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NCT02326298 · BASELINE

Baseline characteristics

An Efficacy and Safety Study of Two Dose Levels of Certolizumab Pegol (CZP) in Subjects With Plaque Psoriasis (PSO) · Source last updated 2019-11-07

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
      51
    2. group Id
      BG001
      value
      95
    3. group Id
      BG002
      value
      88
    4. group Id
      BG003
      value
      234
    units
    Participants
groups
  1. description
    Placebo sc injection Q2W. Treatment received from Week 16 - 48 was based on initial treatment and response to treatment: * PASI50 responders at Week 16, who did not achieve a PASI75 response at Week 16 received CZP 400 mg at Weeks 16, 18 and 20 (loading doses) followed by CZP 200 mg Q2W starting at Week 22. * PASI75 responders at Week 16 continued to receive Placebo. * PASI50 non-responders at Week 16 were removed from blinded study medication and escaped to unblinded 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 Participants who received unblinded CZP 400 mg Q2W for 16 weeks and did not achieve a PASI50 response were withdrawn from the study. * PASI50 non-responders at Week 32 or a later time point were withdrawn from the study. Participants who completed the Maintenance Period (with PASI50 response at Week 48) entered the Open-label Extension (OLE) Period on CZP 200 mg Q2W. Week 48 completers in the escape arm continued to receive CZP 400 mg Q2W or may have switched to CZP 200 mg Q2W.
    id
    BG000
    title
    Placebo Q2W
  2. description
    CZP 400 mg at Weeks 0, 2, 4, followed by CZP 200 mg Q2W from Week 6 to Week 14. Treatment received from Week 16 - 48 was based on initial treatment and response to treatment: * PASI50 responders at Week 16 continued to receive CZP 200 mg Q2W. * PASI50 non-responders at Week 16 were removed from blinded study medication and escaped to unblinded 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 Participants who received unblinded CZP 400 mg Q2W for 16 weeks and did not achieve a PASI50 response were withdrawn from the study. * PASI50 non-responders at Week 32 or a later time point were withdrawn from the study. Participants who completed the Maintenance Period (with PASI50 response at Week 48) entered the OLE Period on CZP 200 mg Q2W. Week 48 completers in the escape arm continued to receive CZP 400 mg Q2W or may have switched to CZP 200 mg Q2W. Depending on PASI50 or PASI75 responses at Week 60 or a later time point, participants may have switched to CZP 400 mg Q2W or withdrew from the study.
    id
    BG001
    title
    CZP 200 mg Q2W
  3. description
    CZP 400 mg Q2W through Week 14. Treatment received from Week 16 - 48 was based on initial treatment and response to treatment: * PASI50 responders at Week 16 continued to receive CZP 400 mg Q2W. * PASI50 non-responders at Week 16 were removed from blinded study medication and escaped to unblinded 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. * PASI50 non-responders at Week 32 or a later time point were withdrawn from the study. Participants who completed the Maintenance Period (with PASI50 response at Week 48) entered the OLE Period on CZP 200 mg Q2W. Week 48 completers in the escape arm continued to receive CZP 400 mg Q2W or may have switched to CZP 200 mg Q2W. Participants who achieved a PASI75 response during the OLE Period may have switched to CZP 200 mg Q2W.
    id
    BG002
    title
    CZP 400 mg Q2W
  4. id
    BG003
    title
    Total Title
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        title
        <=18 years
      2. measurements
        1. group Id
          BG000
          value
          45
        2. group Id
          BG001
          value
          90
        3. group Id
          BG002
          value
          86
        4. group Id
          BG003
          value
          221
        title
        Between 18 and 65 years
      3. measurements
        1. group Id
          BG000
          value
          6
        2. group Id
          BG001
          value
          5
        3. group Id
          BG002
          value
          2
        4. group Id
          BG003
          value
          13
        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
          12.8
          value
          47.9
        2. group Id
          BG001
          spread
          13.1
          value
          44.5
        3. group Id
          BG002
          spread
          12.1
          value
          43.6
        4. group Id
          BG003
          spread
          12.7
          value
          44.9
    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
          16
        2. group Id
          BG001
          value
          28
        3. group Id
          BG002
          value
          28
        4. group Id
          BG003
          value
          72
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          35
        2. group Id
          BG001
          value
          67
        3. group Id
          BG002
          value
          60
        4. group Id
          BG003
          value
          162
        title
        Male
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Sex: Female, Male
