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    Clinical Trial Results:
    A Multicenter, Open-Label Study to Evaluate the Long Term Efficacy, Safety, and Tolerability of Repeated Administration of Adalimumab in Subjects With Crohn's Disease

    Summary
    EudraCT number
    		 2013-004034-15
    Trial protocol
    		 HU   GB   DE   ES   CZ   IT   SK   DK   AT   BE   FR  
    Global end of trial date
    03 Nov 2017

    Results information
    Results version number
    		 v1(current)
    This version publication date
    31 Oct 2018
    First version publication date
    31 Oct 2018
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    M14-347
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02185014
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    AbbVie Deutschland GmbH & Co. KG
    Sponsor organisation address
    AbbVie House, Vanwall Business Park, Vanwall Road, Maidenhead, Berkshire, United Kingdom, SL6-4UB
    Public contact
    Global Medical Services, AbbVie, 001 800-633-9110,
    Scientific contact
    Anne Robinson, AbbVie, anne.robinson@abbvie.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 Nov 2017
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    03 Nov 2017
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The purpose of this study is to evaluate the long term efficacy, safety, and tolerability of repeated administration of adalimumab in subjects with Crohn's disease.
    Protection of trial subjects
    Subject and/or his or her representative read and understood the information provided about the study and gave written permission.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    12 Aug 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
    Austria: 6
    Country: Number of subjects enrolled
    Belgium: 3
    Country: Number of subjects enrolled
    Canada: 46
    Country: Number of subjects enrolled
    Czech Republic: 27
    Country: Number of subjects enrolled
    Denmark: 4
    Country: Number of subjects enrolled
    France: 6
    Country: Number of subjects enrolled
    Germany: 9
    Country: Number of subjects enrolled
    Hungary: 2
    Country: Number of subjects enrolled
    Israel: 7
    Country: Number of subjects enrolled
    Italy: 12
    Country: Number of subjects enrolled
    Netherlands: 12
    Country: Number of subjects enrolled
    Poland: 22
    Country: Number of subjects enrolled
    Slovakia: 1
    Country: Number of subjects enrolled
    Switzerland: 5
    Country: Number of subjects enrolled
    Ukraine: 8
    Country: Number of subjects enrolled
    United Kingdom: 6
    Country: Number of subjects enrolled
    United States: 76
    Worldwide total number of subjects
    252
    EEA total number of subjects
    110
    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)
    245
    From 65 to 84 years
    7
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 Subjects who completed Study M14-115 (NCT02185014) were eligible to enroll in this study.

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

    Arms
    Arm title
    		 Adalimumab
    Arm description
    		 Participants received open-label adalimumab 40 mg by subcutaneous injection every other week for 40 weeks.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Adalimumab
    Investigational medicinal product code
    Other name
    Humira, ABT-D2E7
    Pharmaceutical forms
    Solution for injection in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Adalimumab pre-filled syringe, administered by subcutaneous injection

    Number of subjects in period 1
    		Adalimumab
    Started
    252
    Completed
    198
    Not completed
    54
         Requires Alternative/Prohibited Therapy
    5
         Not Specified
    4
         Adverse event
    18
         Subject Noncompliance
    1
         Withdrew consent
    8
         Lost to follow-up
    4
         Lack of efficacy
    14

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Adalimumab
    Reporting group description
    		 Participants received open-label adalimumab 40 mg by subcutaneous injection every other week for 40 weeks.

    Reporting group values
    		 Adalimumab Total
    Number of subjects
    		 252 252
    Age categorical
    Units: Subjects
    Age continuous
    Baseline characteristics from lead-in study M14-115
    Units: years
        arithmetic mean (standard deviation)
    		 37.5 ( 12.71 ) -
    Gender categorical
    Baseline characteristics from lead-in study M14-115
    Units: Subjects
        Female
    		 139 139
        Male
    		 113 113
    Ethnicity (NIH/OMB)
    Baseline characteristics from lead-in study M14-115
    Units: Subjects
        Hispanic or Latino
    		 7 7
        Not Hispanic or Latino
    		 0 0
        Unknown or Not Reported
    		 245 245
    Race (NIH/OMB)
    Baseline characteristics from lead-in study M14-115
    Units: Subjects
        American Indian or Alaska Native
    		 0 0
        Asian
    		 10 10
        Native Hawaiian or Other Pacific Islander
    		 0 0
        Black or African American
    		 12 12
        White
    		 229 229
        More than one race
    		 1 1
        Unknown or Not Reported
    		 0 0
    Simplified endoscopic score for crohn's disease (SES-CD) Total Score
    The SES-CD evaluates 4 endoscopic variables in 5 segments assessed during ileocolonoscopy. The SES-CD total score is the sum of the 4 endoscopic variable scores and range from 0 to 56, where higher scores indicate more severe disease. Baseline characteristics from lead-in study M14-115.
