Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register allows you to search for protocol and results information on:
  • interventional clinical trials that are conducted in the European Union (EU) and the European Economic Area (EEA);
  • clinical trials conducted outside the EU / EEA that are linked to European paediatric-medicine development.
  • Learn   more about the EU Clinical Trials Register   including the source of the information and the legal basis.


    The EU Clinical Trials Register currently displays   41470   clinical trials with a EudraCT protocol, of which   6815   are clinical trials conducted with subjects less than 18 years old.
    The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).


    Phase 1 trials conducted solely in adults and that are not part of an agreed PIP are not public in the EU CTR (refer to European Guidance 2008/C 168/02   Art. 3 par. 2 and   Commission Guideline 2012/C 302/03,   Art. 5) .
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Download PDF

    Clinical Trial Results:
    A Randomized, Double-Blind, Placebo-Controlled, Parallel- Group, Phase 2 Study of Baricitinib in Patients with Systemic Lupus Erythematosus (SLE)

    Summary
    EudraCT number
    2015-004404-35
    Trial protocol
    AT   PL   ES   FR  
    Global end of trial date
    09 Nov 2017

    Results information
    Results version number
    v2(current)
    This version publication date
    23 Jan 2019
    First version publication date
    14 Oct 2018
    Other versions
    v1
    Version creation reason
    • Correction of full data set
    Correction of full data set

    Trial information

    Close Top of page
    Trial identification
    Sponsor protocol code
    I4V-MC-JAHH
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT02708095
    WHO universal trial number (UTN)
    -
    Other trial identifiers
    Trial Number: 16270
    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)
    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
    09 Nov 2017
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    09 Nov 2017
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The main purpose of this study is to evaluate the efficacy and safety of the study drug known as baricitinib in participants with systemic lupus erythematosus.
    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
    24 Mar 2016
    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
    Argentina: 28
    Country: Number of subjects enrolled
    Puerto Rico: 17
    Country: Number of subjects enrolled
    Austria: 8
    Country: Number of subjects enrolled
    Korea, Democratic People's Republic of: 6
    Country: Number of subjects enrolled
    Romania: 13
    Country: Number of subjects enrolled
    United States: 95
    Country: Number of subjects enrolled
    Japan: 33
    Country: Number of subjects enrolled
    Taiwan: 18
    Country: Number of subjects enrolled
    Poland: 32
    Country: Number of subjects enrolled
    Mexico: 33
    Country: Number of subjects enrolled
    France: 16
    Country: Number of subjects enrolled
    Spain: 15
    Worldwide total number of subjects
    314
    EEA total number of subjects
    84
    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)
    294
    From 65 to 84 years
    20
    85 years and over
    0

    Subject disposition

    Close Top of page
    Recruitment
    Recruitment details
    -

    Pre-assignment
    Screening details
    Not applicable

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    Yes
    Allocation method
    Randomised - controlled
    Blinding used
    Double blind
    Roles blinded
    Subject, Investigator

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    Placebo
    Arm description
    Participants received Placebo orally once daily (QD) for 24 weeks.
    Arm type
    Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    1 placebo tablet matching baricitinib 4-mg and 1 placebo tablet matching baricitinib 2-mg were administered orally once daily (QD) for 24 weeks.

    Arm title
    2 mg Baricitinib
    Arm description
    Participants received 2 mg of Baricitinib orally QD for 24 weeks.
    Arm type
    Experimental

    Investigational medicinal product name
    Baricitinib
    Investigational medicinal product code
    LY3009104
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    1 baricitinib 2-mg tablet and 1 placebo tablet matching baricitinib 4-mg administered orally QD for 24 weeks.

    Arm title
    4 mg Baricitinib
    Arm description
    Participants received 4 mg of Baricitinib orally QD for 24 weeks.
    Arm type
    Experimental

    Investigational medicinal product name
    Baricitinib
    Investigational medicinal product code
    LY3009104
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    1 baricitinib 4-mg tablet and 1 placebo tablet matching baricitinib 2-mg administered orally QD for 24 weeks.