    unit Of Measure
    Participants
population Description
Baseline Characteristics refer to the Randomized Set, which consisted of all participants randomized into the study.
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      51
    2. group Id
      BG001
      value
      95
    3. group Id
      BG002
      value
      88
    4. group Id
      BG003
      value
      234
    units
    Participants
groups
  1. description
    Placebo sc injection Q2W. Treatment received from Week 16 - 48 was based on initial treatment and response to treatment: * PASI50 responders at Week 16, who did not achieve a PASI75 response at Week 16 received CZP 400 mg at Weeks 16, 18 and 20 (loading doses) followed by CZP 200 mg Q2W starting at Week 22. * PASI75 responders at Week 16 continued to receive Placebo. * PASI50 non-responders at Week 16 were removed from blinded study medication and escaped to unblinded 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. * PASI50 non-responders at Week 32 or a later time point were withdrawn from the study. Participants who completed the Maintenance Period (with PASI50 response at Week 48) entered the Open-label Extension (OLE) Period on CZP 200 mg Q2W. Week 48 completers in the escape arm continued to receive CZP 400 mg Q2W or may have switched to CZP 200 mg Q2W.
    id
    BG000
    title
    Placebo Q2W
  2. description
    CZP 400 mg at Weeks 0, 2, 4, followed by CZP 200 mg Q2W from Week 6 to Week 14. Treatment received from Week 16 - 48 was based on initial treatment and response to treatment: * PASI50 responders at Week 16 continued to receive CZP 200 mg Q2W. * PASI50 non-responders at Week 16 were removed from blinded study medication and escaped to unblinded 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. * PASI50 non-responders at Week 32 or a later time point were withdrawn from the study. Participants who completed the Maintenance Period (with PASI50 response at Week 48) entered the OLE Period on CZP 200 mg Q2W. Week 48 completers in the escape arm continued to receive CZP 400 mg Q2W or may have switched to CZP 200 mg Q2W. Depending on PASI50 or PASI75 responses at Week 60 or a later time point, participants may have switched to CZP 400 mg Q2W or withdrew from the study.
    id
    BG001
    title
    CZP 200 mg Q2W
  3. description
    CZP 400 mg Q2W through Week 14. Treatment received from Week 16 - 48 was based on initial treatment and response to treatment: * PASI50 responders at Week 16 continued to receive CZP 400 mg Q2W. * PASI50 non-responders at Week 16 were removed from blinded study medication and escaped to unblinded 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. * PASI50 non-responders at Week 32 or a later time point were withdrawn from the study. Participants who completed the Maintenance Period (with PASI50 response at Week 48) entered the OLE Period on CZP 200 mg Q2W. Week 48 completers in the escape arm continued to receive CZP 400 mg Q2W or may have switched to CZP 200 mg Q2W. Participants who achieved a PASI75 response during the OLE Period may have switched to CZP 200 mg Q2W.
    id
    BG002
    title
    CZP 400 mg Q2W
  4. id
    BG003
    title
    Total Title
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        title
        <=18 years
      2. measurements
        1. group Id
          BG000
          value
          45
        2. group Id
          BG001
          value
          90
        3. group Id
          BG002
          value
          86
        4. group Id
          BG003
          value
          221
        title
        Between 18 and 65 years
      3. measurements
        1. group Id
          BG000
          value
          6
        2. group Id
          BG001
          value
          5
        3. group Id
          BG002
          value
          2
        4. group Id
          BG003
          value
          13
        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
          12.8
          value
          47.9
        2. group Id
          BG001
          spread
          13.1
          value
          44.5
        3. group Id
          BG002
          spread
          12.1
          value
          43.6
        4. group Id
          BG003
          spread
          12.7
          value
          44.9
    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
          16
        2. group Id
          BG001
          value
          28
        3. group Id
          BG002
          value
          28
        4. group Id
          BG003
          value
          72
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          35
        2. group Id
          BG001
          value
          67
        3. group Id
          BG002
          value
          60
        4. group Id
          BG003
          value
          162
        title
        Male
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Sex: Female, Male
    unit Of Measure
    Participants
population Description
Baseline Characteristics refer to the Randomized Set, which consisted of all participants randomized into the study.

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

Preserved source evidence · Not medical advice