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NCT02552212 · BASELINE

Baseline characteristics

Multicenter Study Evaluating Certolizumab Pegol Compared to Placebo in Subjects With axSpA Without X-ray Evidence of AS · Source last updated 2022-08-18

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
      158
    2. group Id
      BG001
      value
      159
    3. group Id
      BG002
      value
      317
    units
    Participants
groups
  1. description
    Matching placebo to certolizumab pegol (CZP) injections were administered every 2 weeks from Week 0 onwards.
    id
    BG000
    title
    Placebo
  2. description
    Certolizumab pegol (CZP) 400 mg subcutaneous (sc) on Weeks 0, 2 and 4, followed by 200 mg CZP sc every 2 weeks (Q2W) from Week 6 onwards.
    id
    BG001
    title
    CZP 200 mg Q2W
  3. id
    BG002
    title
    Total Title
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          4
        title
        <=18 years
      2. measurements
        1. group Id
          BG000
          value
          154
        2. group Id
          BG001
          value
          156
        3. group Id
          BG002
          value
          310
        title
        Between 18 and 65 years
      3. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          3
        title
        >=65 years
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Age, Categorical
    unit Of Measure
    Participants
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          10.8
          value
          37.4
        2. group Id
          BG001
          spread
          10.5
          value
          37.3
        3. group Id
          BG002
          spread
          10.6
          value
          37.3
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Age, Continuous
    unit Of Measure
    years
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          82
        2. group Id
          BG001
          value
          81
        3. group Id
          BG002
          value
          163
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          76
        2. group Id
          BG001
          value
          78
        3. group Id
          BG002
          value
          154
        title
        Male
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Sex: Female, Male
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          8
        2. group Id
          BG001
          value
          5
        3. group Id
          BG002
          value
          13
        title
        Asian
      2. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
        title
        Black
      3. measurements
        1. group Id
          BG000
          value
          148
        2. group Id
          BG001
          value
          152
        3. group Id
          BG002
          value
          300
        title
        White
      4. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          3
        title
        Other/mixed
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race/Ethnicity, Customized
    unit Of Measure
    Participants
population Description
Baseline Characteristics refer to the Randomized Set witch consisted of all subjects randomized into the study.
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      158
    2. group Id
      BG001
      value
      159
    3. group Id
      BG002
      value
      317
    units
    Participants
groups
  1. description
    Matching placebo to certolizumab pegol (CZP) injections were administered every 2 weeks from Week 0 onwards.
    id
    BG000
    title
    Placebo
  2. description
    Certolizumab pegol (CZP) 400 mg subcutaneous (sc) on Weeks 0, 2 and 4, followed by 200 mg CZP sc every 2 weeks (Q2W) from Week 6 onwards.
    id
    BG001
    title
    CZP 200 mg Q2W
  3. id
    BG002
    title
    Total Title
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          4
        title
        <=18 years
      2. measurements
        1. group Id
          BG000
          value
          154
        2. group Id
          BG001
          value
          156
        3. group Id
          BG002
          value
          310
        title
        Between 18 and 65 years
      3. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          3
        title
        >=65 years
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Age, Categorical
    unit Of Measure
    Participants
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          10.8
          value
          37.4
        2. group Id
          BG001
          spread
          10.5
          value
          37.3
        3. group Id
          BG002
          spread
          10.6
          value
          37.3
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Age, Continuous
    unit Of Measure
    years
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          82
        2. group Id
          BG001
          value
          81
        3. group Id
          BG002
          value
          163
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          76
        2. group Id
          BG001
          value
          78
        3. group Id
          BG002
          value
          154
        title
        Male
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Sex: Female, Male
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          8
        2. group Id
          BG001
          value
          5
        3. group Id
          BG002
          value
          13
        title
        Asian
      2. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
        title
        Black
      3. measurements
        1. group Id
          BG000
          value
          148
        2. group Id
          BG001
          value
          152
        3. group Id
          BG002
          value
          300
        title
        White
      4. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          3
        title
        Other/mixed
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race/Ethnicity, Customized
    unit Of Measure
    Participants
population Description
Baseline Characteristics refer to the Randomized Set witch consisted of all subjects randomized into the study.

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Preserved source evidence · Not medical advice