    Number of subjects in period 1
    Placebo 2 mg Baricitinib 4 mg Baricitinib
    Started
    105
    105
    104
    Completed
    83
    86
    86
    Not completed
    22
    19
    18
         Protocol deviation
    -
    -
    1
         Physician decision
    2
    3
    2
         Lack of efficacy
    9
    3
    -
         Adverse event, non-fatal
    4
    10
    11
         Consent withdrawn by subject
    5
    3
    4
         Lost to follow-up
    2
    -
    -

    Baseline characteristics

    Close Top of page
    Baseline characteristics reporting groups
    Reporting group title
    Placebo
    Reporting group description
    Participants received Placebo orally once daily (QD) for 24 weeks.

    Reporting group title
    2 mg Baricitinib
    Reporting group description
    Participants received 2 mg of Baricitinib orally QD for 24 weeks.

    Reporting group title
    4 mg Baricitinib
    Reporting group description
    Participants received 4 mg of Baricitinib orally QD for 24 weeks.

    Reporting group values
    Placebo 2 mg Baricitinib 4 mg Baricitinib Total
    Number of subjects
    105 105 104 314
    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
        arithmetic mean (standard deviation)
    44.9 ± 12.8 43.2 ± 11.0 45.0 ± 12.4 -
    Gender categorical
    Units: Subjects
        Female
    99 96 99 294
        Male
    6 9 5 20
    Ethnicity (NIH/OMB)
    Units: Subjects
        Hispanic or Latino
    38 32 32 102
        Not Hispanic or Latino
    52 62 60 174
        Unknown or Not Reported
    15 11 12 38
    Race (NIH/OMB)
    Units: Subjects
        American Indian or Alaska Native
    9 6 10 25
        Asian
    20 20 20 60
        Native Hawaiian or Other Pacific Islander
    0 0 0 0
        Black or African American
    5 9 7 21
        White
    71 68 65 204
        More than one race
    0 1 1 2
        Unknown or Not Reported
    0 1 1 2
    Region of Enrollment
    Units: Subjects
        Puerto Rico
    6 5 6 17
        Argentina
    9 12 7 28
        Austria
    3 2 3 8
        South Korea
    1 2 3 6
        Romania
    4 2 7 13
        United States
    31 34 30 95
        Japan
    13 10 10 33
        Taiwan
    6 7 5 18
        Poland
    13 10 9 32
        Mexico
    11 8 14 33
        France
    2 7 7 16
        Spain
    6 6 3 15

    End points

    Close Top of page
    End points reporting groups
    Reporting group title
    Placebo
    Reporting group description
    Participants received Placebo orally once daily (QD) for 24 weeks.

    Reporting group title
    2 mg Baricitinib
    Reporting group description
    Participants received 2 mg of Baricitinib orally QD for 24 weeks.

    Reporting group title
    4 mg Baricitinib
    Reporting group description
    Participants received 4 mg of Baricitinib orally QD for 24 weeks.

    Primary: Percentage of Participants who Achieve Remission of Arthritis and/or Rash defined by the Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K)

    Close Top of page
    End point title
    Percentage of Participants who Achieve Remission of Arthritis and/or Rash defined by the Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K)
    End point description
    Participants were defined as responders as follows using SLEDAI-2K definitions of arthritis and rash. If only arthritis is present at baseline, then arthritis must be absent at Week 24 to meet the primary endpoint. If only rash is present at baseline, then rash must be absent at Week 24 to meet the primary endpoint. If both arthritis and rash are present at baseline, then the primary endpoint is met if either arthritis, or rash, or both arthritis and rash are absent at Week 24. Analysis Population Description: All randomized participants who received at least 1 dose of study drug with baseline and post-baseline values at the specified time point for remission of arthritis and/or rash.
    End point type
    Primary
    End point timeframe
    Week 24
    End point values
    Placebo 2 mg Baricitinib 4 mg Baricitinib
    Number of subjects analysed
    105
    105
    104
    Units: Percentage of Participants
        number (not applicable)
    53.3
    58.1
    67.3
    Statistical analysis title
    Remission of Arthritis and/or Rash
    Comparison groups
    Placebo v 2 mg Baricitinib
    Number of subjects included in analysis
    210
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.392
    Method
    Regression, Logistic
    Parameter type
    Odds ratio (OR)
    Point estimate
    1.28
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    0.73
         upper limit
    2.27
    Statistical analysis title
    Remission of Arthritis and/or Rash
    Comparison groups
    Placebo v 4 mg Baricitinib
    Number of subjects included in analysis
    209
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.041
    Method
    Regression, Logistic
    Parameter type
    Odds ratio (OR)
    Point estimate
    1.84
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    1.02
         upper limit
    3.29

