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    Clinical Trial Results:
    A Phase 1b Study to Evaluate SIMPONI® (golimumab) Therapy in Children, Adolescents, and Young Adults with Pre-Symptomatic Type 1 Diabetes

    Summary
    EudraCT number
    		 2017-000225-12
    Trial protocol
    		 SE   FI  
    Global end of trial date
    20 Dec 2020

    Results information
    Results version number
    		 v1(current)
    This version publication date
    07 Jul 2021
    First version publication date
    07 Jul 2021
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    CNTO148DML1001
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT03298542
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Janssen Research and Development, LLC
    Sponsor organisation address
    920, US Highway, Route 202, South Raritan, United States, 08869
    Public contact
    Clinical Registry Group, Janssen Research and Development, LLC, ClinicalTrialsEU@its.jnj.com
    Scientific contact
    Clinical Registry Group, Janssen Research and Development, LLC, ClinicalTrialsEU@its.jnj.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    Yes
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    20 Dec 2020
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    20 Dec 2020
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The main objective of this study was to determine the safety and tolerability of golimumab in children, adolescents, and young adults with pre-symptomatic Stage 2 Type 1 diabetes (T1D).
    Protection of trial subjects
    This study was conducted in accordance with the ethical principles that have their origin in the Declaration of Helsinki and that are consistent with Good Clinical Practices and applicable regulatory requirements. Safety evaluations included regular monitoring for clinically related adverse events (AEs), monitoring of clinical laboratory changes (that is hematological and serum chemistry panel) and active monitoring of early detection of active tuberculosis (TB), vital signs and physical examination findings were evaluated. Monitoring of cytomegalovirus (CMV) and Epstein-Barr virus (EBV) viral load was done to detect if there is any study treatment effect on primary immune response to these infections that often take place during childhood and adolescence or could impact reactivation of these viruses in those who have been infected previously.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    22 Jan 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
    Finland: 2
    Country: Number of subjects enrolled
    United States: 6
    Worldwide total number of subjects
    8
    EEA total number of subjects
    2
    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)
    6
    Adolescents (12-17 years)
    2
    Adults (18-64 years)
    0
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 A total of 21 subjects were screened of which 8 subjects with Stage 2 Type 1 Diabetes (T1D) were enrolled.

    Period 1
    Period 1 title
    Active Treatment Period (Week 0-26)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Carer

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Placebo
    Arm description
    		 Subjects received a subcutaneous (SC) placebo injection every 2 weeks (q2w) through Week 26 to match the active arm.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo (for Golimumab)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Subjects received a SC placebo injection q2w through Week 26 to match the active arm.

    Arm title
    		 Golimumab
    Arm description
    		 Subjects weighing (<) 45 kilograms (kg) received an induction dose of golimumab 60 milligrams per meter square (mg/m^2) SC at Weeks 0 and 2 followed by a maintenance dose of 30 mg/m^2 SC at Week 4 and q2w through Week 26. Participants weighing greater than or equal to (>=) 45 kg received an induction dose of golimumab 100 mg SC at Weeks 0 and 2 followed by a maintenance dose of golimumab 50 mg SC at Week 4 and q2w through Week 26.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Golimumab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Subjects <45 kg received an induction dose of golimumab 60 mg/m^2 SC at Weeks 0 and 2 followed by a maintenance dose of 30 mg/m^2 SC at Week 4 and q2w through Week 26. Participants weighing >= 45 kg received an induction dose of golimumab 100 mg SC at Weeks 0 and 2 followed by a maintenance dose of golimumab 50 mg SC at Week 4 and q2w through Week 26.

    Number of subjects in period 1
    		Placebo Golimumab
    Started
    3
    5
    Completed
    3
    5
    Period 2
    Period 2 title
    Off-therapy Follow-up Period(Week 26-52)
    Is this the baseline period?
    		 No
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Placebo
    Arm description
    		 Following the 26-week active treatment period, participants were monitored for an additional 26 weeks for safety.
    Arm type
    		 No intervention

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Arm title
    		 Golimumab
    Arm description
    		 Following the 26-week active treatment period, participants were monitored for an additional 26 weeks for safety.
    Arm type
    		 No intervention

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Number of subjects in period 2
    		Placebo Golimumab
    Started
    3
    5
    Completed
    3
    5

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Subjects received a subcutaneous (SC) placebo injection every 2 weeks (q2w) through Week 26 to match the active arm.

