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    Clinical Trial Results:
    A Multicenter Open-Label Study of the Long-term Safety and Efficacy of the Human Anti-TNF Monoclonal Antibody Adalimumab in Subjects with Non-infectious Intermediate Uveitis, Posterior Uveitis, or Panuveitis

    Summary
    EudraCT number
    2009-016196-29
    Trial protocol
    FR   ES   BE   PT   GB   DE   DK   AT   IT   CZ   GR  
    Global end of trial date
    21 May 2018

    Results information
    Results version number
    v1(current)
    This version publication date
    19 Apr 2019
    First version publication date
    19 Apr 2019
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    M11-327
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT01148225
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    AbbVie Deutschland GmbH & Co. KG
    Sponsor organisation address
    AbbVie House, Vanwall Business Park, Vanwall Road, Maidenhead, Berkshire, United Kingdom, SL6-4UB
    Public contact
    Global Medical Services, AbbVie, 001 800-633-9110,
    Scientific contact
    Alexandra Song, AbbVie, Alex.Song@abbvie.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    21 May 2018
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    21 May 2018
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The purpose of this study is to evaluate the long term efficacy and safety of adalimumab participants with non-infectious intermediate uveitis, posterior uveitis, or panuveitis.
    Protection of trial subjects
    Subject and/or legal guardian read and understood the information provided about the study and gave written permission.
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    23 Nov 2010
    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
    Argentina: 21
    Country: Number of subjects enrolled
    Australia: 16
    Country: Number of subjects enrolled
    Austria: 9
    Country: Number of subjects enrolled
    Belgium: 43
    Country: Number of subjects enrolled
    Brazil: 2
    Country: Number of subjects enrolled
    Canada: 19
    Country: Number of subjects enrolled
    Czech Republic: 2
    Country: Number of subjects enrolled
    Denmark: 5
    Country: Number of subjects enrolled
    France: 8
    Country: Number of subjects enrolled
    Germany: 24
    Country: Number of subjects enrolled
    Greece: 3
    Country: Number of subjects enrolled
    Israel: 9
    Country: Number of subjects enrolled
    Italy: 34
    Country: Number of subjects enrolled
    Japan: 44
    Country: Number of subjects enrolled
    Mexico: 7
    Country: Number of subjects enrolled
    Poland: 13
    Country: Number of subjects enrolled
    Portugal: 3
    Country: Number of subjects enrolled
    Spain: 9
    Country: Number of subjects enrolled
    Switzerland: 10
    Country: Number of subjects enrolled
    United Kingdom: 22
    Country: Number of subjects enrolled
    United States: 121
    Worldwide total number of subjects
    424
    EEA total number of subjects
    175
    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)
    390
    From 65 to 84 years
    34
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    -

    Pre-assignment
    Screening details
    A total of 424 participants were enrolled and received ≥1 dose of study drug (Safety population); 364 participants were included in the intent-to-treat (ITT) population (reasons for exclusion: incomplete efficacy data or GCP compliance issues at 2 sites (n=7); diabetic retinopathy [n=1]; cataract surgery [n=26]; and previous vitrectomy [n=26]).

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

    Arms
    Arm title
    Adalimumab
    Arm description
    Participants received open label (OL) adalimumab 40 mg by subcutaneous (SC) injection every other week (eow) until the final visit.
    Arm type
    Experimental

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

    Number of subjects in period 1
    Adalimumab
    Started
    424
    Completed
    239
    Not completed
    185
         Not specified
             185

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Adalimumab
    Reporting group description
    Participants received open label (OL) adalimumab 40 mg by subcutaneous (SC) injection every other week (eow) until the final visit.

    Reporting group values
    Adalimumab Total
    Number of subjects
    424 424
    Age categorical
    Units: Subjects
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    43.44 ± 14.066 -
    Gender categorical
    Units: Subjects
        Female
    249 249
        Male
    175 175
    Ethnicity (NIH/OMB)
    Units: Subjects
        Hispanic or Latino
    77 77
        Not Hispanic or Latino
    347 347

    End points

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    End points reporting groups
    Reporting group title
    Adalimumab
    Reporting group description
    Participants received open label (OL) adalimumab 40 mg by subcutaneous (SC) injection every other week (eow) until the final visit.

    Subject analysis set title
    Adalimumab
    Subject analysis set type
    Safety analysis
    Subject analysis set description
    Safety analysis set: includes all participants who received at least one dose of study medication.

    Primary: Number of Participants With Adverse Events

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    End point title
    Number of Participants With Adverse Events [1]
    End point description
    An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. The investigator assessed the relationship of each event to the use of study drug as either probably related, possibly related, probably not related or not related. A serious adverse event (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the subject and may require medical or surgical intervention to prevent any of the outcomes listed above. Treatment-emergent events (TEAEs/TESAEs) are defined as any event with an onset date on or after the first dose of study drug and up to 70 days after the last dose. See the Adverse Event section for details.
    End point type
    Primary
    End point timeframe
    Baseline to Final Visit (up to 366 weeks)
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Descriptive data are summarized for this end point per protocol.
    End point values
    Adalimumab
    Number of subjects analysed
    424 [2]
    Units: Participants
        Any TEAE
    398
        Any TESAE
    101
    Notes
    [2] - Safety analysis set: includes all participants who received at least one dose of study medication.
    No statistical analyses for this end point

    Primary: Hematology: Number of Participants With Potentially Clinically Significant (PCS) Values

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    End point title
    Hematology: Number of Participants With Potentially Clinically Significant (PCS) Values [3]
    End point description
    PCS laboratory values were defined as Common Toxicity Criteria (CTC) according to the National Cancer Institute Common Terminology for Adverse Events (NCI CTCAE) v3.0 ≥ Grade 3. Abbreviations used include g=grams; L=liters.
    End point type
    Primary
    End point timeframe
    Baseline to Final Visit (Up to 366 weeks)
    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 data are summarized for this end point per protocol.
    End point values
    Adalimumab
    Number of subjects analysed
    424 [4]
    Units: Participants
        Hemoglobin (Low: <80-65)
    3
        Neutrophils (Low:<1.0-0.5*10^9/L)
    6
        Lymphocytes (Low:<0.5-0.2*10^9/L)
    7
    Notes
    [4] - Safety analysis set: includes all participants who received at least one dose of study medication.
    No statistical analyses for this end point

    Primary: Chemistry: Number of Participants With PCS Values

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    End point title
    Chemistry: Number of Participants With PCS Values [5]
    End point description
    PCS laboratory values were defined as Common Toxicity Criteria (CTC) according to the National Cancer Institute Common Terminology for Adverse Events (NCI CTCAE) v3.0 ≥ Grade 3. Abbreviations include ALT/SGPT=alanine aminotransferase/serum glutamate pyruvate transaminase; AST/SGOT=aspartate aminotransferase/serum glutamate oxaloacetate transaminase; g/L=grams/liter; mmol/L=millimoles/liter; ULN=upper limit of normal.
    End point type
    Primary
    End point timeframe
    Baseline to Final Visit (Up to 366 weeks)
    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 data are summarized for this end point per protocol.
    End point values
    Adalimumab
    Number of subjects analysed
    424 [6]
    Units: Participants
        ALT/SGPT (High:>5.0-20.0*ULN)
    2
        AST/SGOT (High: >5.0-20.0*ULN)
    3
        Bilirubin, Total (High: >3.0-10.0*ULN)
    1
        Creatinine (High:>3.0-6.0*ULN)
    2
        Phosphate Inorganic (Low:<0.6-0.3 mmol/L)
    5
        Sodium (Low: <130-120 mmol/L)
    4
        Potassium (Low:<3.0-2.5 mmol/L)
    7
        Glucose (High: >13.9-27.8 mmol/L)
    18
        Albumin (Low: <20.0 g/L)
    2
        Cholesterol (High: >10.34-12.92 mmol/L)
    3
        Triglycerides (High: >5.0-10*ULN)
    8
    Notes
    [6] - Safety analysis set: includes all participants who received at least one dose of study medication.
    No statistical analyses for this end point

    Primary: Pulse (Sitting): Mean Change (Beats Per Minute) From Baseline To Final Visit

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    End point title
    Pulse (Sitting): Mean Change (Beats Per Minute) From Baseline To Final Visit [7]
    End point description
    Heart rate (beats per minute) was measured while the participant was sitting.
    End point type
    Primary
    End point timeframe
    Baseline to Final Visit (Up to 366 weeks)
    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 data are summarized for this end point per protocol.
    End point values
    Adalimumab
    Number of subjects analysed
    424 [8]
    Units: beats per minute
    arithmetic mean (standard deviation)
        beats per minute
    -1.0 ± 11.92
    Notes
    [8] - Safety analysis set: includes all participants who received at least one dose of study medication.
    No statistical analyses for this end point

    Primary: Respiratory Rate (Sitting): Mean Change (Respirations Per Minute) From Baseline To Final Visit

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    End point title
    Respiratory Rate (Sitting): Mean Change (Respirations Per Minute) From Baseline To Final Visit [9]
    End point description
    Respiratory rate (respirations per minute) was measured while the participant was sitting.
    End point type
    Primary
    End point timeframe
    Baseline to Final Visit (Up to 366 weeks)
    Notes
    [9] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Descriptive data are summarized for this end point per protocol.
    End point values
    Adalimumab
    Number of subjects analysed
    424 [10]
    Units: respirations per minute
    arithmetic mean (standard deviation)
        respirations per minute
    -0.1 ± 2.94
    Notes
    [10] - Safety analysis set: includes all participants who received at least one dose of study medication.
    No statistical analyses for this end point

    Primary: Temperature (Sitting): Mean Change (Centigrade) From Baseline To Final Visit

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    End point title
    Temperature (Sitting): Mean Change (Centigrade) From Baseline To Final Visit [11]
    End point description
    Temperature was measured while the participant was sitting.
    End point type
    Primary
    End point timeframe
    Baseline to Final Visit (Up to 366 weeks)
    Notes
    [11] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Descriptive data are summarized for this end point per protocol.
    End point values
    Adalimumab
    Number of subjects analysed
    424 [12]
    Units: Centigrade
    arithmetic mean (standard deviation)
        Centigrade
    -0.03 ± 0.516
    Notes
    [12] - Safety analysis set: includes all participants who received at least one dose of study medication.
    No statistical analyses for this end point

    Primary: Diastolic and Systolic Blood Pressure (Sitting): Mean Change (mmHg) From Baseline To Final Visit

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    End point title
    Diastolic and Systolic Blood Pressure (Sitting): Mean Change (mmHg) From Baseline To Final Visit [13]
    End point description
    Blood pressure was measured while the participant was sitting. Abbreviations used include mmHg=millimeters of mercury.
    End point type
    Primary
    End point timeframe
    Baseline to Final Visit (Up to 366 weeks)
    Notes
    [13] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Descriptive data are summarized for this end point per protocol.
    End point values
    Adalimumab
    Number of subjects analysed
    424 [14]
    Units: mmHg
    arithmetic mean (standard deviation)
        Diastolic Blood Pressure (Sitting)
    1.443 ± 10.4373
        Systolic Blood Pressure (Sitting)
    1.955 ± 14.6281
    Notes
    [14] - Safety analysis set: includes all participants who received at least one dose of study medication.
    No statistical analyses for this end point

    Secondary: Percentage of Participants in Quiescence Over Time

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    End point title
    Percentage of Participants in Quiescence Over Time
    End point description
    Quiescence is defined as no active inflammatory lesions and anterior chamber (AC) cell grade ≤ 0.5+ and vitreous haze (VH) grade ≤0.5+. Participants with active uveitis at study entry could have been in quiescence at Week 0 because all participants were evaluated for uveitis status at the Final/Early Termination visit of the lead-in study and the Week 0 visit could have occurred up to 28 days later during which time the participant's disease status may have changed. n=the number of participants at given time point.
    End point type
    Secondary
    End point timeframe
    Weeks 0, 2, 4, 8, 12, 18, 30, 42, 54, 66, 78, 90, 102, 114, 126, 138, 150, 162, 174, 186, 198, 210, 222, 234, and 246
    End point values
    Adalimumab
    Number of subjects analysed
    364 [15]
    Units: percentage of participants
    number (confidence interval 95%)
        Week 0 (n=364)
    33.5 (28.7 to 38.6)
        Week 2 (n=348)
    56.3 (50.9 to 61.6)
        Week 4 (n=323)
    63.8 (58.3 to 69.0)
        Week 8 (n=343)
    72.0 (66.9 to 76.7)
        Week 12 (n=333)
    72.4 (67.2 to 77.1)
        Week 18 (n=330)
    75.2 (70.1 to 79.7)
        Week 30 (n=319)
    79.9 (75.1 to 84.2)
        Week 42 (n=310)
    81.3 (76.5 to 85.5)
        Week 54 (n=296)
    81.1 (76.1 to 85.4)
        Week 66 (n=284)
    85.9 (81.3 to 89.7)
        Week 78 (n=271)
    86.3 (81.7 to 90.2)
        Week 90 (n=261)
    87.4 (82.7 to 91.1)
        Week 102 (n=245)
    87.3 (82.5 to 91.2)
        Week 114 (n=231)
    87.9 (83.0 to 91.8)
        Week 126 (n=215)
    88.4 (83.3 to 92.3)
        Week 138 (n=196)
    89.3 (84.1 to 93.2)
        Week 150 (n=180)
    85.0 (78.9 to 89.9)
        Week 162 (n=154)
    87.0 (80.7 to 91.9)
        Week 174 (n=142)
    87.3 (80.7 to 92.3)
        Week 186 (n=128)
    90.6 (84.2 to 95.1)
        Week 198 (n=113)
    89.4 (82.2 to 94.4)
        Week 210 (n=88)
    88.6 (80.1 to 94.4)
        Week 222 (n=70)
    92.9 (84.1 to 97.6)
        Week 234 (n=51)
    96.1 (86.5 to 99.5)
        Week 246 (n=42)
    95.2 (83.8 to 99.4)
    Notes
    [15] - ITT set: all participants with at least 1 dose of study drug and evaluable data at a given timepoint
    No statistical analyses for this end point

