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NCT00488631 · BASELINE

Baseline characteristics

An Efficacy and Safety Study of Golimumab (CNTO 148) in Participants With Moderately to Severely Active Ulcerative Colitis · Source last updated 2016-04-26

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
      156
    2. group Id
      BG001
      value
      154
    3. group Id
      BG002
      value
      154
    4. group Id
      BG003
      value
      129
    5. group Id
      BG004
      value
      230
    6. group Id
      BG005
      value
      405
    7. group Id
      BG006
      value
      1228
    units
    Participants
groups
  1. description
    Participants in clinical response to golimumab at Week 6 of induction study C0524T16 (NCT00488774) or C0524T17 (NCT00487539) and randomized to placebo subcutaneous injection matching to golimumab administered every 4 weeks through Week 52 in the maintenance study C0524T18 (NCT00488631). Participants with loss of clinical response had their dose increased to golimumab 100 mg subcutaneous injection administered every 4 weeks through Week 52. For participants with dose adjustment, adverse events are presented from Week 0 up to the time of dose adjustment.
    id
    BG000
    title
    Golimumab Induction Responders (GLM-I-Rsp)-Placebo Maintenance
  2. description
    Participants in clinical response to golimumab at Week 6 of induction study C0524T16 (NCT00488774) or C0524T17 (NCT00487539) and randomized to golimumab 50 mg subcutaneous injection administered every 4 weeks through Week 52 in C0524T18 (NCT00488631). Participants with loss of clinical response were re-randomized to receive golimumab 50 mg or 100 mg subcutaneous injection administered every 4 weeks through Week 52. For participants with dose adjustment, adverse events are presented from Week 0 up to the time of dose increase.
    id
    BG001
    title
    GLM-I-Rsp-Golimumab 50 mg Maintenance
  3. description
    Participants in clinical response to golimumab at Week 6 of induction study C0524T16 (NCT00488774) or C0524T17 (NCT00487539) and randomized to golimumab 100 mg subcutaneous injection administered every 4 weeks through Week 52 in maintenance study C0524T18 (NCT00488631). Participants with loss of clinical response were re-randomized to receive golimumab 100 mg or 200 mg subcutaneous injection administered every 4 weeks through Week 52 (prior to protocol amendment 3). For participants with dose adjustment, adverse events are presented from Week 0 up to the time of dose increase.
    id
    BG002
    title
    GLM-I-Rsp-Golimumab 100 mg Maintenance
  4. description
    Participants in clinical response to placebo at Week 6 of an induction study C0524T16 (NCT00488774) or C0524T17 (NCT00487539) and received placebo subcutaneous injection matching to golimumab every 4 weeks through Week 52 in maintenance study C0524T18 (NCT00488631); not randomized. Participants with loss of clinical response had their dose increased to golimumab 100 mg subcutaneous injection administered every 4 weeks through Week 52. For participants with dose adjustment, adverse events are presented from Week 0 up to the time of dose adjustment.
    id
    BG003
    title
    Placebo Induction Responders (PBO-I-Rsp)-Placebo Maintenance
  5. description
    Participants not in clinical response to placebo at Week 6 of induction study C0524T16 (NCT00488774) or C0524T17 (NCT00487539) and received golimumab 100 mg subcutaneous injection administered every 4 weeks through Week 52 in maintenance study C0524T18 (NCT00488631); not randomized.
    id
    BG004
    title
    PBO-I-nonRsp-Golimumab 100 mg Maintenance
  6. description
    Participants not in clinical response to golimumab at Week 6 of induction study C0524T16 (NCT00488774) or C0524T17 (NCT00487539) and received golimumab 100 mg subcutaneous injection administered every 4 weeks through Week 52 in maintenance study C0524T18 (NCT00488631); not randomized.
    id
    BG005
    title
    GLM-I-nonRsp-Golimumab 100 mg Maintenance
  7. description
    Total of all reporting groups
    id
    BG006
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          14.05
          value
          40.2
        2. group Id
          BG001
          spread
          13.84
          value
          41.4
        3. group Id
          BG002
          spread
          13.11
          value
          39.1
        4. group Id
          BG003
          spread
          13.27
          value
          38
        5. group Id
          BG004
          spread
          12.67
          value
          40.3
        6. group Id
          BG005
          spread
          13.6
          value
          41.2
        7. group Id
          BG006
          spread
          13.44
          value
          40.3
    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
          81
        2. group Id
          BG001
          value
          77
        3. group Id
          BG002
          value
          65
        4. group Id
          BG003
          value
          68
        5. group Id
          BG004
          value
          99
        6. group Id
          BG005
          value
          138
        7. group Id
          BG006
          value
          528
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          75
        2. group Id
          BG001
          value
          77
        3. group Id
          BG002
          value
          89
        4. group Id
          BG003
          value
          61
        5. group Id
          BG004
          value
          131
        6. group Id
          BG005
          value
          267
        7. group Id
          BG006
          value
          700
        title
        Male