    Reporting group title
    Golimumab
    Reporting group description
    		 Subjects weighing (<) 45 kilograms (kg) received an induction dose of golimumab 60 milligrams per meter square (mg/m^2) SC at Weeks 0 and 2 followed by a maintenance dose of 30 mg/m^2 SC at Week 4 and q2w through Week 26. Participants weighing greater than or equal to (>=) 45 kg received an induction dose of golimumab 100 mg SC at Weeks 0 and 2 followed by a maintenance dose of golimumab 50 mg SC at Week 4 and q2w through Week 26.

    Reporting group values
    		 Placebo Golimumab Total
    Number of subjects
    		 3 5 8
    Title for AgeCategorical
    Units: subjects
        Children (2-11 years)
    		 2 3 5
        Adolescents (12-17 years)
    		 1 2 3
        Adults (18-64 years)
    		 0 0 0
        From 65 to 84 years
    		 0 0 0
        85 years and over
    		 0 0 0
    Title for AgeContinuous
    Units: years
        arithmetic mean (standard deviation)
    		 10.04 ± 1.873 11.08 ± 2.79 -
    Title for Gender
    Units: subjects
        Female
    		 1 0 1
        Male
    		 2 5 7

    End points

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    End points reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Subjects received a subcutaneous (SC) placebo injection every 2 weeks (q2w) through Week 26 to match the active arm.

    Reporting group title
    Golimumab
    Reporting group description
    		 Subjects weighing (<) 45 kilograms (kg) received an induction dose of golimumab 60 milligrams per meter square (mg/m^2) SC at Weeks 0 and 2 followed by a maintenance dose of 30 mg/m^2 SC at Week 4 and q2w through Week 26. Participants weighing greater than or equal to (>=) 45 kg received an induction dose of golimumab 100 mg SC at Weeks 0 and 2 followed by a maintenance dose of golimumab 50 mg SC at Week 4 and q2w through Week 26.
    Reporting group title
    Placebo
    Reporting group description
    		 Following the 26-week active treatment period, participants were monitored for an additional 26 weeks for safety.

    Reporting group title
    Golimumab
    Reporting group description
    		 Following the 26-week active treatment period, participants were monitored for an additional 26 weeks for safety.

    Subject analysis set title
    Placebo
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Subjects who received at least 1 dose of study agent.

    Subject analysis set title
    Golimumab
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Subjects who received at least 1 dose of study agent.

    Primary: Percentage of Subjects with Treatment-emergent Adverse Events (TEAEs) Up to Week 26

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    End point title
    		 Percentage of Subjects with Treatment-emergent Adverse Events (TEAEs) Up to Week 26 [1]
    End point description
    An adverse event (AE) was defined as any untoward medical occurrence in clinical study subject administered medicinal product. It could be any unfavorable and unintended sign (including an abnormal finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not related to that medicinal product. Treatment emergent AEs were defined as AEs with onset during the treatment phase or that are a consequence of a pre-existing condition that has worsened since baseline. Safety analysis set included all subjects who had received at least 1 dose of study agent.
    End point type
    Primary
    End point timeframe
    Up to Week 26
    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 statistics was done, no inferential statistical analysis was performed.
    End point values
    		 Placebo Golimumab
    Number of subjects analysed
    3
    5
    Units: percentage of subjects
        number (not applicable)
    100
    100
    No statistical analyses for this end point

    Primary: Percentage of Subjects with Treatment-emergent Serious Adverse Events (SAEs) Up to Week 26

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    End point title
    		 Percentage of Subjects with Treatment-emergent Serious Adverse Events (SAEs) Up to Week 26 [2]
    End point description
    An AE was defined as any untoward medical occurrence in clinical study subject administered medicinal product. It could be any unfavorable and unintended sign (including an abnormal finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not related to that medicinal product. A SAE was defined as any untoward medical occurrence that at any dose: resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, was a suspected transmission of any infectious treatment via medicinal product and was medically important. Safety analysis set included all subjects who had received at least 1 dose of study agent.
    End point type
    Primary
    End point timeframe
    Up to Week 26
    Notes
    [2] - 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 statistics was done, no inferential statistical analysis was performed.
    End point values
    		 Placebo Golimumab
    Number of subjects analysed
    3
    5
    Units: percentage of subjects
        number (not applicable)
    0
    0
    No statistical analyses for this end point

