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NCT01469013 · BASELINE

Baseline characteristics

Oral Baricitinib (LY3009104)Treatment in Japanese Participants With Active Rheumatoid Arthritis on Background Methotrexate Therapy · Source last updated 2019-09-20

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
      24
    2. group Id
      BG001
      value
      24
    3. group Id
      BG002
      value
      24
    4. group Id
      BG003
      value
      24
    5. group Id
      BG004
      value
      49
    6. group Id
      BG005
      value
      145
    units
    Participants
groups
  1. description
    Participants on background methotrexate therapy were administered 1 mg baricitinib (LY3009104) orally once daily for 12 weeks in Part A and received 4 mg or 8 mg baricitinib (LY3009104) tablets orally once daily for 52 weeks in Part B.
    id
    BG000
    title
    Part A: 1 mg Baricitinib (LY3009104)
  2. description
    Participants on background methotrexate therapy were administered 2 mg baricitinib (LY3009104) orally once daily for 12 weeks in Part A and received 4 mg or 8 mg baricitinib (LY3009104) tablets orally once daily for 52 weeks in Part B.
    id
    BG001
    title
    Part A: 2 mg Baricitinib (LY3009104)
  3. description
    Participants on background methotrexate therapy were administered 4 mg baricitinib (LY3009104) orally once daily for 12 weeks in Part A and received 4 mg or 8 mg baricitinib (LY3009104) tablets orally once daily for 52 weeks in Part B.
    id
    BG002
    title
    Part A: 4 mg Baricitinib (LY3009104)
  4. description
    Participants on background methotrexate therapy were administered 8 mg baricitinib (LY3009104) orally once daily for 12 weeks in Part A and received 4 mg or 8 mg baricitinib (LY3009104) tablets orally once daily for 52 weeks in Part B.
    id
    BG003
    title
    Part A: 8 mg Baricitinib (LY3009104)
  5. description
    Participants on background methotrexate therapy were administered placebo orally once daily for 12 weeks in Part A and received 4 mg or 8 mg baricitinib (LY3009104) tablets orally once daily for 52 weeks in Part B.
    id
    BG004
    title
    Part A: Placebo
  6. description
    Total of all reporting groups
    id
    BG005
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          12.8
          value
          52.7
        2. group Id
          BG001
          spread
          11.5
          value
          56.1
        3. group Id
          BG002
          spread
          10.4
          value
          57.5
        4. group Id
          BG003
          spread
          11.3
          value
          53.6
        5. group Id
          BG004
          spread
          12.0
          value
          51.1
        6. group Id
          BG005
          spread
          11.8
          value
          53.6
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Age, Continuous
    unit Of Measure
    years
  2. calculate Pct
    false
    classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          22
        2. group Id
          BG001
          value
          21
        3. group Id
          BG002
          value
          19
        4. group Id
          BG003
          value
          17
        5. group Id
          BG004
          value
          39
        6. group Id
          BG005
          value
          118
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          5
        4. group Id
          BG003
          value
          7
        5. group Id
          BG004
          value
          10
        6. group Id
          BG005
          value
          27
        title
        Male
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Sex: Female, Male
    unit Of Measure
    Participants
  3. calculate Pct
    false
    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
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          0
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          24
        2. group Id
          BG001
          value
          24
        3. group Id
          BG002
          value
          24
        4. group Id
          BG003
          value
          24
        5. group Id
          BG004
          value
          49
        6. group Id
          BG005
          value
          145
        title
        Not Hispanic or Latino
      3. 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
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          0
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Ethnicity (NIH/OMB)
    unit Of Measure
    Participants
  4. calculate Pct
    false
    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
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          0
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          24
        2. group Id
          BG001
          value
          24
        3. group Id
          BG002
          value
          24
        4. group Id
          BG003
          value
          24
        5. group Id
          BG004
          value
          49
        6. group Id
          BG005
          value
          145
        title
        Asian
      3. 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
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          0
        title
        Native Hawaiian or Other Pacific Islander
      4. 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
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          0
        title
        Black or African American
      5. 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
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          0
        title
        White
      6. 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
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          0
        title
        More than one race
      7. 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
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          0
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race (NIH/OMB)
    unit Of Measure
    Participants
  5. calculate Pct
    false
    classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          24
        2. group Id
          BG001
          value
          24
        3. group Id
          BG002
          value
          24
        4. group Id
          BG003
          value
          24
        5. group Id
          BG004
          value
          49
        6. group Id
          BG005
          value
          145
      title
      Japan
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Region of Enrollment
    unit Of Measure
    Participants
population Description