    Secondary: Percentage of Participants With Uveitis Flare Among Participants With Inactive Uveitis at Study Start

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    End point title
    Percentage of Participants With Uveitis Flare Among Participants With Inactive Uveitis at Study Start
    End point description
    Uveitis flare is defined as no quiescence (active inflammatory lesions and AC cell grade > 0.5+ and/or VH grade >0.5+).
    End point type
    Secondary
    End point timeframe
    366 Weeks
    End point values
    Adalimumab
    Number of subjects analysed
    124 [16]
    Units: percentage of participants
    number (confidence interval 95%)
        Percentage of Participants
    38.7 (30.1 to 47.9)
    Notes
    [16] - ITT set: all participants with inactive uveitis with evaluable data at a given timepoint.
    No statistical analyses for this end point

    Secondary: Percentage of Participants With Uveitis Flare From Week 8 Through Last Visit Among Participants With Active Uveitis at Study Start

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    End point title
    Percentage of Participants With Uveitis Flare From Week 8 Through Last Visit Among Participants With Active Uveitis at Study Start
    End point description
    Uveitis flare is defined as no quiescence (active inflammatory lesions and AC cell grade > 0.5+ and/or VH grade >0.5+).
    End point type
    Secondary
    End point timeframe
    Weeks 8 to 246 (238 Weeks)
    End point values
    Adalimumab
    Number of subjects analysed
    232 [17]
    Units: percentage of participants
    number (confidence interval 95%)
        Percentage of Participants
    67.7 (61.2 to 73.6)
    Notes
    [17] - ITT set: all participants with active uveitis at study start and evaluable data at a given timepoint
    No statistical analyses for this end point

    Secondary: Percentage of Participants With New Active Inflammatory Lesions or Grade ≥2 in Anterior Chamber (AC) Cells or Grade ≥2 in Vitreous Haze (VH) Over Time

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    End point title
    Percentage of Participants With New Active Inflammatory Lesions or Grade ≥2 in Anterior Chamber (AC) Cells or Grade ≥2 in Vitreous Haze (VH) Over Time
    End point description
    Dilated indirect ophthalmoscopy is performed to determine both vitreous haze grading and the absence/presence of inflammatory chorioretinal and/or inflammatory retinal vascular lesions. The number of AC cells observed within a 1 mm * 1 mm slit beam was recorded for each eye and this number was used to determine the grade according to Standardization of Uveitis Nomenclature (SUN) criteria. Grading of VH was based on the National Eye Institute (NEI) publication which was adapted by the SUN working group. The percentage of participants with new active inflammatory lesions or grade ≥2 in AC cells or grade ≥2 in VH are presented. n=the number of participants at given time point.
    End point type
    Secondary
    End point timeframe
    Weeks 2, 4, 8, 12, 18, 30, 42, 54, 66, 78, 90, 102, 114, 126, 138, 150, 162, 174, 186, 198, 210, 222, 234, and 246
    End point values
    Adalimumab
    Number of subjects analysed
    364 [18]
    Units: Percentage of Participants
    number (confidence interval 95%)
        Week 2 (n=348)
    11.8 (8.6 to 15.6)
        Week 4 (n=323)
    8.4 (5.6 to 11.9)
        Week 8 (n=343)
    7.6 (5.0 to 10.9)
        Week 12 (n=333)
    6.9 (4.4 to 10.2)
        Week 18 (n=330)
    3.6 (1.9 to 6.3)
        Week 30 (n=319)
    5.3 (3.1 to 8.4)
        Week 42 (n=310)
    4.2 (2.3 to 7.1)
        Week 54 (n=296)
    4.1 (2.1 to 7.0)
        Week 66 (n= 284)
    1.4 (0.4 to 3.6)
        Week 78 (n= 271)
    4.1 (2.0 to 7.1)
        Week 90 (n=261)
    4.6 (2.4 to 7.9)
        Week 102 (n=245)
    4.1 (2.0 to 7.4)
        Week 114 (n=231)
    4.8 (2.4 to 8.4)
        Week 126 (n=215)
    3.3 (1.3 to 6.6)
        Week 138 (n=196)
    2.0 (0.6 to 5.1)
        Week 150 (n=180)
    4.4 (1.9 to 8.6)
        Week 162 (n=154)
    3.2 (1.1 to 7.4)
        Week 174 (n=142)
    1.4 (0.2 to 5.0)
        Week 186 (n=128)
    1.6 (0.2 to 5.5)
        Week 198 (n=113)
    0 (0 to 0)
        Week 210 (n=88)
    3.4 (0.7 to 9.6)
        Week 222 (n=70)
    1.4 (0 to 7.7)
        Week 234 (n=51)
    0 (0 to 0)
        Week 246 (n=42)
    0 (0 to 0)
    Notes
    [18] - All participants in the ITT analysis set with evaluable data at a given time point.
    No statistical analyses for this end point

    Secondary: Percentage of Participants With Steroid-free Quiescence Over Time

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    End point title
    Percentage of Participants With Steroid-free Quiescence Over Time
    End point description
    Steroid-free quiescence is defined as no active inflammatory lesions and AC cell grade ≤ 0.5+ and VH grade ≤0.5+ and no uveitis-related corticosteroids on the day of assessment. n=the number of participants at given time point. n=the number of participants at given time point.
    End point type
    Secondary
    End point timeframe
    Weeks 0, 2, 4, 8, 12, 18, 30, 42, 54, 66, 78, 90, 102, 114, 126, 138, 150, 162, 174, 186, 198, 210, 222, 234, and 246
    End point values
    Adalimumab
    Number of subjects analysed
    364 [19]
    Units: Percentage of Participants
    number (confidence interval 95%)
        Week 0 (n=364)
    30.5 (25.8 to 35.5)
        Week 2 (n=348)
    34.8 (29.8 to 40.0)
        Week 4 (n=323)
    35.6 (30.4 to 41.1)
        Week 8 (n=343)
    41.4 (36.1 to 46.8)
        Week 12 (n=333)
    44.4 (39.0 to 50.0)
        Week 18 (n=330)
    47.6 (42.1 to 53.1)
        Week 30 (n=319)
    52.4 (46.7 to 57.9)
        Week 42 (n=310)
    55.8 (50.1 to 61.4)
        Week 54 (n=296)
    55.7 (49.9 to 61.5)
        Week 66 (n=284)
    56.7 (50.7 to 62.5)
        Week 78 (n=272)
    57.7 (51.6 to 63.7)
        Week 90 (n=261)
    60.2 (53.9 to 66.1)
        Week 102 (n=245)
    65.7 (59.4 to 71.6)
        Week 114 (n=231)
    66.2 (59.7 to 72.3)
        Week 126 (n=215)
    66.0 (59.3 to 72.3)
        Week 138 (n=196)
    67.9 (60.8 to 74.3)
        Week 150 (n=180)
    65.0 (57.6 to 71.9)
        Week 162 (n=154)
    63.0 (54.8 to 70.6)
        Week 174 (n=142)
    65.5 (57.1 to 73.3)
        Week 186 (n=128)
    68.0 (59.1 to 75.9)
        Week 198 (n=113)
    64.6 (55.0 to 73.4)
        Week 210 (n=89)
    64.0 (53.2 to 73.9)
        Week 222 (n=71)
    69.0 (56.9 to 79.5)
        Week 234 (n=51)
    78.4 (64.7 to 88.7)
        Week 246 (n=42)
    83.3 (68.6 to 93.0)
    Notes
    [19] - All participants in the ITT set in steroid-free quiescence with evaluable data at a given timepoint.
    No statistical analyses for this end point

    Secondary: Percentage of Participants in Non-quiescence (With/Without Change in Concomitant Medications Within 5 Days and With/Without Quiescence at Next Visit at Least 8 Weeks After Non-quiescence) Among Participants With Inactive Uveitis at Study Start

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    End point title
    Percentage of Participants in Non-quiescence (With/Without Change in Concomitant Medications Within 5 Days and With/Without Quiescence at Next Visit at Least 8 Weeks After Non-quiescence) Among Participants With Inactive Uveitis at Study Start
    End point description
    Percentage of participants, without quiescence, with/without change in concomitant medications within 5 days after non-quiescence and with/without quiescence at next visit at least 8 weeks after non-quiescence among participants with inactive uveitis at study start. Quiescence is defined as no active inflammatory lesions and AC cell grade ≤ 0.5+ and VH grade ≤0.5+. Abbreviations used are as follows: CM=concomitant medications; NQ=non-quiescence.
    End point type
    Secondary
    End point timeframe
    366 Weeks
    End point values
    Adalimumab
    Number of subjects analysed
    124 [20]
    Units: Percentage of Participants
    number (not applicable)
        NQ With CM Change and quiescence at next visit
    10.5
        NQ With CM Change and nonquiescence at next visit
    2.4
        NQ Without CM Change and quiescence at next visit
    13.7
        NQ Without CM Change and NQ at next visit
    8.9
        NQ With Premature Discontinuation
    3.2
        NQ And Completion
    0.8
    Notes
    [20] - ITT set: all with inactive uveitis at Week 0 in nonquiescence with evaluable data at given timepoint
    No statistical analyses for this end point

    Secondary: Percentage of Participants in Non-quiescence (With/Without Change in Concomitant Medications Within 5 Days and With/Without Quiescence at Next Visit at Least 8 Weeks After Non-quiescence) Among Participants With Active Uveitis at Study Start

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    End point title
    Percentage of Participants in Non-quiescence (With/Without Change in Concomitant Medications Within 5 Days and With/Without Quiescence at Next Visit at Least 8 Weeks After Non-quiescence) Among Participants With Active Uveitis at Study Start
    End point description
    Percentage of participants, without quiescence, with/without change in concomitant medications within 5 days after non-quiescence and with/without quiescence at next visit at least 8 weeks after non-quiescence, among participants with active uveitis at study start. Quiescence is defined as no active inflammatory lesions and AC cell grade ≤ 0.5+ and VH grade ≤0.5+. Abbreviations used include: CM=concomitant medications, NQ=non-quiescence.
    End point type
    Secondary
    End point timeframe
    366 Weeks
    End point values
    Adalimumab
    Number of subjects analysed
    240 [21]
    Units: Percentage of Participants
    number (not applicable)
        NQ With CM Change and quiescence at next visit
    19.2
        NQ With CM Change and nonquiescence at next visit
    10.8
        NQ Without CM Change and quiescence at next visit
    15.0
        NQ Without CM Change and NQ at next visit
    15.4
        NQ With Premature Discontinuation
    6.7
        NQ And Completion
    0.4
    Notes
    [21] - ITT set: all with active uveitis at Week 0 in nonquiescence with evaluable data at given timepoint
    No statistical analyses for this end point

    Secondary: Percentage of Participants Who Started Uveitis-related Systemic Corticosteroids During the Study

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    End point title
    Percentage of Participants Who Started Uveitis-related Systemic Corticosteroids During the Study
    End point description
    Percentage of participants who started uveitis-related systemic corticosteroids during the study.
    End point type
    Secondary
    End point timeframe
    366 Weeks
    End point values
    Adalimumab
    Number of subjects analysed
    364 [22]
    Units: Percentage of Participants
    number (confidence interval 95%)
        Percentage of Participants
    20.3 (16.3 to 24.8)
    Notes
    [22] - ITT set: all without systemic corticosteroids at baseline with evaluable data at a given timepoint
    No statistical analyses for this end point

    Secondary: Mean Daily Dose in Milligrams (mg) of Uveitis-related Systemic Corticosteroids in Participants With Active Uveitis Over Time

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    End point title
    Mean Daily Dose in Milligrams (mg) of Uveitis-related Systemic Corticosteroids in Participants With Active Uveitis Over Time
    End point description
    Corticosteroid doses were converted into prednisone equivalents. Participants with uveitis-related systemic corticosteroid that could not be converted to prednisone equivalents were excluded. Individual mean daily doses were calculated within the respective visit windows. For Week 0, only uveitis-related systemic corticosteroids at Baseline (Day 1 for all participants) were considered. Baseline was defined as Week 0 for all participants. n=the number of participants at given time point.
    End point type
    Secondary
    End point timeframe
    Weeks 0, 2, 4, 8, 12, 18, 30, 42, 54, 66, 78, 90, 102, 114, 126, 138, 150, 162, 174, 186, 198, 210, 222, 234, and 246
    End point values
    Adalimumab
    Number of subjects analysed
    235 [23]
    Units: Milligrams
    arithmetic mean (standard deviation)
        Week 0 (n=235)
    13.6 ± 19.21
        Week 2 (n=235)
    14.8 ± 17.12
        Week 4 (n=230)
    10.1 ± 12.27
        Week 8 (n=227)
    7.3 ± 9.75
        Week 12 (n=222)
    6.0 ± 9.34
        Week 18 (n=216)
    5.1 ± 8.47
        Week 30 (n=207)
    4.4 ± 7.12
        Week 42 (n=196)
    3.5 ± 5.54
        Week 54 (n=188)
    3.5 ± 6.71
        Week 66 (n=179)
    3.1 ± 6.32
        Week 78 (n=171)
    2.6 ± 5.10
        Week 90 (n=164)
    2.2 ± 4.47
        Week 102 (n=155)
    2.1 ± 4.80
        Week 114 (n=148)
    1.8 ± 4.50
        Week 126 (n=139)
    1.6 ± 4.16
        Week 138 (n=132)
    2.2 ± 5.65
        Week 150 (n=122)
    2.0 ± 4.49
        Week 162 (n=115)
    1.9 ± 4.31
        Week 174 (n=109)
    1.9 ± 4.46
        Week 186 (n=96)
    1.6 ± 4.27
        Week 198 (n=86)
    1.6 ± 4.05
        Week 210 (n=74)
    1.4 ± 3.57
        Week 222 (n=59)
    2.3 ± 8.48
        Week 234 (n=42)
    1.1 ± 3.17
        Week 246 (n=35)
    0.6 ± 1.69
    Notes
    [23] - ITT set: active uveitis, daily dose of uveitis-related systemic corticosteroids, and evaluable data
    No statistical analyses for this end point