    Primary: Percentage of Subjects with Treatment-emergent AEs Up to Week 52

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    End point title
    		 Percentage of Subjects with Treatment-emergent AEs Up to Week 52 [3]
    End point description
    An adverse event (AE) was defined as any untoward medical occurrence in clinical study subject administered medicinal product. It could be any unfavorable and unintended sign (including an abnormal finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not related to that medicinal product. Treatment emergent AEs were defined as AEs with onset during the treatment phase or that are a consequence of a pre-existing condition that has worsened since baseline. Safety analysis set included all subjects who had received at least 1 dose of study agent.
    End point type
    Primary
    End point timeframe
    Up to Week 52
    Notes
    [3] - 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 statistics was done, no inferential statistical analysis was performed.
    End point values
    		 Placebo Golimumab
    Number of subjects analysed
    3
    5
    Units: percentage of subjects
        number (not applicable)
    100
    100
    No statistical analyses for this end point

    Primary: Percentage of Subjects with Treatment-emergent SAEs Up to Week 52

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    End point title
    		 Percentage of Subjects with Treatment-emergent SAEs Up to Week 52 [4]
    End point description
    An AE was defined as any untoward medical occurrence in clinical study subject administered medicinal product. It could be any unfavorable and unintended sign (including an abnormal finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not related to that medicinal product. A SAE was defined as any untoward medical occurrence that at any dose: resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, was a suspected transmission of any infectious treatment via medicinal product and was medically important. Safety analysis set included all subjects who had received at least 1 dose of study agent.
    End point type
    Primary
    End point timeframe
    Up to Week 52
    Notes
    [4] - 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 statistics was done, no inferential statistical analysis was performed.
    End point values
    		 Placebo Golimumab
    Number of subjects analysed
    3
    5
    Units: percentage of subjects
        number (not applicable)
    0
    0
    No statistical analyses for this end point

    Primary: Percentage of Subjects with Treatment-emergent Infections Up to Week 26

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    End point title
    		 Percentage of Subjects with Treatment-emergent Infections Up to Week 26 [5]
    End point description
    Subjects who had developed non-severe infections such as influenza, upper respiratory tract infection, rhinitis, nasopharyngitis, otitis externa (active), and gastroenteritis were reported. The safety analysis set included all subjects who had received at least 1 dose of study agent.
    End point type
    Primary
    End point timeframe
    Up to Week 26
    Notes
    [5] - 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 statistics was done, no inferential statistical analysis was performed.
    End point values
    		 Placebo Golimumab
    Number of subjects analysed
    3
    5
    Units: percentage of subjects
        number (not applicable)
    100
    60
    No statistical analyses for this end point

    Primary: Percentage of Subjects with Treatment-emergent Infections Up to Week 52

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    End point title
    		 Percentage of Subjects with Treatment-emergent Infections Up to Week 52 [6]
    End point description
    Subjects who had developed non-severe infections such as influenza, upper respiratory tract infection, rhinitis, nasopharyngitis, otitis externa (active), and gastroenteritis were reported. The safety analysis set included all subjects who had received at least 1 dose of study agent.
    End point type
    Primary
    End point timeframe
    Up to Week 52
    Notes
    [6] - 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 statistics was done, no inferential statistical analysis was performed.
    End point values
    		 Placebo Golimumab
    Number of subjects analysed
    3
    5
    Units: percentage of subjects
        number (not applicable)
    100
    60
    No statistical analyses for this end point

    Primary: Percentage of Subjects with Study Treatment Injection Site Reactions

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    End point title
    		 Percentage of Subjects with Study Treatment Injection Site Reactions [7]
    End point description
    An injection site reaction was any unfavorable or unintended sign that occurred at the study agent injection site. If an injection site reaction was observed, the participant was treated at the investigator’s discretion. The safety analysis set included all subjects who had received at least 1 dose of study agent.
    End point type
    Primary
    End point timeframe
    Up to Week 52
    Notes
    [7] - 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 statistics was done, no inferential statistical analysis was performed.
    End point values
    		 Placebo Golimumab
    Number of subjects analysed
    3
    5
    Units: percentage of subjects
        number (not applicable)
    0
    40
    No statistical analyses for this end point