    Secondary: Percentage of Participants who Achieve SLE Responder Index 4 (SRI-4) Response

    Close Top of page
    End point title
    Percentage of Participants who Achieve SLE Responder Index 4 (SRI-4) Response
    End point description
    The SRI-4 is a composite index used to assess disease activity in SLE. SRI-4 response is defined as: 1) Reduction of ≥4 points from baseline in Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) score; 2) no new British Isles Lupus Assessment Group (BILAG) A or no more than 1 new BILAG B disease activity scores; and 3) no worsening (defined as an increase of ≥0.3 points [10 mm] from baseline) in Physician’s Global Assessment of Disease Activity. Analysis Population Description: All randomized participants who received at least 1 dose of study drug with baseline and post-baseline values at the specified time point for SRI-4 response.
    End point type
    Secondary
    End point timeframe
    Week 24
    End point values
    Placebo 2 mg Baricitinib 4 mg Baricitinib
    Number of subjects analysed
    105
    105
    104
    Units: Percentage of Participants
        number (not applicable)
    47.6
    51.4
    64.4
    Statistical analysis title
    SLE Responder Index-4 Response
    Comparison groups
    Placebo v 2 mg Baricitinib
    Number of subjects included in analysis
    210
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.44
    Method
    Regression, Logistic
    Parameter type
    Log odds ratio
    Point estimate
    1.25
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    0.71
         upper limit
    2.19
    Statistical analysis title
    SLE Responder Index-4 Response
    Comparison groups
    Placebo v 4 mg Baricitinib
    Number of subjects included in analysis
    209
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.015
    Method
    Regression, Logistic
    Parameter type
    Odds ratio (OR)
    Point estimate
    2.04
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    1.15
         upper limit
    3.62

    Secondary: Change from Baseline in SLEDAI-2K Score

    Close Top of page
    End point title
    Change from Baseline in SLEDAI-2K Score
    End point description
    SLE Disease Activity Index 2000 (SLEDAI-2K) score is a weighted, cumulative index of lupus disease activity. SLEDAI-2K is calculated from 24 individual descriptors across 9 organ systems; 0 indicates inactive disease and the maximum theoretical score is 105. Least Squares (LS) mean was determined by mixed-model repeated measures (MMRM) model with baseline of response, region, baseline disease activity (SLEDAI-2K <10, >=10), baseline anti-dsDNA status (positive, negative), treatment, time, treatment*time (type III sum of squares). Analysis Population Description: All randomized participants who received at least 1 dose of study drug with baseline and post-baseline values at the specified time point for SLEDAI-2K.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 24
    End point values
    Placebo 2 mg Baricitinib 4 mg Baricitinib
    Number of subjects analysed
    86
    88
    86
    Units: Units on a scale
        least squares mean (standard error)
    -3.82 ± 0.352
    -4.07 ± 0.356
    -4.39 ± 0.353
    Statistical analysis title
    Change From Baseline in SLEDAI-2K Score
    Comparison groups
    Placebo v 2 mg Baricitinib
    Number of subjects included in analysis
    174
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.6
    Method
    Mixed models analysis
    Parameter type
    LS Mean Difference (Final Vaules)
    Point estimate
    -0.26
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -1.23
         upper limit
    0.71
    Statistical analysis title
    Change From Baseline in SLEDAI-2K Score
    Comparison groups
    Placebo v 4 mg Baricitinib
    Number of subjects included in analysis
    172
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.243
    Method
    Mixed models analysis
    Parameter type
    LS Mean Difference (Final Vaules)
    Point estimate
    -0.58
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -1.55
         upper limit
    0.39

    Secondary: Change from Baseline in Patient's Global Assessment of Disease Activity