    Units: units on a scale
        arithmetic mean (standard deviation)
    		 14.2 ( 6.74 ) -

    End points

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    End points reporting groups
    Reporting group title
    Adalimumab
    Reporting group description
    		 Participants received open-label adalimumab 40 mg by subcutaneous injection every other week for 40 weeks.

    Primary: Percentage of participants with endoscopic improvement at week 40 in Participants with endoscopic improvement at Week 0

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    End point title
    		 Percentage of participants with endoscopic improvement at week 40 in Participants with endoscopic improvement at Week 0 [1]
    End point description
    Endoscopic improvement defined as a simple endoscopic score for Crohn's Disease (SES-CD) score of ≤4 and at least a 2-point reduction compared with Study M14-115 (NCT02185014) Baseline and no subscore greater than 1 in any individual endoscopic variable. The SES-CD evaluates 4 endoscopic variables (ulcer size ranging from 0 [none] to 3 [very large]; ulcerated surface ranging from 0 [none] to 3 [>30%]; affected surface ranging from 0 [none] to 3 [>75%], and narrowing ranging from 0 [none] to 3 [cannot be passed]) in 5 segments assessed during ileocolonoscopy (ileum, right colon, transverse colon, sigmoid and left colon, and rectum). The score for each endoscopic variable is the sum of values obtained for each segment and range from 0 to 15 where higher scores indicate more severe disease. The Total Score is the sum of the 4 endoscopic variable scores and range from 0 to 56, where higher scores indicate more severe disease. Nonresponder imputation (NRI) was used for missing data.
    End point type
    Primary
    End point timeframe
    Week 40
    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: Descriptive data are summarized for this end point per protocol.
    End point values
    		 Adalimumab
    Number of subjects analysed
    76 [2]
    Units: percentage of participants
        number (confidence interval 95%)
    31.6 (21.1 to 42.0)
    Notes
    [2] - All subjects with endoscopic improvement at Week 0 in Study M14-347 (end of lead-in Study M14-115)
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 48 weeks).
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    21.0
    Reporting groups
    Reporting group title
    Adalimumab
    Reporting group description
    		 Participants received open-label adalimumab 40 mg by subcutaneous injection every other week for 40 weeks.

    Serious adverse events
    		 Adalimumab
    Total subjects affected by serious adverse events
         subjects affected / exposed
    27 / 252 (10.71%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    Injury, poisoning and procedural complications
    POST PROCEDURAL HAEMORRHAGE
         subjects affected / exposed
    1 / 252 (0.40%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Nervous system disorders
    HEADACHE
         subjects affected / exposed
    1 / 252 (0.40%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    General disorders and administration site conditions
    NON-CARDIAC CHEST PAIN
         subjects affected / exposed
    1 / 252 (0.40%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Gastrointestinal disorders
    ABDOMINAL PAIN UPPER
         subjects affected / exposed
    1 / 252 (0.40%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    CROHN'S DISEASE
         subjects affected / exposed
    14 / 252 (5.56%)
         occurrences causally related to treatment / all
    0 / 16
         deaths causally related to treatment / all
    0 / 0
    ILEAL STENOSIS
         subjects affected / exposed
    1 / 252 (0.40%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    INTESTINAL OBSTRUCTION
         subjects affected / exposed
    3 / 252 (1.19%)
         occurrences causally related to treatment / all
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    SMALL INTESTINAL OBSTRUCTION
         subjects affected / exposed
    4 / 252 (1.59%)
         occurrences causally related to treatment / all
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    Renal and urinary disorders
    NEPHROLITHIASIS
         subjects affected / exposed
    1 / 252 (0.40%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Musculoskeletal and connective tissue disorders
    INTERVERTEBRAL DISC PROTRUSION
         subjects affected / exposed
    1 / 252 (0.40%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Infections and infestations
    ANAL ABSCESS
         subjects affected / exposed
    3 / 252 (1.19%)
         occurrences causally related to treatment / all
    1 / 3
