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    Clinical Trial Results:
    An Open-label, Active-Controlled, Safety and Efficacy Study of Oral Baricitinib in Patients from 2 Years to Less Than 18 Years Old with Active Juvenile Idiopathic Arthritis-Associated Uveitis or Chronic Anterior Antinuclear Antibody Positive Uveitis

    Summary
    EudraCT number
    		 2019-000119-10
    Trial protocol
    		 GB   FR   DE   IT  
    Global end of trial date

    Results information
    Results version number
    		 v1(current)
    This version publication date
    02 Aug 2024
    First version publication date
    02 Aug 2024
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    I4V-MC-JAHW
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT04088409
    WHO universal trial number (UTN)
    		 -
    Other trial identifiers
    		 Trial Number: 16277
    Sponsors
    Sponsor organisation name
    Eli Lilly and Company
    Sponsor organisation address
    Lilly Corporate Center, Indianapolis, IN, United States, 46285
    Public contact
    Available Mon ‐ Fri 9 AM ‐ 5 PM EST, Eli Lilly and Company, 1 877‐CTLilly,
    Scientific contact
    Available Mon ‐ Fri 9 AM ‐ 5 PM EST, Eli Lilly and Company, 1 877‐285‐4559,
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    Yes
    EMA paediatric investigation plan number(s)
    		 EMEA-001220-PIP01-11
    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
    Interim
    Date of interim/final analysis
    17 Jul 2023
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    17 Jul 2023
    Global end of trial reached?
    No
    General information about the trial
    Main objective of the trial
    The reason for this study is to see if the study drug baricitinib given orally is safe and effective in participants with active juvenile idiopathic arthritis (JIA)-associated uveitis or chronic anterior antinuclear antibody-positive uveitis from 2 years to less than 18 years old.
    Protection of trial subjects
    This study was conducted in accordance with International Conference on Harmonization (ICH) Good Clinical Practice, and the principles of the Declaration of Helsinki, in addition to following the laws and regulations of the country or countries in which a study is conducted.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    16 Oct 2019
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    France: 4
    Country: Number of subjects enrolled
    Germany: 2
    Country: Number of subjects enrolled
    Italy: 5
    Country: Number of subjects enrolled
    Spain: 3
    Country: Number of subjects enrolled
    United Kingdom: 15
    Worldwide total number of subjects
    29
    EEA total number of subjects
    14
    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)
    16
    Adolescents (12-17 years)
    13
    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
    		 Overall, 30 participants were enrolled in the study. One participant (in baricitinib arm) withdrew from the study before administration of the study drug. This study is conducted in 2 parts. Part A (24 weeks) and Part B (260 weeks). Participants assigned to baricitinib and completed the Part A as a responder continued receiving (contd..)

    Pre-assignment
    Screening details
    		 (contd..) baricitinib until the end of study or discontinuation from the study.

    Period 1
    Period 1 title
    Part A
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Baricitinib
    Arm description
    		 Participants ≥9 to <18 years of age were administered 4 milligrams (mg) baricitinib once daily (QD). Participants <9 years of age were administered 2 mg baricitinib QD. Participants <6 years of age received an oral suspension. Participants ≥6 to <12 years of age had the option of receiving an oral suspension. Participants >12 years of age were supplied tablets.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Baricitinib
    Investigational medicinal product code
    Other name
    LY3009104
    Pharmaceutical forms
    Tablet, Oral drops, suspension
    Routes of administration
    Oral use
    Dosage and administration details
    Administered orally

    Arm title
    		 Adalimumab
    Arm description
    		 Participants received adalimumab administered subcutaneously (SC) once every 2 weeks. The dose was based on body weight: 20 mg every 2 weeks for participants weighing <30 kilograms (kg), or 40 mg every 2 weeks for participants weighing ≥30 kg.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Adalimumab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Administered SC

    Number of subjects in period 1
    		Baricitinib Adalimumab
    Started
    24
    5
    Received At Least 1 Dose of Study Drug
    24
    5
    Completed
    10
    0
    Not completed
    14
    5
         Consent withdrawn by subject
    1
    1
         Adverse event, non-fatal
    1
    -
         Did Not Meet Randomization Criteria
    2
    -
         Lost to follow-up
    1
    -
         Per Protocol, Participants Discontinued Study
    -
    4
         Lack of efficacy
    9
    -
    Period 2
    Period 2 title
    Part B
    Is this the baseline period?
    		 No
    Allocation method
    Non-randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 Baricitinib
    Arm description
    		 Participants ≥9 to <18 years of age were administered 4 milligrams (mg) baricitinib once daily (QD). Participants <9 years of age were administered 2 mg baricitinib QD. Participants <6 years of age received an oral suspension. Participants ≥6 to <12 years of age had the option of receiving an oral suspension. Participants >12 years of age were supplied tablets.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Baricitinib
    Investigational medicinal product code
    Other name
    LY3009104
    Pharmaceutical forms
    Oral suspension, Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Administered orally

