Skip to content
Triangle logo TriangleGet started
← Full study record

NCT02065557 · BASELINE

Baseline characteristics

Efficacy and Safety of Adalimumab in Pediatric Subjects With Moderate to Severe Ulcerative Colitis · Source last updated 2020-10-05

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

denoms
  1. counts
    1. group Id
      BG000
      value
      32
    2. group Id
      BG001
      value
      51
    3. group Id
      BG002
      value
      18
    4. group Id
      BG003
      value
      101
    units
    Participants
groups
  1. description
    Participants randomized to receive adalimumab 2.4 mg/kg (maximum dose of 160 mg) at Baseline and matching placebo at Week 1, 1.2 mg/kg (maximum dose of 80 mg) at Week 2, followed by 0.6 mg/kg (maximum dose of 40 mg) at Week 4 and Week 6.
    id
    BG000
    title
    Integrated Study (Main + Japan Sub- Study): I-SD
  2. description
    Participants randomized to receive adalimumab 2.4 mg/kg (maximum dose of 160 mg) at Baseline and at Week 1, 1.2 mg/kg (maximum dose of 80 mg) at Week 2, followed by 0.6 mg/kg (maximum dose of 40 mg) at Week 4 and Week 6.
    id
    BG001
    title
    Integrated Study (Main + Japan Sub- Study): I-HD
  3. description
    (After Amendment 4) participants assigned to open-label adalimumab 2.4 mg/kg (maximum dose of 160 mg) at Baseline and at Week 1, 1.2 mg/kg (maximum dose of 80 mg) at Week 2, followed by 0.6 mg/kg (maximum dose of 40 mg) at Week 4 and Week 6.
    id
    BG002
    title
    Integrated Study (Main + Japan Sub- Study): I-HD-OL
  4. description
    Total of all reporting groups
    id
    BG003
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          2.66
          value
          14.7
        2. group Id
          BG001
          spread
          3.06
          value
          13.8
        3. group Id
          BG002
          spread
          2.82
          value
          13.8
        4. group Id
          BG003
          spread
          2.90
          value
          14.1
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Age, Continuous
    unit Of Measure
    years
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          15
        2. group Id
          BG001
          value
          23
        3. group Id
          BG002
          value
          13
        4. group Id
          BG003
          value
          51
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          17
        2. group Id
          BG001
          value
          28
        3. group Id
          BG002
          value
          5
        4. group Id
          BG003
          value
          50
        title
        Male
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Sex: Female, Male
    unit Of Measure
    Participants
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          28
        2. group Id
          BG001
          value
          45
        3. group Id
          BG002
          value
          15
        4. group Id
          BG003
          value
          88
      title
      White
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          3
      title
      Black
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          2
        4. group Id
          BG003
          value
          9
      title
      Asian
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          1
      title
      Multiple
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race/Ethnicity, Customized
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          4
      title
      Hispanic or Latino
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          2
        4. group Id
          BG003
          value
          8
      title
      Japanese
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          29
        2. group Id
          BG001
          value
          45
        3. group Id
          BG002
          value
          15
        4. group Id
          BG003
          value
          89
      title
      No Ethnicity
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race/Ethnicity, Customized
    unit Of Measure
    Participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          1.22
          value
          7.8
        2. group Id
          BG001
          spread
          1.25
          value
          7.7
        3. group Id
          BG002
          spread
          1.09
          value
          7.7
        4. group Id
          BG003
          spread
          1.20
          value
          7.8
    description
    The Mayo score is a tool designed to measure disease activity for ulcerative colitis. The FMS ranges from 0 (normal or inactive disease) to 12 (severe disease) and is calculated as the sum of 4 subscores (stool frequency, rectal bleeding, endoscopy, and physician's global assessment), each of which ranges from 0 (normal) to 3 (severe disease).
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Full Mayo Score (FMS)
    unit Of Measure
    score on a scale
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          1.14
          value
          5.7
        2. group Id
          BG001
          spread
          1.24
          value
          5.5
        3. group Id
          BG002
          spread
          1.06
          value
          5.5
        4. group Id
          BG003
          spread
          1.17
          value
          5.6
    description