         deaths causally related to treatment / all
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Adalimumab
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    65 / 252 (25.79%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    ACROCHORDON
         subjects affected / exposed
    2 / 252 (0.79%)
         occurrences all number
    2
    GASTROINTESTINAL TRACT ADENOMA
         subjects affected / exposed
    1 / 252 (0.40%)
         occurrences all number
    1
    UTERINE LEIOMYOMA
         subjects affected / exposed
    1 / 252 (0.40%)
         occurrences all number
    1
    Vascular disorders
    FLUSHING
         subjects affected / exposed
    1 / 252 (0.40%)
         occurrences all number
    1
    HOT FLUSH
         subjects affected / exposed
    1 / 252 (0.40%)
         occurrences all number
    1
    HYPERTENSION
         subjects affected / exposed
    3 / 252 (1.19%)
         occurrences all number
    4
    PERIPHERAL VENOUS DISEASE
         subjects affected / exposed
    1 / 252 (0.40%)
         occurrences all number
    3
    General disorders and administration site conditions
    CHEST PAIN
         subjects affected / exposed
    2 / 252 (0.79%)
         occurrences all number
    2
    DRUG INTOLERANCE
         subjects affected / exposed
    1 / 252 (0.40%)
         occurrences all number
    1
    HYPERTHERMIA
         subjects affected / exposed
    1 / 252 (0.40%)
         occurrences all number
    1
    FATIGUE
         subjects affected / exposed
    2 / 252 (0.79%)
         occurrences all number
    2
    INFLUENZA LIKE ILLNESS
         subjects affected / exposed
    1 / 252 (0.40%)
         occurrences all number
    1
    INJECTION SITE BRUISING
         subjects affected / exposed
    1 / 252 (0.40%)
         occurrences all number
    1
    INJECTION SITE PAIN
         subjects affected / exposed
    1 / 252 (0.40%)
         occurrences all number
    1
    INJECTION SITE PRURITUS
         subjects affected / exposed
    1 / 252 (0.40%)
         occurrences all number
    1
    INJECTION SITE REACTION
         subjects affected / exposed
    1 / 252 (0.40%)
         occurrences all number
    2
    NON-CARDIAC CHEST PAIN
         subjects affected / exposed
    1 / 252 (0.40%)
         occurrences all number
    1
    OEDEMA PERIPHERAL
         subjects affected / exposed
    2 / 252 (0.79%)
         occurrences all number
    2
    PAIN
         subjects affected / exposed
    1 / 252 (0.40%)
         occurrences all number
    1
    PERIPHERAL SWELLING
         subjects affected / exposed
    1 / 252 (0.40%)
         occurrences all number
    1
    POLYP
         subjects affected / exposed
    1 / 252 (0.40%)
         occurrences all number
    1
    PYREXIA
         subjects affected / exposed
    7 / 252 (2.78%)
         occurrences all number
    7
    Immune system disorders
    DRUG HYPERSENSITIVITY
         subjects affected / exposed
    1 / 252 (0.40%)
         occurrences all number
    1
    SEASONAL ALLERGY
         subjects affected / exposed
    1 / 252 (0.40%)
         occurrences all number
    1
    Reproductive system and breast disorders
    BREAST CYST
         subjects affected / exposed
    1 / 252 (0.40%)
         occurrences all number
    1
    CERVICAL DYSPLASIA
         subjects affected / exposed
    1 / 252 (0.40%)
         occurrences all number
    1
    DYSMENORRHOEA
         subjects affected / exposed
    1 / 252 (0.40%)
         occurrences all number
    1
    DYSPAREUNIA
         subjects affected / exposed
    1 / 252 (0.40%)
         occurrences all number
    1
    PROSTATITIS
         subjects affected / exposed
    1 / 252 (0.40%)
         occurrences all number
    1
    VAGINAL HAEMORRHAGE
         subjects affected / exposed
    1 / 252 (0.40%)
         occurrences all number
    1
    VAGINAL DISCHARGE
         subjects affected / exposed
    1 / 252 (0.40%)
         occurrences all number
    1
    VULVOVAGINAL DRYNESS
         subjects affected / exposed
    1 / 252 (0.40%)
         occurrences all number
    1
    Respiratory, thoracic and mediastinal disorders
    COUGH
         subjects affected / exposed
    6 / 252 (2.38%)
         occurrences all number
    8
    NASAL ULCER
         subjects affected / exposed
    1 / 252 (0.40%)
         occurrences all number
    1
    EPISTAXIS
         subjects affected / exposed
    1 / 252 (0.40%)
         occurrences all number
    1
    OROPHARYNGEAL PAIN
         subjects affected / exposed
    2 / 252 (0.79%)
         occurrences all number
    3
    PARANASAL SINUS HYPERSECRETION
         subjects affected / exposed
    1 / 252 (0.40%)
         occurrences all number
    1
    RHINITIS ALLERGIC
         subjects affected / exposed