    Secondary: Mean Daily Dose (mg) of Uveitis-related Systemic Corticosteroids in Participants With Inactive Uveitis Over Time

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    End point title
    Mean Daily Dose (mg) of Uveitis-related Systemic Corticosteroids in Participants With Inactive Uveitis Over Time
    End point description
    Corticosteroid doses were converted into prednisone equivalents. Participants with uveitis-related systemic corticosteroid that could not be converted to prednisone equivalents were excluded. Individual mean daily doses were calculated within the respective visit windows. For Week 0, only uveitis-related systemic corticosteroids at Baseline (Day 1 for all participants) were considered. Baseline was defined as Week 0 for all participants. n=the number of participants at given time point. n=the number of participants at given time point.
    End point type
    Secondary
    End point timeframe
    Weeks 0, 2, 4, 8, 12, 18, 30, 42, 54, 66, 78, 90, 102, 114, 126, 138, 150, 162, 174, 186, 198, 210, 222, 234, and 246
    End point values
    Adalimumab
    Number of subjects analysed
    124 [24]
    Units: Milligrams
    arithmetic mean (standard deviation)
        Week 0 (n=124)
    1.5 ± 7.32
        Week 2 (n=124)
    1.6 ± 6.65
        Week 4 (n=123)
    1.4 ± 4.89
        Week 8 (n=117)
    0.9 ± 3.41
        Week 12 (n=115)
    0.9 ± 4.12
        Week 18 (n=114)
    0.8 ± 3.29
        Week 30 (n=113)
    0.7 ± 2.74
        Week 42 (n=112)
    0.7 ± 2.64
        Week 54 (n=108)
    1.8 ± 7.09
        Week 66 (n=103)
    1.3 ± 5.32
        Week 78 (n=99)
    1.1 ± 4.36
        Week 90 (n=95)
    1.2 ± 4.54
        Week 102 (n=91)
    0.6 ± 2.63
        Week 114 (n=84)
    0.6 ± 2.67
        Week 126 (n=77)
    0.7 ± 2.95
        Week 138 (n=64)
    0.5 ± 2.09
        Week 150 (n=59)
    0.5 ± 1.91
        Week 162 (n=39)
    0.2 ± 1.00
        Week 174 (n=34)
    0.2 ± 1.07
        Week 186 (n= 31)
    0.3 ± 1.12
        Week 198 (n=26)
    0.3 ± 1.23
        Week 210 (n=16)
    0.4 ± 1.50
        Week 222 (n=12)
    0.5 ± 1.73
        Week 234 (n=9)
    0.5 ± 1.57
        Week 246 (n=7)
    0.0 ± 0.00
    Notes
    [24] - ITT set: inactive uveitis, daily dose uveitis-related systemic corticosteroids, and evaluable data
    No statistical analyses for this end point

    Secondary: Percent Change in Mean Daily Dose of Uveitis-related Systemic Corticosteroids Relative to Week 0 in Participants With Inactive Uveitis Using Systemic Corticosteroids at Week 0 Over Time

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    End point title
    Percent Change in Mean Daily Dose of Uveitis-related Systemic Corticosteroids Relative to Week 0 in Participants With Inactive Uveitis Using Systemic Corticosteroids at Week 0 Over Time
    End point description
    Corticosteroid doses were converted into prednisone equivalents. Participants with uveitis-related systemic corticosteroid that could not be converted to prednisone equivalents were excluded. Individual mean daily doses were calculated within the respective visit windows. For Week 0, only uveitis-related systemic corticosteroids at Baseline (Day 1 for all participants) were considered. Baseline was defined as Week 0 for all participants. Data not presented after Week 198 as no participants remained on study as of Week 198. n=the number of participants at given time point.
    End point type
    Secondary
    End point timeframe
    Weeks 0, 2, 4, 8, 12, 18, 30, 42, 54, 66, 78, 90, 102, 114, 126, 138, 150, 162, 174, 186, and 198
    End point values
    Adalimumab
    Number of subjects analysed
    7 [25]
    Units: Percent Change from Baseline
    arithmetic mean (confidence interval 95%)
        Week 2 (n=7)
    -11.8 (-21.6 to -2.1)
        Week 4 (n=7)
    -46.6 (-64.2 to -29.0)
        Week 8 (n=7)
    -64.5 (-88.1 to -40.8)
        Week 12 (n=7)
    -29.7 (-91.5 to 32.1)
        Week 18 (n=7)
    -30.8 (-128.4 to 66.7)
        Week 30 (n=6)
    -25.0 (-159.6 to 109.5)
        Week 42 (n=6)
    -36.7 (-150.4 to 76.9)
        Week 54 (n=5)
    -11.9 (-186.2 to 162.5)
        Week 66 (n=5)
    -25.1 (-156.9 to 106.6)
        Week 78 (n=5)
    -28.3 (-157.9 to 101.2)
        Week 90 (n=5)
    -27.5 (-162.6 to 107.6)
        Week 102 (n=4)
    -78.1 (-120.7 to -35.4)
        Week 114 (n=4)
    -84.2 (-96.8 to -67.2)
        Week 126 (n=4)
    -88.9 (-113.9 to -63.9)
        Week 138 (n=2)
    -95.9 (-148.4 to -43.3)
        Week 150 (n=2)
    -99.5 (-106.3 to -92.7)
        Week 162 (n=1)
    -100.0 (-100.0 to -100.0)
        Week 174 (n=1)
    -100.0 (-100.0 to -100.0)
        Week 186 (n=1)
    -100.0 (-100.0 to -100.0)
        Week 198 (n=1)
    -100.0 (-100.0 to -100.0)
    Notes
    [25] - ITT set who received systemic corticosteroids at Week 0 with evaluable data at a given timepoint
    No statistical analyses for this end point

    Secondary: Percent Change in Mean Daily Dose of Uveitis-related Systemic Corticosteroids Relative to Week 0 in Participants With Active Uveitis Using Systemic Corticosteroids at Week 0 Over Time

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    End point title
    Percent Change in Mean Daily Dose of Uveitis-related Systemic Corticosteroids Relative to Week 0 in Participants With Active Uveitis Using Systemic Corticosteroids at Week 0 Over Time
    End point description
    Corticosteroid doses were converted into prednisone equivalents. Participants with uveitis-related systemic corticosteroid that could not be converted to prednisone equivalents were excluded. Individual mean daily doses were calculated within the respective visit windows. For Week 0, only uveitis-related systemic corticosteroids at Baseline (Day 1 for all participants) were considered. Baseline was defined as Week 0 for all participants. n=the number of participants at given time point.
    End point type
    Secondary
    End point timeframe
    Weeks 0, 2, 4, 8, 12, 18, 30, 42, 54, 66, 78, 90, 102, 114, 126, 138, 150, 162, 174, 186, 198, 210, 222, 234, and 246
    End point values
    Adalimumab
    Number of subjects analysed
    114 [26]
    Units: Percent Change from Baseline
    arithmetic mean (confidence interval 95%)
        Week 2 (n=114)
    -4.6 (-14.2 to 5.0)
        Week 4 (n=112)
    -25.0 (-38.6 to -11.4)
        Week 8 (n=112)
    -41.7 (-55.0 to -28.4)
        Week 12 (n=107)
    -46.3 (-65.0 to -27.7)
        Week 18 (n=106)
    -55.1 (-73.1 to -37.1)
        Week 30 (n=102)
    -62.8 (-78.1 to -47.5)
        Week 42 (n=96)
    -73.4 (-85.0 to -61.9)
        Week 54 (n=93)
    -73.2 (-85.3 to -61.0)
        Week 66 (n=87)
    -77.1 (-89.3 to -64.9)
        Week 78 (n=84)
    -77.3 (-90.2 to -64.4)
        Week 90 (n=80)
    -82.1 (-93.3 to -70.9)
        Week 102 (n=76)
    -78.8 (-95.7 to -62.0)
        Week 114 (n=72)
    -82.0 (-96.8 to -66.9)
        Week 126 (n=65)
    -82.8 (-98.6 to -66.9)
        Week 138 (n=62)
    -87.8 (-94.2 to -81.4)
        Week 150 (n=57)
    -86.9 (-94.5 to -79.2)
        Week 162 (n=55)
    -90.7 (-94.9 to -86.4)
        Week 174 (n=52)
    -91.4 (-95.8 to -86.9)
        Week 186 (n=47)
    -90.3 (-95.9 to -84.7)
        Week 198 (n=42)
    -91.0 (-96.6 to -85.5)
        Week 210 (n=38)
    -89.9 (-96.8 to -82.9)
        Week 222 (n=30)
    -87.1 (-102.0 to -72.2)
        Week 234 (n=20)
    -93.8 (-103.8 to -83.9)
        Week 246 (n=18)
    -98.3 (-101.3 to -95.4)
    Notes
    [26] - ITT set who received systemic corticosteroids at Week 0 with evaluable data at a given timepoint
    No statistical analyses for this end point

    Secondary: Percentage of Participants Not Using Systemic Corticosteroids Over Time

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    End point title
    Percentage of Participants Not Using Systemic Corticosteroids Over Time
    End point description
    Corticosteroid doses were converted into prednisone equivalents. Participants with uveitis-related systemic corticosteroid that could not be converted to prednisone equivalents were excluded. Individual mean daily doses were calculated within the respective visit windows. For Week 0, only uveitis-related systemic corticosteroids at Baseline (Day 1 for all participants) were considered. Baseline was defined as Week 0 for all participants. Data presented for participants not using systemic corticosteroids at each timepoint. n=the number of participants at given time point.
    End point type
    Secondary
    End point timeframe
    Weeks 0, 2, 4, 8, 12, 18, 30, 42, 54, 66, 78, 90, 102, 114, 126, 138, 150, 162, 174, 186, 198, 210, 222, 234, and 246
    End point values
    Adalimumab
    Number of subjects analysed
    359 [27]
    Units: Percentage of Participants
    number (confidence interval 95%)
        Week 0 (n=359)
    66.3 (61.1 to 71.2)
        Week 2 (n=358)
    58.7 (53.4 to 63.8)
        Week 4 (n=349)
    60.2 (54.8 to 65.3)
        Week 8 (n=339)
    61.9 (56.5 to 67.1)
        Week 12 (n=334)
    64.7 (59.3 to 69.8)
        Week 18 (n=328)
    68.3 (63.0 to 73.3)
        Week 30 (n=312)
    70.2 (64.8 to 75.2)
        Week 42 (n=306)
    70.9 (65.5 to 75.9)
        Week 54 (n=292)
    71.9 (66.4 to 77.0)
        Week 66 (n=275)
    73.1 (67.4 to 78.2)
        Week 78 (n=266)
    75.2 (69.5 to 80.3)
        Week 90 (n=257)
    77.0 (71.4 to 82.0)
        Week 102 (n=239)
    80.8 (75.2 to 85.6)
        Week 114 (n=225)
    83.6 (78.1 to 88.1)
        Week 126 (n=209)
    84.2 (78.5 to 88.9)
        Week 138 (n=190)
    82.1 (75.9 to 87.3)
        Week 150 (n= 173)
    81.5 (74.9 to 87.0)
        Week 162 (n=149)
    80.5 (73.3 to 86.6)
        Week 174 (n=136)
    79.4 (71.6 to 85.9)
        Week 186 (n=123)
    80.5 (72.4 to 87.1)
        Week 198 (n=97)
    80.4 (71.1 to 87.8)
        Week 210 (n=82)
    81.7 (71.6 to 89.4)
        Week 222 (n=59)
    86.4 (75.0 to 94.0)
        Week 234 (n=48)
    89.6 (77.3 to 96.5)
        Week 246 (n=34)
    94.1 (80.3 to 99.3)
    Notes
    [27] - All participants in the ITT analysis set with evaluable data at each timepoint.
    No statistical analyses for this end point

    Secondary: Percentage of Participants Without Worsening of Best Corrected Visual Acuity (BCVA) by ≥15 Letters on Early Treatment Diabetic Retinopathy Study (ETDRS) in Both Eyes Relative to Baseline Over Time Among Participants Who Had Inactive Uveitis at Study Entry