    Close Top of page
    End point title
    Change from Baseline in Patient's Global Assessment of Disease Activity
    End point description
    The Patient’s Global Assessment of Disease Activity is a single-item, patient reported scale developed for the assessment of the patient’s overall rating of their disease activity due to SLE. The scale measures disease activity through a 5 point Likert scale ranging from 0 (“No disease activity”) to 4 (“Severe disease activity”) at its worst over the past 7 days. LS mean was determined by MMRM model with baseline of response, region, baseline disease activity (SLEDAI-2K <10, >=10), baseline anti-dsDNA status (positive, negative), treatment, time, treatment*time (type III sum of squares). Analysis Population Description: All randomized participants who received at least 1 dose of study drug with baseline and post-baseline values at the specified time point for Patient's Global Assessment of Disease Activity.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 24
    End point values
    Placebo 2 mg Baricitinib 4 mg Baricitinib
    Number of subjects analysed
    84
    86
    86
    Units: Units on a scale
        least squares mean (standard error)
    -0.67 ± 0.105
    -0.83 ± 0.107
    -1.00 ± 0.105
    Statistical analysis title
    Change From Baseline in PGA
    Comparison groups
    Placebo v 2 mg Baricitinib
    Number of subjects included in analysis
    170
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.285
    Method
    Mixed models analysis
    Parameter type
    LS Mean Difference (Final Vaules)
    Point estimate
    -0.16
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -0.45
         upper limit
    0.13
    Statistical analysis title
    Change From Baseline in PGA
    Comparison groups
    Placebo v 4 mg Baricitinib
    Number of subjects included in analysis
    170
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.026
    Method
    Mixed models analysis
    Parameter type
    LS Mean Difference (Final Vaules)
    Point estimate
    -0.33
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -0.62
         upper limit
    -0.04

    Secondary: Population Pharmacokinetics (PK): Area Under the Concentration-Time Curve of Baricitinib at Steady State (AUCτ, ss)

    Close Top of page
    End point title
    Population Pharmacokinetics (PK): Area Under the Concentration-Time Curve of Baricitinib at Steady State (AUCτ, ss) [1]
    End point description
    Plasma samples for pharmacokinetic (PK) analysis were obtained in week 0, week 4, week 8, week 16 and 24. AUC takes all time points post dose into account and one value is reported. Analysis Population Description: All randomized participants who received at least one dose of study drug and had evaluable PK (pharmacokinetics) data.
    End point type
    Secondary
    End point timeframe
    Week (Wk) 0: 15-30 minutes (min) postdose; Wk 4: Predose, 1.5 - 4 hour (hr) postdose; Wk 8: 1 - 3 hr postdose; Wk 16: Predose.
    Notes
    [1] - 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: No arm comparison analyses were planned or conducted.
    End point values
    2 mg Baricitinib 4 mg Baricitinib
    Number of subjects analysed
    104
    104
    Units: nanogram*hour per milliliter (ng*h/mL)
        geometric mean (geometric coefficient of variation)
    265 ± 55
    569 ± 50
    No statistical analyses for this end point

    Secondary: Population Pharmacokinetics (PK): Maximum Observed Drug Concentration at Steady State (Cmax,ss)

    Close Top of page
    End point title
    Population Pharmacokinetics (PK): Maximum Observed Drug Concentration at Steady State (Cmax,ss) [2]
    End point description
    Plasma samples for pharmacokinetic (PK) analysis were obtained in week 0, week 4, week 8, week 16 and 24. Cmax takes all time points post dose into account and one value is reported. Analysis Population Description: All randomized participants who received at least one dose of study drug and had evaluable PK (pharmacokinetics) data.
    End point type
    Secondary
    End point timeframe
    Week (Wk) 0: 15-30 minutes (min) postdose; Wk 4: Predose, 1.5 - 4 hour (hr) postdose; Wk 8: 1 - 3 hr postdose; Wk 16: Predose.
    Notes
    [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: No arm comparison analyses were planned or conducted.
    End point values
    2 mg Baricitinib 4 mg Baricitinib
    Number of subjects analysed
    104
    104
    Units: nanogram per milliliter (ng/mL)
        geometric mean (geometric coefficient of variation)
    29.0 ± 30
    59.2 ± 24
    No statistical analyses for this end point

    Adverse events

    Close Top of page
    Adverse events information
    Timeframe for reporting adverse events
    Entire Study
    Adverse event reporting additional description
    I4V-MC-JAHH
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    20.0
    Reporting groups
    Reporting group title
    Placebo
    Reporting group description
    -

