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    Clinical Trial Results:
    INDUCTION AND MAINTENANCE OF MUCOSAL HEALING IN CROHN’S DISEASE WITH USTEKINUMAB IN CLINICAL PRACTICE

    Summary
    EudraCT number
    		 2017-005151-83
    Trial protocol
    		 DE  
    Global end of trial date
    30 Jan 2023

    Results information
    Results version number
    		 v1(current)
    This version publication date
    17 Feb 2024
    First version publication date
    17 Feb 2024
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    MUCUS
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Charité- Universitätsmedizin Berlin
    Sponsor organisation address
    Charitéplatz 1, Berlin, Germany, 10117
    Public contact
    Dr. Andreas Fischer, National Coordinator, Charité Medical School, +49 30450553836, andi.fischer@charite.de
    Scientific contact
    Prof. Daniel C. Baumgart, Medizinische Klinik m.S. Hepatologie und Gastroenterologie Charité - Campus Virchow Klinikum, daniel.baumgart@charite.de
    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
    30 Mar 2023
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    30 Jan 2023
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To evaluate the real world effectiveness of ustekinumab (routine care) as combined clinical and endoscopic response in week 52.
    Protection of trial subjects
    Subjects were instructed to contact the study coordinator/investigator if their health status changed significantly. Ustekinumab was not be administered to a subject with a clinically important, active infection. Investigators evaluated subjects for any signs or symptoms of infection, and also reviewed subjects’ diary cards for signs of infection, at scheduled visits. All subjects completed a final follow-up safety assessment 16 weeks after the last administration of ustekinumab in the study.
    Background therapy
    		 Ustekinumab is a fully human immunoglobulin G1 kappa (IgG1k) monoclonal antibody to human IL-12/23p40 that binds with high affinity to the p40 subunit of human IL-12 and IL-23. Inhibition of IL-12 and IL-23 and associated inflammatory pathways via blockade of the shared p40 subunit constitutes a novel mechanism of action for the treatment of Crohn’s disease (CD). Since clinical trials rarely represent the real-world patient population and ustekinumab’s impact on induction and maintenance of mucosal healing, fistula healing and extraintestinal manifestations are largely unknown and long-term remission, patient reported outcome and quality of life data are incomplete we plan to close these knowledge gaps with a prospective nationwide study in Germany across all care levels.
    Evidence for comparator
    		 -
    Actual start date of recruitment
    31 May 2018
    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
    Germany: 52
    Worldwide total number of subjects
    52
    EEA total number of subjects
    52
    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)
    51
    From 65 to 84 years
    1
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 The study was conducted at 10 study centers in Germany, between Date 2018-11-28 and 2023-03-13.

    Pre-assignment
    Screening details
    		 A total of 79 subjects entered the 2-weeks screening period, of whom 52 adult subjects with a Harvey Bradshaw index score of ≥ 5 at Baseline and Endoscopy with evidence of active CD (SES-CD score ≥3 ) were randomized. Subjects will be allowed to intake oral corticosteroids at a prednisone-equivalent dose of ≤40 mg/day or ≤9 mg/day of budesonide.

    Period 1
    Period 1 title
    overall study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded
    Blinding implementation details
    This was a prospective, open-label, nationwide, multicenter, national, Phase IV study of ustekinumab in adult subjects with active, moderate to severe, ileal and/or colonic CD. The effectiveness was investigated in a real world setting in 10 German centers representing all care levels - private practice, community hospitals and academic institutions. To ensured a balanced, unbiased real world cohort subjects were stratified 1:1:1 at baseline.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Native
    Arm description
    		 Subjects enrolled are either native to biologic treatment or will have previously had an inadequate response to conventional therapy (no biological treatment)
    Arm type
    		 subgroup of real world cohort

    Investigational medicinal product name
    ustekinumab
    Investigational medicinal product code
    815610-63-0
    Other name
    Stelara, SUB27761
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    In week 0, the subjects received a weight-based dose of approximately 6 mg/kg IV induction treatment with ustekinumab. Ustekinumab was administered to each subject over a period of no less than 1 hour. The infusion was to be completed within 5 hours of preparation. At week 8, all subjects received a 90 mg SC injection of ustekinumab. The timing of the injections was in line with the GERMAN LABEL for the treatment of CD, where administration at 12-week intervals is recommended. After week 8, the subjects were trained in the self-injection of SC ustekinumab under the guidance of the investigator.

