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    Clinical Trial Results:
    A Phase II, Multicentre, Randomised, Double-Blind, Parallel Group, Placebo Controlled Study to Evaluate Safety, Tolerability and Clinical Efficacy of MT 1303 in Subjects with Moderate to Severe Active Crohn’s Disease

    Summary
    EudraCT number
    		 2014-002556-77
    Trial protocol
    		 CZ   HU   SK   NL   IT   PL  
    Global end of trial date
    10 Oct 2016

    Results information
    Results version number
    		 v1(current)
    This version publication date
    26 Oct 2017
    First version publication date
    26 Oct 2017
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    MT-1303-E13
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02378688
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Mitsubishi Tanabe Pharma Corporation
    Sponsor organisation address
    17-10, Nihonbashi-Koamicho, Chuo-ku, Tokyo, Japan, 103-8405
    Public contact
    General Information, Mitsubishi Tanabe Pharma Europe Ltd (MTPE), 0044 (0)2070655000, regulatory@mt-pharma-eu.com
    Scientific contact
    General Information, Mitsubishi Tanabe Pharma Europe Ltd (MTPE), 0044 (0)2070655000, regulatory@mt-pharma-eu.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
    15 Dec 2016
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    10 Oct 2016
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objectives of the trial were to evaluate the safety and tolerability of MT-1303 in subjects with moderate to severe active Crohn’s disease (CD) and to evaluate the clinical efficacy of MT-1303 in subjects with moderate to severe active CD. Secondary objectives were to explore the pharmacokinetics (PK) and pharmacodynamics (PD) of MT-1303 in subjects with moderate to severe active CD.
    Protection of trial subjects
    The study was conducted in accordance with the 2013 (Fortaleza) revision of the 1964 Declaration of Helsinki, Good Clinical Practice (GCP) as required by the International Conference on Harmonisation (ICH) guidelines, applicable regional and local legislation, and standard operating procedures in place at Mitsubishi Tanabe Pharma Europe Ltd (MTPE). Before implementing the study, the Protocol and all other appropriate documents were reviewed and approved by an Independent Ethics Committee (IEC) and regulatory authorities. The study was carefully designed to minimise the identified and potential risks to subjects; all subjects underwent screening procedures aimed at minimising the likelihood and impact of any such risks. In addition, regular safety monitoring during the treatment and safety Follow-up Periods for all subjects ensured that any unanticipated effects of study participation were identified promptly and managed appropriately. At the level of the individual subject, the Protocol stated well-defined criteria for intensive Cardiovascular Safety Monitoring, including extended monitoring and permanent discontinuation of study medication. In addition, an independent Data and Safety Monitoring Board (DSMB) reviewed selected data across the study, at regular, predefined intervals. The DSMB was empowered to make recommendations regarding continuation, termination or modification of the study, as appropriate. In particular, if it became clear that continuing treatment with MT-1303 was not clinically or ethically justified, the MT 1303-E13 study could be terminated. Given that this was a proof-of-concept study, there were no guaranteed benefits for subjects; however, there was an expectation that subjects treated with MT-1303 would experience a selective reduction in lymphocytes which may be translated into clinical benefit.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    02 Mar 2015
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Netherlands: 4
    Country: Number of subjects enrolled
    Poland: 6
    Country: Number of subjects enrolled
    Slovakia: 8
    Country: Number of subjects enrolled
    Czech Republic: 6
    Country: Number of subjects enrolled
    France: 1
    Country: Number of subjects enrolled
    Germany: 4
    Country: Number of subjects enrolled
    Hungary: 8
    Country: Number of subjects enrolled
    Italy: 18
    Country: Number of subjects enrolled
    Israel: 1
    Country: Number of subjects enrolled
    Japan: 5
    Country: Number of subjects enrolled
    Ukraine: 17
    Worldwide total number of subjects
    78
    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)
    78
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 Up to 4 weeks screening period

    Period 1
    Period 1 title
    Overall Trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor, Data analyst, Carer, Assessor
    Blinding implementation details
    Lymphocyte count and white blood cell differential were not provided to any site/study personnel except the Unblinded Independent Monitor to maintain the study medication blind. PK results were not provided by the PK lab until after database lock. MT-1303/placebo capsules appeared the same and same number of capsules were given.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Placebo
    Arm description
    		 Placebo oral capsules administered once daily from Week 0 to Week 14.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    One placebo capsule administered orally once daily from Week 0 to Week 14.

