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NCT02346240 · BASELINE

Baseline characteristics

Efficacy and Safety Study of Certolizumab Pegol (CZP) Versus Active Comparator and Placebo in Subjects With Plaque Psoriasis (PSO) · Source last updated 2021-07-16

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
      57
    2. group Id
      BG001
      value
      170
    3. group Id
      BG002
      value
      165
    4. group Id
      BG003
      value
      167
    5. group Id
      BG004
      value
      559
    units
    Participants
groups
  1. description
    Placebo subcutaneous (sc) injections every 2 weeks (Q2W) through Week 14. Treatment received from Week 16-48 is based on initial treatment and response to treatment: •PASI75 responders at Week 16 continued to receive blinded Placebo. PASI75 non-responders at Week 16 were removed from blinded study medication and escaped to Certolizumab pegol (CZP) 400 mg Q2W. Participants who received unblinded CZP 400 mg Q2W for 16 weeks and did not achieve a PASI50 response were withdrawn from the study. Participants could enter a 96-week open-label extension period after completing the Maintenance Period (Weeks 16-48) and receive CZP under certain conditions.
    id
    BG000
    title
    Placebo Q2W
  2. description
    Etanercept (ETN) 50 mg subcutaneous (sc) injections twice per week throughout Week 11.5. •PASI75 responders at Week 16 were re-randomized to either CZP (loading dose of 400 mg at Weeks 16, 18, and 20 followed by 200 mg Q2W) or Placebo Q2W. Participants who did not achieve a PASI75 response at Week 16 escaped to CZP 400 mg Q2W. Participants who received unblinded CZP 400 mg Q2W for 16 weeks and did not achieve a PASI50 response were withdrawn from the study. Participants could enter a 96-week open-label extension period after completing the Maintenance Period and receive CZP under certain conditions.
    id
    BG001
    title
    Etanercept
  3. description
    CZP 400 mg injections at Weeks 0, 2, 4, followed by CZP 200 mg every 2 weeks (Q2W) from Week 6 to Week 14. Treatment received from Week 16-48 is based on initial treatment and response to treatment: •PASI75 responders at Week 16 were re-randomized to receive either CZP 200 mg Q2W or CZP 400 mg every 4 weeks (Q4W); with Placebo administered on alternate dosing weeks to maintain the blind) Or Placebo Q2W. Participants who did not achieve a PASI75 response at Week 16 were removed from blinded study medication and escaped to CZP 400 mg Q2W. Participants who received unblinded CZP 400 mg Q2W for 16 weeks and did not achieve a PASI50 response were withdrawn from the study. Participants could enter a 96-week open-label extension period after completing the Maintenance Period and receive CZP under certain conditions.
    id
    BG002
    title
    CZP 200 mg Q2W
  4. description
    CZP 400 mg injections every 2 weeks (Q2W) through Week 14. Treatment received from Week 16-48 is based on initial treatment and response to treatment: •PASI75 responders at Week 16 were re-randomized to CZP 200 mg Q2W or CZP 400 mg Q2W or Placebo Q2W. Participants who did not achieve a PASI75 response at Week 16 were removed from blinded study medication and escaped to CZP 400 mg Q2W. Participants who received unblinded CZP 400 mg Q2W for 16 weeks and did not achieve a PASI50 response were withdrawn from the study. Participants could enter a 96-week open-label extension period after completing the Maintenance Period and receive CZP under certain conditions.
    id
    BG003
    title
    CZP 400 mg Q2W
  5. id
    BG004
    title
    Total Title
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          2
        5. group Id
          BG004
          value
          3
        title
        <=18 years
      2. measurements
        1. group Id
          BG000
          value
          53
        2. group Id
          BG001
          value
          156
        3. group Id
          BG002
          value
          153
        4. group Id
          BG003
          value
          154
        5. group Id
          BG004
          value
          516
        title
        Between 18 and 65 years
      3. measurements
        1. group Id
          BG000
          value
          4
        2. group Id
          BG001
          value
          13
        3. group Id
          BG002
          value
          12
        4. group Id
          BG003
          value
          11
        5. group Id
          BG004
          value
          40
        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
          12.5
          value
          46.5
        2. group Id
          BG001
          spread
          14.1
          value
          44.6
        3. group Id
          BG002
          spread
          13.5
          value
          46.7
        4. group Id
          BG003
          spread
          12.4
          value
          45.4
        5. group Id
          BG004
          spread
          13.3
          value
          45.7
    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
          23
        2. group Id
          BG001
          value
          43
        3. group Id
          BG002
          value
          52
        4. group Id
          BG003
          value
          60
        5. group Id
          BG004
          value
          178
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          34
        2. group Id
          BG001
          value
          127
        3. group Id
          BG002
          value
          113
        4. group Id
          BG003
          value
          107
        5. group Id
          BG004
          value
          381
        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
          0
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          3
        4. group Id
          BG003
          value
          3
        5. group Id
          BG004
          value
          7
        title
        Asian
      2. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          2
        4. group Id
          BG003
          value
          2
        5. group Id
          BG004
          value
          7
        title
        Black or African American
      3. measurements
        1. group Id
          BG000
          value
          57
        2. group Id
          BG001
          value
          163
        3. group Id
          BG002
          value
          158
        4. group Id
          BG003
          value
          162
        5. group Id
          BG004
          value
          540
        title
        White
      4. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          2
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          5