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    End point title
    Percentage of Participants Without Worsening of Best Corrected Visual Acuity (BCVA) by ≥15 Letters on Early Treatment Diabetic Retinopathy Study (ETDRS) in Both Eyes Relative to Baseline Over Time Among Participants Who Had Inactive Uveitis at Study Entry
    End point description
    Percentage of participants at each study time point without a worsening of Best Corrected Visual Acuity (BCVA) by ≥15 letters on the Early Treatment Diabetic Retinopathy Study (ETDRS) in both eyes relative to Baseline for participants who had inactive uveitis when they entered the study. n=the number of participants at given time point.
    End point type
    Secondary
    End point timeframe
    Weeks 2, 4, 8, 12, 18, 30, 42, 54, 66, 78, 90, 102, 114, 126, 138, 150, 162, 174, 186, 198, 210, 222, 234, and 246
    End point values
    Adalimumab
    Number of subjects analysed
    124 [28]
    Units: Percentage of Participants
    number (confidence interval 95%)
        Week 2 (n=118)
    100 (96.9 to 100)
        Week 4 (n=108)
    99.1 (94.9 to 100)
        Week 8 (n=113)
    100 (96.8 to 100)
        Week 12 (n=112)
    100 (96.8 to 100)
        Week 18 (n=112)
    100 (96.8 to 100)
        Week 30 (n=112)
    99.1 (95.1 to 100)
        Week 42 (n=112)
    98.2 (93.7 to 99.8)
        Week 54 (n=107)
    97.2 (92.0 to 99.4)
        Week 66 (n=103)
    98.1 (93.2 to 99.8)
        Week 78 (n=99)
    97.0 (91.4 to 99.4)
        Week 90 (n=95)
    98.9 (94.3 to 100)
        Week 102 (n=89)
    97.8 (92.1 to 99.7)
        Week 114 (n=84)
    97.6 (91.7 to 99.7)
        Week 126 (n=76)
    96.1 (88.9 to 99.2)
        Week 138 (n=64)
    96.9 (89.2 to 99.6)
        Week 150 (n=57)
    100 (93.7 to 100)
        Week 162 (n=39)
    100 (91.0 to 100)
        Week 174 (n=34)
    100 (89.7 to 100)
        Week 186 (n=31)
    100 (88.8 to 100)
        Week 198 (n=26)
    100 (86.8 to 100)
        Week 210 (n=16)
    100 (79.4 to 100)
        Week 222 (n=12)
    91.7 (61.5 to 99.8)
        Week 234 (n=9)
    88.9 (51.8 to 99.7)
        Week 246 (n=7)
    85.7 (42.1 to 99.6)
    Notes
    [28] - All participants in the ITT analysis set with evaluable data at each timepoint.
    No statistical analyses for this end point

    Secondary: Percentage of Participants Without Worsening of BCVA by ≥15 Letters on the ETDRS in Both Eyes Relative to Week 8 Over Time Among Participants With Active Uveitis at Study Entry

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    End point title
    Percentage of Participants Without Worsening of BCVA by ≥15 Letters on the ETDRS in Both Eyes Relative to Week 8 Over Time Among Participants With Active Uveitis at Study Entry
    End point description
    Percentage of participants at each study time point without a worsening of BCVA by ≥15 letters on the ETDRS in both eyes relative to Week 8 for participant who had active uveitis when they entered the study. n=the number of participants at given time point.
    End point type
    Secondary
    End point timeframe
    Weeks 12, 18, 30, 42, 54, 66, 78, 90, 102, 114, 126, 138, 150, 162, 174, 186, 198, 210, 222, 234, and 246
    End point values
    Adalimumab
    Number of subjects analysed
    222 [29]
    Units: Percentage of Participants
    number (confidence interval 95%)
        Week 12 (n=219)
    96.8 (93.5 to 98.7)
        Week 18 (n=214)
    96.3 (92.8 to 98.4)
        Week 30 (n=206)
    96.6 (93.1 to 98.6)
        Week 42 (n=196)
    94.9 (90.8 to 97.5)
        Week 54 (n=188)
    94.7 (90.4 to 97.4)
        Week 66 (n=179)
    93.3 (88.6 to 96.5)
        Week 78 (n=172)
    93.6 (88.8 to 96.8)
        Week 90 (n=165)
    96.4 (92.3 to 98.7)
        Week 102 (n=153)
    94.8 (90.0 to 97.7)
        Week 114 (n=146)
    93.8 (88.6 to 97.1)
        Week 126 (n=140)
    95.0 (90.0 to 98.0)
        Week 138 (n=131)
    93.9 (88.3 to 97.3)
        Week 150 (n=123)
    92.7 (86.6 to 96.6)
        Week 162 (n=114)
    93.9 (87.8 to 97.5)
        Week 174 (n=107)
    91.6 (84.6 to 96.1)
        Week 186 (n=96)
    92.7 (85.6 to 97.0)
        Week 198 (n=86)
    95.3 (88.5 to 98.7)
        Week 210 (n=71)
    95.8 (88.1 to 99.1)
        Week 222 (n=58)
    96.6 (88.1 to 99.6)
        Week 234 (n=42)
    95.2 (83.8 to 99.4)
        Week 246 (n=34)
    91.2 (76.3 to 98.1)
    Notes
    [29] - All participants in the ITT analysis set with evaluable data at each timepoint
    No statistical analyses for this end point

    Secondary: Mean of Both Eyes of the Logarithm of the Minimum Angle of Resolution (LogMAR) BCVA Over Time

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    End point title
    Mean of Both Eyes of the Logarithm of the Minimum Angle of Resolution (LogMAR) BCVA Over Time
    End point description
    Using corrective lenses based on that visit's refraction testing, participant's BCVA was measured using an ETDRS logMAR chart. On the logMAR scale, 0 is equivalent to 20/20 visual acuity, the range of normal vision is considered to be from -0.2 to 0.1; higher values indicate visual impairment. Data presented includes the mean of both eyes for all participants (active or inactive uveitis) for all study time points. n=the number of participants at given time point.
    End point type
    Secondary
    End point timeframe
    Weeks 0, 2, 4, 8, 12, 18, 30, 42, 54, 66, 78, 90, 102, 114, 126, 138, 150, 162, 174, 186, 198, 210, 222, 234, and 246
    End point values
    Adalimumab
    Number of subjects analysed
    364 [30]
    Units: Log (Mar) BCVA Both Eyes
    arithmetic mean (standard deviation)
        Week 0 (n=364)
    0.20 ± 0.275
        Week 2 (n=348)
    0.17 ± 0.265
        Week 4 (n=325)
    0.15 ± 0.248
        Week 8 (n=342)
    0.14 ± 0.247
        Week 12 (n=333)
    0.13 ± 0.244
        Week 18 (n=329)
    0.12 ± 0.240
        Week 30 (n=319)
    0.12 ± 0.249
        Week 42 (n=309)
    0.12 ± 0.227
        Week 54 (n=296)
    0.11 ± 0.238
        Week 66 (n=284)
    0.11 ± 0.241
        Week 78 (n=272)
    0.11 ± 0.238
        Week 90 (n=261)
    0.90 ± 0.214
        Week 102 (n=244)
    0.90 ± 0.219
        Week 114 (n=231)
    0.90 ± 0.233
        Week 126 (n=217)
    0.90 ± 0.231
        Week 138 (n=197)
    0.90 ± 0.224
        Week 150 (n=181)
    0.10 ± 0.255
        Week 162 (n=154)
    0.90 ± 0.249
        Week 174 (n=142)
    0.90 ± 0.261
        Week 186 (n=128)
    0.90 ± 0.244
        Week 198 (n=113)
    0.70 ± 0.205
        Week 210 (n=88)
    0.70 ± 0.211
        Week 222 (n=71)
    0.70 ± 0.218
        Week 234 (n=51)
    0.70 ± 0.222
        Week 246 (n=41)
    0.80 ± 0.217
    Notes
    [30] - All participants in the ITT analysis set with evaluable data at each study timepoint.
    No statistical analyses for this end point

    Other pre-specified: Percent Change in Left Eye in Central Retinal Thickness (1 mm Subfield) From Baseline to Each Study Time Point Relative to Baseline for Participants Who Had Inactive Uveitis at Study Entry Over Time

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    End point title
    Percent Change in Left Eye in Central Retinal Thickness (1 mm Subfield) From Baseline to Each Study Time Point Relative to Baseline for Participants Who Had Inactive Uveitis at Study Entry Over Time
    End point description
    Central retinal thickness was measured using optical coherence tomography (OCT) and assessed by a central reader. Percent change in left eye from baseline (Week 0) to each study time point relative to baseline for participants who had inactive uveitis at study entry is presented. n=the number of participants at given time point.
    End point type
    Other pre-specified
    End point timeframe
    Baseline (Week 0) and Weeks 2, 4, 8, 12, 18, 30, 42, 54, 66, 78, 90, 102, 114, 126, 138, 150, 162, 174, 186, 198, 210, 222, 234, and 246
    End point values
    Adalimumab
    Number of subjects analysed
    111 [31]
    Units: Percent Change from Baseline
    arithmetic mean (confidence interval 95%)
        Week 2 (n=111)
    0.3 (-1.41 to 1.97)
        Week 4 (n=100)
    -0.2 (-2.03 to 1.56)
        Week 8 (n=106)
    -0.7 (-2.07 to 0.72)
        Week 12 (n=105)
    -1.0 (-2.27 to 0.23)
        Week 18 (n=105)
    -0.5 (-2.02 to 1.07)
        Week 30 (n=104)
    -1.9 (-3.25 to -0.60)
        Week 42 (n=103)
    -1.3 (-2.83 to 0.17)
        Week 54 (n=101)
    -2.1 (-3.90 to -0.22)
        Week 66 (n=96)
    -1.9 (-3.95 to 0.11)
        Week 78 (n=88)
    -1.4 (-4.54 to 1.70)
        Week 90 (n=85)
    -2.9 (-4.51 to -1.22)
        Week 102 (n=82)
    -3.1 (-4.95 to -1.34)
        Week 114 (n=75)
    -2.8 (-4.44 to -1.14)
        Week 126 (n=67)
    -3.7 (-5.66 to -1.68)
        Week 138 (n=58)
    -3.4 (-5.38 to -1.46)
        Week 150 (n=52)
    -3.5 (-5.48 to -1.58)
        Week 162 (n=32)
    -3.3 (-6.25 to -0.29)
        Week 174 (n=29)
    -3.0 (-5.45 to -0.52)
        Week 186 (n=27)
    -3.8 (-6.69 to -1.00)
        Week 198 (n=23)
    -3.2 (-5.99 to -0.35)
        Week 210 (n=13)
    -5.2 (-10.23 to -0.17)
        Week 222 (n=10)
    -4.6 (-11.17 to 1.93)
        Week 234 (n=8)
    -3.6 (-13.06 to 5.77)
        Week 246 (n=6)
    -3.4 (-14.83 to 7.93)
    Notes
    [31] - All participants in the ITT analysis set with evaluable data at each timepoint.
    No statistical analyses for this end point

    Other pre-specified: Percent Change in Right Eye in Central Retinal Thickness (1 mm Subfield) From Baseline to Each Study Time Point Relative to Baseline for Participants Who Had Inactive Uveitis at Study Entry Over Time

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    End point title
    Percent Change in Right Eye in Central Retinal Thickness (1 mm Subfield) From Baseline to Each Study Time Point Relative to Baseline for Participants Who Had Inactive Uveitis at Study Entry Over Time
    End point description
    Central retinal thickness was measured using optical coherence tomography (OCT) and assessed by a central reader. Percent change in right eye from baseline (Week 0) to each study time point relative to baseline for participants who had inactive uveitis at study entry is presented. n=the number of participants at given time point.
    End point type
    Other pre-specified
    End point timeframe
    Baseline (Week 0) and Weeks 2, 4, 8, 12, 18, 30, 42, 54, 66, 78, 90, 102, 114, 126, 138, 150, 162, 174, 186, 198, 210, 222, 234, and 246
    End point values
    Adalimumab
    Number of subjects analysed
    109 [32]
    Units: Percent Change from Baseline
    arithmetic mean (confidence interval 95%)
        Week 2 (n=109)
    -0.2 (-1.92 to 1.45)
        Week 4 (n=99)
    -0.8 (-2.99 to 1.39)
        Week 8 (n=104)
    -1.5 (-3.19 to 0.25)
        Week 12 (n=103)
    -1.0 (-2.76 to 0.66)
        Week 18 (n=103)
    -0.4 (-2.73 to 1.84)
        Week 30 (n=102)
    -2.8 (-4.78 to -0.86)
        Week 42 (n=101)
    -2.2 (-4.31 to -0.15)
        Week 54 (n=99)
    -3.7 (-6.00 to -1.44)
        Week 66 (n=94)
    -3.3 (-5.66 to -0.97)
        Week 78 (n=86)
    -3.9 (-6.36 to -1.38)
        Week 90 (n=83)
    -3.8 (-6.47 to -1.08)
        Week 102 (n=80)
    -5.3 (-7.99 to -2.67)
        Week 114 (n=73)
    -5.6 (-8.65 to -2.53)
        Week 126 (n=65)
    -5.4 (-8.57 to -2.21)
        Week 138 (n=56)
    -4.7 (-7.75 to -1.72)
        Week 150 (n=51)
    -2.1 (-9.07 to 4.90)
        Week 162 (n=32)
    -2.9 (-6.06 to 0.36)
        Week 174 (n=29)
    -2.7 (-5.88 to 0.56)
        Week 186 (n=27)
    -2.0 (-5.49 to 1.46)
        Week 198 (n=23)
    -1.2 (-5.91 to 3.48)
        Week 210 (n=13)
    -2.3 (-6.35 to 1.66)
        Week 222 (n=10)
    -1.7 (-4.76 to 1.44)
        Week 234 (n=8)
    -1.3 (-6.32 to 3.78)
        Week 246 (n=6)
    1.6 (-0.78 to 3.93)
    Notes
    [32] - All participants in the ITT analysis set with evaluable data at each timepoint.
    No statistical analyses for this end point