    Arm title
    		 MT-1303 0.4 mg
    Arm description
    		 MT-1303 0.4 mg oral capsules administered once daily from Week 0 to Week 14.
    Arm type
    		 Experimental

    Investigational medicinal product name
    MT-1303
    Investigational medicinal product code
    MT-1303
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    One 0.4 mg MT-1303 capsule administered orally once daily from Week 0 to Week 14.

    Number of subjects in period 1
    		Placebo MT-1303 0.4 mg
    Started
    38
    40
    Completed
    33
    28
    Not completed
    5
    12
         Consent withdrawn by subject
    2
    4
         Adverse event, non-fatal
    2
    3
         False positive serum HCG
    -
    1
         Lack of efficacy
    1
    3
         Protocol deviation
    -
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Placebo oral capsules administered once daily from Week 0 to Week 14.

    Reporting group title
    MT-1303 0.4 mg
    Reporting group description
    		 MT-1303 0.4 mg oral capsules administered once daily from Week 0 to Week 14.

    Reporting group values
    		 Placebo MT-1303 0.4 mg Total
    Number of subjects
    		 38 40 78
    Age categorical
    Units: Subjects
        In utero
    		 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0
        Newborns (0-27 days)
    		 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0
        Children (2-11 years)
    		 0 0 0
        Adolescents (12-17 years)
    		 0 0 0
        Adults (18-64 years)
    		 38 40 78
        From 65-84 years
    		 0 0 0
        85 years and over
    		 0 0 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 32.1 ± 10.2 35.2 ± 8.93 -
    Gender categorical
    Units: Subjects
        Female
    		 13 16 29
        Male
    		 25 24 49
    Subject analysis sets

    Subject analysis set title
    Placebo - ITT
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Placebo oral capsules administered once daily from Week 0 to Week 14.

    Subject analysis set title
    MT-1303 0.4 mg - ITT
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    MT-1303 0.4 mg oral capsules administered once daily from Week 0 to Week 14.

    Subject analysis set title
    MT-1303 0.4 mg - PK pop
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    MT-1303 0.4 mg oral capsules administered once daily from Week 0 to Week 14.

    Subject analysis sets values
    		 Placebo - ITT MT-1303 0.4 mg - ITT MT-1303 0.4 mg - PK pop
    Number of subjects
    37
    39
    38
    Age categorical
    Units: Subjects
        In utero
    0
    0
    0
        Preterm newborn infants (gestational age < 37 wks)
    0
    0
    0
        Newborns (0-27 days)
    0
    0
    0
        Infants and toddlers (28 days-23 months)
    0
    0
    0
        Children (2-11 years)
    0
    0
    0
        Adolescents (12-17 years)
    0
    0
    0
        Adults (18-64 years)
    37
    39
    38
        From 65-84 years
    0
    0
    0
        85 years and over
    0
    0
    0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    32.4 ± 10.2
    35.5 ± 8.9
    35.7 ± 8.9
    Gender categorical
    Units: Subjects
        Female
    13
    16
    15
        Male
    24
    23
    23

    End points

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    End points reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Placebo oral capsules administered once daily from Week 0 to Week 14.

    Reporting group title
    MT-1303 0.4 mg
    Reporting group description
    		 MT-1303 0.4 mg oral capsules administered once daily from Week 0 to Week 14.

    Subject analysis set title
    Placebo - ITT
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Placebo oral capsules administered once daily from Week 0 to Week 14.

    Subject analysis set title
    MT-1303 0.4 mg - ITT
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    MT-1303 0.4 mg oral capsules administered once daily from Week 0 to Week 14.