    Number of subjects in period 2
    		Baricitinib
    Started
    10
    Completed
    0
    Not completed
    10
         Ongoing Treatment
    10

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Baricitinib
    Reporting group description
    		 Participants ≥9 to <18 years of age were administered 4 milligrams (mg) baricitinib once daily (QD). Participants <9 years of age were administered 2 mg baricitinib QD. Participants <6 years of age received an oral suspension. Participants ≥6 to <12 years of age had the option of receiving an oral suspension. Participants >12 years of age were supplied tablets.

    Reporting group title
    Adalimumab
    Reporting group description
    		 Participants received adalimumab administered subcutaneously (SC) once every 2 weeks. The dose was based on body weight: 20 mg every 2 weeks for participants weighing <30 kilograms (kg), or 40 mg every 2 weeks for participants weighing ≥30 kg.

    Reporting group values
    		 Baricitinib Adalimumab Total
    Number of subjects
    		 24 5 29
    Age categorical
    Units: Subjects
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 11.60 ( 3.53 ) 6.60 ( 2.51 ) -
    Gender categorical
    Units: Subjects
        Female
    		 14 5 19
        Male
    		 10 0 10
    Ethnicity (NIH/OMB)
    Units: Subjects
        Hispanic or Latino
    		 2 0 2
        Not Hispanic or Latino
    		 12 4 16
        Unknown or Not Reported
    		 10 1 11
    Race (NIH/OMB)
    Units: Subjects
        American Indian or Alaska Native
    		 0 0 0
        Asian
    		 0 0 0
        Native Hawaiian or Other Pacific Islander
    		 0 0 0
        Black or African American
    		 0 1 1
        White
    		 20 4 24
        More than one race
    		 0 0 0
        Unknown or Not Reported
    		 4 0 4
    Region of Enrollment
    Units: Subjects
        France
    		 4 0 4
        Germany
    		 1 1 2
        Italy
    		 3 2 5
        Spain
    		 3 0 3
        United Kingdom
    		 13 2 15
    Subject analysis sets

    Subject analysis set title
    Baricitinib
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Participants ≥9 to <18 years of age were administered 4 mg baricitinib QD. Participants <9 years of age were administered 2 mg baricitinib QD. Participants <6 years of age received an oral suspension. Participants ≥6 to <12 years of age had the option of receiving an oral suspension. Participants >12 years of age were supplied tablets.

    Subject analysis sets values
    		 Baricitinib
    Number of subjects
    24
    Age categorical
    Units: Subjects
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    11.60 ( 3.53 )
    Gender categorical
    Units: Subjects
        Female
    14
        Male
    10
    Ethnicity (NIH/OMB)
    Units: Subjects
        Hispanic or Latino
    2
        Not Hispanic or Latino
    12
        Unknown or Not Reported
    10
    Race (NIH/OMB)
    Units: Subjects
        American Indian or Alaska Native
    0
        Asian
    0
        Native Hawaiian or Other Pacific Islander
    0
        Black or African American
    0
        White
    20
        More than one race
    0
        Unknown or Not Reported
    4
    Region of Enrollment
    Units: Subjects
        France
    4
        Germany
    1
        Italy
    3
        Spain
    3
        United Kingdom
    13

    End points

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    End points reporting groups
    Reporting group title
    Baricitinib
    Reporting group description
    		 Participants ≥9 to <18 years of age were administered 4 milligrams (mg) baricitinib once daily (QD). Participants <9 years of age were administered 2 mg baricitinib QD. Participants <6 years of age received an oral suspension. Participants ≥6 to <12 years of age had the option of receiving an oral suspension. Participants >12 years of age were supplied tablets.

    Reporting group title
    Adalimumab
    Reporting group description
    		 Participants received adalimumab administered subcutaneously (SC) once every 2 weeks. The dose was based on body weight: 20 mg every 2 weeks for participants weighing <30 kilograms (kg), or 40 mg every 2 weeks for participants weighing ≥30 kg.
    Reporting group title
    Baricitinib
    Reporting group description
    		 Participants ≥9 to <18 years of age were administered 4 milligrams (mg) baricitinib once daily (QD). Participants <9 years of age were administered 2 mg baricitinib QD. Participants <6 years of age received an oral suspension. Participants ≥6 to <12 years of age had the option of receiving an oral suspension. Participants >12 years of age were supplied tablets.