    Other pre-specified: Percent Change in Left Eye of Central Retinal Thickness (1 mm Subfield) at Each Study Time Point Relative to Week 8 for Participants Who Had Active Uveitis at Study Entry Over Time

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    End point title
    Percent Change in Left Eye of Central Retinal Thickness (1 mm Subfield) at Each Study Time Point Relative to Week 8 for Participants Who Had Active Uveitis at Study Entry Over Time
    End point description
    Central retinal thickness was measured using OCT and assessed by a central reader. Percent change in left eye at each study time point relative to Week 8 (baseline) for participants who had active uveitis at study entry is presented. n=the number of participants at given time point.
    End point type
    Other pre-specified
    End point timeframe
    Baseline (Week 8) and Weeks 12, 18, 30, 42, 54, 66, 78, 90, 102, 114, 126, 138, 150, 162, 174, 186, 198, 210, 222, 234, and 246
    End point values
    Adalimumab
    Number of subjects analysed
    206 [33]
    Units: Percent Change from Baseline
    arithmetic mean (confidence interval 95%)
        Week 12 (n=206)
    1.0 (-0.50 to 2.42)
        Week 18 (n=201)
    -0.3 (-2.36 to 1.71)
        Week 30 (n=194)
    -2.4 (-4.24 to -0.55)
        Week 42 (n=183)
    -2.8 (-4.62 to -1.00)
        Week 54 (n=177)
    -3.2 (-5.52 to -0.90)
        Week 66 (n=166)
    -2.3 (-4.52 to 0.01)
        Week 78 (n=161)
    -3.5 (-5.99 to -1.02)
        Week 90 (n=150)
    -4.8 (-7.19 to -2.42)
        Week 102 (n=142)
    -5.3 (-7.41 to -3.10)
        Week 114 (n=126)
    -6.6 (-9.15 to -3.95)
        Week 126 (n=124)
    -5.3 (-8.66 to -1.92)
        Week 138 (n=118)
    -7.0 (-9.96 to -3.99)
        Week 150 (n=109)
    -7.3 (-10.22 to -4.48)
        Week 162 (n=104)
    -7.5 (-11.31 to -3.72)
        Week 174 (n=92)
    -9.5 (-13.20 to -5.81)
        Week 186 (n=83)
    -7.6 (-10.21 to -4.93)
        Week 198 (n=74)
    -8.4 (-11.84 to -4.99)
        Week 210 (n=67)
    -6.6 (-10.40 to -2.74)
        Week 222 (n=53)
    -9.3 (-13.42 to -5.17)
        Week 234 (n=39)
    -8.2 (-11.85 to -4.46)
        Week 246 (n=32)
    -9.1 (-13.41 to -4.82)
    Notes
    [33] - All participants in the ITT analysis set with evaluable data at each timepoint.
    No statistical analyses for this end point

    Other pre-specified: Percent Change in Right Eye of Central Retinal Thickness (1 mm Subfield) at Each Study Time Point Relative to Week 8 for Participants Who Had Active Uveitis at Study Entry Over Time

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    End point title
    Percent Change in Right Eye of Central Retinal Thickness (1 mm Subfield) at Each Study Time Point Relative to Week 8 for Participants Who Had Active Uveitis at Study Entry Over Time
    End point description
    Central retinal thickness was measured using OCT and assessed by a central reader. Percent change in right eye at each study time point relative to Week 8 (baseline) for participants who had active uveitis at study entry is presented. n=the number of participants at given time point.
    End point type
    Other pre-specified
    End point timeframe
    Baseline (Week 8) and Weeks 12, 18, 30, 42, 54, 66, 78, 90, 102, 114, 126, 138, 150, 162, 174, 186, 198, 210, 222, 234, and 246
    End point values
    Adalimumab
    Number of subjects analysed
    205 [34]
    Units: Percent Change from Baseline
    arithmetic mean (confidence interval 95%)
        Week 12 (n=205)
    0.4 (-1.58 to 2.47)
        Week 18 (n=202)
    -0.7 (-2.71 to 1.30)
        Week 30 (n=194)
    -0.7 (-3.36 to 1.90)
        Week 42 (n=183)
    -2.4 (-4.85 to 0.05)
        Week 54 (n=176)
    -2.4 (-5.25 to 0.36)
        Week 66 (n=167)
    -1.3 (-4.81 to 2.27)
        Week 78 (n=160)
    -2.1 (-5.61 to 1.50)
        Week 90 (n=149)
    -3.6 (-6.44 to -0.76)
        Week 102 (n=142)
    -3.4 (-6.98 to 0.13)
        Week 114 (n=125)
    -2.2 (-6.18 to 1.81)
        Week 126 (n=124)
    -3.5 (-7.43 to 0.47)
        Week 138 (n=118)
    -4.6 (-8.22 to -0.92)
        Week 150 (n=109)
    -6.5 (-9.81 to -3.15)
        Week 162 (n=104)
    -4.8 (-8.91 to -0.75)
        Week 174 (n=93)
    -5.4 (-9.46 to -1.27)
        Week 186 (n=83)
    -7.9 (-12.74 to -3.03)
        Week 198 (n=75)
    -8.2 (-12.30 to -4.13)
        Week 210 (n=67)
    -6.6 (-10.76 to -2.43)
        Week 222 (n=52)
    -9.7 (-13.24 to -6.19)
        Week 234 (n=39)
    -9.7 (-14.24 to -5.07)
        Week 246 (n=32)
    -9.9 (-15.43 to -4.35)
    Notes
    [34] - All participants in the ITT analysis set with evaluable data at each timepoint.
    No statistical analyses for this end point

    Other pre-specified: Percentage of Participants With Grade ≤0.5+ in Anterior Chamber (AC) Cells in Both Eyes on Slit Lamp Exam According to Standardization of Uveitis Nomenclature (SUN) Criteria Over Time

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    End point title
    Percentage of Participants With Grade ≤0.5+ in Anterior Chamber (AC) Cells in Both Eyes on Slit Lamp Exam According to Standardization of Uveitis Nomenclature (SUN) Criteria Over Time
    End point description
    Slit lamp examinations were conducted at each visit to assess AC cell count. The number of AC cells observed within a 1 mm * 1 mm slit beam was used to determine the grade according to the Standardization of Uveitis Nomenclature (SUN) criteria: Grade 0: ˂ 1 cell; Grade 0.5+: 1 - 5 cells; Grade 1+: 6 - 15 cells; Grade 2+: 16 - 25 cells; Grade 3+: 26 - 50 cells; and Grade 4+: ≥ 50 cells. n=the number of participants at given time point.
    End point type
    Other pre-specified
    End point timeframe
    Weeks 0, 2, 4, 8, 12, 18, 30, 42, 54, 66, 78, 90, 102, 114, 126, 138, 150, 162, 174, 186, 198, 210, 222, 234, and 246
    End point values
    Adalimumab
    Number of subjects analysed
    364 [35]
    Units: Percentage of Participants
    number (confidence interval 95%)
        Week 0 (n=364)
    65.4 (60.3 to 70.3)
        Week 2 (n=348)
    85.9 (81.8 to 89.4)
        Week 4 (n=323)
    90.4 (86.7 to 93.4)
        Week 8 (n=343)
    91.5 (88.1 to 94.3)
        Week 12 (n=333)
    91.3 (87.7 to 94.1)
        Week 18 (n=330)
    90.9 (87.3 to 93.8)
        Week 30 (n=319)
    94.7 (91.6 to 96.9)
        Week 42 (n=310)
    92.3 (88.7 to 95.0)
        Week 54 (n=296)
    92.9 (89.4 to 95.6)
        Week 66 (n=284)
    95.1 (91.9 to 97.3)
        Week 78 (n=272)
    93.0 (89.3 to 95.7)
        Week 90 (n=261)
    94.4 (90.7 to 96.7)
        Week 102 (n=245)
    93.5 (89.6 to 96.2)
        Week 114 (n=231)
    93.5 (89.5 to 96.3)
        Week 126 (n=217)
    94.0 (90.0 to 96.8)
        Week 138 (n=197)
    93.4 (89.0 to 96.4)
        Week 150 (n=181)
    94.5 (90.1 to 97.3)
        Week 162 (n=154)
    95.5 (90.9 to 98.2)
        Week 174 (n=142)
    94.4 (89.2 to 97.5)
        Week 186 (n=128)
    96.1 (91.1 to 98.7)
        Week 198 (n=113)
    94.7 (88.8 to 98.0)
        Week 210 (n=89)
    96.6 (90.5 to 99.3)
        Week 222 (n=71)
    98.6 (92.4 to 100)
        Week 234 (n=51)
    100 (93.0 to 100)
        Week 246 (n=42)
    95.2 (83.8 to 99.4)
    Notes
    [35] - All participants in the ITT analysis set with evaluable data at each timepoint.
    No statistical analyses for this end point

    Other pre-specified: Percentage of Participants Achieving a ≥50% Reduction in Immunosuppression Load Relative to Baseline Over Time Among Participants With Inactive Uveitis at Study Entry

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    End point title
    Percentage of Participants Achieving a ≥50% Reduction in Immunosuppression Load Relative to Baseline Over Time Among Participants With Inactive Uveitis at Study Entry
    End point description
    Immunosuppression load was assessed using a weighted semiquantitative scale, applying grades ranging from 0 to 9 for each immunosuppressive agent on a scale for the total daily dose in milligrams per kilogram per day or per week if dosed weekly. A higher score indicating a higher immunosuppression load and a lower or decreased score indicated improvement or less need for immunosuppressive therapy. The grading scheme was used to accommodate the simultaneous use of multiple agents and provided a combined, single numeric score for the total immunosuppression load per unit body weight per day at each visit. For participants receiving multiple medications, the sum of the grading scores for each drug was used to calculate a total immunosuppression score at each visit. Data not presented after Week 234 as no participants remained on study as of Week 234. n=the number of participants at given time point.
    End point type
    Other pre-specified
    End point timeframe
    Weeks 2, 4, 8, 12, 18, 30, 42, 54, 66, 78, 90, 102, 114, 126, 138, 150, 162, 174, 186, 198, 210, 222, and 234
    End point values
    Adalimumab
    Number of subjects analysed
    55 [36]
    Units: Percentage of Participants
    number (confidence interval 95%)
        Week 2 (n=55)
    3.6 (0.4 to 12.5)
        Week 4 (n=55)
    9.1 (3.0 to 20.0)
        Week 8 (n=52)
    17.3 (8.2 to 30.3)
        Week 12 (n=52)
    17.3 (8.2 to 30.3)
        Week 18 (n=51)
    21.6 (11.3 to 35.3)
        Week 30 (n=49)
    24.5 (13.3 to 38.9)
        Week 42 (n=48)
    22.9 (12.0 to 37.3)
        Week 54 (n=45)
    17.8 (8.0 to 32.1)
        Week 66 (n=40)
    15.0 (5.7 to 29.8)
        Week 78 (n=40)
    15.0 (5.7 to 29.8)
        Week 90 (n=37)
    13.5 (4.5 to 28.8)
        Week 102 (n=34)
    14.7 (5.0 to 31.1)
        Week 114 (n=32)
    25.0 (11.5 to 43.4)
        Week 126 (n=28)
    25.0 (10.7 to 44.9)
        Week 138 (n=24)
    25.0 (9.8 to 46.7)
        Week 150 (n=21)
    23.8 (8.2 to 47.2)
        Week 162 (n=16)
    18.8 (4.0 to 45.6)
        Week 174 (n=16)
    12.5 (1.6 to 38.3)
        Week 186 (n=16)
    12.5 (1.6 to 38.3)
        Week 198 (n=10)
    0 (0 to 0)
        Week 210 (n=8)
    12.5 (0.3 to 52.7)
        Week 222 (n=4)
    25.0 (0.6 to 80.6)
        Week 234 (n=4)
    50.0 (6.8 to 93.2)
    Notes
    [36] - ITT set with immunosuppression load ˃0 at baseline (Week 0) with evaluable data at each timepoint
    No statistical analyses for this end point

    Other pre-specified: Percentage of Participants Achieving a ≥50% Reduction in Immunosuppression Load Relative to Week 8 Over Time Among Participants With Active Uveitis at Study Entry