    Subject analysis set title
    MT-1303 0.4 mg - PK pop
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    MT-1303 0.4 mg oral capsules administered once daily from Week 0 to Week 14.

    Primary: Proportion of Subjects Achieving a 100-Point Decrease from Baseline in CDAI Score (CDAI 100) at Week 12

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    End point title
    		 Proportion of Subjects Achieving a 100-Point Decrease from Baseline in CDAI Score (CDAI 100) at Week 12
    End point description
    End point type
    Primary
    End point timeframe
    Week 12
    End point values
    		 Placebo - ITT MT-1303 0.4 mg - ITT
    Number of subjects analysed
    37
    39
    Units: Percent
        number (confidence interval 95%)
    54.1 (38.4 to 69.0)
    48.7 (33.9 to 63.8)
    Statistical analysis title
    		 Logistic Regression Model (NRI)
    Statistical analysis description
    Logistic regression model with treatment as a fixed effect and baseline CDAI score and previous exposure to anti-TNF-α agents as covariates.
    Comparison groups
    Placebo - ITT v MT-1303 0.4 mg - ITT
    Number of subjects included in analysis
    76
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.598 [1]
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    0.79
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.31
         upper limit
    		 1.98
    Notes
    [1] - p-values were computed using Cochran Mantel Haenszel test stratified by previous exposure to anti-TNF-α agents.

    Secondary: Proportion of Subjects Achieving a 70-Point Decrease from Baseline in CDAI Score (CDAI 70)

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    End point title
    		 Proportion of Subjects Achieving a 70-Point Decrease from Baseline in CDAI Score (CDAI 70)
    End point description
    End point type
    Secondary
    End point timeframe
    Weeks 2, 4, 8, 12 and 14
    End point values
    		 Placebo - ITT MT-1303 0.4 mg - ITT
    Number of subjects analysed
    37
    39
    Units: Percent
    number (not applicable)
        Week 2
    32.4
    43.6
        Week 4
    62.2
    43.6
        Week 8
    56.8
    51.3
        Week 12
    64.9
    53.8
        Week 14
    64.9
    53.8
    No statistical analyses for this end point

    Secondary: Proportion of Subjects Achieving a 100-Point Decrease from Baseline in CDAI Score (CDAI 100)

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    End point title
    		 Proportion of Subjects Achieving a 100-Point Decrease from Baseline in CDAI Score (CDAI 100)
    End point description
    End point type
    Secondary
    End point timeframe
    Weeks 2, 4, 8, 12 and 14
    End point values
    		 Placebo - ITT MT-1303 0.4 mg - ITT
    Number of subjects analysed
    37
    39
    Units: Percent
    number (not applicable)
        Week 2
    18.9
    20.5
        Week 4
    51.4
    30.8
        Week 8
    45.9
    41
        Week 12
    54.1
    48.7
        Week 14
    59.5
    41
    No statistical analyses for this end point

    Secondary: Proportion of Subjects Achieving Clinical Remission (CDAI score of <150)

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    End point title
    		 Proportion of Subjects Achieving Clinical Remission (CDAI score of <150)
    End point description
    End point type
    Secondary
    End point timeframe
    Weeks 2, 4, 8, 12 and 14
    End point values
    		 Placebo - ITT MT-1303 0.4 mg - ITT
    Number of subjects analysed
    37
    39
    Units: Percent
    number (not applicable)
        Week 2
    8.1
    10.3
        Week 4
    27
    15.4
        Week 8
    32.4
    25.6
        Week 12
    40.5
    28.2
        Week 14
    51.4
    17.9
    No statistical analyses for this end point

    Secondary: CDAI Score by Week

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    End point title
    		 CDAI Score by Week
    End point description
    End point type
    Secondary
    End point timeframe
    Weeks 2, 4, 8, 12 and 14
    End point values
    		 Placebo - ITT MT-1303 0.4 mg - ITT
    Number of subjects analysed
    37
    39
    Units: Score on a scale
    arithmetic mean (standard deviation)
        Baseline
    307 ± 63.2
    305.1 ± 50.7
        Week 2
    252.2 ± 77.3
    239.8 ± 75.8
        Week 4
    214 ± 90.7
    233.8 ± 79.4
        Week 8
    180.6 ± 84.2
    205.6 ± 83.6
        Week 12
    170 ± 115
    182.4 ± 102.7
        Week 14
    167 ± 98.8
    161.3 ± 69.8
    No statistical analyses for this end point

