 / 40 (0.00%)
         occurrences all number
    1
    3
    1
    2
    0
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    3 / 43 (6.98%)
    3 / 42 (7.14%)
    2 / 43 (4.65%)
    2 / 41 (4.88%)
    2 / 40 (5.00%)
         occurrences all number
    4
    4
    3
    2
    4
    Muscle spasms
         subjects affected / exposed
    1 / 43 (2.33%)
    0 / 42 (0.00%)
    0 / 43 (0.00%)
    0 / 41 (0.00%)
    3 / 40 (7.50%)
         occurrences all number
    1
    0
    0
    0
    4
    Rheumatoid arthritis
         subjects affected / exposed
    2 / 43 (4.65%)
    2 / 42 (4.76%)
    4 / 43 (9.30%)
    2 / 41 (4.88%)
    2 / 40 (5.00%)
         occurrences all number
    2
    2
    7
    2
    3
    Infections and infestations
    Bronchitis
         subjects affected / exposed
    4 / 43 (9.30%)
    1 / 42 (2.38%)
    0 / 43 (0.00%)
    4 / 41 (9.76%)
    3 / 40 (7.50%)
         occurrences all number
    6
    3
    0
    6
    4
    Influenza
         subjects affected / exposed
    4 / 43 (9.30%)
    2 / 42 (4.76%)
    0 / 43 (0.00%)
    0 / 41 (0.00%)
    2 / 40 (5.00%)
         occurrences all number
    4
    2
    0
    0
    2
    Nasopharyngitis
         subjects affected / exposed
    0 / 43 (0.00%)
    7 / 42 (16.67%)
    2 / 43 (4.65%)
    4 / 41 (9.76%)
    5 / 40 (12.50%)
         occurrences all number
    0
    8
    2
    7
    5
    Pneumonia
         subjects affected / exposed
    0 / 43 (0.00%)
    3 / 42 (7.14%)
    1 / 43 (2.33%)
    0 / 41 (0.00%)
    0 / 40 (0.00%)
         occurrences all number
    0
    3
    1
    0
    0
    Upper respiratory tract infection
         subjects affected / exposed
    6 / 43 (13.95%)
    8 / 42 (19.05%)
    10 / 43 (23.26%)
    3 / 41 (7.32%)
    2 / 40 (5.00%)
         occurrences all number
    8
    11
    19
    4
    4
    Urinary tract infection
         subjects affected / exposed
    6 / 43 (13.95%)
    2 / 42 (4.76%)
    6 / 43 (13.95%)
    3 / 41 (7.32%)
    3 / 40 (7.50%)
         occurrences all number
    6
    3
    8
    3
    4

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    30 Oct 2009
    Clarification of stable doses of methotrexate use throughout the course of the study was added. Documentation of tuberculosis test results were to be available 4 weeks prior to screening visit not baseline visit. Conclusion of Participation eCRF for subjects entering the Follow-up Phase was completed. The 2 urine tests were added to obtain a more sensitive measure of renal function.Text modified to include urine samples for future testing. Blood and urine samples were collected and stored for future safety testing if necessary.
    23 Feb 2010
    CRP inclusion criterion was modified to reflect changes in the normal range at the central lab over a period of time. As the normal value is =< 5 mg/L this new CRP represents a value 140% above the upper limit of normal (ULN). Added history of tuberculosis in exclusion criteria 5 to ensure subjects with higher risk (ie, history of TB) were not enrolled. Subjects with very low lymphocyte counts at screening were to be excluded from the study. Additional information was added to the protocol to help investigators determine the severity of injection site reactions that may occur in the study. Overdose language was clarified to ensure that dosing errors do not occur.
    02 Dec 2010
    The timing of vital signs was changed to correspond to the change in amount of time that subjects are required to stay at the site after dosing on days 1, 15, and 84. Chest x-ray was to be performed within 24 weeks of the screening visit documenting the absence of any significant findings was available, the screening X-ray was not required. On-site post-dose safety monitoring period was reduced as subjects were required to stay at the site for at least 6 hours after dosing on days 1, 15 and 84.
    12 Nov 2012
    Two new subject discontinuation criteria were added: subjects with B-cell levels that achieved a new stable baseline or subjects who completed 2 years of follow-up after the last dose of study drug administration. The recommended list of repeated laboratory tests was updated to include prothrombin time. More inclusive definition of AEs and of SAEs were added.

    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.
    Certain secondary outcome measures (hybrid measure of ACR, ACR­-N, ACR-­n curve, EULAR response) were not analyzed due to the Sponsor’s decision to terminate development of the compound.
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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