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    End point title
    Percentage of Participants Achieving a ≥50% Reduction in Immunosuppression Load Relative to Week 8 Over Time Among Participants With Active Uveitis at Study Entry
    End point description
    Immunosuppression load was assessed using a weighted semiquantitative scale, applying grades ranging from 0 to 9 for each immunosuppressive agent on a scale for the total daily dose in milligrams per kilogram per day or per week if dosed weekly. A higher score indicating a higher immunosuppression load and a lower or decreased score indicated improvement or less need for immunosuppressive therapy. The grading scheme was used to accommodate the simultaneous use of multiple agents and provided a combined, single numeric score for the total immunosuppression load per unit body weight per day at each visit. For participants receiving multiple medications, the sum of the grading scores for each drug was used to calculate a total immunosuppression score at each visit. n=the number of participants at given time point.
    End point type
    Other pre-specified
    End point timeframe
    Weeks 12, 18, 30, 42, 54, 66, 78, 90, 102, 114, 126, 138, 150, 162, 174, 186, 198, 210, 222, 234, and 246
    End point values
    Adalimumab
    Number of subjects analysed
    140 [37]
    Units: Percentage of Participants
    number (confidence interval 95%)
        Week 12 (n=140)
    17.1 (11.3 to 24.4)
        Week 18 (n=136)
    27.2 (19.9 to 35.5)
        Week 30 (n=128)
    33.6 (25.5 to 42.5)
        Week 42 (n=125)
    41.6 (32.9 to 50.8)
        Week 54 (n=119)
    44.5 (35.4 to 53.9)
        Week 66 (n=113)
    48.7 (39.2 to 58.3)
        Week 78 (n=109)
    48.6 (38.9 to 58.4)
        Week 90 (n=106)
    53.8 (43.8 to 63.5)
        Week 102 (n=98)
    54.1 (43.7 to 64.2)
        Week 114 (n=90)
    51.1 (40.3 to 61.8)
        Week 126 (n=87)
    52.9 (41.9 to 63.7)
        Week 138 (n=80)
    52.5 (41.0 to 63.8)
        Week 150 (n=76)
    53.9 (42.1 to 65.5)
        Week 162 (n=71)
    53.5 (41.3 to 65.5)
        Week 174 (n=63)
    55.6 (42.5 to 68.1)
        Week 186 (n=59)
    55.9 (42.4 to 68.8)
        Week 198 (n=50)
    52.0 (37.4 to 66.3)
        Week 210 (n=41)
    51.2 (35.1 to 67.1)
        Week 222 (n=31)
    54.8 (36.0 to 72.7)
        Week 234 (n=23)
    56.5 (34.5 to 76.8)
        Week 246 (n=19)
    63.2 (38.4 to 83.7)
    Notes
    [37] - ITT set with immunosuppression load ˃0 at baseline (Week 8) with evaluable data at each timepoint
    No statistical analyses for this end point

    Other pre-specified: Percentage of Participants With No New Active, Inflammatory Chorioretinal or Inflammatory Retinal Vascular Lesion in Both Eyes Relative to Baseline Over Time Among Participants With Inactive Uveitis at Study Entry

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    End point title
    Percentage of Participants With No New Active, Inflammatory Chorioretinal or Inflammatory Retinal Vascular Lesion in Both Eyes Relative to Baseline Over Time Among Participants With Inactive Uveitis at Study Entry
    End point description
    Percentage of participants at each study time point with no new active, inflammatory chorioretinal or inflammatory retinal vascular lesion in both eyes relative to Baseline for participants who had inactive uveitis when they entered the study. n=the number of participants at given time point.
    End point type
    Other pre-specified
    End point timeframe
    Weeks 2, 4, 8, 12, 18, 30, 42, 54, 66, 78, 90, 102, 114, 126, 138, 150, 162, 174, 186, 198, 210, 222, 234, and 246
    End point values
    Adalimumab
    Number of subjects analysed
    124 [38]
    Units: Percentage of Participants
    number (confidence interval 95%)
        Week 2 (n=118)
    100 (96.9 to 100)
        Week 4 (n=107)
    99.1 (94.9 to 100)
        Week 8 (n=113)
    100 (96.8 to 100)
        Week 12 (n=112)
    100 (96.8 to 100)
        Week 18 (n=112)
    98.2 (93.7 to 99.8)
        Week 30 (n=112)
    100 (96.8 to 100)
        Week 42 (n=112)
    98.2 (93.7 to 99.8)
        Week 54 (n=107)
    99.1 (94.9 to 100)
        Week 66 (n=103)
    100 (96.5 to 100)
        Week 78 (n=99)
    100 (96.3 to 100)
        Week 90 (n=95)
    98.9 (94.3 to 100)
        Week 102 (n=89)
    98.9 (93.9 to 100)
        Week 114 (n=84)
    100 (95.7 to 100)
        Week 126 (n=75)
    100 (95.2 to 100)
        Week 138 (n=64)
    98.4 (91.6 to 100)
        Week 150 (n=57)
    96.5 (87.9 to 99.6)
        Week 162 (n=39)
    97.4 (86.5 to 99.9)
        Week 174 (n=34)
    100 (89.7 to 100)
        Week 186 (n=31)
    100 (88.8 to 100)
        Week 198 (n=26)
    100 (86.8 to 100)
        Week 210 (n=16)
    100 (79.4 to 100)
        Week 222 (n=12)
    100 (73.5 to 100)
        Week 234 (n=9)
    100 (66.4 to 100)
        Week 246 (n=7)
    100 (59.0 to 100)
    Notes
    [38] - All participants in the ITT analysis set that had evaluable data at each timepoint.
    No statistical analyses for this end point

    Other pre-specified: Percentage of Participants With No New Active, Inflammatory Chorioretinal or Inflammatory Retinal Vascular Lesion in Both Eyes Relative to Week 8 Over Time Among Participants With Active Uveitis at Study Entry

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    End point title
    Percentage of Participants With No New Active, Inflammatory Chorioretinal or Inflammatory Retinal Vascular Lesion in Both Eyes Relative to Week 8 Over Time Among Participants With Active Uveitis at Study Entry
    End point description
    Percentage of participants at each study time point with no new active, inflammatory chorioretinal or inflammatory retinal vascular lesion in both eyes relative to Week 8 for participants who had active uveitis when they entered the study. n=the number of participants at given time point.
    End point type
    Other pre-specified
    End point timeframe
    Weeks 12, 18, 30, 42, 54, 66, 78, 90, 102, 114, 126, 138, 150, 162, 174, 186, 198, 210, 222, 234, and 246
    End point values
    Adalimumab
    Number of subjects analysed
    225 [39]
    Units: Percentage of Participants
    number (confidence interval 95%)
        Week 12 (n=221)
    97.7 (94.8 to 99.3)
        Week 18 (n=218)
    99.1 (96.7 to 99.9)
        Week 30 (n=207)
    97.1 (93.8 to 98.9)
        Week 42 (n=198)
    99.0 (96.4 to 99.9)
        Week 54 (n=188)
    98.9 (96.2 to 99.9)
        Week 66 (n=181)
    98.3 (95.2 to 99.7)
        Week 78 (n=173)
    97.7 (94.2 to 99.4)
        Week 90 (n=166)
    97.6 (93.9 to 99.3)
        Week102 (n=156)
    99.4 (96.5 to 100)
        Week 114 (n=147)
    97.3 (93.2 to 99.3)
        Week 126 (n=140)
    99.3 (96.1 to 100)
        Week 138 (n=132)
    100 (97.2 to 100)
        Week 150 (n=123)
    96.7 (91.9 to 99.1)
        Week 162 (n=115)
    97.4 (92.6 to 99.5)
        Week 174 (n=108)
    100 (96.6 to 100)
        Week 186 (n=97)
    99.0 (94.4 to 100)
        Week 198 (n=87)
    100 (95.8 to 100)
        Week 210 (n=73)
    100 (95.1 to 100)
        Week 222 (n=59)
    100 (93.9 to 100)
        Week 234 (n=42)
    100 (91.6 to 100)
        Week 246 (n=35)
    100 (90.0 to 100)
    Notes
    [39] - All participants in the ITT analysis set with evaluable data at each timepoint
    No statistical analyses for this end point

    Other pre-specified: Percentage of Participants With Grade ≤0.5+ in VH in Both Eyes on Indirect Ophthalmoscopy According to NEI/SUN Criteria Over Time

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    End point title
    Percentage of Participants With Grade ≤0.5+ in VH in Both Eyes on Indirect Ophthalmoscopy According to NEI/SUN Criteria Over Time
    End point description
    Vitreous haze was measured using dilated indirect ophthalmoscopy (DIO) and assessed by the Investigator according to NEI and SUN criteria: Grade 0: No evident vitreous haze; Grade 0.5+: Slight blurring of the optic disc margin because of the haze; normal striations and reflex of the nerve fiber layer cannot be visualized; Grade 1+: Permits a better definition of both the optic nerve head and the retinal vessels (compared to higher grades); Grade 2+: Permits better visualization of the retinal vessels (compared to higher grades); Grade 3+: Permits the observer to see the optic nerve head, but the borders are quite blurry; Grade 4+: Optic nerve head is obscured. n=the number of participants at given time point.
    End point type
    Other pre-specified
    End point timeframe
    Weeks 0, 2, 4, 8, 12, 18, 30, 42, 54, 66, 78, 90, 102, 114, 126, 138, 150, 162, 174, 186, 198, 210, 222, 234, and 246
    End point values
    Adalimumab
    Number of subjects analysed
    364 [40]
    Units: Percentage of Participants
    number (confidence interval 95%)
        Week 0 (n=364)
    58.0 (52.7 to 63.1)
        Week 2 (n=348)
    75.6 (70.7 to 80.0)
        Week 4 (n=323)
    77.7 (72.8 to 82.1)
        Week 8 (n=342)
    84.2 (79.9 to 87.9)
        Week 12 (n=333)
    84.4 (80.0 to 88.1)
        Week 18 (n=330)
    87.3 (83.2 to 90.7)
        Week 30 (n=319)
    87.1 (83.0 to 90.6)
        Week 42 (n=310)
    90.3 (86.5 to 93.4)
        Week 54 (n=295)
    89.5 (85.4 to 92.7)
        Week 66 (n=283)
    92.2 (88.5 to 95.1)
        Week 78 (n=270)
    93.3 (89.7 to 96.0)
        Week 90 (n=261)
    93.5 (89.8 to 96.2)
        Week 102 (n=245)
    93.9 (90.1 to 96.5)
        Week 114 (n=231)
    93.1 (89.0 to 96.0)
        Week 126 (n=215)
    94.9 (91.0 to 97.4)
        Week 138 (n=196)
    95.4 (91.5 to 97.9)
        Week 150 (n=180)
    92.2 (87.3 to 95.7)
        Week 162 (n=154)
    91.6 (86.0 to 95.4)
        Week 174 (n=142)
    92.3 (86.6 to 96.1)
        Week 186 (n=128)
    96.1 (91.1 to 98.7)
        Week 198 (n=113)
    93.8 (87.7 to 97.5)
        Week 210 (n=88)
    92.0 (84.3 to 96.7)
        Week 222 (n=70)
    95.7 (88.0 to 99.1)
        Week 234 (n=51)
    96.1 (86.5 to 99.5)
        Week 246 (n=42)
    97.6 (87.4 to 99.9)
    Notes
    [40] - All participants in the ITT analysis set with evaluable data at each timepoint
    No statistical analyses for this end point

    Other pre-specified: Change in National Eye Institute (NEI) Visual Functioning Questionnaire (VFQ-25) Score at Each Study Time Point Relative to Baseline for Participants Who Had Inactive Uveitis at Study Entry Over Time

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    End point title
    Change in National Eye Institute (NEI) Visual Functioning Questionnaire (VFQ-25) Score at Each Study Time Point Relative to Baseline for Participants Who Had Inactive Uveitis at Study Entry Over Time
    End point description
    The National Eye Institute (NEI) Visual Functioning Questionnaire (VFQ-25) is an ocular disease-specific survey that measures the influence of visual disability and visual symptoms on generic health domains such as emotional well-being and social functioning, in addition to task-oriented domains related to daily visual functioning. The VFQ-25 consists of a base set of 25 vision-targeted questions plus an additional single-item general health rating question. The overall composite score ranges from 0 to 100, where higher scores or increases in score indicate better vision-related functioning. Baseline was defined as Week 0 for participants with inactive uveitis. n=the number of participants at given time point.
    End point type
    Other pre-specified
    End point timeframe
    Weeks 0, 8, 18, 30, 42, 54, 66, 78, 90, 102, 114, 126, 138, 150, 162, 174, 186, 198, 210, 222, 234, and 246
    End point values
    Adalimumab
    Number of subjects analysed
    122 [41]
    Units: Score on a Scale
    arithmetic mean (confidence interval 95%)
        Week 0 (n=122)
    84.77 (81.93 to 87.62)
        Week 8 (n=111)
    84.37 (81.37 to 87.37)
        Week 18 (n=112)
    85.21 (82.30 to 88.13)
        Week 30 (n=111)
    84.75 (81.91 to 87.59)
        Week 42 (n=111)
    84.41 (81.29 to 87.53)
        Week 54 (n=105)
    84.47 (81.82 to 87.91)
        Week 66 (n=103)
    84.09 (80.97 to 87.21)
        Week 78 (n=99)
    83.59 (80.33 to 86.85)
        Week 90 (n=95)
    83.66 (80.18 to 87.15)
        Week 102 (n=89)
    84.19 (80.62 to 87.76)
        Week 114 (n=83)
    84.09 (80.40 to 87.78)
        Week 126 (n=76)
    84.44 (80.59 to 88.28)
        Week 138 (n=64)
    84.85 (80.56 to 89.14)
        Week 150 (n=57)
    83.90 (78.95 to 88.85)
        Week 162 (n=39)
    86.60 (81.31 to 91.90)
        Week 174 (n=34)
    87.25 (81.51 to 92.99)
        Week 186 (n=31)
    87.25 (81.43 to 93.06)
        Week 198 (n=26)
    85.30 (78.35 to 92.26)
        Week 210 (n=16)
    85.71 (76.61 to 94.82)
        Week 222 (n=12)
    85.67 (74.60 to 96.74)
        Week 234 (n=9)
    82.90 (68.16 to 97.63)
        Week 246 (n=7)
    79.83 (61.00 to 98.66)
    Notes
    [41] - All participants in the ITT analysis set with evaluable data at each timepoint
    No statistical analyses for this end point

    Other pre-specified: Change in NEI VFQ-25 Score at Each Study Time Point Relative to Week 8 for Participants Who Had Active Uveitis at Study Entry Over Time