    Secondary: Percent Decrease from Baseline in CDAI Score by Week

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    End point title
    		 Percent Decrease from Baseline in CDAI Score by Week
    End point description
    End point type
    Secondary
    End point timeframe
    Weeks 2, 4, 8, 12 and 14
    End point values
    		 Placebo - ITT MT-1303 0.4 mg - ITT
    Number of subjects analysed
    37
    39
    Units: Percent
    arithmetic mean (standard deviation)
        Week 2
    16.81 ± 22.32
    21.53 ± 21.84
        Week 4
    29.39 ± 31.6
    21.12 ± 30.26
        Week 8
    39.37 ± 27.6
    32.2 ± 28.97
        Week 12
    44.74 ± 35.2
    40.63 ± 34.15
        Week 14
    43.55 ± 32.76
    47.78 ± 22.68
    No statistical analyses for this end point

    Secondary: Plasma Concentrations of MT-1303 and its Active Metabolite MT-1303-P by Week

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    End point title
    		 Plasma Concentrations of MT-1303 and its Active Metabolite MT-1303-P by Week
    End point description
    End point type
    Secondary
    End point timeframe
    Pre-dose to Week 26
    End point values
    		 MT-1303 0.4 mg - PK pop
    Number of subjects analysed
    38
    Units: ng/mL
    arithmetic mean (standard deviation)
        MT-1303, Week 0
    0.000 ± 0.000
        MT-1303-P, Week 0
    0.001 ± 0.008
        MT-1303, Week 2
    1.990 ± 0.958
        MT-1303-P, Week 2
    3.569 ± 1.574
        MT-1303, Week 4
    2.829 ± 1.115
        MT-1303-P, Week 4
    5.099 ± 1.897
        MT-1303, Week 8
    3.309 ± 1.105
        MT-1303-P, Week 8
    6.036 ± 2.180
        MT-1303, Week 12
    3.479 ± 1.137
        MT-1303-P, Week 12
    6.139 ± 2.380
        MT-1303, Week 14
    3.493 ± 1.147
        MT-1303-P, Week 14
    6.620 ± 2.396
        MT-1303, Week 18
    0.742 ± 0.387
        MT-1303-P, Week 18
    1.196 ± 0.793
        MT-1303, Week 22
    0.292 ± 0.164
        MT-1303-P, Week 22
    0.429 ± 0.339
        MT-1303, Week 26
    0.109 ± 0.085
        MT-1303-P, Week 26
    0.183 ± 0.181
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    All adverse events occurring from the signing of the informed consent form until the end of the safety Follow-up Period or the withdrawal of the subject from the study were documented, regardless of the relationship to study drug.
    Adverse event reporting additional description
    During the study visits, regular questioning of each subject was done by study staff. No leading questions were asked. Data recorded under "Non-Serious Adverse Events" also includes serious adverse events as that is how data were reported.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    19
    Reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Placebo oral capsules administered once daily from Week 0 to Week 14.

    Reporting group title
    MT-1303 0.4 mg
    Reporting group description
    		 MT-1303 0.4 mg oral capsules administered once daily from Week 0 to Week 14.