    2 / 252 (0.79%)
         occurrences all number
    2
    RHINORRHOEA
         subjects affected / exposed
    2 / 252 (0.79%)
         occurrences all number
    2
    SINUS CONGESTION
         subjects affected / exposed
    2 / 252 (0.79%)
         occurrences all number
    2
    SINUS PAIN
         subjects affected / exposed
    1 / 252 (0.40%)
         occurrences all number
    1
    TONSILLAR HYPERTROPHY
         subjects affected / exposed
    1 / 252 (0.40%)
         occurrences all number
    1
    Psychiatric disorders
    ACUTE STRESS DISORDER
         subjects affected / exposed
    1 / 252 (0.40%)
         occurrences all number
    1
    ANXIETY
         subjects affected / exposed
    4 / 252 (1.59%)
         occurrences all number
    4
    BIPOLAR DISORDER
         subjects affected / exposed
    1 / 252 (0.40%)
         occurrences all number
    1
    DEPRESSION
         subjects affected / exposed
    4 / 252 (1.59%)
         occurrences all number
    4
    INSOMNIA
         subjects affected / exposed
    4 / 252 (1.59%)
         occurrences all number
    4
    MOOD SWINGS
         subjects affected / exposed
    1 / 252 (0.40%)
         occurrences all number
    1
    NIGHTMARE
         subjects affected / exposed
    1 / 252 (0.40%)
         occurrences all number
    1
    RESTLESSNESS
         subjects affected / exposed
    1 / 252 (0.40%)
         occurrences all number
    1
    SLEEP DISORDER
         subjects affected / exposed
    1 / 252 (0.40%)
         occurrences all number
    1
    Investigations
    BLOOD BILIRUBIN INCREASED
         subjects affected / exposed
    1 / 252 (0.40%)
         occurrences all number
    1
    ALANINE AMINOTRANSFERASE INCREASED
         subjects affected / exposed
    1 / 252 (0.40%)
         occurrences all number
    1
    BLOOD CHOLESTEROL INCREASED
         subjects affected / exposed
    1 / 252 (0.40%)
         occurrences all number
    1
    BLOOD CREATININE INCREASED
         subjects affected / exposed
    1 / 252 (0.40%)
         occurrences all number
    1
    BLOOD TRIGLYCERIDES INCREASED
         subjects affected / exposed
    4 / 252 (1.59%)
         occurrences all number
    7
    BLOOD URINE PRESENT
         subjects affected / exposed
    3 / 252 (1.19%)
         occurrences all number
    4
    C-REACTIVE PROTEIN INCREASED
         subjects affected / exposed
    1 / 252 (0.40%)
         occurrences all number
    1
    CLOSTRIDIUM TEST POSITIVE
         subjects affected / exposed
    1 / 252 (0.40%)
         occurrences all number
    1
    LIVER FUNCTION TEST INCREASED
         subjects affected / exposed
    2 / 252 (0.79%)
         occurrences all number
    2
    NEUTROPHIL COUNT INCREASED
         subjects affected / exposed
    1 / 252 (0.40%)
         occurrences all number
    1
    NITRITE URINE PRESENT
         subjects affected / exposed
    1 / 252 (0.40%)
         occurrences all number
    1
    PROTEIN URINE PRESENT
         subjects affected / exposed
    1 / 252 (0.40%)
         occurrences all number
    3
    RED BLOOD CELLS URINE
         subjects affected / exposed
    1 / 252 (0.40%)
         occurrences all number
    1
    RED BLOOD CELLS URINE POSITIVE
         subjects affected / exposed
    1 / 252 (0.40%)
         occurrences all number
    2
    WEIGHT DECREASED
         subjects affected / exposed
    1 / 252 (0.40%)
         occurrences all number
    1
    WHITE BLOOD CELL COUNT INCREASED
         subjects affected / exposed
    2 / 252 (0.79%)
         occurrences all number
    2
    Injury, poisoning and procedural complications
    ARTHROPOD STING
         subjects affected / exposed
    1 / 252 (0.40%)
         occurrences all number
    1
    CONTUSION
         subjects affected / exposed
    1 / 252 (0.40%)
         occurrences all number
    1
    CORNEAL ABRASION
         subjects affected / exposed
    1 / 252 (0.40%)
         occurrences all number
    1
    LIMB INJURY
         subjects affected / exposed
    1 / 252 (0.40%)
         occurrences all number
    1
    POST PROCEDURAL DIARRHOEA
         subjects affected / exposed
    1 / 252 (0.40%)
         occurrences all number
    1
    POST PROCEDURAL HAEMORRHAGE
         subjects affected / exposed
    1 / 252 (0.40%)
         occurrences all number
    1
    POST-TRAUMATIC NECK SYNDROME
         subjects affected / exposed
    1 / 252 (0.40%)
         occurrences all number
    1
    PROCEDURAL HAEMORRHAGE
         subjects affected / exposed
    1 / 252 (0.40%)
         occurrences all number
    1
    RIB FRACTURE
         subjects affected / exposed
    1 / 252 (0.40%)
         occurrences all number
    1
    ROAD TRAFFIC ACCIDENT
         subjects affected / exposed
    1 / 252 (0.40%)
         occurrences all number
    1
    TOOTH FRACTURE
         subjects affected / exposed
    1 / 252 (0.40%)
         occurrences all number
    1
    Cardiac disorders
    PALPITATIONS
         subjects affected / exposed
    2 / 252 (0.79%)
         occurrences all number
    2
    Nervous system disorders
    BURNING SENSATION
         subjects affected / exposed
    1 / 252 (0.40%)
         occurrences all number
    1
    DIZZINESS
         subjects affected / exposed
    2 / 252 (0.79%)
         occurrences all number
    2
    HEADACHE
         subjects affected / exposed
    12 / 252 (4.76%)
         occurrences all number
    24
    HYPOAESTHESIA
         subjects affected / exposed
    1 / 252 (0.40%)
         occurrences all number
    1
    LETHARGY
         subjects affected / exposed
    1 / 252 (0.40%)
         occurrences all number
    1
    MIGRAINE
         subjects affected / exposed
    2 / 252 (0.79%)
         occurrences all number
    2
    PARAESTHESIA
         subjects affected / exposed
    2 / 252 (0.79%)
         occurrences all number
    2
    SCIATICA
         subjects affected / exposed
    1 / 252 (0.40%)
         occurrences all number
    1
    SPINAL CLAUDICATION
         subjects affected / exposed
    1 / 252 (0.40%)
         occurrences all number
    1
    SYNCOPE
         subjects affected / exposed
    1 / 252 (0.40%)
         occurrences all number
    1
    Blood and lymphatic system disorders
    ANAEMIA
         subjects affected / exposed
    3 / 252 (1.19%)
         occurrences all number
    3
    IRON DEFICIENCY ANAEMIA
         subjects affected / exposed
    2 / 252 (0.79%)
         occurrences all number
    2
    LEUKOPENIA
         subjects affected / exposed
    3 / 252 (1.19%)
         occurrences all number
    3
    LYMPHADENOPATHY
         subjects affected / exposed
    1 / 252 (0.40%)
         occurrences all number
    1
    Eye disorders
    CATARACT
         subjects affected / exposed
    1 / 252 (0.40%)
         occurrences all number
    1
    KERATITIS
         subjects affected / exposed
    1 / 252 (0.40%)
         occurrences all number
    1
    VISION BLURRED
         subjects affected / exposed
    1 / 252 (0.40%)
         occurrences all number
    1
    Gastrointestinal disorders
    ABDOMINAL DISTENSION
         subjects affected / exposed
    2 / 252 (0.79%)
         occurrences all number
    2
    ABDOMINAL MASS
         subjects affected / exposed
    3 / 252 (1.19%)
         occurrences all number
    3
    ABDOMINAL PAIN
         subjects affected / exposed
    12 / 252 (4.76%)
         occurrences all number
    13
    ABDOMINAL PAIN LOWER
         subjects affected / exposed
    3 / 252 (1.19%)
         occurrences all number
    3
    ABDOMINAL PAIN UPPER
         subjects affected / exposed
    6 / 252 (2.38%)
         occurrences all number
    6
    ABDOMINAL RIGIDITY
         subjects affected / exposed
    1 / 252 (0.40%)
         occurrences all number
    1
    ABDOMINAL TENDERNESS
         subjects affected / exposed
    2 / 252 (0.79%)
         occurrences all number
    2
    ANAL FISSURE
         subjects affected / exposed
    7 / 252 (2.78%)
         occurrences all number
    8
    ANAL FISTULA
         subjects affected / exposed
    3 / 252 (1.19%)
         occurrences all number
    6
    ANAL STENOSIS
         subjects affected / exposed
    1 / 252 (0.40%)
         occurrences all number
    1
    ANAL ULCER
         subjects affected / exposed
    1 / 252 (0.40%)
         occurrences all number
    1
    ANORECTAL DISCOMFORT
         subjects affected / exposed
    2 / 252 (0.79%)
         occurrences all number
    2
    ANORECTAL DISORDER
         subjects affected / exposed
    1 / 252 (0.40%)
         occurrences all number
    1
    CHEILITIS
         subjects affected / exposed
    1 / 252 (0.40%)
         occurrences all number
    1
    CONSTIPATION
         subjects affected / exposed
    6 / 252 (2.38%)
         occurrences all number
    6
    CROHN'S DISEASE
         subjects affected / exposed
    46 / 252 (18.25%)
         occurrences all number
    59
    DENTAL CARIES
         subjects affected / exposed
    2 / 252 (0.79%)
         occurrences all number
    2
    DIARRHOEA
         subjects affected / exposed
    7 / 252 (2.78%)
         occurrences all number
    7
    DRY MOUTH
         subjects affected / exposed
    1 / 252 (0.40%)
         occurrences all number
    1
    DYSPEPSIA
         subjects affected / exposed
    1 / 252 (0.40%)
         occurrences all number
    1
    FLATULENCE
         subjects affected / exposed
    1 / 252 (0.40%)
         occurrences all number
    1
    FREQUENT BOWEL MOVEMENTS
