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NCT00422383 · BASELINE

Baseline characteristics

A Study of Retreatment With MabThera (Rituximab) in Combination With Methotrexate in Patients With Rheumatoid Arthritis (RA) · Source last updated 2015-05-04

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
      134
    2. group Id
      BG001
      value
      119
    3. group Id
      BG002
      value
      93
    4. group Id
      BG003
      value
      6
    5. group Id
      BG004
      value
      25
    6. group Id
      BG005
      value
      377
    units
    Participants
groups
  1. description
    Participants received rituximab, 0.5 g, IV, on Days 1, 15, 168, and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
    id
    BG000
    title
    Rituximab Low Dose + Methotrexate
  2. description
    Participants received rituximab, 0.5 g, IV, on Days 1 and 15 and 1.0 g, IV, on Days 168 and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
    id
    BG001
    title
    Rituximab Escalated Dose + Methotrexate
  3. description
    Participants received rituximab, 1.0 g, IV, on Days 1, 15, 168, and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
    id
    BG002
    title
    Rituximab High Dose + Methotrexate
  4. description
    Participants received rituximab, 1.0 g, IV, on Days 1 and 15, and a placebo, IV, on Days 168 and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose. This treatment group was not part of the planned analysis and was not analyzed for all outcomes measures since they did not receive the planned treatment.
    id
    BG003
    title
    Rituximab/Placebo + Methotrexate
  5. description
    Participants received rituximab, 1.0 g, IV, on Days 1 and 15 and 0.5 g, IV, on Days 168 and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose. This treatment group was not part of the planned analysis and was not analyzed for all outcomes measures since they did not receive the planned treatment.
    id
    BG004
    title
    Rituximab Decreased Dose + Methotrexate
  6. description
    Total of all reporting groups
    id
    BG005
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          12.805
          value
          53.58
        2. group Id
          BG001
          spread
          12.115
          value
          52.32
        3. group Id
          BG002
          spread
          12.179
          value
          51.26
        4. group Id
          BG003
          spread
          6.274
          value
          51.83
        5. group Id
          BG004
          spread
          8.882
          value
          52.32
        6. group Id
          BG005
          spread
          12.10
          value
          52.48
    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
          110
        2. group Id
          BG001
          value
          90
        3. group Id
          BG002
          value
          77
        4. group Id
          BG003
          value
          4
        5. group Id
          BG004
          value
          16
        6. group Id
          BG005
          value
          297
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          24
        2. group Id
          BG001
          value
          29
        3. group Id
          BG002
          value
          16
        4. group Id
          BG003
          value
          2
        5. group Id
          BG004
          value
          9
        6. group Id
          BG005
          value
          80
        title
        Male
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Sex: Female, Male
    unit Of Measure
    Participants
population Description
The intent-to-treat-modified 2 (ITT-M2) population included all randomized participants who received at least 1 infusion of study treatment. Due to a UK protocol amendment error, 6 participants incorrectly received placebo. Due to medication list error, 25 participants received an incorrect dose of treatment. Participants were analyzed as treated.
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      134
    2. group Id
      BG001
      value
      119
    3. group Id
      BG002
      value
      93
    4. group Id
      BG003
      value
      6
    5. group Id
      BG004
      value
      25
    6. group Id
      BG005
      value
      377
    units
    Participants
groups
  1. description
    Participants received rituximab, 0.5 g, IV, on Days 1, 15, 168, and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
    id
    BG000
    title
    Rituximab Low Dose + Methotrexate
  2. description
    Participants received rituximab, 0.5 g, IV, on Days 1 and 15 and 1.0 g, IV, on Days 168 and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
    id
    BG001
    title
    Rituximab Escalated Dose + Methotrexate
  3. description
    Participants received rituximab, 1.0 g, IV, on Days 1, 15, 168, and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
    id
    BG002
    title
    Rituximab High Dose + Methotrexate
  4. description
    Participants received rituximab, 1.0 g, IV, on Days 1 and 15, and a placebo, IV, on Days 168 and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose. This treatment group was not part of the planned analysis and was not analyzed for all outcomes measures since they did not receive the planned treatment.
    id
    BG003
    title
    Rituximab/Placebo + Methotrexate
  5. description
    Participants received rituximab, 1.0 g, IV, on Days 1 and 15 and 0.5 g, IV, on Days 168 and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose. This treatment group was not part of the planned analysis and was not analyzed for all outcomes measures since they did not receive the planned treatment.
    id
    BG004
    title
    Rituximab Decreased Dose + Methotrexate
  6. description
    Total of all reporting groups
    id
    BG005
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          12.805
          value
          53.58
        2. group Id
          BG001
          spread
          12.115
          value
          52.32
        3. group Id
          BG002
          spread
          12.179
          value
          51.26
        4. group Id
          BG003
          spread
          6.274
          value
          51.83
        5. group Id
          BG004
          spread
          8.882
          value
          52.32
        6. group Id
          BG005
          spread
          12.10
          value
          52.48
    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
          110
        2. group Id
          BG001
          value
          90
        3. group Id
          BG002
          value
          77
        4. group Id
          BG003
          value
          4
        5. group Id
          BG004
          value
          16
        6. group Id
          BG005
          value
          297
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          24
        2. group Id
          BG001
          value
          29
        3. group Id
          BG002
          value
          16
        4. group Id
          BG003
          value
          2
        5. group Id
          BG004
          value
          9
        6. group Id
          BG005
          value
          80
        title
        Male
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Sex: Female, Male
    unit Of Measure
    Participants
population Description
The intent-to-treat-modified 2 (ITT-M2) population included all randomized participants who received at least 1 infusion of study treatment. Due to a UK protocol amendment error, 6 participants incorrectly received placebo. Due to medication list error, 25 participants received an incorrect dose of treatment. Participants were analyzed as treated.

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

Preserved source evidence · Not medical advice