    Subject analysis set title
    Baricitinib
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Participants ≥9 to <18 years of age were administered 4 mg baricitinib QD. Participants <9 years of age were administered 2 mg baricitinib QD. Participants <6 years of age received an oral suspension. Participants ≥6 to <12 years of age had the option of receiving an oral suspension. Participants >12 years of age were supplied tablets.

    Primary: Part A: Percentage of Responders for Baricitinib at Week 24

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    End point title
    		 Part A: Percentage of Responders for Baricitinib at Week 24 [1] [2]
    End point description
    Response was defined according to the Standardization of Uveitis Nomenclature (SUN) criteria as a 2-step decrease in the level of inflammation (anterior chamber cells) or decrease to zero through week 24, in the eye most severely affected at baseline. Analysis population description: All participants who received at least one dose of baricitinib in Part A.
    End point type
    Primary
    End point timeframe
    Week 24
    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: No inferential statistics was planned for this end point.
    [2] - 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: Descriptive statistics was added in baseline period reporting arms. The complete results will be disclosed after the study is completed.
    End point values
    		 Baricitinib
    Number of subjects analysed
    24
    Units: Percentage of participants
        number (not applicable)
    33.3
    No statistical analyses for this end point

    Secondary: Change from Baseline in SUN Grade of Cells in the Anterior Chamber in the Most Severely Affected Eye

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    End point title
    		 Change from Baseline in SUN Grade of Cells in the Anterior Chamber in the Most Severely Affected Eye [3]
    End point description
    Outcome data will be provided after the study is completed.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 24
    Notes
    [3] - 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: Descriptive statistics was added in baseline period reporting arms. The complete results will be disclosed after the study is completed.
    End point values
    		 Baricitinib
    Number of subjects analysed
    0 [4]
    Units: Score on a Scale
        number (not applicable)
    Notes
    [4] - Outcome data will be provided after the study is completed.
    No statistical analyses for this end point

    Secondary: Change from Baseline in SUN Grade of Cells in the Anterior Chamber in the Less Severely Affected Eye (If Applicable)

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    End point title
    		 Change from Baseline in SUN Grade of Cells in the Anterior Chamber in the Less Severely Affected Eye (If Applicable) [5]
    End point description
    Outcome data will be provided after the study is completed.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 24
    Notes
    [5] - 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: Descriptive statistics was added in baseline period reporting arms. The complete results will be disclosed after the study is completed.
    End point values
    		 Baricitinib
    Number of subjects analysed
    0 [6]
    Units: score on a Scale
        number (not applicable)
    Notes
    [6] - Outcome data will be provided after the study is completed.
    No statistical analyses for this end point

    Secondary: Percentage of Responders in Participants with Bilateral Uveitis Disease at Baseline

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    End point title
    		 Percentage of Responders in Participants with Bilateral Uveitis Disease at Baseline [7]
    End point description
    Outcome data will be provided after the study is completed.
    End point type
    Secondary
    End point timeframe
    Week 24
    Notes
    [7] - 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: Descriptive statistics was added in baseline period reporting arms. The complete results will be disclosed after the study is completed.
    End point values
    		 Baricitinib
    Number of subjects analysed
    0 [8]
    Units: Percentage of Participants
        number (not applicable)
    Notes
    [8] - Outcome data will be provided after the study is completed.
    No statistical analyses for this end point

    Secondary: Change from Baseline in Visual Acuity Measured by Age-AppropriateLogarithm of the Minimum Angle of Resolution (LogMAR) Test

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    End point title
    		 Change from Baseline in Visual Acuity Measured by Age-AppropriateLogarithm of the Minimum Angle of Resolution (LogMAR) Test [9]
    End point description
    Outcome data will be provided after the study is completed.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 24
    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: Descriptive statistics was added in baseline period reporting arms. The complete results will be disclosed after the study is completed.
    End point values
    		 Baricitinib
    Number of subjects analysed
    0 [10]
    Units: Score on a Scale
        number (not applicable)
    Notes
    [10] - Outcome data will be provided after the study is completed.
    No statistical analyses for this end point

    Secondary: Change from Baseline in Vitreous Haze

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    End point title
    		 Change from Baseline in Vitreous Haze [11]
    End point description
    Outcome data will be provided after the study is completed.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 24
    Notes
    [11] - 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: Descriptive statistics was added in baseline period reporting arms. The complete results will be disclosed after the study is completed.
    End point values
    		 Baricitinib
    Number of subjects analysed
    0 [12]
    Units: Score on a Scale
        number (not applicable)
    Notes
    [12] - Outcome data will be provided after the study is completed.
    No statistical analyses for this end point