    Arm title
    		 Biological-exposed to 1
    Arm description
    		 subjects with medical contraindications to one previous biologic therapies approved for the treatment of CD in Germany (i.e., infliximab, adalimumab or vedolizumab).
    Arm type
    		 subgroup of real world cohort

    Investigational medicinal product name
    ustekinumab
    Investigational medicinal product code
    815610-63-0
    Other name
    Stelara, SUB27761
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    In week 0, the subjects received a weight-based dose of approximately 6 mg/kg IV induction treatment with ustekinumab. Ustekinumab was administered to each subject over a period of no less than 1 hour. The infusion was to be completed within 5 hours of preparation. At week 8, all subjects received a 90 mg SC injection of ustekinumab. The timing of the injections was in line with the GERMAN LABEL for the treatment of CD, where administration at 12-week intervals is recommended. After week 8, the subjects were trained in the self-injection of SC ustekinumab under the guidance of the investigator.

    Arm title
    		 Biological exposed to multiple
    Arm description
    		 subjects with medical contraindications to more than one previous biologic therapies approved for the treatment of CD in Germany (i.e., infliximab, adalimumab or vedolizumab)
    Arm type
    		 sub group of real world Cohort

    Investigational medicinal product name
    ustekinumab
    Investigational medicinal product code
    815610-63-0
    Other name
    Stelara, SUB27761
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    In week 0, the subjects received a weight-based dose of approximately 6 mg/kg IV induction treatment with ustekinumab. Ustekinumab was administered to each subject over a period of no less than 1 hour. The infusion was to be completed within 5 hours of preparation. At week 8, all subjects received a 90 mg SC injection of ustekinumab. The timing of the injections was in line with the GERMAN LABEL for the treatment of CD, where administration at 12-week intervals is recommended. After week 8, the subjects were trained in the self-injection of SC ustekinumab under the guidance of the investigator.

    Number of subjects in period 1
    		Native Biological-exposed to 1 Biological exposed to multiple
    Started
    13
    22
    17
    Completed
    10
    14
    10
    Not completed
    3
    8
    7
         Consent withdrawn by subject
    1
    2
    1
         unknown
    -
    1
    1
         Adverse event, non-fatal
    1
    1
    1
         Pregnancy
    -
    1
    -
         Non-HBI-Responder
    1
    3
    1
         Lost to follow-up
    -
    -
    3

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Native
    Reporting group description
    		 Subjects enrolled are either native to biologic treatment or will have previously had an inadequate response to conventional therapy (no biological treatment)

    Reporting group title
    Biological-exposed to 1
    Reporting group description
    		 subjects with medical contraindications to one previous biologic therapies approved for the treatment of CD in Germany (i.e., infliximab, adalimumab or vedolizumab).

    Reporting group title
    Biological exposed to multiple
    Reporting group description
    		 subjects with medical contraindications to more than one previous biologic therapies approved for the treatment of CD in Germany (i.e., infliximab, adalimumab or vedolizumab)