         subjects affected / exposed
    1 / 252 (0.40%)
         occurrences all number
    1
    GASTROOESOPHAGEAL REFLUX DISEASE
         subjects affected / exposed
    1 / 252 (0.40%)
         occurrences all number
    1
    HAEMATOCHEZIA
         subjects affected / exposed
    2 / 252 (0.79%)
         occurrences all number
    2
    HAEMORRHOIDS
         subjects affected / exposed
    1 / 252 (0.40%)
         occurrences all number
    1
    HIATUS HERNIA
         subjects affected / exposed
    1 / 252 (0.40%)
         occurrences all number
    1
    ILEAL STENOSIS
         subjects affected / exposed
    1 / 252 (0.40%)
         occurrences all number
    2
    INTESTINAL OBSTRUCTION
         subjects affected / exposed
    4 / 252 (1.59%)
         occurrences all number
    4
    INTESTINAL STENOSIS
         subjects affected / exposed
    1 / 252 (0.40%)
         occurrences all number
    1
    IRRITABLE BOWEL SYNDROME
         subjects affected / exposed
    1 / 252 (0.40%)
         occurrences all number
    1
    LARGE INTESTINE POLYP
         subjects affected / exposed
    2 / 252 (0.79%)
         occurrences all number
    2
    MOUTH ULCERATION
         subjects affected / exposed
    1 / 252 (0.40%)
         occurrences all number
    1
    MUCOUS STOOLS
         subjects affected / exposed
    1 / 252 (0.40%)
         occurrences all number
    1
    NAUSEA
         subjects affected / exposed
    15 / 252 (5.95%)
         occurrences all number
    21
    PROCTALGIA
         subjects affected / exposed
    1 / 252 (0.40%)
         occurrences all number
    1
    RECTAL DISCHARGE
         subjects affected / exposed
    1 / 252 (0.40%)
         occurrences all number
    1
    RECTAL HAEMORRHAGE
         subjects affected / exposed
    2 / 252 (0.79%)
         occurrences all number
    3
    SMALL INTESTINAL OBSTRUCTION
         subjects affected / exposed
    6 / 252 (2.38%)
         occurrences all number
    6
    TONGUE DRY
         subjects affected / exposed
    1 / 252 (0.40%)
         occurrences all number
    1
    TOOTHACHE
         subjects affected / exposed
    3 / 252 (1.19%)
         occurrences all number
    3
    VOMITING
         subjects affected / exposed
    11 / 252 (4.37%)
         occurrences all number
    12
    Hepatobiliary disorders
    CHOLELITHIASIS
         subjects affected / exposed
    1 / 252 (0.40%)
         occurrences all number
    1
    HEPATIC STEATOSIS
         subjects affected / exposed
    1 / 252 (0.40%)
         occurrences all number
    1
    HYPERTRANSAMINASAEMIA
         subjects affected / exposed
    1 / 252 (0.40%)
         occurrences all number
    1
    Skin and subcutaneous tissue disorders
    ACNE
         subjects affected / exposed
    5 / 252 (1.98%)
         occurrences all number
    5
    ALOPECIA
         subjects affected / exposed
    1 / 252 (0.40%)
         occurrences all number
    1
    ANGIOEDEMA
         subjects affected / exposed
    1 / 252 (0.40%)
         occurrences all number
    1
    DERMATITIS
         subjects affected / exposed
    5 / 252 (1.98%)
         occurrences all number
    5
    DERMATITIS ALLERGIC
         subjects affected / exposed
    1 / 252 (0.40%)
         occurrences all number
    1
    DERMATITIS CONTACT
         subjects affected / exposed
    1 / 252 (0.40%)
         occurrences all number
    1
    DRY SKIN
         subjects affected / exposed
    3 / 252 (1.19%)
         occurrences all number
    3
    ECZEMA
         subjects affected / exposed
    2 / 252 (0.79%)
         occurrences all number
    2
    ERYTHEMA
         subjects affected / exposed
    2 / 252 (0.79%)
         occurrences all number
    2
    MILIARIA
         subjects affected / exposed
    1 / 252 (0.40%)
         occurrences all number
    1
    PAPULE
         subjects affected / exposed
    1 / 252 (0.40%)
         occurrences all number
    1
    PRURITUS
         subjects affected / exposed
    4 / 252 (1.59%)
         occurrences all number
    7
    PRURITUS GENERALISED
         subjects affected / exposed
    1 / 252 (0.40%)
         occurrences all number
    2
    PSORIASIS
         subjects affected / exposed
    3 / 252 (1.19%)
         occurrences all number
    4
    RASH
         subjects affected / exposed
    6 / 252 (2.38%)
         occurrences all number
    6
    RASH GENERALISED
         subjects affected / exposed
    1 / 252 (0.40%)
         occurrences all number
    1
    RASH MACULAR
         subjects affected / exposed
    1 / 252 (0.40%)
         occurrences all number
    1
    RASH PRURITIC
         subjects affected / exposed
    1 / 252 (0.40%)
         occurrences all number
    1
    SKIN EXFOLIATION