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Sex: Female, Male
    unit Of Measure
    Participants
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      156
    2. group Id
      BG001
      value
      154
    3. group Id
      BG002
      value
      154
    4. group Id
      BG003
      value
      129
    5. group Id
      BG004
      value
      230
    6. group Id
      BG005
      value
      405
    7. group Id
      BG006
      value
      1228
    units
    Participants
groups
  1. description
    Participants in clinical response to golimumab at Week 6 of induction study C0524T16 (NCT00488774) or C0524T17 (NCT00487539) and randomized to placebo subcutaneous injection matching to golimumab administered every 4 weeks through Week 52 in the maintenance study C0524T18 (NCT00488631). Participants with loss of clinical response had their dose increased to golimumab 100 mg subcutaneous injection administered every 4 weeks through Week 52. For participants with dose adjustment, adverse events are presented from Week 0 up to the time of dose adjustment.
    id
    BG000
    title
    Golimumab Induction Responders (GLM-I-Rsp)-Placebo Maintenance
  2. description
    Participants in clinical response to golimumab at Week 6 of induction study C0524T16 (NCT00488774) or C0524T17 (NCT00487539) and randomized to golimumab 50 mg subcutaneous injection administered every 4 weeks through Week 52 in C0524T18 (NCT00488631). Participants with loss of clinical response were re-randomized to receive golimumab 50 mg or 100 mg subcutaneous injection administered every 4 weeks through Week 52. For participants with dose adjustment, adverse events are presented from Week 0 up to the time of dose increase.
    id
    BG001
    title
    GLM-I-Rsp-Golimumab 50 mg Maintenance
  3. description
    Participants in clinical response to golimumab at Week 6 of induction study C0524T16 (NCT00488774) or C0524T17 (NCT00487539) and randomized to golimumab 100 mg subcutaneous injection administered every 4 weeks through Week 52 in maintenance study C0524T18 (NCT00488631). Participants with loss of clinical response were re-randomized to receive golimumab 100 mg or 200 mg subcutaneous injection administered every 4 weeks through Week 52 (prior to protocol amendment 3). For participants with dose adjustment, adverse events are presented from Week 0 up to the time of dose increase.
    id
    BG002
    title
    GLM-I-Rsp-Golimumab 100 mg Maintenance
  4. description
    Participants in clinical response to placebo at Week 6 of an induction study C0524T16 (NCT00488774) or C0524T17 (NCT00487539) and received placebo subcutaneous injection matching to golimumab every 4 weeks through Week 52 in maintenance study C0524T18 (NCT00488631); not randomized. Participants with loss of clinical response had their dose increased to golimumab 100 mg subcutaneous injection administered every 4 weeks through Week 52. For participants with dose adjustment, adverse events are presented from Week 0 up to the time of dose adjustment.
    id
    BG003
    title
    Placebo Induction Responders (PBO-I-Rsp)-Placebo Maintenance
  5. description
    Participants not in clinical response to placebo at Week 6 of induction study C0524T16 (NCT00488774) or C0524T17 (NCT00487539) and received golimumab 100 mg subcutaneous injection administered every 4 weeks through Week 52 in maintenance study C0524T18 (NCT00488631); not randomized.
    id
    BG004
    title
    PBO-I-nonRsp-Golimumab 100 mg Maintenance
  6. description
    Participants not in clinical response to golimumab at Week 6 of induction study C0524T16 (NCT00488774) or C0524T17 (NCT00487539) and received golimumab 100 mg subcutaneous injection administered every 4 weeks through Week 52 in maintenance study C0524T18 (NCT00488631); not randomized.
    id
    BG005
    title
    GLM-I-nonRsp-Golimumab 100 mg Maintenance
  7. description
    Total of all reporting groups
    id
    BG006
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          14.05
          value
          40.2
        2. group Id
          BG001
          spread
          13.84
          value
          41.4
        3. group Id
          BG002
          spread
          13.11
          value
          39.1
        4. group Id
          BG003
          spread
          13.27
          value
          38
        5. group Id
          BG004
          spread
          12.67
          value
          40.3
        6. group Id
          BG005
          spread
          13.6
          value
          41.2
        7. group Id
          BG006
          spread
          13.44
          value
          40.3
    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
          81
        2. group Id
          BG001
          value
          77
        3. group Id
          BG002
          value
          65
        4. group Id
          BG003
          value
          68
        5. group Id
          BG004
          value
          99
        6. group Id
          BG005
          value
          138
        7. group Id
          BG006
          value
          528
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          75
        2. group Id
          BG001
          value
          77
        3. group Id
          BG002
          value
          89
        4. group Id
          BG003
          value
          61
        5. group Id
          BG004
          value
          131
        6. group Id
          BG005
          value
          267
        7. group Id
          BG006
          value
          700
        title
        Male
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Sex: Female, Male
    unit Of Measure
    Participants

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

Preserved source evidence · Not medical advice