    Reporting group values
    		 Native Biological-exposed to 1 Biological exposed to multiple Total
    Number of subjects
    		 13 22 17 52
    Age categorical
    Units: Subjects
        In utero
    		 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0
        Newborns (0-27 days)
    		 0
        Infants and toddlers (28 days-23 months)
    		 0
        Children (2-11 years)
    		 0
        Adolescents (12-17 years)
    		 0
        Adults (18-64 years)
    		 0
        From 65-84 years
    		 0
        85 years and over
    		 0
    Age continuous
    Units: years
        median (full range (min-max))
    		 39.2 (20 to 64) 36.7 (21 to 74) 42.4 (21 to 57) -
    Gender categorical
    Units: Subjects
        Female
    		 8 14 6 28
        Male
    		 5 8 11 24
    Prior Crohn's Surgery (PCS)
    Prior Crohn´s Surgery
    Units: Subjects
        Yes (PCS)
    		 0 3 4 7
        No (PCS)
    		 13 19 13 45
    Concomitant Monotherapy Immunomodulators (CMI)
    Units: Subjects
        Yes (CMI)
    		 0 2 1 3
        No (CMI)
    		 13 20 16 49
    Concomitant Combination Therapy Immunomodulators (CCTI)
    Units: Subjects
        Yes (CCTI)
    		 0 0 0 0
        No (CCTI)
    		 13 22 17 52
    Fistulizing Crohn´s (FC)
    Units: Subjects
        Yes (FC)
    		 0 2 5 7
        No (FC)
    		 13 20 12 45
    Weight
    Units: kg
        median (full range (min-max))
    		 75.9 (39 to 93) 68 (51 to 103) 72 (47 to 106) -
    Height
    Units: cm
        median (full range (min-max))
    		 169 (147 to 195) 169 (157 to 192) 172 (161 to 195) -

    End points

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    End points reporting groups
    Reporting group title
    Native
    Reporting group description
    		 Subjects enrolled are either native to biologic treatment or will have previously had an inadequate response to conventional therapy (no biological treatment)

    Reporting group title
    Biological-exposed to 1
    Reporting group description
    		 subjects with medical contraindications to one previous biologic therapies approved for the treatment of CD in Germany (i.e., infliximab, adalimumab or vedolizumab).

    Reporting group title
    Biological exposed to multiple
    Reporting group description
    		 subjects with medical contraindications to more than one previous biologic therapies approved for the treatment of CD in Germany (i.e., infliximab, adalimumab or vedolizumab)

    Primary: ITT-Analysis Clinical and Endoscopic Response at week 52

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    End point title
    		 ITT-Analysis Clinical and Endoscopic Response at week 52
    End point description
    Intent-to-Treat Analysis set, N= number of randomized subjects Outcome: Reduction from baseline in SES-CD Score >= 50% and Harvey Bradshaw Index decrease >= 3 points
    End point type
    Primary
    End point timeframe
    overall study
    End point values
    		 Native Biological-exposed to 1 Biological exposed to multiple
    Number of subjects analysed
    13
    22
    17
    Units: number
        Responder
    3
    5
    5
        Non- Responder
    10
    17
    12
    Attachments
    		 Untitled (Filename: secondary endpoint_clinical remission.pdf)
    Statistical analysis title
    		 efficacy Native vs. Biological-exposed to 1
    Comparison groups
    Biological-exposed to 1 v Native
    Number of subjects included in analysis
    35
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.981
    Method
    		 Proc Logistic
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1.02
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.2
         upper limit
    		 5.209
    Statistical analysis title
    		 efficacy Native vs. Biological exposed multiple
    Comparison groups
    Native v Biological exposed to multiple
    Number of subjects included in analysis
    30
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.698
    Method
    		 Proc Logistic
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    0.72
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.137
         upper limit
    		 3.784
    Statistical analysis title
    		 efficacy Biological-exposed to 1 vs. multiple
    Comparison groups
    Biological-exposed to 1 v Biological exposed to multiple
    Number of subjects included in analysis
    39
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.636
    Method
    		 Proc Logistic
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    0.706
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.167
         upper limit
    		 2.989

    Primary: PP-Analysis Clinical and Endoscopic Response at week 52

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    End point title
    		 PP-Analysis Clinical and Endoscopic Response at week 52
    End point description
    Per Protocol Analysis set, N= number of randomized subjects Outcome: Reduction from baseline in SES-CD Score >= 50% and Harvey Bradshaw Index decrease >= 3 points
    End point type
    Primary
    End point timeframe
    52 weeks
    End point values
    		 Native Biological-exposed to 1 Biological exposed to multiple
    Number of subjects analysed
    6
    11
    8
    Units: number
        Responder
    3
    5
    5
        Non-Responder
    3
    6
    3
    Statistical analysis title
    		 efficacy Native vs. Biological-exposed to 1
    Comparison groups
    Native v Biological-exposed to 1
    Number of subjects included in analysis
    17
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.858
    Method
    		 Proc Logistic
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1.2
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.164
         upper limit
    		 8.799
    Statistical analysis title
    		 efficacy Native vs. Biological exposed to multiple
    Comparison groups
    Native v Biological exposed to multiple
    Number of subjects included in analysis
    14
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.641
    Method
    		 Proc Logistic
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    0.6
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.07
         upper limit
    		 5.136
    Statistical analysis title
    		 efficacy Biological-exposed to 1 vs. multiple
    Comparison groups
    Biological-exposed to 1 v Biological exposed to multiple
    Number of subjects included in analysis
    19
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.465
    Method
    		 Proc Regression
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    0.5
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.078
         upper limit
    		 3.21