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    End point title
    Change in NEI VFQ-25 Score at Each Study Time Point Relative to Week 8 for Participants Who Had Active Uveitis at Study Entry Over Time
    End point description
    The National Eye Institute (NEI) Visual Functioning Questionnaire (VFQ-25) is an ocular disease-specific survey that measures the influence of visual disability and visual symptoms on generic health domains such as emotional well-being and social functioning, in addition to task-oriented domains related to daily visual functioning. The VFQ-25 consists of a base set of 25 vision-targeted questions plus an additional single-item general health rating question. The overall composite score ranges from 0 to 100, where higher scores or increases in score indicate better vision-related functioning. Baseline was defined as Week 8 for participants with active uveitis. n=the number of participants at given time point.
    End point type
    Other pre-specified
    End point timeframe
    Weeks 0, 8, 18, 30, 42, 54, 66, 78, 90, 102, 114, 126, 138, 150, 162, 174, 186, 198, 210, 222, 234, and 246
    End point values
    Adalimumab
    Number of subjects analysed
    240 [42]
    Units: Score on a Scale
    arithmetic mean (confidence interval 95%)
        Week 0 (n=240)
    72.00 (69.52 to 74.48)
        Week 8 (n=226)
    75.77 (73.27 to 78.26)
        Week 18 (n=215)
    78.12 (75.65 to 80.58)
        Week 30 (n=206)
    78.98 (76.46 to 81.50)
        Week 42 (n=197)
    79.77 (77.37 to 82.18)
        Week 54 (n=188)
    80.10 (77.69 to 82.50)
        Week 66 (n=180)
    80.42 (77.87 to 82.97)
        Week 78 (n=169)
    80.98 (78.39 to 83.58)
        Week 90 (n=163)
    81.85 (79.32 to 84.37)
        Week 102 (n=156)
    81.44 (78.74 to 84.14)
        Week 114 (n=146)
    81.76 (78.99 to 84.54)
        Week 126 (n=140)
    81.86 (79.11 to 84.61)
        Week 138 (n=133)
    81.76 (78.94 to 84.59)
        Week 150 (n=123)
    82.41 (79.51 to 85.31)
        Week 162 (n=115)
    81.87 (78.90 to 84.85)
        Week 174 (n=108)
    81.96 (78.78 to 85.14)
        Week 186 (n=97)
    81.27 (78.07 to 84.46)
        Week 198 (n=87)
    82.08 (78.82 to 85.34)
        Week 210 (n=72)
    80.75 (76.99 to 84.51)
        Week 222 (n=59)
    81.65 (77.24 to 86.05)
        Week 234 (n=42)
    81.86 (76.32 to 87.40)
        Week 246 (n=35)
    81.57 (75.44 to 87.70)
    Notes
    [42] - All participants in the ITT analysis set with evaluable data at each timepoint
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until either 70 days after the last dose of study drug or until the first dose of commercially available drug (up to 370 weeks).
    Adverse event reporting additional description
    TEAEs/SAEs are defined as any AE or SAE with onset or worsening reported by a participant from the time first dose of adalimumab is administered in Study M11-327 until 5 half-lives (70 days) have elapsed following discontinuation of adalimumab or until first dose of commercially available adalimumab post regulatory and/or reimbursement approval.
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    19.0
    Reporting groups
    Reporting group title
    ADALIMUMAB
    Reporting group description
    -

    Serious adverse events
    ADALIMUMAB
    Total subjects affected by serious adverse events
         subjects affected / exposed
    101 / 424 (23.82%)
         number of deaths (all causes)
    4
         number of deaths resulting from adverse events
    Vascular disorders
    BEHCET'S SYNDROME
         subjects affected / exposed
    1 / 424 (0.24%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    AORTIC DILATATION
         subjects affected / exposed
    1 / 424 (0.24%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    HYPERTENSION
         subjects affected / exposed
    1 / 424 (0.24%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    B-CELL LYMPHOMA
         subjects affected / exposed
    1 / 424 (0.24%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    ADENOCARCINOMA OF COLON
         subjects affected / exposed
    1 / 424 (0.24%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    BASAL CELL CARCINOMA
         subjects affected / exposed
    2 / 424 (0.47%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    LOBULAR BREAST CARCINOMA IN SITU
         subjects affected / exposed
    1 / 424 (0.24%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    COLORECTAL CANCER
         subjects affected / exposed
    1 / 424 (0.24%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    PANCREATIC CARCINOMA METASTATIC
         subjects affected / exposed
    1 / 424 (0.24%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    RECTAL ADENOCARCINOMA
         subjects affected / exposed
    1 / 424 (0.24%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    SQUAMOUS CELL CARCINOMA OF SKIN
         subjects affected / exposed
    1 / 424 (0.24%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    UTERINE LEIOMYOMA
         subjects affected / exposed
    1 / 424 (0.24%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Immune system disorders
    SARCOIDOSIS
         subjects affected / exposed
    1 / 424 (0.24%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Pregnancy, puerperium and perinatal conditions
    ECTOPIC PREGNANCY
         subjects affected / exposed
    1 / 424 (0.24%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    HYPEREMESIS GRAVIDARUM
         subjects affected / exposed
    1 / 424 (0.24%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    General disorders and administration site conditions
    CHEST PAIN
         subjects affected / exposed
    2 / 424 (0.47%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    DEATH
         subjects affected / exposed
    1 / 424 (0.24%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    GENERALISED OEDEMA
         subjects affected / exposed
    1 / 424 (0.24%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Reproductive system and breast disorders
    HYDROCELE FEMALE
         subjects affected / exposed
    1 / 424 (0.24%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    CYSTOCELE
         subjects affected / exposed
    1 / 424 (0.24%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    RECTOCELE
         subjects affected / exposed
    1 / 424 (0.24%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    VAGINAL HAEMORRHAGE
         subjects affected / exposed
    1 / 424 (0.24%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Injury, poisoning and procedural complications
    COMMINUTED FRACTURE
         subjects affected / exposed
    1 / 424 (0.24%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    CORNEAL ABRASION
         subjects affected / exposed
    1 / 424 (0.24%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    ELSCHNIG'S BODIES
         subjects affected / exposed
    1 / 424 (0.24%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    EPICONDYLITIS
         subjects affected / exposed
    1 / 424 (0.24%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    FALL
         subjects affected / exposed
    1 / 424 (0.24%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    JOINT DISLOCATION
         subjects affected / exposed
    1 / 424 (0.24%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    FOREARM FRACTURE
         subjects affected / exposed
    1 / 424 (0.24%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    POST PROCEDURAL HAEMORRHAGE
         subjects affected / exposed
    1 / 424 (0.24%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    LACERATION
         subjects affected / exposed
    1 / 424 (0.24%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    STRESS FRACTURE
         subjects affected / exposed
    1 / 424 (0.24%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    SPINAL COMPRESSION FRACTURE
         subjects affected / exposed
    2 / 424 (0.47%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    UPPER LIMB FRACTURE
         subjects affected / exposed
    1 / 424 (0.24%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    TIBIA FRACTURE
         subjects affected / exposed
    1 / 424 (0.24%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Investigations
    HEPATIC ENZYME INCREASED
         subjects affected / exposed
    1 / 424 (0.24%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    CARDIAC MURMUR
         subjects affected / exposed
    1 / 424 (0.24%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    INTRAOCULAR PRESSURE INCREASED
         subjects affected / exposed
    1 / 424 (0.24%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    MYCOBACTERIUM TUBERCULOSIS COMPLEX TEST POSITIVE
         subjects affected / exposed
    1 / 424 (0.24%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    TUBERCULIN TEST POSITIVE
         subjects affected / exposed
    1 / 424 (0.24%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Cardiac disorders
    AORTIC VALVE STENOSIS
         subjects affected / exposed
    1 / 424 (0.24%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    ACUTE MYOCARDIAL INFARCTION
         subjects affected / exposed
    1 / 424 (0.24%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    CARDIAC FAILURE ACUTE
         subjects affected / exposed
    1 / 424 (0.24%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    CORONARY ARTERY DISEASE
         subjects affected / exposed
    1 / 424 (0.24%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    MYOCARDIAL INFARCTION
         subjects affected / exposed
    1 / 424 (0.24%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Congenital, familial and genetic disorders
    BICUSPID AORTIC VALVE
         subjects affected / exposed
    1 / 424 (0.24%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    ACUTE RESPIRATORY FAILURE
         subjects affected / exposed
    1 / 424 (0.24%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    PLEURAL EFFUSION
         subjects affected / exposed
    1 / 424 (0.24%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    NASAL POLYPS
         subjects affected / exposed
    1 / 424 (0.24%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    PNEUMOTHORAX
         subjects affected / exposed
    1 / 424 (0.24%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    PULMONARY EMBOLISM
         subjects affected / exposed
    1 / 424 (0.24%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    PULMONARY FIBROSIS
         subjects affected / exposed
    1 / 424 (0.24%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    SLEEP APNOEA SYNDROME
         subjects affected / exposed
    1 / 424 (0.24%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Blood and lymphatic system disorders
    PSEUDOLYMPHOMA
         subjects affected / exposed
    1 / 424 (0.24%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Nervous system disorders
    ATAXIA
         subjects affected / exposed
    1 / 424 (0.24%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    ENCEPHALITIS AUTOIMMUNE
         subjects affected / exposed
    1 / 424 (0.24%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    DEMYELINATION
         subjects affected / exposed
    1 / 424 (0.24%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    MULTIPLE SCLEROSIS
         subjects affected / exposed
    2 / 424 (0.47%)
         occurrences causally related to treatment / all
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    TENSION HEADACHE
         subjects affected / exposed
    1 / 424 (0.24%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    TRANSIENT ISCHAEMIC ATTACK
         subjects affected / exposed
    1 / 424 (0.24%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Eye disorders
    CATARACT
         subjects affected / exposed
    7 / 424 (1.65%)
         occurrences causally related to treatment / all
    0 / 11
         deaths causally related to treatment / all
    0 / 0
    CILIARY ZONULAR DEHISCENCE
         subjects affected / exposed
    1 / 424 (0.24%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    BLINDNESS
         subjects affected / exposed
    1 / 424 (0.24%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    EYE INFLAMMATION
         subjects affected / exposed
    1 / 424 (0.24%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    CORNEAL OEDEMA
         subjects affected / exposed
    1 / 424 (0.24%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    MACULAR FIBROSIS
         subjects affected / exposed
    1 / 424 (0.24%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    GLAUCOMA
         subjects affected / exposed
    1 / 424 (0.24%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    OCULAR HYPERTENSION
         subjects affected / exposed
    1 / 424 (0.24%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    OPTIC NEUROPATHY
         subjects affected / exposed
    1 / 424 (0.24%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    PAPILLOEDEMA
         subjects affected / exposed
    1 / 424 (0.24%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    RETINAL DETACHMENT
         subjects affected / exposed
    3 / 424 (0.71%)
         occurrences causally related to treatment / all
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    UVEITIS
         subjects affected / exposed
    5 / 424 (1.18%)
         occurrences causally related to treatment / all
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    RETINAL VASCULITIS
         subjects affected / exposed
    1 / 424 (0.24%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    VITREOUS FLOATERS
         subjects affected / exposed
    1 / 424 (0.24%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    VISUAL ACUITY REDUCED
         subjects affected / exposed
    2 / 424 (0.47%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    VITREOUS HAEMORRHAGE
         subjects affected / exposed
    3 / 424 (0.71%)
         occurrences causally related to treatment / all
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    VITREOUS OPACITIES
         subjects affected / exposed
    1 / 424 (0.24%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Gastrointestinal disorders
    COLITIS
         subjects affected / exposed
    1 / 424 (0.24%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    CROHN'S DISEASE
         subjects affected / exposed
    2 / 424 (0.47%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    GASTRIC ULCER
         subjects affected / exposed
    1 / 424 (0.24%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    INTESTINAL OBSTRUCTION
         subjects affected / exposed
    1 / 424 (0.24%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    GASTRITIS
         subjects affected / exposed
    1 / 424 (0.24%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    LARGE INTESTINE POLYP
         subjects affected / exposed
    2 / 424 (0.47%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    PANCREATITIS
         subjects affected / exposed
    1 / 424 (0.24%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Renal and urinary disorders
    ACUTE KIDNEY INJURY
         subjects affected / exposed
    1 / 424 (0.24%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    BLADDER DIVERTICULUM
         subjects affected / exposed
    1 / 424 (0.24%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    MICTURITION DISORDER
         subjects affected / exposed
    1 / 424 (0.24%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    NEPHROLITHIASIS
         subjects affected / exposed
    2 / 424 (0.47%)
         occurrences causally related to treatment / all
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    URETEROLITHIASIS
         subjects affected / exposed
    1 / 424 (0.24%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    RENAL COLIC
         subjects affected / exposed
    1 / 424 (0.24%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Hepatobiliary disorders
    BILIARY COLIC
         subjects affected / exposed
    1 / 424 (0.24%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    CHOLELITHIASIS
         subjects affected / exposed
    3 / 424 (0.71%)
         occurrences causally related to treatment / all
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    Product issues
    DEVICE DISLOCATION
         subjects affected / exposed
    1 / 424 (0.24%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Skin and subcutaneous tissue disorders
    INGROWING NAIL
         subjects affected / exposed
    1 / 424 (0.24%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Musculoskeletal and connective tissue disorders
    ARTHRALGIA
         subjects affected / exposed
    2 / 424 (0.47%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    MUSCULOSKELETAL PAIN
         subjects affected / exposed
    1 / 424 (0.24%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    MYOPATHY
         subjects affected / exposed
    1 / 424 (0.24%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    OSTEOARTHRITIS
         subjects affected / exposed
    2 / 424 (0.47%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    OSTEOLYSIS
         subjects affected / exposed
    1 / 424 (0.24%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    PATELLOFEMORAL PAIN SYNDROME
         subjects affected / exposed
    1 / 424 (0.24%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    SYNOVITIS
         subjects affected / exposed
    1 / 424 (0.24%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Metabolism and nutrition disorders
    HYPOGLYCAEMIA
         subjects affected / exposed
    1 / 424 (0.24%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    OBESITY
         subjects affected / exposed
    3 / 424 (0.71%)
         occurrences causally related to treatment / all
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    Infections and infestations
    APPENDICITIS
         subjects affected / exposed
    1 / 424 (0.24%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    APPENDICITIS PERFORATED
         subjects affected / exposed
    1 / 424 (0.24%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    ASPERGILLUS INFECTION
         subjects affected / exposed
    1 / 424 (0.24%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    BRAIN ABSCESS
         subjects affected / exposed
    1 / 424 (0.24%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    CELLULITIS
         subjects affected / exposed
    1 / 424 (0.24%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    CYTOMEGALOVIRUS CHORIORETINITIS
         subjects affected / exposed
    1 / 424 (0.24%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    DEVICE RELATED INFECTION
         subjects affected / exposed
    1 / 424 (0.24%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    CYTOMEGALOVIRUS INFECTION
         subjects affected / exposed
    1 / 424 (0.24%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    DIVERTICULITIS
         subjects affected / exposed
    2 / 424 (0.47%)
         occurrences causally related to treatment / all
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    ESCHERICHIA URINARY TRACT INFECTION
         subjects affected / exposed
    1 / 424 (0.24%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    GASTROENTERITIS
         subjects affected / exposed
    1 / 424 (0.24%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    INFECTION
         subjects affected / exposed
    1 / 424 (0.24%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    LATENT TUBERCULOSIS
         subjects affected / exposed
    1 / 424 (0.24%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    MENINGITIS
         subjects affected / exposed
    1 / 424 (0.24%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    PERITONSILLAR ABSCESS
         subjects affected / exposed
    1 / 424 (0.24%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    OPHTHALMIC HERPES ZOSTER
         subjects affected / exposed
    1 / 424 (0.24%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    PYELONEPHRITIS
         subjects affected / exposed
    2 / 424 (0.47%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    PNEUMONIA
         subjects affected / exposed
    3 / 424 (0.71%)
         occurrences causally related to treatment / all
    1 / 3
         deaths causally related to treatment / all
    0 / 0
    PYONEPHROSIS
         subjects affected / exposed
    1 / 424 (0.24%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    SINUSITIS
         subjects affected / exposed
    2 / 424 (0.47%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    SEPTIC SHOCK
         subjects affected / exposed
    1 / 424 (0.24%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    SINUSITIS FUNGAL
         subjects affected / exposed
    1 / 424 (0.24%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    SOFT TISSUE INFECTION
         subjects affected / exposed
    1 / 424 (0.24%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    SUBCUTANEOUS ABSCESS
         subjects affected / exposed
    1 / 424 (0.24%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    TOOTH ABSCESS
         subjects affected / exposed
    1 / 424 (0.24%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    URINARY TRACT INFECTION
         subjects affected / exposed
    5 / 424 (1.18%)
         occurrences causally related to treatment / all
    1 / 5
         deaths causally related to treatment / all
    0 / 0
    TUBERCULOSIS
         subjects affected / exposed
    1 / 424 (0.24%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    UROSEPSIS
         subjects affected / exposed
    1 / 424 (0.24%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    ADALIMUMAB
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    332 / 424 (78.30%)
    Vascular disorders
    HYPERTENSION
         subjects affected / exposed
    27 / 424 (6.37%)
         occurrences all number
    28
    Investigations
    INTRAOCULAR PRESSURE INCREASED
         subjects affected / exposed
    23 / 424 (5.42%)
         occurrences all number
    30
    Respiratory, thoracic and mediastinal disorders
    COUGH
         subjects affected / exposed
    42 / 424 (9.91%)
         occurrences all number
    45
    OROPHARYNGEAL PAIN
         subjects affected / exposed
    32 / 424 (7.55%)
         occurrences all number
    39
    Nervous system disorders
    HEADACHE
         subjects affected / exposed
    63 / 424 (14.86%)
         occurrences all number
    83
    Eye disorders
    CATARACT
         subjects affected / exposed
    30 / 424 (7.08%)
         occurrences all number
    38
    CYSTOID MACULAR OEDEMA
         subjects affected / exposed
    43 / 424 (10.14%)
         occurrences all number
    70
    DRY EYE
         subjects affected / exposed
    30 / 424 (7.08%)
         occurrences all number
    33
    EYE PAIN
         subjects affected / exposed
    25 / 424 (5.90%)
         occurrences all number
    27
    IRIDOCYCLITIS
         subjects affected / exposed
    22 / 424 (5.19%)
         occurrences all number
    29
    MACULAR OEDEMA
         subjects affected / exposed
    24 / 424 (5.66%)
         occurrences all number
    31
    UVEITIS
         subjects affected / exposed
    123 / 424 (29.01%)
         occurrences all number
    217
    VISUAL ACUITY REDUCED
         subjects affected / exposed
    30 / 424 (7.08%)
         occurrences all number
    36
    General disorders and administration site conditions
    FATIGUE
         subjects affected / exposed
    36 / 424 (8.49%)
         occurrences all number
    42
    PYREXIA
         subjects affected / exposed
    24 / 424 (5.66%)
         occurrences all number
    28
    Gastrointestinal disorders
    DIARRHOEA
         subjects affected / exposed
    28 / 424 (6.60%)
         occurrences all number
    33
    NAUSEA
         subjects affected / exposed
    32 / 424 (7.55%)
         occurrences all number
    45
    Skin and subcutaneous tissue disorders
    RASH
         subjects affected / exposed
    24 / 424 (5.66%)
         occurrences all number
    30
    Musculoskeletal and connective tissue disorders
    ARTHRALGIA
         subjects affected / exposed
    72 / 424 (16.98%)
         occurrences all number
    94
    BACK PAIN
         subjects affected / exposed
    26 / 424 (6.13%)
         occurrences all number
    30
    PAIN IN EXTREMITY
         subjects affected / exposed
    24 / 424 (5.66%)
         occurrences all number
    25
    Infections and infestations
    BRONCHITIS
         subjects affected / exposed
    38 / 424 (8.96%)
         occurrences all number
    50
    INFLUENZA
         subjects affected / exposed
    36 / 424 (8.49%)
         occurrences all number
    44
    SINUSITIS
         subjects affected / exposed
    33 / 424 (7.78%)
         occurrences all number
    43
    NASOPHARYNGITIS
         subjects affected / exposed
    105 / 424 (24.76%)
         occurrences all number
    214
    URINARY TRACT INFECTION
         subjects affected / exposed
    47 / 424 (11.08%)
         occurrences all number
    66
    UPPER RESPIRATORY TRACT INFECTION
         subjects affected / exposed
    43 / 424 (10.14%)
         occurrences all number
    65