    Reporting group title
    4 mg Baricitinib
    Reporting group description
    -

    Reporting group title
    2 mg Baricitinib
    Reporting group description
    -

    Serious adverse events
    Placebo 4 mg Baricitinib 2 mg Baricitinib
    Total subjects affected by serious adverse events
         subjects affected / exposed
    5 / 105 (4.76%)
    10 / 104 (9.62%)
    11 / 105 (10.48%)
         number of deaths (all causes)
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    Vascular disorders
    deep vein thrombosis
    alternative dictionary used: MedDRA 20.0
         subjects affected / exposed
    0 / 105 (0.00%)
    1 / 104 (0.96%)
    0 / 105 (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
    hypertension
    alternative dictionary used: MedDRA 20.0
         subjects affected / exposed
    0 / 105 (0.00%)
    0 / 104 (0.00%)
    1 / 105 (0.95%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pregnancy, puerperium and perinatal conditions
    abortion
    alternative dictionary used: MedDRA 20.0
         subjects affected / exposed [1]
    0 / 99 (0.00%)
    0 / 99 (0.00%)
    1 / 96 (1.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Psychiatric disorders
    anxiety
    alternative dictionary used: MedDRA 20.0
         subjects affected / exposed
    0 / 105 (0.00%)
    0 / 104 (0.00%)
    1 / 105 (0.95%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    depression
    alternative dictionary used: MedDRA 20.0
         subjects affected / exposed
    0 / 105 (0.00%)
    2 / 104 (1.92%)
    0 / 105 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    mental status changes
    alternative dictionary used: MedDRA 20.0
         subjects affected / exposed
    0 / 105 (0.00%)
    0 / 104 (0.00%)
    1 / 105 (0.95%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    ankle fracture
    alternative dictionary used: MedDRA 20.0
         subjects affected / exposed
    1 / 105 (0.95%)
    0 / 104 (0.00%)
    0 / 105 (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
    joint dislocation
    alternative dictionary used: MedDRA 20.0
         subjects affected / exposed
    0 / 105 (0.00%)
    0 / 104 (0.00%)
    1 / 105 (0.95%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    tibia fracture
    alternative dictionary used: MedDRA 20.0
         subjects affected / exposed
    1 / 105 (0.95%)
    1 / 104 (0.96%)
    0 / 105 (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
    Investigations
    lipase increased
    alternative dictionary used: MedDRA 20.0
         subjects affected / exposed
    0 / 105 (0.00%)
    1 / 104 (0.96%)
    0 / 105 (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
    Cardiac disorders
    angina pectoris
    alternative dictionary used: MedDRA 20.0
         subjects affected / exposed
    0 / 105 (0.00%)
    0 / 104 (0.00%)
    1 / 105 (0.95%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    cervical dysplasia
    Additional description: This event is gender specific, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
    alternative dictionary used: MedDRA 20.0
         subjects affected / exposed [2]
    0 / 99 (0.00%)
    0 / 99 (0.00%)
    1 / 96 (1.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    lymphadenopathy
    alternative dictionary used: MedDRA 20.0
         subjects affected / exposed
    0 / 105 (0.00%)
    0 / 104 (0.00%)
    1 / 105 (0.95%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    migraine
    alternative dictionary used: MedDRA 20.0
         subjects affected / exposed
    0 / 105 (0.00%)
    0 / 104 (0.00%)
    1 / 105 (0.95%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    syncope
    alternative dictionary used: MedDRA 20.0
         subjects affected / exposed
    0 / 105 (0.00%)
    0 / 104 (0.00%)
    1 / 105 (0.95%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    diarrhoea
    alternative dictionary used: MedDRA 20.0
         subjects affected / exposed
    0 / 105 (0.00%)
    1 / 104 (0.96%)
    0 / 105 (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
    gastric ulcer
    alternative dictionary used: MedDRA 20.0
         subjects affected / exposed
    0 / 105 (0.00%)
    1 / 104 (0.96%)
    0 / 105 (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
    intestinal perforation
    alternative dictionary used: MedDRA 20.0
         subjects affected / exposed
    0 / 105 (0.00%)
    1 / 104 (0.96%)
    0 / 105 (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
    nausea
    alternative dictionary used: MedDRA 20.0
         subjects affected / exposed
    0 / 105 (0.00%)
    1 / 104 (0.96%)
    0 / 105 (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
    umbilical hernia
    alternative dictionary used: MedDRA 20.0
         subjects affected / exposed
    1 / 105 (0.95%)
    0 / 104 (0.00%)
    0 / 105 (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
    volvulus
    alternative dictionary used: MedDRA 20.0
         subjects affected / exposed
    0 / 105 (0.00%)