        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 consisting of all participants randomized into the study.
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      57
    2. group Id
      BG001
      value
      170
    3. group Id
      BG002
      value
      165
    4. group Id
      BG003
      value
      167
    5. group Id
      BG004
      value
      559
    units
    Participants
groups
  1. description
    Placebo subcutaneous (sc) injections every 2 weeks (Q2W) through Week 14. Treatment received from Week 16-48 is based on initial treatment and response to treatment: •PASI75 responders at Week 16 continued to receive blinded Placebo. PASI75 non-responders at Week 16 were removed from blinded study medication and escaped to Certolizumab pegol (CZP) 400 mg Q2W. Participants who received unblinded CZP 400 mg Q2W for 16 weeks and did not achieve a PASI50 response were withdrawn from the study. Participants could enter a 96-week open-label extension period after completing the Maintenance Period (Weeks 16-48) and receive CZP under certain conditions.
    id
    BG000
    title
    Placebo Q2W
  2. description
    Etanercept (ETN) 50 mg subcutaneous (sc) injections twice per week throughout Week 11.5. •PASI75 responders at Week 16 were re-randomized to either CZP (loading dose of 400 mg at Weeks 16, 18, and 20 followed by 200 mg Q2W) or Placebo Q2W. Participants who did not achieve a PASI75 response at Week 16 escaped to CZP 400 mg Q2W. Participants who received unblinded CZP 400 mg Q2W for 16 weeks and did not achieve a PASI50 response were withdrawn from the study. Participants could enter a 96-week open-label extension period after completing the Maintenance Period and receive CZP under certain conditions.
    id
    BG001
    title
    Etanercept
  3. description
    CZP 400 mg injections at Weeks 0, 2, 4, followed by CZP 200 mg every 2 weeks (Q2W) from Week 6 to Week 14. Treatment received from Week 16-48 is based on initial treatment and response to treatment: •PASI75 responders at Week 16 were re-randomized to receive either CZP 200 mg Q2W or CZP 400 mg every 4 weeks (Q4W); with Placebo administered on alternate dosing weeks to maintain the blind) Or Placebo Q2W. Participants who did not achieve a PASI75 response at Week 16 were removed from blinded study medication and escaped to CZP 400 mg Q2W. Participants who received unblinded CZP 400 mg Q2W for 16 weeks and did not achieve a PASI50 response were withdrawn from the study. Participants could enter a 96-week open-label extension period after completing the Maintenance Period and receive CZP under certain conditions.
    id
    BG002
    title
    CZP 200 mg Q2W
  4. description
    CZP 400 mg injections every 2 weeks (Q2W) through Week 14. Treatment received from Week 16-48 is based on initial treatment and response to treatment: •PASI75 responders at Week 16 were re-randomized to CZP 200 mg Q2W or CZP 400 mg Q2W or Placebo Q2W. Participants who did not achieve a PASI75 response at Week 16 were removed from blinded study medication and escaped to CZP 400 mg Q2W. Participants who received unblinded CZP 400 mg Q2W for 16 weeks and did not achieve a PASI50 response were withdrawn from the study. Participants could enter a 96-week open-label extension period after completing the Maintenance Period and receive CZP under certain conditions.
    id
    BG003
    title
    CZP 400 mg Q2W
  5. id
    BG004
    title
    Total Title
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          2
        5. group Id
          BG004
          value
          3
        title
        <=18 years
      2. measurements
        1. group Id
          BG000
          value
          53
        2. group Id
          BG001
          value
          156
        3. group Id
          BG002
          value
          153
        4. group Id
          BG003
          value
          154
        5. group Id
          BG004
          value
          516
        title
        Between 18 and 65 years
      3. measurements
        1. group Id
          BG000
          value
          4
        2. group Id
          BG001
          value
          13
        3. group Id
          BG002
          value
          12
        4. group Id
          BG003
          value
          11
        5. group Id
          BG004
          value
          40
        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
          12.5
          value
          46.5
        2. group Id
          BG001
          spread
          14.1
          value
          44.6
        3. group Id
          BG002
          spread
          13.5
          value
          46.7
        4. group Id
          BG003
          spread
          12.4
          value
          45.4
        5. group Id
          BG004
          spread
          13.3
          value
          45.7
    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
          23
        2. group Id
          BG001
          value
          43
        3. group Id
          BG002
          value
          52
        4. group Id
          BG003
          value
          60
        5. group Id
          BG004
          value
          178
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          34
        2. group Id
          BG001
          value
          127
        3. group Id
          BG002
          value
          113
        4. group Id
          BG003
          value
          107
        5. group Id
          BG004
          value
          381
        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
          0
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          3
        4. group Id
          BG003
          value
          3
        5. group Id
          BG004
          value
          7
        title
        Asian
      2. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          2
        4. group Id
          BG003
          value
          2
        5. group Id
          BG004
          value
          7
        title
        Black or African American
      3. measurements
        1. group Id
          BG000
          value
          57
        2. group Id
          BG001
          value
          163
        3. group Id
          BG002
          value
          158
        4. group Id
          BG003
          value
          162
        5. group Id
          BG004
          value
          540
        title
        White
      4. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          2
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          5
        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 consisting of all participants randomized into the study.

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

Preserved source evidence · Not medical advice