    Secondary: Change from Baseline in Grade of Flare in the Anterior Chamber

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    End point title
    		 Change from Baseline in Grade of Flare in the Anterior Chamber [13]
    End point description
    Outcome data will be provided after the study is completed.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 24
    Notes
    [13] - 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: Descriptive statistics was added in baseline period reporting arms. The complete results will be disclosed after the study is completed.
    End point values
    		 Baricitinib
    Number of subjects analysed
    0 [14]
    Units: Score on a Scale
        number (not applicable)
    Notes
    [14] - Outcome data will be provided after the study is completed.
    No statistical analyses for this end point

    Secondary: Percentage of Participants with Inactive Anterior Uveitis (usingSUN Definition)

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    End point title
    		 Percentage of Participants with Inactive Anterior Uveitis (usingSUN Definition) [15]
    End point description
    Outcome data will be provided after the study is completed.
    End point type
    Secondary
    End point timeframe
    Week 24
    Notes
    [15] - 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: Descriptive statistics was added in baseline period reporting arms. The complete results will be disclosed after the study is completed.
    End point values
    		 Baricitinib
    Number of subjects analysed
    0 [16]
    Units: Percentage of Participants
        number (not applicable)
    Notes
    [16] - Outcome data will be provided after the study is completed.
    No statistical analyses for this end point

    Secondary: Time to Inactive Anterior Uveitis Disease (Using SUNDefinition)

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    End point title
    		 Time to Inactive Anterior Uveitis Disease (Using SUNDefinition) [17]
    End point description
    Outcome data will be provided after the study is completed.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 24
    Notes
    [17] - 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: Descriptive statistics was added in baseline period reporting arms. The complete results will be disclosed after the study is completed.
    End point values
    		 Baricitinib
    Number of subjects analysed
    0 [18]
    Units: Weeks
        number (not applicable)
    Notes
    [18] - Outcome data will be provided after the study is completed.
    No statistical analyses for this end point

    Secondary: Percentage of Participants who are Able to Taper ConcomitantTopical Corticosteroids to <2 Drops Per Day

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    End point title
    		 Percentage of Participants who are Able to Taper ConcomitantTopical Corticosteroids to <2 Drops Per Day [19]
    End point description
    Outcome data will be provided after the study is completed.
    End point type
    Secondary
    End point timeframe
    Week 24
    Notes
    [19] - 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: Descriptive statistics was added in baseline period reporting arms. The complete results will be disclosed after the study is completed.
    End point values
    		 Baricitinib
    Number of subjects analysed
    0 [20]
    Units: Percentage of Participants
        number (not applicable)
    Notes
    [20] - Outcome data will be provided after the study is completed.
    No statistical analyses for this end point

    Secondary: Pediatric American College of Rheumatology (PediACR30) Response Rate (For Participants with JIA-U)

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    End point title
    		 Pediatric American College of Rheumatology (PediACR30) Response Rate (For Participants with JIA-U) [21]
    End point description
    Outcome data will be provided after the study is completed.
    End point type
    Secondary
    End point timeframe
    Week 24
    Notes
    [21] - 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: Descriptive statistics was added in baseline period reporting arms. The complete results will be disclosed after the study is completed.
    End point values
    		 Baricitinib
    Number of subjects analysed
    0 [22]
    Units: Percentage of Participants
        number (not applicable)
    Notes
    [22] - Outcome data will be provided after the study is completed.
    No statistical analyses for this end point

    Secondary: Change from Baseline in Overall Uveitis-Related Disability

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    End point title
    		 Change from Baseline in Overall Uveitis-Related Disability [23]
    End point description
    Outcome data will be provided after the study is completed.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 24
    Notes
    [23] - 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: Descriptive statistics was added in baseline period reporting arms. The complete results will be disclosed after the study is completed.
    End point values
    		 Baricitinib
    Number of subjects analysed
    0 [24]
    Units: Score on a Scale
        number (not applicable)
    Notes
    [24] - Outcome data will be provided after the study is completed.
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Baseline To Up To 55 Weeks
    Adverse event reporting additional description
    I4V-MC-JAHW
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    26.1
    Reporting groups
    Reporting group title
    Adalimumab
    Reporting group description
    		 -