    0 / 104 (0.00%)
    1 / 105 (0.95%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Renal and urinary disorders
    acute kidney injury
    alternative dictionary used: MedDRA 20.0
         subjects affected / exposed
    0 / 105 (0.00%)
    1 / 104 (0.96%)
    0 / 105 (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
    lupus nephritis
    alternative dictionary used: MedDRA 20.0
         subjects affected / exposed
    1 / 105 (0.95%)
    0 / 104 (0.00%)
    0 / 105 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    osteonecrosis
    alternative dictionary used: MedDRA 20.0
         subjects affected / exposed
    0 / 105 (0.00%)
    1 / 104 (0.96%)
    0 / 105 (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
    pain in extremity
    alternative dictionary used: MedDRA 20.0
         subjects affected / exposed
    0 / 105 (0.00%)
    1 / 104 (0.96%)
    0 / 105 (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
    Infections and infestations
    appendicitis
    alternative dictionary used: MedDRA 20.0
         subjects affected / exposed
    0 / 105 (0.00%)
    1 / 104 (0.96%)
    0 / 105 (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
    cellulitis
    alternative dictionary used: MedDRA 20.0
         subjects affected / exposed
    1 / 105 (0.95%)
    0 / 104 (0.00%)
    0 / 105 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    diverticulitis
    alternative dictionary used: MedDRA 20.0
         subjects affected / exposed
    0 / 105 (0.00%)
    1 / 104 (0.96%)
    0 / 105 (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
    influenza
    alternative dictionary used: MedDRA 20.0
         subjects affected / exposed
    0 / 105 (0.00%)
    1 / 104 (0.96%)
    0 / 105 (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
    pneumonia
    alternative dictionary used: MedDRA 20.0
         subjects affected / exposed
    0 / 105 (0.00%)
    2 / 104 (1.92%)
    1 / 105 (0.95%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    tooth abscess
    alternative dictionary used: MedDRA 20.0
         subjects affected / exposed
    1 / 105 (0.95%)
    0 / 104 (0.00%)
    0 / 105 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    urinary tract infection
    alternative dictionary used: MedDRA 20.0
         subjects affected / exposed
    0 / 105 (0.00%)
    1 / 104 (0.96%)
    1 / 105 (0.95%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Notes
    [1] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
    Justification: This event is gender specific, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
    [2] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
    Justification: This event is gender specific, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    Placebo 4 mg Baricitinib 2 mg Baricitinib
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    27 / 105 (25.71%)
    32 / 104 (30.77%)
    36 / 105 (34.29%)
    Nervous system disorders
    headache
    alternative dictionary used: MedDRA 20.0
         subjects affected / exposed
    3 / 105 (2.86%)
    3 / 104 (2.88%)
    6 / 105 (5.71%)
         occurrences all number
    3
    4
    8
    Infections and infestations
    pharyngitis
    alternative dictionary used: MedDRA 20.0
         subjects affected / exposed
    3 / 105 (2.86%)
    5 / 104 (4.81%)
    6 / 105 (5.71%)
         occurrences all number
    3
    5
    6
    upper respiratory tract infection
    alternative dictionary used: MedDRA 20.0
         subjects affected / exposed
    6 / 105 (5.71%)
    8 / 104 (7.69%)
    7 / 105 (6.67%)
         occurrences all number
    6
    8
    7
    urinary tract infection
    alternative dictionary used: MedDRA 20.0
         subjects affected / exposed
    11 / 105 (10.48%)
    9 / 104 (8.65%)
    10 / 105 (9.52%)
         occurrences all number
    15
    15
    12
    viral upper respiratory tract infection
    alternative dictionary used: MedDRA 20.0
         subjects affected / exposed
    4 / 105 (3.81%)
    10 / 104 (9.62%)
    10 / 105 (9.52%)
         occurrences all number
    5
    12
    13

    More information

    Close Top of page

    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? No

    Interruptions (globally)

    Were there any global interruptions to the trial? No

    Limitations and caveats

    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
    For support, visit the EMA Service Desk , log in using your EMA account and open a ticket specifying "EU CTR" in your request.
    If you do not have an account, please visit the EMA Account management page page click on "Create an EMA account" and follow the instructions.
    The status of studies in GB is no longer updated from 1.1.2021
    For the UK, as from 1.1.2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI
    EU Clinical Trials Register Service Desk: https://servicedesk.ema.europa.eu
    European Medicines Agency © 1995-2022 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    Legal notice
    EMA HMA