         subjects affected / exposed
    1 / 252 (0.40%)
         occurrences all number
    1
    SKIN LESION
         subjects affected / exposed
    1 / 252 (0.40%)
         occurrences all number
    1
    URTICARIA
         subjects affected / exposed
    1 / 252 (0.40%)
         occurrences all number
    1
    Renal and urinary disorders
    INCONTINENCE
         subjects affected / exposed
    1 / 252 (0.40%)
         occurrences all number
    1
    NEPHROLITHIASIS
         subjects affected / exposed
    2 / 252 (0.79%)
         occurrences all number
    2
    POLLAKIURIA
         subjects affected / exposed
    1 / 252 (0.40%)
         occurrences all number
    1
    RENAL COLIC
         subjects affected / exposed
    2 / 252 (0.79%)
         occurrences all number
    2
    Endocrine disorders
    THYROID DISORDER
         subjects affected / exposed
    1 / 252 (0.40%)
         occurrences all number
    1
    Musculoskeletal and connective tissue disorders
    ARTHRALGIA
         subjects affected / exposed
    18 / 252 (7.14%)
         occurrences all number
    20
    ARTHRITIS
         subjects affected / exposed
    4 / 252 (1.59%)
         occurrences all number
    4
    ARTHROPATHY
         subjects affected / exposed
    1 / 252 (0.40%)
         occurrences all number
    1
    BACK PAIN
         subjects affected / exposed
    11 / 252 (4.37%)
         occurrences all number
    12
    BURSITIS
         subjects affected / exposed
    1 / 252 (0.40%)
         occurrences all number
    1
    FISTULA DISCHARGE
         subjects affected / exposed
    1 / 252 (0.40%)
         occurrences all number
    1
    INTERVERTEBRAL DISC PROTRUSION
         subjects affected / exposed
    3 / 252 (1.19%)
         occurrences all number
    4
    LUMBAR SPINAL STENOSIS
         subjects affected / exposed
    1 / 252 (0.40%)
         occurrences all number
    1
    MUSCLE SPASMS
         subjects affected / exposed
    2 / 252 (0.79%)
         occurrences all number
    2
    MUSCULOSKELETAL PAIN
         subjects affected / exposed
    3 / 252 (1.19%)
         occurrences all number
    3
    MUSCULOSKELETAL STIFFNESS
         subjects affected / exposed
    1 / 252 (0.40%)
         occurrences all number
    1
    PAIN IN EXTREMITY
         subjects affected / exposed
    6 / 252 (2.38%)
         occurrences all number
    7
    ROTATOR CUFF SYNDROME
         subjects affected / exposed
    1 / 252 (0.40%)
         occurrences all number
    1
    TENDONITIS
         subjects affected / exposed
    1 / 252 (0.40%)
         occurrences all number
    1
    Infections and infestations
    ABSCESS
         subjects affected / exposed
    2 / 252 (0.79%)
         occurrences all number
    2
    ACUTE SINUSITIS
         subjects affected / exposed
    1 / 252 (0.40%)
         occurrences all number
    1
    ANAL ABSCESS
         subjects affected / exposed
    9 / 252 (3.57%)
         occurrences all number
    10
    BACTERIAL VAGINOSIS
         subjects affected / exposed
    1 / 252 (0.40%)
         occurrences all number
    1
    BACTERIAL VULVOVAGINITIS
         subjects affected / exposed
    1 / 252 (0.40%)
         occurrences all number
    1
    BRONCHITIS
         subjects affected / exposed
    4 / 252 (1.59%)
         occurrences all number
    5
    CELLULITIS
         subjects affected / exposed
    1 / 252 (0.40%)
         occurrences all number
    1
    CONJUNCTIVITIS
         subjects affected / exposed
    3 / 252 (1.19%)
         occurrences all number
    4
    CYSTITIS
         subjects affected / exposed
    4 / 252 (1.59%)
         occurrences all number
    4
    EAR INFECTION
         subjects affected / exposed
    4 / 252 (1.59%)
         occurrences all number
    4
    ECZEMA INFECTED
         subjects affected / exposed
    2 / 252 (0.79%)
         occurrences all number
    2
    EPIDIDYMITIS
         subjects affected / exposed
    2 / 252 (0.79%)
         occurrences all number
    2
    FUNGAL INFECTION
         subjects affected / exposed
    1 / 252 (0.40%)
         occurrences all number
    1
    GASTROENTERITIS
         subjects affected / exposed
    2 / 252 (0.79%)
         occurrences all number
    2
    GASTROINTESTINAL INFECTION
         subjects affected / exposed
    1 / 252 (0.40%)
         occurrences all number
    1
    GINGIVITIS
         subjects affected / exposed
    3 / 252 (1.19%)
         occurrences all number
    3
    HERPES SIMPLEX
         subjects affected / exposed
    1 / 252 (0.40%)
         occurrences all number
    1
    HERPES ZOSTER
         subjects affected / exposed
    3 / 252 (1.19%)
         occurrences all number
    3
    HORDEOLUM
         subjects affected / exposed