    Secondary: Serum Concentrations of Golimumab

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    End point title
    		 Serum Concentrations of Golimumab [8]
    End point description
    Serum samples for the measurement of golimumab concentrations were collected at Weeks 0, 2, 4, 8, 12, and 26. Samples at Week 0, 2, and 4 were associated with the induction doses administered at Weeks 0 and 2. Pharmacokinetics (PK) analysis set included 5 subjects who received at least 1 golimumab injection and had sufficient PK samples for analysis. Here 'n' (number analyzed) included all subjects who were analyzed at specified timepoints.
    End point type
    Secondary
    End point timeframe
    Weeks 0, 2, 4, 8, 12 and 26
    Notes
    [8] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Endpoint was planned to be analyzed for specified arms only.
    End point values
    		 Golimumab
    Number of subjects analysed
    5
    Units: micrograms per milliliter (μg/mL)
    arithmetic mean (standard deviation)
        Week 0: Preinjection (n=5)
    0 ± 0
        Week 2: Preinjection (n=4)
    5.09 ± 1.351
        Week 4: Preinjection (n=5)
    9.01 ± 2.78
        Week 8: Preinjection (n=5)
    5.09 ± 2.211
        Week 12: Preinjection (n=5)
    4.52 ± 2.404
        Week 26: Preinjection (n=5)
    3.95 ± 2.845
    No statistical analyses for this end point

    Secondary: Number of Subjects with Antibodies to Golimumab

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    End point title
    		 Number of Subjects with Antibodies to Golimumab [9]
    End point description
    Number of subjects with antibodies to golimumab were reported. Full Analysis Set included all subjects who received at least 1 dose of golimumab and had appropriate samples for detection of antibodies to golimumab.
    End point type
    Secondary
    End point timeframe
    Up to Week 26
    Notes
    [9] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Endpoint was planned to be analyzed for specified arms only.
    End point values
    		 Golimumab
    Number of subjects analysed
    5
    Units: subjects
    2
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Up to Week 52
    Adverse event reporting additional description
    The safety analysis set included all subjects who had received at least 1 dose of study agent.
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    23.0
    Reporting groups
    Reporting group title
    Placebo (Week 0 - 26)
    Reporting group description
    		 Subjects received a SC placebo injection q2w through Week 26 to match the active arm.

    Reporting group title
    Golimumab (Week 0 - 26)
    Reporting group description
    		 Subjects <45 kg received an induction dose of golimumab 60 mg/m^2 SC at Weeks 0 and 2 followed by a maintenance dose of 30 mg/m^2 SC at Week 4 and q2w through Week 26. Participants weighing >= 45 kg received an induction dose of golimumab 100 mg SC at Weeks 0 and 2 followed by a maintenance dose of golimumab 50 mg SC at Week 4 and q2w through Week 26.

    Reporting group title
    Placebo (Week 26 - 52)
    Reporting group description
    		 Following the 26-week active treatment period, participants were monitored for an additional 26 weeks for safety.

    Reporting group title
    Golimumab (Week 26 - 52)
    Reporting group description
    		 Following the 26-week active treatment period, participants were monitored for an additional 26 weeks for safety.