All randomized participants who received any amount of study treatment. All participants who completed Part A were re-randomized to 4 mg or 8 mg in Part B.
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      24
    2. group Id
      BG001
      value
      24
    3. group Id
      BG002
      value
      24
    4. group Id
      BG003
      value
      24
    5. group Id
      BG004
      value
      49
    6. group Id
      BG005
      value
      145
    units
    Participants
groups
  1. description
    Participants on background methotrexate therapy were administered 1 mg baricitinib (LY3009104) orally once daily for 12 weeks in Part A and received 4 mg or 8 mg baricitinib (LY3009104) tablets orally once daily for 52 weeks in Part B.
    id
    BG000
    title
    Part A: 1 mg Baricitinib (LY3009104)
  2. description
    Participants on background methotrexate therapy were administered 2 mg baricitinib (LY3009104) orally once daily for 12 weeks in Part A and received 4 mg or 8 mg baricitinib (LY3009104) tablets orally once daily for 52 weeks in Part B.
    id
    BG001
    title
    Part A: 2 mg Baricitinib (LY3009104)
  3. description
    Participants on background methotrexate therapy were administered 4 mg baricitinib (LY3009104) orally once daily for 12 weeks in Part A and received 4 mg or 8 mg baricitinib (LY3009104) tablets orally once daily for 52 weeks in Part B.
    id
    BG002
    title
    Part A: 4 mg Baricitinib (LY3009104)
  4. description
    Participants on background methotrexate therapy were administered 8 mg baricitinib (LY3009104) orally once daily for 12 weeks in Part A and received 4 mg or 8 mg baricitinib (LY3009104) tablets orally once daily for 52 weeks in Part B.
    id
    BG003
    title
    Part A: 8 mg Baricitinib (LY3009104)
  5. description
    Participants on background methotrexate therapy were administered placebo orally once daily for 12 weeks in Part A and received 4 mg or 8 mg baricitinib (LY3009104) tablets orally once daily for 52 weeks in Part B.
    id
    BG004
    title
    Part A: Placebo
  6. description
    Total of all reporting groups
    id
    BG005
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          12.8
          value
          52.7
        2. group Id
          BG001
          spread
          11.5
          value
          56.1
        3. group Id
          BG002
          spread
          10.4
          value
          57.5
        4. group Id
          BG003
          spread
          11.3
          value
          53.6
        5. group Id
          BG004
          spread
          12.0
          value
          51.1
        6. group Id
          BG005
          spread
          11.8
          value
          53.6
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Age, Continuous
    unit Of Measure
    years
  2. calculate Pct
    false
    classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          22
        2. group Id
          BG001
          value
          21
        3. group Id
          BG002
          value
          19
        4. group Id
          BG003
          value
          17
        5. group Id
          BG004
          value
          39
        6. group Id
          BG005
          value
          118
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          5
        4. group Id
          BG003
          value
          7
        5. group Id
          BG004
          value
          10
        6. group Id
          BG005
          value
          27
        title
        Male
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Sex: Female, Male
    unit Of Measure
    Participants
  3. calculate Pct
    false
    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
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          0
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          24
        2. group Id
          BG001
          value
          24
        3. group Id
          BG002
          value
          24
        4. group Id
          BG003
          value
          24
        5. group Id
          BG004
          value
          49
        6. group Id
          BG005
          value
          145
        title
        Not Hispanic or Latino
      3. 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
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          0
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Ethnicity (NIH/OMB)
    unit Of Measure
    Participants
  4. calculate Pct
    false
    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
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          0
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          24
        2. group Id
          BG001
          value
          24
        3. group Id
          BG002
          value
          24
        4. group Id
          BG003
          value
          24
        5. group Id
          BG004
          value
          49
        6. group Id
          BG005
          value
          145
        title
        Asian
      3. 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
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          0
        title
        Native Hawaiian or Other Pacific Islander
      4. 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
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          0
        title
        Black or African American
      5. 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
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          0
        title
        White
      6. 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
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          0
        title
        More than one race
      7. 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
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          0
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race (NIH/OMB)
    unit Of Measure
    Participants
  5. calculate Pct
    false
    classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          24
        2. group Id
          BG001
          value
          24
        3. group Id
          BG002
          value
          24
        4. group Id
          BG003
          value
          24
        5. group Id
          BG004
          value
          49
        6. group Id
          BG005
          value
          145
      title
      Japan
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Region of Enrollment
    unit Of Measure
    Participants
population Description
All randomized participants who received any amount of study treatment. All participants who completed Part A were re-randomized to 4 mg or 8 mg in Part B.

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Preserved source evidence · Not medical advice