    1 / 252 (0.40%)
         occurrences all number
    1
    INFLUENZA
         subjects affected / exposed
    4 / 252 (1.59%)
         occurrences all number
    4
    LOCALISED INFECTION
         subjects affected / exposed
    1 / 252 (0.40%)
         occurrences all number
    1
    LOWER RESPIRATORY TRACT INFECTION
         subjects affected / exposed
    1 / 252 (0.40%)
         occurrences all number
    1
    NASOPHARYNGITIS
         subjects affected / exposed
    9 / 252 (3.57%)
         occurrences all number
    10
    ONYCHOMYCOSIS
         subjects affected / exposed
    1 / 252 (0.40%)
         occurrences all number
    1
    ORAL CANDIDIASIS
         subjects affected / exposed
    1 / 252 (0.40%)
         occurrences all number
    2
    ORAL HERPES
         subjects affected / exposed
    4 / 252 (1.59%)
         occurrences all number
    4
    OTITIS EXTERNA
         subjects affected / exposed
    1 / 252 (0.40%)
         occurrences all number
    1
    PERIODONTITIS
         subjects affected / exposed
    1 / 252 (0.40%)
         occurrences all number
    1
    PHARYNGITIS
         subjects affected / exposed
    1 / 252 (0.40%)
         occurrences all number
    1
    PHARYNGITIS STREPTOCOCCAL
         subjects affected / exposed
    1 / 252 (0.40%)
         occurrences all number
    1
    PULPITIS DENTAL
         subjects affected / exposed
    1 / 252 (0.40%)
         occurrences all number
    1
    RESPIRATORY TRACT INFECTION
         subjects affected / exposed
    1 / 252 (0.40%)
         occurrences all number
    1
    RESPIRATORY TRACT INFECTION VIRAL
         subjects affected / exposed
    1 / 252 (0.40%)
         occurrences all number
    1
    RHINITIS
         subjects affected / exposed
    3 / 252 (1.19%)
         occurrences all number
    3
    SINUSITIS
         subjects affected / exposed
    2 / 252 (0.79%)
         occurrences all number
    2
    SUBCUTANEOUS ABSCESS
         subjects affected / exposed
    3 / 252 (1.19%)
         occurrences all number
    3
    TONSILLITIS
         subjects affected / exposed
    2 / 252 (0.79%)
         occurrences all number
    2
    TOOTH ABSCESS
         subjects affected / exposed
    2 / 252 (0.79%)
         occurrences all number
    2
    TOOTH INFECTION
         subjects affected / exposed
    2 / 252 (0.79%)
         occurrences all number
    2
    UPPER RESPIRATORY TRACT INFECTION
         subjects affected / exposed
    13 / 252 (5.16%)
         occurrences all number
    13
    URINARY TRACT INFECTION
         subjects affected / exposed
    9 / 252 (3.57%)
         occurrences all number
    9
    VIRAL INFECTION
         subjects affected / exposed
    1 / 252 (0.40%)
         occurrences all number
    1
    VULVOVAGINAL MYCOTIC INFECTION
         subjects affected / exposed
    3 / 252 (1.19%)
         occurrences all number
    4
    WOUND INFECTION
         subjects affected / exposed
    1 / 252 (0.40%)
         occurrences all number
    1
    Metabolism and nutrition disorders
    DECREASED APPETITE
         subjects affected / exposed
    2 / 252 (0.79%)
         occurrences all number
    2
    FOLATE DEFICIENCY
         subjects affected / exposed
    1 / 252 (0.40%)
         occurrences all number
    1
    FOOD INTOLERANCE
         subjects affected / exposed
    1 / 252 (0.40%)
         occurrences all number
    1
    GOUT
         subjects affected / exposed
    1 / 252 (0.40%)
         occurrences all number
    1
    HYPOVITAMINOSIS
         subjects affected / exposed
    1 / 252 (0.40%)
         occurrences all number
    1
    IRON DEFICIENCY
         subjects affected / exposed
    1 / 252 (0.40%)
         occurrences all number
    1
    VITAMIN B12 DEFICIENCY
         subjects affected / exposed
    3 / 252 (1.19%)
         occurrences all number
    3
    VITAMIN D DEFICIENCY
         subjects affected / exposed
    1 / 252 (0.40%)
         occurrences all number
    1

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    13 May 2014
    The main purpose of this study was to update Crohn's disease flare and inadequate response criteria, update de-escalation and re-escalation criteria, clarify corticosteroid use, clarify inclusion criteria (contraception) and exclusion criteria (tuberculosis), and clarify endpoints and analyses.
    04 Dec 2014
    The main purpose of this study was to update the definition of inadequate response and first week when subjects are allowed to dose-escalate and clarifystudy procedures, including procedures required at unscheduled visit .

    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
    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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