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    Clinical Trial Results:
    A Phase 2a Open-label Study to Evaluate Prediction of Response to Golimumab Using a Transcriptomic Profile in Subjects with Moderately to Severely Active Ulcerative Colitis

    Summary
    EudraCT number
    		 2013-002042-36
    Trial protocol
    		 BE   HU   CZ   BG   PL   DE   NL   FR  
    Global end of trial date
    29 Jan 2016

    Results information
    Results version number
    		 v1(current)
    This version publication date
    21 Jan 2017
    First version publication date
    21 Jan 2017
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    CNTO148UCO2001
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01988961
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Janssen Biologics B.V.
    Sponsor organisation address
    Einsteinweg 101, Leiden, Netherlands, 2333 CB
    Public contact
    Clinical Registry Group-JB BV, Janssen Research and Development, ClinicalTrialsEU@its.jnj.com
    Scientific contact
    Clinical Registry Group-JB BV, Janssen Research and Development, ClinicalTrialsEU@its.jnj.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
    29 Jan 2016
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    29 Jan 2016
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The purpose of the study was to evaluate the accuracy of the length-109 (subsequently defined as the length-13) probe set panel in predicting mucosal healing (ie, improvement in the endoscopic appearance of the mucosa) at Week 6 as measured by the area under a Receiver Operating Characteristic (ROC) curve (AUCROC).
    Protection of trial subjects
    The safety assessments included adverse events (AEs), clinical laboratory data (hematology, serum chemistry, antinuclear antibody [ANA] and anti-double-stranded deoxyribonucleic acid [dsDNA] antibodies, Immunogenicity and Injection-site Reactions).
    Background therapy
    		 Subjects could have been receiving concomitant treatment with 5-aminosalicylates (5-ASAs), corticosteroids, and /or immunomodulators {(ie. 6-mercaptopurine (6-MP), azathioprine (AZA), or methotrexate (MTX)}.
    Evidence for comparator
    		 -
    Actual start date of recruitment
    10 Feb 2014
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Belgium: 2
    Country: Number of subjects enrolled
    Bulgaria: 3
    Country: Number of subjects enrolled
    Canada: 15
    Country: Number of subjects enrolled
    Czech Republic: 6
    Country: Number of subjects enrolled
    Germany: 3
    Country: Number of subjects enrolled
    France: 2
    Country: Number of subjects enrolled
    Hungary: 1
    Country: Number of subjects enrolled
    Poland: 21
    Country: Number of subjects enrolled
    Russian Federation: 2
    Country: Number of subjects enrolled
    Ukraine: 7
    Country: Number of subjects enrolled
    United States: 41
    Worldwide total number of subjects
    103
    EEA total number of subjects
    38
    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)
    98
    From 65 to 84 years
    5
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 The study was conducted from 10 February 2014 to 29 January 2016.

    Pre-assignment
    Screening details
    		 A total of 103 subjects were enrolled in study among these subjects 3 subjects received no maintenance treatment and 100 subjects received maintenance treatment.

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Golimumab Induction Only
    Arm description
    		 All subjects only received golimumab induction subcutaneous (SC) dose of 200 milligram (mg) at week 0 followed by 100 mg at week 2. No maintenance dose given to subjects in this reporting group.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Golimumab 200 mg
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Subjects received golimumab SC dose of 200 mg as 2 pre-filled syringes of 100 mg each at week 0.

    Investigational medicinal product name
    Golimumab 100 mg
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Subjects received golimumab SC dose of 100 mg at week 2.

    Arm title
    		 Golimumab Induction + 50 mg maintenance
    Arm description
    		 Subjects received golimumab induction SC dose of 200 mg at week 0 and 100 mg at week 2 followed by SC maintenance dose of golimumab 50 mg at week 6 and every 4 weeks (q4w) thereafter through week 50.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Golimumab 200 mg
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Subjects received golimumab SC dose of 200 mg as 2 pre-filled syringes of 100 mg each at week 0.

    Investigational medicinal product name
    Golimumab 100 mg
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Subjects received golimumab SC dose of 100 mg at week 2.

    Investigational medicinal product name
    Golimumab 50 mg
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Subjects received golimumab SC dose of 50 mg at week 6 and q4w thereafter through week 50.