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    overall trial
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    19
    Reporting groups
    Reporting group title
    Native
    Reporting group description
    		 -

    Reporting group title
    Biological-exposed to 1
    Reporting group description
    		 -

    Reporting group title
    Biological exposed to multiple
    Reporting group description
    		 -

    Serious adverse events
    		 Native Biological-exposed to 1 Biological exposed to multiple
    Total subjects affected by serious adverse events
         subjects affected / exposed
    3 / 13 (23.08%)
    6 / 22 (27.27%)
    2 / 17 (11.76%)
         number of deaths (all causes)
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    Injury, poisoning and procedural complications
    Procedural pain
         subjects affected / exposed
    0 / 13 (0.00%)
    1 / 22 (4.55%)
    0 / 17 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    Ataxia
         subjects affected / exposed
    0 / 13 (0.00%)
    1 / 22 (4.55%)
    0 / 17 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pregnancy, puerperium and perinatal conditions
    Abortion missed
         subjects affected / exposed
    0 / 13 (0.00%)
    1 / 22 (4.55%)
    0 / 17 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pregnancy
         subjects affected / exposed
    0 / 13 (0.00%)
    1 / 22 (4.55%)
    0 / 17 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    0 / 13 (0.00%)
    1 / 22 (4.55%)
    0 / 17 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Drug ineffective
         subjects affected / exposed
    1 / 13 (7.69%)
    0 / 22 (0.00%)
    0 / 17 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pyrexia
         subjects affected / exposed
    0 / 13 (0.00%)
    1 / 22 (4.55%)
    1 / 17 (5.88%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Crohn's disease
         subjects affected / exposed
    0 / 13 (0.00%)
    3 / 22 (13.64%)
    0 / 17 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Ileal stenosis
         subjects affected / exposed
    1 / 13 (7.69%)
    0 / 22 (0.00%)
    0 / 17 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Subileus
         subjects affected / exposed
    1 / 13 (7.69%)
    0 / 22 (0.00%)
    0 / 17 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Cholangitis
         subjects affected / exposed
    1 / 13 (7.69%)
    0 / 22 (0.00%)
    0 / 17 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Abscess
         subjects affected / exposed
    0 / 13 (0.00%)
    1 / 22 (4.55%)
    0 / 17 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    COVID-19
         subjects affected / exposed
    0 / 13 (0.00%)
    1 / 22 (4.55%)
    0 / 17 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Norovirus infection
         subjects affected / exposed
    1 / 13 (7.69%)
    0 / 22 (0.00%)
    0 / 17 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 1%
    Non-serious adverse events
    		 Native Biological-exposed to 1 Biological exposed to multiple
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    6 / 13 (46.15%)
    5 / 22 (22.73%)
    9 / 17 (52.94%)
    Vascular disorders
    Hypertension
         subjects affected / exposed
    0 / 13 (0.00%)
    1 / 22 (4.55%)
    0 / 17 (0.00%)
         occurrences all number
    0
    1
    0
    Blood and lymphatic system disorders
    Iron deficiency anaemia
         subjects affected / exposed
    0 / 13 (0.00%)
    0 / 22 (0.00%)
    1 / 17 (5.88%)
         occurrences all number
    0
    0
    1
    General disorders and administration site conditions
    Injection site erythema
         subjects affected / exposed
    0 / 13 (0.00%)
    1 / 22 (4.55%)
    0 / 17 (0.00%)
         occurrences all number
    0
    1
    0
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    1 / 13 (7.69%)