    Serious adverse events
    		 Placebo (Week 0 - 26) Golimumab (Week 0 - 26) Placebo (Week 26 - 52) Golimumab (Week 26 - 52)
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
         number of deaths (all causes)
    0
    0
    0
    0
         number of deaths resulting from adverse events
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Placebo (Week 0 - 26) Golimumab (Week 0 - 26) Placebo (Week 26 - 52) Golimumab (Week 26 - 52)
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    3 / 3 (100.00%)
    5 / 5 (100.00%)
    3 / 3 (100.00%)
    5 / 5 (100.00%)
    General disorders and administration site conditions
    Injection Site Pain
         subjects affected / exposed
    0 / 3 (0.00%)
    1 / 5 (20.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Injection Site Urticaria
         subjects affected / exposed
    0 / 3 (0.00%)
    1 / 5 (20.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Malaise
         subjects affected / exposed
    0 / 3 (0.00%)
    1 / 5 (20.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
         occurrences all number
    0
    2
    0
    0
    Immune system disorders
    Serum Sickness
         subjects affected / exposed
    1 / 3 (33.33%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    1 / 3 (33.33%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
         occurrences all number
    2
    0
    0
    0
    Nasal Congestion
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    1 / 5 (20.00%)
         occurrences all number
    0
    0
    0
    1
    Oropharyngeal Pain
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    1 / 3 (33.33%)
    1 / 5 (20.00%)
         occurrences all number
    0
    0
    1
    1
    Investigations
    Body Temperature Decreased
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    1 / 5 (20.00%)
         occurrences all number
    0
    0
    0
    1
    Injury, poisoning and procedural complications
    Head Injury
         subjects affected / exposed
    1 / 3 (33.33%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Skin Abrasion
         subjects affected / exposed
    1 / 3 (33.33%)
    1 / 5 (20.00%)
    1 / 3 (33.33%)
    1 / 5 (20.00%)
         occurrences all number
    1
    1
    1
    2
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    1 / 3 (33.33%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Headache
         subjects affected / exposed
    2 / 3 (66.67%)
    1 / 5 (20.00%)
    1 / 3 (33.33%)
    0 / 5 (0.00%)
         occurrences all number
    3
    2
    1
    0
    Syncope
         subjects affected / exposed
    1 / 3 (33.33%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Blood and lymphatic system disorders
    Neutropenia
         subjects affected / exposed
    0 / 3 (0.00%)
    1 / 5 (20.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
         occurrences all number
    0
    7
    0
    0
    Eye disorders
    Eye Pain
         subjects affected / exposed
    0 / 3 (0.00%)
    1 / 5 (20.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Gastrointestinal disorders
    Abdominal Pain
         subjects affected / exposed
    1 / 3 (33.33%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Skin and subcutaneous tissue disorders
    Dermatitis Atopic
         subjects affected / exposed
    0 / 3 (0.00%)
    1 / 5 (20.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Nail Bed Inflammation
         subjects affected / exposed
    0 / 3 (0.00%)
    1 / 5 (20.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Papule
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    1 / 5 (20.00%)
         occurrences all number
    0
    0
    0
    1
    Pigmentation Disorder
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    1 / 5 (20.00%)
         occurrences all number
    0
    0
    0
    1
    Rash
         subjects affected / exposed
    0 / 3 (0.00%)
    1 / 5 (20.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Urticaria
         subjects affected / exposed
    1 / 3 (33.33%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    1 / 3 (33.33%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Myalgia
         subjects affected / exposed
    1 / 3 (33.33%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Infections and infestations
    Gastroenteritis
         subjects affected / exposed
    1 / 3 (33.33%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
         occurrences all number
    2
    0
    0
    0
    Influenza
         subjects affected / exposed
    1 / 3 (33.33%)
    1 / 5 (20.00%)
    1 / 3 (33.33%)
    1 / 5 (20.00%)
         occurrences all number
    1
    1
    1
    3
    Nasopharyngitis
         subjects affected / exposed
    2 / 3 (66.67%)
    1 / 5 (20.00%)
    0 / 3 (0.00%)
    1 / 5 (20.00%)
         occurrences all number
    2
    1
    0
    2
    Otitis Externa
         subjects affected / exposed
    0 / 3 (0.00%)
    1 / 5 (20.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Rhinitis
         subjects affected / exposed
    1 / 3 (33.33%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Upper Respiratory Tract Infection
         subjects affected / exposed
    1 / 3 (33.33%)
    1 / 5 (20.00%)
    1 / 3 (33.33%)
    1 / 5 (20.00%)
         occurrences all number
    1
    1
    2
    1
    Metabolism and nutrition disorders
    Type 1 Diabetes Mellitus
         subjects affected / exposed
    0 / 3 (0.00%)
    1 / 5 (20.00%)
    0 / 3 (0.00%)
    1 / 5 (20.00%)
         occurrences all number
    0
    1
    0
    1

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    12 Apr 2019
    Amendment 2 had the following key changes: This sample size no longer supported the stratification on HbA1c and the population PK modeling or PK/PD analysis that was planned, which had been removed from the protocol. A change in randomization ratio from 2:1 to 6:1 (active:placebo) provided a more customary proportion of subjects on active drug to assess safety and allowed for improved recruitment, and had a higher proportion of subjects exposed to active treatment. Due to the reduced number of study subjects, the number of database locks (DBLs) had been reduced to one final DBL at Week 52.

    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.
    Sample size of 5 subjects in golimumab treatment and 3 in placebo group.For safety(5 on treatment),the limitation gives early read of safety of golimumab in younger population; also makes it not possible to draw conclusions on metabolic assessments.
    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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