    Arm title
    		 Golimumab induction + 100 mg maintenance
    Arm description
    		 Subjects received golimumab induction SC dose of 200 mg at week 0 and 100 mg at week 2 followed by SC maintenance dose of golimumab 100 mg at week 6 and every 4 weeks (q4w) thereafter through week 50.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Golimumab 200 mg
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Subjects received golimumab SC dose of 200 mg as 2 pre-filled syringes of 100 mg each at week 0.

    Investigational medicinal product name
    Golimumab 100 mg
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Subjects received golimumab SC dose of 100 mg at week 2 as induction dose followed by 100 mg dose at week 6 and q4w thereafter through week 50 as maintenance dose.

    Number of subjects in period 1
    		Golimumab Induction Only Golimumab Induction + 50 mg maintenance Golimumab induction + 100 mg maintenance
    Started
    3
    24
    76
    Completed
    0
    21
    63
    Not completed
    3
    3
    13
         Consent withdrawn by subject
    1
    -
    3
         Other
    1
    3
    10
         Lost to follow-up
    1
    -
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Golimumab Induction Only
    Reporting group description
    		 All subjects only received golimumab induction subcutaneous (SC) dose of 200 milligram (mg) at week 0 followed by 100 mg at week 2. No maintenance dose given to subjects in this reporting group.

    Reporting group title
    Golimumab Induction + 50 mg maintenance
    Reporting group description
    		 Subjects received golimumab induction SC dose of 200 mg at week 0 and 100 mg at week 2 followed by SC maintenance dose of golimumab 50 mg at week 6 and every 4 weeks (q4w) thereafter through week 50.

    Reporting group title
    Golimumab induction + 100 mg maintenance
    Reporting group description
    		 Subjects received golimumab induction SC dose of 200 mg at week 0 and 100 mg at week 2 followed by SC maintenance dose of golimumab 100 mg at week 6 and every 4 weeks (q4w) thereafter through week 50.

    Reporting group values
    		 Golimumab Induction Only Golimumab Induction + 50 mg maintenance Golimumab induction + 100 mg maintenance Total
    Number of subjects
    		 3 24 76 103
    Title for AgeCategorical
    Units: subjects
        Children (2-11 years)
    		 0 0 0 0
        Adolescents (12-17 years)
    		 0 0 0 0
        Adults (18-64 years)
    		 3 23 72 98
        From 65 to 84 years
    		 0 1 4 5
        85 years and over
    		 0 0 0 0
    Title for AgeContinuous
    Units: years
        arithmetic mean (standard deviation)
    		 46 ( 21.66 ) 37.5 ( 15.09 ) 43.3 ( 13.36 ) -
    Title for Gender
    Units: subjects
        Female
    		 1 13 32 46
        Male
    		 2 11 44 57

    End points

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    End points reporting groups
    Reporting group title
    Golimumab Induction Only
    Reporting group description
    		 All subjects only received golimumab induction subcutaneous (SC) dose of 200 milligram (mg) at week 0 followed by 100 mg at week 2. No maintenance dose given to subjects in this reporting group.

    Reporting group title
    Golimumab Induction + 50 mg maintenance
    Reporting group description
    		 Subjects received golimumab induction SC dose of 200 mg at week 0 and 100 mg at week 2 followed by SC maintenance dose of golimumab 50 mg at week 6 and every 4 weeks (q4w) thereafter through week 50.

    Reporting group title
    Golimumab induction + 100 mg maintenance
    Reporting group description
    		 Subjects received golimumab induction SC dose of 200 mg at week 0 and 100 mg at week 2 followed by SC maintenance dose of golimumab 100 mg at week 6 and every 4 weeks (q4w) thereafter through week 50.

    Subject analysis set title
    Biomarker analysis set
    Subject analysis set type
    		 Modified intention-to-treat
    Subject analysis set description
    The biomarker analysis set consisted of all treated subjects (subjects who received at least 1 [partial or complete] administration of golimumab) who had their biomarker measurement at baseline.

    Primary: The Area Under the Receiver Operating Characteristic Curve (AUCROC) of a Subset of the Length-109 Probe set Panel as a Predictor of Mucosal Healing at Week 6

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    End point title
    		 The Area Under the Receiver Operating Characteristic Curve (AUCROC) of a Subset of the Length-109 Probe set Panel as a Predictor of Mucosal Healing at Week 6 [1]
    End point description
    The area under the Receiver Operating Characteristic curve is a mathematical model used to measure the accuracy of a test. The accuracy of a subset of the length-109 probe set panel (a genetic test administered at screening) is being evaluated in terms of its ability to predict mucosal healing at Week 6. An area of 1.0 represents a perfect test; an area of 0.5 represents a test that is no better at predicting mucosal healing than "flipping a coin". Areas above 0.5 represent increasing accuracy. The accuracy of the length-13 probe set panel in predicting mucosal healing at Week 6 is significantly greater than 0.5 (AUCROC: 0.688; lower bound of 95% CI: 0.589; p-value=0.002).
    End point type
    Primary
    End point timeframe
    Week 6
    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 involving treatment comparisons is not reported for this endpoint as the analysis is based on biomarker analysis set without treatment comparisons.
    End point values
    		 Biomarker analysis set
    Number of subjects analysed
    93 [2]
    Units: probability
        number (not applicable)
    0.688
    Notes
    [2] - Biomarker analysis set
    No statistical analyses for this end point

    Secondary: The Area Under the Receiver Operating Characteristic Curve of a Subset of the Length-109 Probe set Panel as a Predictor of Clinical Response at Week 6 and at Week 30

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    End point title
    		 The Area Under the Receiver Operating Characteristic Curve of a Subset of the Length-109 Probe set Panel as a Predictor of Clinical Response at Week 6 and at Week 30
    End point description
    The area under the Receiver Operating Characteristic curve is a mathematical model used to measure the accuracy of a test. The accuracy of a subset of the length-109 probe set panel (a genetic test administered at screening) is being evaluated in terms of its ability to predict clinical response. An area of 1.0 represents a perfect test; an area of 0.5 represents a test that is no better at predicting clinical response than "flipping a coin". Areas above 0.5 represent increasing accuracy. The accuracy of the length-13 probe set panel in predicting clinical response at Week 6 (AUCROC: 0.520; lower bound of 95% CI: 0.419; p-value=0.740) and at Week 30 (AUCROC: 0.588; lower bound of 95% CI:0.488; pvalue= 0.148) is not significantly greater than 0.5.
    End point type
    Secondary
    End point timeframe
    Week 6 and Week 30
    End point values
    		 Biomarker analysis set
    Number of subjects analysed
    93 [3]
    Units: probability
    number (not applicable)
        Week 6
    0.52
        Week 30
    0.588
    Notes
    [3] - Biomarker analysis set
    No statistical analyses for this end point

    Secondary: The Area Under the Receiver Operating Characteristic Curve of a Subset of the Length-109 Probe set Panel as a Predictor of Clinical Remission at Week 6 and at Week 30

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    End point title
    		 The Area Under the Receiver Operating Characteristic Curve of a Subset of the Length-109 Probe set Panel as a Predictor of Clinical Remission at Week 6 and at Week 30
    End point description
    The area under the Receiver Operating Characteristic curve is a mathematical model used to measure the accuracy of a test. The accuracy of a subset of the length-109 probe set panel (a genetic test administered at screening) is being evaluated in terms of its ability to predict clinical remission. An area of 1.0 represents a perfect test; an area of 0.5 represents a test that is no better at predicting clinical remission than "flipping a coin". Areas above 0.5 represent increasing accuracy. The accuracy of the length-13 probe set panel in predicting clinical remission at Week 6 (AUCROC: 0.558; lower bound of 95% CI: 0.429; p-value=0.462]and at Week 30 (AUCROC: 0.633; lower bound of 95% CI: 0.517; pvalue= 0.059) is not significantly greater than 0.5.
    End point type
    Secondary
    End point timeframe
    Week 6 and Week 30
    End point values
    		 Biomarker analysis set
    Number of subjects analysed
    93 [4]
    Units: probability
    number (not applicable)
        Week 6
    0.558
        Week 30
    0.633
    Notes
    [4] - Biomarker analysis set
    No statistical analyses for this end point

    Secondary: The Area Under the Receiver Operating Characteristic Curve of a Subset of the Length-109 Probe set Panel as a Predictor of Mucosal Healing at Week 30

