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NCT00973479 · BASELINE

Baseline characteristics

An Effectiveness and Safety Study of Intravenous Golimumab in Patients With Active Rheumatoid Arthritis Despite Treatment With Methotrexate Therapy · Source last updated 2013-12-25

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
      197
    2. group Id
      BG001
      value
      395
    3. group Id
      BG002
      value
      592
    units
    Participants
groups
  1. description
    Participants randomized to receive their stable dose of commercial MTX (between 15-25 mg/week) and placebo IV infusions at Weeks 0, 4, 12, 16, and 20. Participants will be crossed over to Golimumab 2 mg/kg at Week 24, and receive administrations at Weeks 24, 28 and q8 weeks thereafter up to Week 100. Subjects randomized to Group I (Placebo + MTX) will have the opportunity to enter early escape at Week 16 and initiate Golimumab 2 mg/kg infusions (Weeks 16, 20, and q8 weeks up to Week 100) if they demonstrate a \< 10% improvement in both tender and swollen joint count.
    id
    BG000
    title
    Group I: Placebo + Methotrexate (MTX)
  2. description
    Participants randomized to receive 2 mg/kg of Golimumab intravenously at Weeks 0, 4, and q8 weeks up to Week 100. Participants will be maintained on their stable dose of commercial MTX (between 15 and 25 mg/week) throughout the study. Participants will receive a placebo infusion at Week 16 and Week 24 to maintain the blind.
    id
    BG001
    title
    Group II: Golimumab 2 mg/kg + Methotrexate (MTX)
  3. description
    Total of all reporting groups
    id
    BG002
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          11.26
          value
          51.4
        2. group Id
          BG001
          spread
          12.55
          value
          51.9
        3. group Id
          BG002
          spread
          12.13
          value
          51.8
    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
          157
        2. group Id
          BG001
          value
          326
        3. group Id
          BG002
          value
          483
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          40
        2. group Id
          BG001
          value
          69
        3. group Id
          BG002
          value
          109
        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
          54
        3. group Id
          BG002
          value
          82
      title
      Argentina
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          6
        3. group Id
          BG002
          value
          9
      title
      Australia
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          12
        2. group Id
          BG001
          value
          25
        3. group Id
          BG002
          value
          37
      title
      Columbia
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          10
        2. group Id
          BG001
          value
          21
        3. group Id
          BG002
          value
          31
      title
      Hungary
    5. categories
      1. measurements
        1. group Id
          BG000
          value
          4
        2. group Id
          BG001
          value
          12
        3. group Id
          BG002
          value
          16
      title
      Korea, Republic of
    6. categories
      1. measurements
        1. group Id
          BG000
          value
          20
        2. group Id
          BG001
          value
          44
        3. group Id
          BG002
          value
          64
      title
      Lithuania
    7. categories
      1. measurements
        1. group Id
          BG000
          value
          8
        2. group Id
          BG001
          value
          18
        3. group Id
          BG002
          value
          26
      title
      Malaysia
    8. categories
      1. measurements
        1. group Id
          BG000
          value
          13
        2. group Id
          BG001
          value
          25
        3. group Id
          BG002
          value
          38
      title
      Mexico
    9. categories
      1. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          6
      title
      New Zealand
    10. categories
      1. measurements
        1. group Id
          BG000
          value
          36
        2. group Id
          BG001
          value
          65
        3. group Id
          BG002
          value
          101
      title
      Poland
    11. categories
      1. measurements
        1. group Id
          BG000
          value
          23
        2. group Id
          BG001
          value
          46
        3. group Id
          BG002
          value
          69
      title
      Russian Federation
    12. categories
      1. measurements
        1. group Id
          BG000
          value
          32
        2. group Id
          BG001
          value
          58
        3. group Id
          BG002
          value
          90
      title
      Ukraine
    param Type
    NUMBER
    title
    Region of Enrollment
    unit Of Measure
    participants
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      197
    2. group Id
      BG001
      value
      395
    3. group Id
      BG002
      value
      592
    units
    Participants
groups
  1. description
    Participants randomized to receive their stable dose of commercial MTX (between 15-25 mg/week) and placebo IV infusions at Weeks 0, 4, 12, 16, and 20. Participants will be crossed over to Golimumab 2 mg/kg at Week 24, and receive administrations at Weeks 24, 28 and q8 weeks thereafter up to Week 100. Subjects randomized to Group I (Placebo + MTX) will have the opportunity to enter early escape at Week 16 and initiate Golimumab 2 mg/kg infusions (Weeks 16, 20, and q8 weeks up to Week 100) if they demonstrate a \< 10% improvement in both tender and swollen joint count.
    id
    BG000
    title
    Group I: Placebo + Methotrexate (MTX)
  2. description
    Participants randomized to receive 2 mg/kg of Golimumab intravenously at Weeks 0, 4, and q8 weeks up to Week 100. Participants will be maintained on their stable dose of commercial MTX (between 15 and 25 mg/week) throughout the study. Participants will receive a placebo infusion at Week 16 and Week 24 to maintain the blind.
    id
    BG001
    title
    Group II: Golimumab 2 mg/kg + Methotrexate (MTX)
  3. description
    Total of all reporting groups
    id
    BG002
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          11.26
          value
          51.4
        2. group Id
          BG001
          spread
          12.55
          value
          51.9
        3. group Id
          BG002
          spread
          12.13
          value
          51.8
    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
          157
        2. group Id
          BG001
          value
          326
        3. group Id
          BG002
          value
          483
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          40
        2. group Id
          BG001
          value
          69
        3. group Id
          BG002
          value
          109
        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
          54
        3. group Id
          BG002
          value
          82
      title
      Argentina
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          6
        3. group Id
          BG002
          value
          9
      title
      Australia
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          12
        2. group Id
          BG001
          value
          25
        3. group Id
          BG002
          value
          37
      title
      Columbia
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          10
        2. group Id
          BG001
          value
          21
        3. group Id
          BG002
          value
          31
      title
      Hungary
    5. categories
      1. measurements
        1. group Id
          BG000
          value
          4
        2. group Id
          BG001
          value
          12
        3. group Id
          BG002
          value
          16
      title
      Korea, Republic of
    6. categories
      1. measurements
        1. group Id
          BG000
          value
          20
        2. group Id
          BG001
          value
          44
        3. group Id
          BG002
          value
          64
      title
      Lithuania
    7. categories
      1. measurements
        1. group Id
          BG000
          value
          8
        2. group Id
          BG001
          value
          18
        3. group Id
          BG002
          value
          26
      title
      Malaysia
    8. categories
      1. measurements
        1. group Id
          BG000
          value
          13
        2. group Id
          BG001
          value
          25
        3. group Id
          BG002
          value
          38
      title
      Mexico
    9. categories
      1. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          6
      title
      New Zealand
    10. categories
      1. measurements
        1. group Id
          BG000
          value
          36
        2. group Id
          BG001
          value
          65
        3. group Id
          BG002
          value
          101
      title
      Poland
    11. categories
      1. measurements
        1. group Id
          BG000
          value
          23
        2. group Id
          BG001
          value
          46
        3. group Id
          BG002
          value
          69
      title
      Russian Federation
    12. categories
      1. measurements
        1. group Id
          BG000
          value
          32
        2. group Id
          BG001
          value
          58
        3. group Id
          BG002
          value
          90
      title
      Ukraine
    param Type
    NUMBER
    title
    Region of Enrollment
    unit Of Measure
    participants

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

Preserved source evidence · Not medical advice