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    23 Apr 2010
    Revisions were made to exclusion criterion 11 for clarity: a separate sentence was created to specify that participants with chronic recurring infections or active tuberculosis should be excluded. The health resources questionnaire administration frequency was updated to be conducted at every visit to better meet protocol objectives.
    09 Jun 2010
    Revisions to the protocol were as follows: The order of eye exams was changed so that they are performed in the correct order to maximize the results of these procedures. For consistency of results, the comprehensive physical exams were to be performed by a qualified physician. Participants could use one periocular corticosteroid injection during the OLE study (these were prohibited in the parent studies). Anti-vascular endothelial growth factor therapy and intraocular or intravitreal injections were specified in prohibited medications. To satisfy local requirements in Japan, chest x-ray assessments and findings were adjusted.
    14 Feb 2011
    Revisions were made to remove exclusion criteria that were already exclusions for which participants were screened and tested for in parent studies. Exclusion criterion 5 was modified to exclude participants with macular edema due to diabetic retinopathy, as clinical manifestations of these comorbidities can interfere with evaluations in the study. Exclusion Criterion 13 clarified that participants with active systemic viral infection or any active viral infection were to be excluded as they are unsuitable candidates for the study. Prohibited medications were modified to include dexamethasone implant to ensure proper participant population. Medical marijuana use was prohibited to ensure study participants were not at risk for aspergillus infection. Requirements were added for pregnancy occurrence and testing by adding instructions for required action in the event of positive urine pregnancy test and adding the requirement for monthly pregnancy test per Austrian regulations. Screening for tuberculosis (TB) using PPD or QuantiFERON-TB Gold and completing a chest x-ray in case of positive TB test was added. Instructions to use consistent examination technique and instrument for indirect ophthalmoscopy throughout the study were added to support collection of consistent data. Requirement for discontinuation of participants with dysplasia of the gastrointestinal tract, lupus like syndrome, multiple sclerosis or demyelinating disease, non-compliance with TB therapy was added. To ensure consistency of data, minimum documentation required for participants lost to follow-up and requirement for the principal investigator to review and sign chest x-ray were added.
    22 Feb 2011
    Instructions were added to document the participant’s initial anti-nuclear antibody status and allow for repeat testing as medically warranted during the study.
    21 Mar 2011
    The use of systemic carbonic anhydrase was prohibited, as it is a therapeutic option for macular edema and hence could impact study endpoints. Detailed instructions were added clarifying chest x-ray requirements if the tuberculosis test was positive.
    23 Aug 2011
    Revisions were made to exclude participants that may have an infection (specifically tuberculosis [TB]) as the origin of their uveitis and exclusion criterion 4 that participants with BCVA worse than 20/200 will be excluded was removed. Exclusion of participants with an infectious (TB) origin of uveitis was done to prevent unnecessary harm due to PPD skin test if this had been documented previously. Concomitant medications were revised to allow participants one periocular corticosteroid injection per eye during the study. Prohibited therapies were revised so that any TB prophylaxis therapy and glucocorticosteroid implant were prohibited. Participants on TB-prophylaxis were to be discontinued beginning with this amendment Urine pregnancy test requirements were changed so that they could be performed locally for all visits to ensure participants of childbearing potential are carefully screened throughout the study. For study procedures, optical coherence tomography was clarified to ensure consistency throughout the study and instructions for dilated indirect ophthalmoscopy to record number, locations, sizes, and whether lesions are active or inactive were added. Efficacy endpoint was changed to percent change in central retinal thickness. Adverse event criteria were modified to include worsening severity to be reported as a new adverse event and hypotony was added to list of uveitis-related events. TB testing was made consistent across regions by removing Japan-specific requirements.
    15 Mar 2012
    The number of sites and countries to be included was increased to accurately reflect the number of sites and countries and timely completion of enrollment. The study duration of 78 weeks was removed to allow for extension of treatment of responding subjects while waiting for approval. Visits every 12 weeks were added following week 66 through end of study to accommodate study extension. A termination clause for when study will end was added. Annual tuberculosis (TB) screening was added due to study extension. A clarification that 70 day call/visit should be noted in source and EDC9 was added. No new risks/benefits added, but language was clarified in the benefits and risks section. A number of changes were made for TB testing: Inclusion criterion 6 of negative TB result at baseline was removed (testing to still be done for TB), changes were made to TB screening to reflect new CDC guidelines, the same type of TB test should be done on study as was done at baseline for consistency, and instructions for TB screening were added. Timing of collecting adverse events and serious adverse events was updated. Uveitis-related event reporting language updated to match reporting for all adverse events and clarified that list of potential uveitis-events was not exhaustive. Tacrolimus was added as an acceptable concomitant immunosuppressant. An equivalent drug to mycophenolate mofetil as approved by medical monitor was added as an option as some regions do not have mycophenolate mofetil. Instructions were added that results of ketone and glucose testing should be interpreted in the context of additional clinical findings.
    28 Dec 2012
    Malignancy in participants who are 30 years old or younger and non-serious events of malignancy in participants 30 years old or younger reporting requirements were updated as AbbVie is participating in an FDA-requested, tumor necrosis factor inhibitor class wide exploration of these rare malignancies. The only other meaningful change was to periocular corticosteroid injection, which was changed to two injections per eye per year.
    26 Jun 2013
    Revisions included the following: The requirement for a 70-day follow up phone call was clarified. Ustekinumab and belimumab were added to prohibited therapies. The same tuberculosis test used in parent protocol was to be used in this study and text clarifying this was added for consistency. The early stopping rule for parent study was removed from this protocol, as was the language on pregnancy forms and registry.
    04 Jun 2015
    Revisions included an update to Sponsor/Emergency Contact information throughout, including the information for serious adverse event reporting. The study end date was changed to March 2018 to allow for extension of treatment for participants that will complete the study prior to indication approval. As part of this extension, additional visits were added every 12 weeks following Week 280 to the end of study to ensure appropriate follow-up for participants continuing the extended treatment. The complaint and product complaint definitions were added to implement a standard collection process to comply with FDA regulation for reporting of post-marketing safety in clinical trials.

    Interruptions (globally)

    Were there any global interruptions to the trial? No

    Limitations and caveats

    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    The study was planned for 78 weeks but extended until regulatory/reimbursement approval obtained locally. Data were collected through Week 366; efficacy data cut off was Week 246, as less than 10% of participants had visits beyond this timepoint.
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