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    End point title
    		 The Area Under the Receiver Operating Characteristic Curve of a Subset of the Length-109 Probe set Panel as a Predictor of Mucosal Healing at Week 30
    End point description
    The area under the Receiver Operating Characteristic curve is a mathematical model used to measure the accuracy of a test. The accuracy of a subset of the length-109 probe set panel (a genetic test administered at screening) is being evaluated in terms of its ability to predict mucosal healing at Week 30. An area of 1.0 represents a perfect test; an area of 0.5 represents a test that is no better at predicting mucosal healing than "flipping a coin". Areas above 0.5 represent increasing accuracy. The accuracy of the length-13 probe set panel in predicting mucosal healing at Week 30 is norminally significantly greater than 0.5 (AUCROC: 0.671; lower bound of 95% CI: 0.569; p-value=0.006.
    End point type
    Secondary
    End point timeframe
    Week 30
    End point values
    		 Biomarker analysis set
    Number of subjects analysed
    93 [5]
    Units: probability
        number (not applicable)
    0.671
    Notes
    [5] - Biomarker analysis set
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Screening up to follow-up (week 58)
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    18.0
    Reporting groups
    Reporting group title
    Golimumab Induction Only
    Reporting group description
    		 All subjects only received golimumab induction subcutaneous (SC) dose of 200 milligram (mg) at week 0 followed by 100 mg at week 2. No maintenance dose given to subjects in this reporting group.

    Reporting group title
    Golimumab induction + 100 mg maintenance
    Reporting group description
    		 Subjects received golimumab induction SC dose of 200 mg at week 0 and 100 mg at week 2 followed by SC maintenance dose of golimumab 100 mg at week 6 and every 4 weeks (q4w) thereafter through week 50.

    Reporting group title
    Total
    Reporting group description
    		 Subjects who received at least 1 dose of study agent.

    Reporting group title
    Golimumab induction + 50 mg maintenance
    Reporting group description
    		 Subjects received golimumab induction SC dose of 200 mg at week 0 and 100 mg at week 2 followed by SC maintenance dose of golimumab 50 mg at week 6 and every 4 weeks (q4w) thereafter through week 50.