    Reporting group title
    Baricitinib
    Reporting group description
    		 -

    Serious adverse events
    		 Adalimumab Baricitinib
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 5 (20.00%)
    2 / 24 (8.33%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    Injury, poisoning and procedural complications
    intentional overdose
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    0 / 5 (0.00%)
    1 / 24 (4.17%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Eye disorders
    uveitis
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    0 / 5 (0.00%)
    1 / 24 (4.17%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    juvenile idiopathic arthritis
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    1 / 5 (20.00%)
    0 / 24 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Adalimumab Baricitinib
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    4 / 5 (80.00%)
    16 / 24 (66.67%)
    Investigations
    alanine aminotransferase increased
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    1 / 5 (20.00%)
    0 / 24 (0.00%)
         occurrences all number
    1
    0
    blood triglycerides increased
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    1 / 5 (20.00%)
    1 / 24 (4.17%)
         occurrences all number
    1
    1
    blood bilirubin increased
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    1 / 5 (20.00%)
    0 / 24 (0.00%)
         occurrences all number
    1
    0
    aspartate aminotransferase increased
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    1 / 5 (20.00%)
    0 / 24 (0.00%)
         occurrences all number
    1
    0
    bilirubin conjugated increased
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    1 / 5 (20.00%)
    0 / 24 (0.00%)
         occurrences all number
    1
    0
    mean platelet volume decreased
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    1 / 5 (20.00%)
    0 / 24 (0.00%)
         occurrences all number
    1
    0
    neutrophil count decreased
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    1 / 5 (20.00%)
    0 / 24 (0.00%)
         occurrences all number
    1
    0
    Injury, poisoning and procedural complications
    injection related reaction
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    1 / 5 (20.00%)
    0 / 24 (0.00%)
         occurrences all number
    1
    0
    Nervous system disorders
    headache
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    0 / 5 (0.00%)
    3 / 24 (12.50%)
         occurrences all number
    0
    3
    General disorders and administration site conditions
    adverse drug reaction
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    1 / 5 (20.00%)
    0 / 24 (0.00%)
         occurrences all number
    1
    0
    illness
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    1 / 5 (20.00%)
    0 / 24 (0.00%)
         occurrences all number
    1
    0
    pyrexia
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    1 / 5 (20.00%)
    3 / 24 (12.50%)
         occurrences all number
    1
    3
    Blood and lymphatic system disorders
    iron deficiency anaemia
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    1 / 5 (20.00%)
    0 / 24 (0.00%)
         occurrences all number
    1
    0
    Eye disorders
    macular oedema
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    1 / 5 (20.00%)
    0 / 24 (0.00%)
         occurrences all number
    1
    0
    Gastrointestinal disorders
    abdominal pain upper
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    1 / 5 (20.00%)
    3 / 24 (12.50%)
         occurrences all number
    1
    3
    nausea
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    0 / 5 (0.00%)
    4 / 24 (16.67%)
         occurrences all number
    0
    4
    vomiting
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    0 / 5 (0.00%)
    3 / 24 (12.50%)
         occurrences all number
    0
    3
    Respiratory, thoracic and mediastinal disorders
    cough
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    0 / 5 (0.00%)
    2 / 24 (8.33%)
         occurrences all number
    0
    2
    oropharyngeal pain
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    0 / 5 (0.00%)
    4 / 24 (16.67%)
         occurrences all number
    0
    4
    Skin and subcutaneous tissue disorders
    acne
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    0 / 5 (0.00%)
    2 / 24 (8.33%)
         occurrences all number
    0
    2
    Musculoskeletal and connective tissue disorders
    bone development abnormal
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    1 / 5 (20.00%)
    0 / 24 (0.00%)
         occurrences all number
    1
    0
    Infections and infestations
    covid-19
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    1 / 5 (20.00%)
    1 / 24 (4.17%)
         occurrences all number
    1
    1
    nasopharyngitis
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    1 / 5 (20.00%)
    2 / 24 (8.33%)
         occurrences all number
    1
    2
    otitis media
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    1 / 5 (20.00%)
    0 / 24 (0.00%)
         occurrences all number
    1
    0
    urinary tract infection
    alternative dictionary used: MedDRA 26.1
         subjects affected / exposed
    1 / 5 (20.00%)
    1 / 24 (4.17%)
         occurrences all number
    1
    1

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    05 Apr 2019
    - Clarified statements in Schedule of Activities section, Inclusion and Exclusion Criteria; - Updated information related to Study Assessments and Procedures.
    31 May 2019
    -Specified number of participants enrolled; -Updated sample size determination secondary analyses table to make the information more specific.
    14 Aug 2020
    -Updated study figure for the overall design; - Updated terms in the Schedule of Activities section.
    07 Nov 2020
    -Updated study figure for the overall design; - Updated terms in the Schedule of Activities section.
    14 Jun 2023
    -Updated cohorts and study figure for more clarity; - Editorial changes made throughout the protocol to improve the clarity.

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

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