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NCT00468546 · BASELINE

Baseline characteristics

A Study to Evaluate the Safety and Efficacy of MabThera (Rituximab) in Combination With Methotrexate (MTX) in Participants With Active Rheumatoid Arthritis Who Failed on Anti-Tumor Necrosis Factor Alpha Therapy · Source last updated 2016-10-25

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
      208
    2. group Id
      BG001
      value
      308
    3. group Id
      BG002
      value
      516
    units
    Participants
groups
  1. description
    Eligible participants were administered placebo by intravenous infusion on Days 1 and 15 along with MTX 10-25 mg p.o. or parenterally once a week up to 24 weeks and were followed up to Week 104.
    id
    BG000
    title
    Placebo Plus Methotrexate
  2. description
    Eligible Participants were administered rituximab 1000 mg as intravenous infusion on Days 1 and 15 along with MTX 10-25 mg p.o. or parenterally once a week up to Week 24 and were followed up to Week 104.
    id
    BG001
    title
    Rituximab Plus Methotrexate
  3. description
    Total of all reporting groups
    id
    BG002
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          20
          upper Limit
          79
          value
          55.0
        2. group Id
          BG001
          lower Limit
          20
          upper Limit
          81
          value
          53.0
        3. group Id
          BG002
          lower Limit
          20
          upper Limit
          81
          value
          53.0
    dispersion Type
    FULL_RANGE
    param Type
    MEDIAN
    title
    Age, Continuous
    unit Of Measure
    years
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          168
        2. group Id
          BG001
          value
          251
        3. group Id
          BG002
          value
          419
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          40
        2. group Id
          BG001
          value
          57
        3. group Id
          BG002
          value
          97
        title
        Male
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Sex: Female, Male
    unit Of Measure
    Participants
population Description
Safety population included participants who were randomized and received any part of an infusion of the study drug.
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      208
    2. group Id
      BG001
      value
      308
    3. group Id
      BG002
      value
      516
    units
    Participants
groups
  1. description
    Eligible participants were administered placebo by intravenous infusion on Days 1 and 15 along with MTX 10-25 mg p.o. or parenterally once a week up to 24 weeks and were followed up to Week 104.
    id
    BG000
    title
    Placebo Plus Methotrexate
  2. description
    Eligible Participants were administered rituximab 1000 mg as intravenous infusion on Days 1 and 15 along with MTX 10-25 mg p.o. or parenterally once a week up to Week 24 and were followed up to Week 104.
    id
    BG001
    title
    Rituximab Plus Methotrexate
  3. description
    Total of all reporting groups
    id
    BG002
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          20
          upper Limit
          79
          value
          55.0
        2. group Id
          BG001
          lower Limit
          20
          upper Limit
          81
          value
          53.0
        3. group Id
          BG002
          lower Limit
          20
          upper Limit
          81
          value
          53.0
    dispersion Type
    FULL_RANGE
    param Type
    MEDIAN
    title
    Age, Continuous
    unit Of Measure
    years
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          168
        2. group Id
          BG001
          value
          251
        3. group Id
          BG002
          value
          419
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          40
        2. group Id
          BG001
          value
          57
        3. group Id
          BG002
          value
          97
        title
        Male
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Sex: Female, Male
    unit Of Measure
    Participants
population Description
Safety population included participants who were randomized and received any part of an infusion of the study drug.

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

Preserved source evidence · Not medical advice