    Serious adverse events
    		 Placebo MT-1303 0.4 mg
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 38 (2.63%)
    6 / 39 (15.38%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Basal cell carcinoma
         subjects affected / exposed
    0 / 38 (0.00%)
    1 / 39 (2.56%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Lymphopenia
         subjects affected / exposed
    0 / 38 (0.00%)
    1 / 39 (2.56%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Pyrexia
         subjects affected / exposed
    1 / 38 (2.63%)
    0 / 39 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Crohn's disease
         subjects affected / exposed
    0 / 38 (0.00%)
    3 / 39 (7.69%)
         occurrences causally related to treatment / all
    0 / 0
    2 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Asthma
         subjects affected / exposed
    0 / 38 (0.00%)
    1 / 39 (2.56%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    Dermatitis allergic
         subjects affected / exposed
    0 / 38 (0.00%)
    1 / 39 (2.56%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Psychiatric disorders
    Anxiety
         subjects affected / exposed
    0 / 38 (0.00%)
    1 / 39 (2.56%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Gastrointestinal infection
         subjects affected / exposed
    0 / 38 (0.00%)
    1 / 39 (2.56%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Dehydration
         subjects affected / exposed
    1 / 38 (2.63%)
    0 / 39 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Placebo MT-1303 0.4 mg
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    21 / 38 (55.26%)
    26 / 39 (66.67%)
    Investigations
    Blood creatine phosphokinase increased
         subjects affected / exposed
    0 / 38 (0.00%)
    2 / 39 (5.13%)
         occurrences all number
    0
    2
    Nervous system disorders
    Headache
         subjects affected / exposed
    6 / 38 (15.79%)
    4 / 39 (10.26%)
         occurrences all number
    6
    4
    General disorders and administration site conditions
    Chills
         subjects affected / exposed
    2 / 38 (5.26%)
    0 / 39 (0.00%)
         occurrences all number
    2
    0
    Pyrexia
         subjects affected / exposed
    2 / 38 (5.26%)
    0 / 39 (0.00%)
         occurrences all number
    2
    0
    Blood and lymphatic system disorders
    Iron deficiency anaemia
         subjects affected / exposed
    2 / 38 (5.26%)
    0 / 39 (0.00%)
         occurrences all number
    2
    0
    Gastrointestinal disorders
    Crohn's disease
         subjects affected / exposed
    1 / 38 (2.63%)
    6 / 39 (15.38%)
         occurrences all number
    1
    6
    Abdominal pain
         subjects affected / exposed
    1 / 38 (2.63%)
    2 / 39 (5.13%)
         occurrences all number
    1
    2
    Diarrhoea
         subjects affected / exposed
    2 / 38 (5.26%)
    0 / 39 (0.00%)
         occurrences all number
    2
    0
    Reproductive system and breast disorders
    Dysmenorrhoea
         subjects affected / exposed
    2 / 38 (5.26%)
    0 / 39 (0.00%)
         occurrences all number
    2
    0
    Respiratory, thoracic and mediastinal disorders
    Oropharyngeal pain
         subjects affected / exposed
    0 / 38 (0.00%)
    2 / 39 (5.13%)
         occurrences all number
    0
    2
    Skin and subcutaneous tissue disorders
    Dermatitis allergic
         subjects affected / exposed
    0 / 38 (0.00%)
    2 / 39 (5.13%)
         occurrences all number
    0
    2
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    3 / 38 (7.89%)
    2 / 39 (5.13%)
         occurrences all number
    3
    2
    Back pain
         subjects affected / exposed
    2 / 38 (5.26%)
    0 / 39 (0.00%)
         occurrences all number
    2
    0
    Myalgia
         subjects affected / exposed
    0 / 38 (0.00%)
    2 / 39 (5.13%)
         occurrences all number
    0
    2
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    2 / 38 (5.26%)
    3 / 39 (7.69%)
         occurrences all number
    2
    3

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    10 Dec 2015
    Exclusion criteria were modified to decrease the prohibited period for adalimumab from 8 weeks prior to Screening to 4 weeks, to permit the prior use of vedolizumab (with a 16 week washout period prior to Visit 1) and to prohibit the use of parenteral nutrition including the use of a central venous catheter. All patients (including non-responders) were allowed into the long term extension study MT-1303- E14. The addition of a database lock after the last patient last dose to facilitate timely data analysis and decision making without comprising the validity of the study was added. Changes to company process regarding adverse events management were also reflected.

    Interruptions (globally)
    Were there any global interruptions to the trial? No

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