    0 / 22 (0.00%)
    0 / 17 (0.00%)
         occurrences all number
    1
    0
    0
    Anal fissure
         subjects affected / exposed
    2 / 13 (15.38%)
    0 / 22 (0.00%)
    0 / 17 (0.00%)
         occurrences all number
    2
    0
    0
    Anal fistula
         subjects affected / exposed
    0 / 13 (0.00%)
    0 / 22 (0.00%)
    1 / 17 (5.88%)
         occurrences all number
    0
    0
    1
    Bile acid malabsorption
         subjects affected / exposed
    0 / 13 (0.00%)
    1 / 22 (4.55%)
    1 / 17 (5.88%)
         occurrences all number
    0
    1
    1
    Reproductive system and breast disorders
    Pruritus genital
         subjects affected / exposed
    0 / 13 (0.00%)
    1 / 22 (4.55%)
    0 / 17 (0.00%)
         occurrences all number
    0
    1
    0
    Skin and subcutaneous tissue disorders
    Alopecia
         subjects affected / exposed
    1 / 13 (7.69%)
    0 / 22 (0.00%)
    0 / 17 (0.00%)
         occurrences all number
    1
    0
    0
    Cold urticaria
         subjects affected / exposed
    0 / 13 (0.00%)
    1 / 22 (4.55%)
    0 / 17 (0.00%)
         occurrences all number
    0
    1
    0
    Eczema
         subjects affected / exposed
    1 / 13 (7.69%)
    0 / 22 (0.00%)
    0 / 17 (0.00%)
         occurrences all number
    1
    0
    0
    Photosensitivity reaction
         subjects affected / exposed
    1 / 13 (7.69%)
    0 / 22 (0.00%)
    0 / 17 (0.00%)
         occurrences all number
    1
    0
    0
    Pruritus
         subjects affected / exposed
    0 / 13 (0.00%)
    0 / 22 (0.00%)
    1 / 17 (5.88%)
         occurrences all number
    0
    0
    1
    Rash
         subjects affected / exposed
    1 / 13 (7.69%)
    0 / 22 (0.00%)
    1 / 17 (5.88%)
         occurrences all number
    1
    0
    1
    Endocrine disorders
    Adrenal insufficiency
         subjects affected / exposed
    0 / 13 (0.00%)
    0 / 22 (0.00%)
    1 / 17 (5.88%)
         occurrences all number
    0
    0
    1
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    0 / 13 (0.00%)
    1 / 22 (4.55%)
    0 / 17 (0.00%)
         occurrences all number
    0
    1
    0
    Infections and infestations
    Gastrointestinal infection
         subjects affected / exposed
    0 / 13 (0.00%)
    0 / 22 (0.00%)
    1 / 17 (5.88%)
         occurrences all number
    0
    0
    1
    Nasopharyngitis
         subjects affected / exposed
    0 / 13 (0.00%)
    0 / 22 (0.00%)
    1 / 17 (5.88%)
         occurrences all number
    0
    0
    1
    Oral herpes
         subjects affected / exposed
    1 / 13 (7.69%)
    0 / 22 (0.00%)
    0 / 17 (0.00%)
         occurrences all number
    1
    0
    0
    Respiratory tract infection
         subjects affected / exposed
    1 / 13 (7.69%)
    0 / 22 (0.00%)
    0 / 17 (0.00%)
         occurrences all number
    1
    0
    0
    Urinary tract infection
         subjects affected / exposed
    0 / 13 (0.00%)
    0 / 22 (0.00%)
    1 / 17 (5.88%)
         occurrences all number
    0
    0
    1

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    04 Jul 2018
    Late registration of additional study centers (ICCC Rhein Main/ Isarklinik München/Hamburger Forschungsinstitut CED)
    21 Dec 2020
    late registration of study center Universitätsklinik Frankfurt.a. Main
    10 Sep 2021
    update protocol Version (09/01/2021)_CNTO 1275 (Ustekinumab/Stelara)

    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 sample size was too small owed to the overall financial budget available and suffered further due to global-pandemic-related factors (sick patients, sick study personnel, limited pharmacy, laboratory in -and out patient services, lost to FU).
    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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