    The PMS (Mayo score without endoscopy) ranges from 0 (normal or inactive disease) to 9 (severe disease) and is calculated as the sum of 3 subscores (stool frequency, rectal bleeding and physician's global assessment), each of which ranges from 0 (normal) to 3 (severe disease).
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Partial Mayo Score (PMS)
    unit Of Measure
    score on a scale
  7. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          0.34
          value
          2.1
        2. group Id
          BG001
          spread
          0.40
          value
          2.2
        3. group Id
          BG002
          spread
          0.43
          value
          2.2
        4. group Id
          BG003
          spread
          0.38
          value
          2.2
    description
    The endoscopy subscore of the FMS ranges from 0 (normal) to 3 (severe disease).
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Endoscopy Subscore
    unit Of Measure
    score on a scale
  8. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          0.93
          value
          1.4
        2. group Id
          BG001
          spread
          0.88
          value
          1.5
        3. group Id
          BG002
          spread
          0.97
          value
          1.4
        4. group Id
          BG003
          spread
          0.91
          value
          1.5
    description
    The rectal bleeding subscore of the FMS ranges from 0 (normal) to 3 (severe disease).
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Rectal Bleeding Subscore
    unit Of Measure
    score on a scale
  9. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          0.40
          value
          2.2
        2. group Id
          BG001
          spread
          0.43
          value
          2.2
        3. group Id
          BG002
          spread
          0.38
          value
          2.2
        4. group Id
          BG003
          spread
          0.41
          value
          2.2
    description
    The physicians global assessment subscore of the FMS ranges from 0 (normal) to 3 (severe disease).
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Physicians Global Assessment Subscore
    unit Of Measure
    score on a scale
  10. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          0.78
          value
          2.1
        2. group Id
          BG001
          spread
          0.88
          value
          1.8
        3. group Id
          BG002
          spread
          0.73
          value
          1.9
        4. group Id
          BG003
          spread
          0.83
          value
          1.9
    description
    The stool frequency subscore of the FMS ranges from 0 (normal) to 3 (severe disease).
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Stool Frequency Subscore
    unit Of Measure
    score on a scale
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      32
    2. group Id
      BG001
      value
      51
    3. group Id
      BG002
      value
      18
    4. group Id
      BG003
      value
      101
    units
    Participants
groups
  1. description
    Participants randomized to receive adalimumab 2.4 mg/kg (maximum dose of 160 mg) at Baseline and matching placebo at Week 1, 1.2 mg/kg (maximum dose of 80 mg) at Week 2, followed by 0.6 mg/kg (maximum dose of 40 mg) at Week 4 and Week 6.
    id
    BG000
    title
    Integrated Study (Main + Japan Sub- Study): I-SD
  2. description
    Participants randomized to receive adalimumab 2.4 mg/kg (maximum dose of 160 mg) at Baseline and at Week 1, 1.2 mg/kg (maximum dose of 80 mg) at Week 2, followed by 0.6 mg/kg (maximum dose of 40 mg) at Week 4 and Week 6.
    id
    BG001
    title
    Integrated Study (Main + Japan Sub- Study): I-HD
  3. description
    (After Amendment 4) participants assigned to open-label adalimumab 2.4 mg/kg (maximum dose of 160 mg) at Baseline and at Week 1, 1.2 mg/kg (maximum dose of 80 mg) at Week 2, followed by 0.6 mg/kg (maximum dose of 40 mg) at Week 4 and Week 6.
    id
    BG002
    title
    Integrated Study (Main + Japan Sub- Study): I-HD-OL
  4. description
    Total of all reporting groups
    id
    BG003
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          2.66
          value
          14.7
        2. group Id
          BG001
          spread
          3.06
          value
          13.8
        3. group Id
          BG002
          spread
          2.82
          value
          13.8
        4. group Id
          BG003
          spread
          2.90
          value
          14.1
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Age, Continuous
    unit Of Measure
    years
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          15
        2. group Id
          BG001
          value
          23
        3. group Id
          BG002
          value
          13
        4. group Id
          BG003
          value
          51
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          17
        2. group Id
          BG001
          value
          28
        3. group Id
          BG002
          value
          5
        4. group Id
          BG003
          value
          50
        title
        Male
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Sex: Female, Male
    unit Of Measure
    Participants
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          28
        2. group Id
          BG001
          value
          45