    Serious adverse events
    		 Golimumab Induction Only Golimumab induction + 100 mg maintenance Total Golimumab induction + 50 mg maintenance
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 3 (33.33%)
    5 / 76 (6.58%)
    11 / 103 (10.68%)
    5 / 24 (20.83%)
         number of deaths (all causes)
    0
    0
    0
    0
         number of deaths resulting from adverse events
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Squamous Cell Carcinoma
         subjects affected / exposed
    0 / 3 (0.00%)
    1 / 76 (1.32%)
    1 / 103 (0.97%)
    0 / 24 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    1 / 3 (33.33%)
    0 / 76 (0.00%)
    1 / 103 (0.97%)
    0 / 24 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Iron Deficiency Anaemia
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 76 (0.00%)
    1 / 103 (0.97%)
    1 / 24 (4.17%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Abdominal Pain
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 76 (0.00%)
    1 / 103 (0.97%)
    1 / 24 (4.17%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Colitis Ulcerative
         subjects affected / exposed
    1 / 3 (33.33%)
    3 / 76 (3.95%)
    7 / 103 (6.80%)
    3 / 24 (12.50%)
         occurrences causally related to treatment / all
    0 / 2
    1 / 3
    1 / 9
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Megacolon
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 76 (0.00%)
    1 / 103 (0.97%)
    1 / 24 (4.17%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Gastroenteritis Viral
         subjects affected / exposed
    0 / 3 (0.00%)
    1 / 76 (1.32%)
    1 / 103 (0.97%)
    0 / 24 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 76 (0.00%)
    1 / 103 (0.97%)
    1 / 24 (4.17%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Hypokalaemia
         subjects affected / exposed
    1 / 3 (33.33%)
    0 / 76 (0.00%)
    1 / 103 (0.97%)
    0 / 24 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hypomagnesaemia
         subjects affected / exposed
    1 / 3 (33.33%)
    0 / 76 (0.00%)
    1 / 103 (0.97%)
    0 / 24 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Golimumab Induction Only Golimumab induction + 100 mg maintenance Total Golimumab induction + 50 mg maintenance
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    2 / 3 (66.67%)
    30 / 76 (39.47%)
    45 / 103 (43.69%)
    13 / 24 (54.17%)
    Cardiac disorders
    Sinus Tachycardia
         subjects affected / exposed
    1 / 3 (33.33%)
    0 / 76 (0.00%)
    1 / 103 (0.97%)
    0 / 24 (0.00%)
         occurrences all number
    1
    0
    1
    0
    Nervous system disorders
    Headache
         subjects affected / exposed
    0 / 3 (0.00%)
    7 / 76 (9.21%)
    7 / 103 (6.80%)
    0 / 24 (0.00%)
         occurrences all number
    0
    15
    15
    0
    General disorders and administration site conditions
    Injection Site Erythema
         subjects affected / exposed
    0 / 3 (0.00%)
    4 / 76 (5.26%)
    4 / 103 (3.88%)
    0 / 24 (0.00%)
         occurrences all number
    0
    6
    6
    0
    Pyrexia
         subjects affected / exposed
    0 / 3 (0.00%)
    1 / 76 (1.32%)
    3 / 103 (2.91%)
    2 / 24 (8.33%)
         occurrences all number
    0
    1
    3
    2
    Gastrointestinal disorders
    Abdominal Discomfort
         subjects affected / exposed
    1 / 3 (33.33%)
    0 / 76 (0.00%)
    1 / 103 (0.97%)
    0 / 24 (0.00%)
         occurrences all number
    1
    0
    1
    0
    Abdominal Pain
         subjects affected / exposed
    0 / 3 (0.00%)
    4 / 76 (5.26%)
    4 / 103 (3.88%)
    0 / 24 (0.00%)
         occurrences all number
    0
    4
    4
    0
    Colitis Ulcerative
         subjects affected / exposed
    0 / 3 (0.00%)
    16 / 76 (21.05%)
    24 / 103 (23.30%)
    8 / 24 (33.33%)
         occurrences all number
    0
    16
    28
    12
    Diarrhoea
         subjects affected / exposed
    1 / 3 (33.33%)
    2 / 76 (2.63%)
    4 / 103 (3.88%)
    1 / 24 (4.17%)
         occurrences all number
    1
    2
    4
    1
    Gastrointestinal Disorder
         subjects affected / exposed
    1 / 3 (33.33%)
    0 / 76 (0.00%)
    1 / 103 (0.97%)
    0 / 24 (0.00%)
         occurrences all number
    1
    0
    1
    0
    Nausea
         subjects affected / exposed
    0 / 3 (0.00%)
    4 / 76 (5.26%)
    5 / 103 (4.85%)
    1 / 24 (4.17%)
         occurrences all number
    0
    4
    6
    2
    Vomiting
         subjects affected / exposed
    0 / 3 (0.00%)
    4 / 76 (5.26%)
    5 / 103 (4.85%)
    1 / 24 (4.17%)
         occurrences all number
    0
    4
    6
    2
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    0 / 3 (0.00%)
    4 / 76 (5.26%)
    5 / 103 (4.85%)
    1 / 24 (4.17%)
         occurrences all number
    0
    4
    5
    1
    Psychiatric disorders
    Depression
         subjects affected / exposed
    1 / 3 (33.33%)
    1 / 76 (1.32%)
    2 / 103 (1.94%)
    0 / 24 (0.00%)
         occurrences all number
    1
    1
    2
    0
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    0 / 3 (0.00%)
    4 / 76 (5.26%)
    4 / 103 (3.88%)
    0 / 24 (0.00%)
         occurrences all number
    0
    4
    4
    0
    Infections and infestations
    Respiratory Tract Infection
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 76 (0.00%)
    2 / 103 (1.94%)
    2 / 24 (8.33%)
         occurrences all number
    0
    0
    2
    2
    Upper Respiratory Tract Infection
         subjects affected / exposed
    0 / 3 (0.00%)
    10 / 76 (13.16%)
    12 / 103 (11.65%)
    2 / 24 (8.33%)
         occurrences all number
    0
    13
    15
    2

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? No

    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.
    The 2 maintenance doses (50 mg q4w and 100 mg q4w) were not randomly assigned but followed regional posology guidelines in each country. Therefore, the interpretation of results was based on the total number of subjects treated.
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    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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