        3. group Id
          BG002
          value
          15
        4. group Id
          BG003
          value
          88
      title
      White
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          3
      title
      Black
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          2
        4. group Id
          BG003
          value
          9
      title
      Asian
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          1
      title
      Multiple
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race/Ethnicity, Customized
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          4
      title
      Hispanic or Latino
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          2
        4. group Id
          BG003
          value
          8
      title
      Japanese
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          29
        2. group Id
          BG001
          value
          45
        3. group Id
          BG002
          value
          15
        4. group Id
          BG003
          value
          89
      title
      No Ethnicity
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race/Ethnicity, Customized
    unit Of Measure
    Participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          1.22
          value
          7.8
        2. group Id
          BG001
          spread
          1.25
          value
          7.7
        3. group Id
          BG002
          spread
          1.09
          value
          7.7
        4. group Id
          BG003
          spread
          1.20
          value
          7.8
    description
    The Mayo score is a tool designed to measure disease activity for ulcerative colitis. The FMS ranges from 0 (normal or inactive disease) to 12 (severe disease) and is calculated as the sum of 4 subscores (stool frequency, rectal bleeding, endoscopy, and physician's global assessment), each of which ranges from 0 (normal) to 3 (severe disease).
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Full Mayo Score (FMS)
    unit Of Measure
    score on a scale
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          1.14
          value
          5.7
        2. group Id
          BG001
          spread
          1.24
          value
          5.5
        3. group Id
          BG002
          spread
          1.06
          value
          5.5
        4. group Id
          BG003
          spread
          1.17
          value
          5.6
    description
    The PMS (Mayo score without endoscopy) ranges from 0 (normal or inactive disease) to 9 (severe disease) and is calculated as the sum of 3 subscores (stool frequency, rectal bleeding and physician's global assessment), each of which ranges from 0 (normal) to 3 (severe disease).
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Partial Mayo Score (PMS)
    unit Of Measure
    score on a scale
  7. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          0.34
          value
          2.1
        2. group Id
          BG001
          spread
          0.40
          value
          2.2
        3. group Id
          BG002
          spread
          0.43
          value
          2.2
        4. group Id
          BG003
          spread
          0.38
          value
          2.2
    description
    The endoscopy subscore of the FMS ranges from 0 (normal) to 3 (severe disease).
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Endoscopy Subscore
    unit Of Measure
    score on a scale
  8. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          0.93
          value
          1.4
        2. group Id
          BG001
          spread
          0.88
          value
          1.5
        3. group Id
          BG002
          spread
          0.97
          value
          1.4
        4. group Id
          BG003
          spread
          0.91
          value
          1.5
    description
    The rectal bleeding subscore of the FMS ranges from 0 (normal) to 3 (severe disease).
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Rectal Bleeding Subscore
    unit Of Measure
    score on a scale
  9. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          0.40
          value
          2.2
        2. group Id
          BG001
          spread
          0.43
          value
          2.2
        3. group Id
          BG002
          spread
          0.38
          value
          2.2
        4. group Id
          BG003
          spread
          0.41
          value
          2.2
    description
    The physicians global assessment subscore of the FMS ranges from 0 (normal) to 3 (severe disease).
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Physicians Global Assessment Subscore
    unit Of Measure
    score on a scale
  10. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          0.78
          value
          2.1
        2. group Id
          BG001
          spread
          0.88
          value
          1.8
        3. group Id
          BG002
          spread
          0.73
          value
          1.9
        4. group Id
          BG003
          spread
          0.83
          value
          1.9
    description
    The stool frequency subscore of the FMS ranges from 0 (normal) to 3 (severe disease).
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Stool Frequency Subscore
    unit Of Measure
    score on a scale

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice