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NCT01185353 · BASELINE

Baseline characteristics

A Study in Participants With Rheumatoid Arthritis on Background Methotrexate Therapy · Source last updated 2017-06-16

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
      49
    2. group Id
      BG001
      value
      52
    3. group Id
      BG002
      value
      52
    4. group Id
      BG003
      value
      50
    5. group Id
      BG004
      value
      98
    6. group Id
      BG005
      value
      301
    units
    Participants
groups
  1. description
    Administered orally QD for initial 12 weeks (Part A) followed by randomization to either 4 mg QD or 2 mg BID for an additional 12 weeks (Part B). After 24 weeks of treatment, participants were eligible to participate in an open-label extension period (Part C). Part C: 4 mg or 8 mg administered orally QD for 52 weeks. After 76 weeks of treatment, participants were eligible to participate in an additional open-label extension period (Part D). Part D: 4 mg administered orally QD for 52 additional weeks. MTX was administered orally as background therapy.
    id
    BG000
    title
    1 mg LY3009104
  2. description
    Administered orally QD for 24 weeks (Parts A and B). After 24 weeks of treatment, participants were eligible to participate in an open-label extension period (Part C). Part C: 4 mg or 8 mg administered orally QD for 52 weeks. After 76 weeks of treatment, participants were eligible to participate in an additional open-label extension period (Part D). Part D: 4 mg administered orally QD for 52 additional weeks. MTX was administered orally as background therapy.
    id
    BG001
    title
    2 mg LY3009104
  3. description
    Administered orally QD for 24 weeks (Parts A and B). After 24 weeks of treatment, participants were eligible to participate in an open-label extension period (Part C). Part C: 4 mg or 8 mg administered orally QD for 52 weeks. After 76 weeks of treatment, participants were eligible to participate in an additional open-label extension period (Part D). Part D: 4 mg administered orally QD for 52 additional weeks. MTX was administered orally as background therapy.
    id
    BG002
    title
    4 mg LY3009104
  4. description
    Administered orally QD for 24 weeks (Parts A and B). After 24 weeks of treatment, participants were eligible to participate in an open-label extension period (Part C). Part C: 8 mg administered orally QD for 52 weeks. After 76 weeks of treatment, participants were eligible to participate in an additional open-label extension period (Part D). Part D: 4 mg administered orally QD for 52 additional weeks. MTX was administered orally as background therapy.
    id
    BG003
    title
    8 mg LY3009104
  5. description
    Placebo administered orally QD for initial 12 weeks (Part A) followed by randomization to either 4 mg QD or 2 mg BID for an additional 12 weeks (Part B). After 24 weeks of treatment, participants were eligible to participate in an open-label extension period (Part C). Part C: 4 mg or 8 mg administered orally QD for 52 weeks. After 76 weeks of treatment participants were eligible to participate in an additional open-label extension period (Part D). Part D: 4 mg administered orally QD for 52 additional weeks. MTX was administered orally as background therapy.
    id
    BG004
    title
    Placebo
  6. description
    Total of all reporting groups
    id
    BG005
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          11.07
          value
          53.1
        2. group Id
          BG001
          spread
          13.12
          value
          50.7
        3. group Id
          BG002
          spread
          10.42
          value
          52.5
        4. group Id
          BG003
          spread
          10.91
          value
          52.7
        5. group Id
          BG004
          spread
          12.15
          value
          49.2
        6. group Id
          BG005
          spread
          11.71
          value
          51.2
      denoms
      1. counts
        1. group Id
          BG000
          value
          49
        2. group Id
          BG001
          value
          52
        3. group Id
          BG002
          value
          52
        4. group Id
          BG003
          value
          50
        5. group Id
          BG004
          value
          98
        6. group Id
          BG005
          value
          301
        units
        Participants
    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
          42
        2. group Id
          BG001
          value
          44
        3. group Id
          BG002
          value
          37
        4. group Id
          BG003
          value
          41
        5. group Id
          BG004
          value
          85
        6. group Id
          BG005
          value
          249
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          7
        2. group Id
          BG001
          value
          8
        3. group Id
          BG002
          value
          15
        4. group Id
          BG003
          value
          9
        5. group Id
          BG004
          value
          13
        6. group Id
          BG005
          value
          52
        title
        Male
      denoms
      1. counts
        1. group Id
          BG000
          value
          49
        2. group Id
          BG001
          value
          52
        3. group Id
          BG002
          value
          52
        4. group Id
          BG003
          value
          50
        5. group Id
          BG004
          value
          98
        6. group Id
          BG005
          value
          301
        units
        Participants
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Sex: Female, Male
    unit Of Measure
    Participants
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          10
        2. group Id
          BG001
          value
          7
        3. group Id
          BG002
          value
          12
        4. group Id
          BG003
          value
          11
        5. group Id
          BG004
          value
          16
        6. group Id
          BG005
          value
          56
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          36
        2. group Id
          BG001
          value
          41
        3. group Id
          BG002
          value
          36
        4. group Id
          BG003
          value
          36
        5. group Id
          BG004
          value
          78
        6. group Id
          BG005
          value
          227
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          4
        4. group Id
          BG003
          value
          3
        5. group Id
          BG004
          value
          4
        6. group Id
          BG005
          value
          18
        title
        Unknown or Not Reported
      denoms
      1. counts
        1. group Id
          BG000
          value
          49
        2. group Id
          BG001
          value
          52
        3. group Id
          BG002
          value
          52
        4. group Id
          BG003
          value
          50
        5. group Id
          BG004
          value
          98
        6. group Id
          BG005
          value
          301
        units
        Participants
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Ethnicity (NIH/OMB)
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          4
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          3
        4. group Id
          BG003
          value
          2
        5. group Id
          BG004
          value
          7
        6. group Id
          BG005
          value
          19
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          8
        2. group Id
          BG001
          value
          8
        3. group Id
          BG002
          value
          7
        4. group Id
          BG003
          value
          9
        5. group Id
          BG004
          value
          15
        6. group Id
          BG005
          value
          47
        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
          1
        3. group Id
          BG002
          value
          2
        4. group Id
          BG003
          value
          2
        5. group Id
          BG004
          value
          6
        6. group Id
          BG005
          value
          11
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          37
        2. group Id
          BG001
          value
          40
        3. group Id
          BG002
          value
          40
        4. group Id
          BG003
          value
          37
        5. group Id
          BG004
          value
          70
        6. group Id
          BG005
          value
          224
        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
      denoms
      1. counts
        1. group Id
          BG000
          value
          49
        2. group Id
          BG001
          value
          52
        3. group Id
          BG002
          value
          52
        4. group Id
          BG003
          value
          50
        5. group Id
          BG004
          value
          98
        6. group Id
          BG005
          value
          301
        units
        Participants
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race (NIH/OMB)
    unit Of Measure
    Participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          16
        2. group Id
          BG001
          value
          16
        3. group Id
          BG002
          value
          16
        4. group Id
          BG003
          value
          16
        5. group Id
          BG004
          value
          31
        6. group Id
          BG005
          value
          95
      denoms
      1. counts
        1. group Id
          BG000
          value
          49
        2. group Id
          BG001
          value
          52
        3. group Id
          BG002
          value
          52
        4. group Id
          BG003
          value
          50
        5. group Id
          BG004
          value
          98
        6. group Id
          BG005
          value
          301
        units
        Participants
      title
      United States
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          3
        4. group Id
          BG003
          value
          2
        5. group Id
          BG004
          value
          2
        6. group Id
          BG005
          value
          13
      denoms
      1. counts
        1. group Id
          BG000
          value
          49
        2. group Id
          BG001
          value
          52
        3. group Id
          BG002
          value
          52
        4. group Id
          BG003
          value
          50
        5. group Id
          BG004
          value
          98
        6. group Id
          BG005
          value
          301
        units
        Participants
      title
      Hungary
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          4
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          6
        4. group Id
          BG003
          value
          3
        5. group Id
          BG004
          value
          7
        6. group Id
          BG005
          value
          23
      denoms
      1. counts
        1. group Id
          BG000
          value
          49
        2. group Id
          BG001
          value
          52
        3. group Id
          BG002
          value
          52
        4. group Id
          BG003
          value
          50
        5. group Id
          BG004
          value
          98
        6. group Id
          BG005
          value
          301
        units
        Participants
      title
      Czech Republic
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          7
        2. group Id
          BG001
          value
          8
        3. group Id
          BG002
          value
          8
        4. group Id
          BG003
          value
          8
        5. group Id
          BG004
          value
          16
        6. group Id
          BG005
          value
          47
      denoms
      1. counts
        1. group Id
          BG000
          value
          49
        2. group Id
          BG001
          value
          52
        3. group Id
          BG002
          value
          52
        4. group Id
          BG003
          value
          50
        5. group Id
          BG004
          value
          98
        6. group Id
          BG005
          value
          301
        units
        Participants
      title
      Mexico
    5. categories
      1. measurements
        1. group Id
          BG000
          value
          4
        2. group Id
          BG001
          value
          5
        3. group Id
          BG002
          value
          6
        4. group Id
          BG003
          value
          7
        5. group Id
          BG004
          value
          11
        6. group Id
          BG005
          value
          33
      denoms
      1. counts
        1. group Id
          BG000
          value
          49
        2. group Id
          BG001
          value
          52
        3. group Id
          BG002
          value
          52
        4. group Id
          BG003
          value
          50
        5. group Id
          BG004
          value
          98
        6. group Id
          BG005
          value
          301
        units
        Participants
      title
      Poland
    6. categories
      1. measurements
        1. group Id
          BG000
          value
          6
        2. group Id
          BG001
          value
          6
        3. group Id
          BG002
          value
          5
        4. group Id
          BG003
          value
          3
        5. group Id
          BG004
          value
          9
        6. group Id
          BG005
          value
          29
      denoms
      1. counts
        1. group Id
          BG000
          value
          49
        2. group Id
          BG001
          value
          52
        3. group Id
          BG002
          value
          52
        4. group Id
          BG003
          value
          50
        5. group Id
          BG004
          value
          98
        6. group Id
          BG005
          value
          301
        units
        Participants
      title
      Ukraine
    7. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          1
        5. group Id
          BG004
          value
          5
        6. group Id
          BG005
          value
          7
      denoms
      1. counts
        1. group Id
          BG000
          value
          49
        2. group Id
          BG001
          value
          52
        3. group Id
          BG002
          value
          52
        4. group Id
          BG003
          value
          50
        5. group Id
          BG004
          value
          98
        6. group Id
          BG005
          value
          301
        units
        Participants
      title
      Croatia
    8. categories
      1. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          3
        5. group Id
          BG004
          value
          3
        6. group Id
          BG005
          value
          11
      denoms
      1. counts
        1. group Id
          BG000
          value
          49
        2. group Id
          BG001
          value
          52
        3. group Id
          BG002
          value
          52
        4. group Id
          BG003
          value
          50
        5. group Id
          BG004
          value
          98
        6. group Id
          BG005
          value
          301
        units
        Participants
      title
      Romania
    9. categories
      1. measurements
        1. group Id
          BG000
          value
          7
        2. group Id
          BG001
          value
          8
        3. group Id
          BG002
          value
          7
        4. group Id
          BG003
          value
          7
        5. group Id
          BG004
          value
          14
        6. group Id
          BG005
          value
          43
      denoms
      1. counts
        1. group Id
          BG000
          value
          49
        2. group Id
          BG001
          value
          52
        3. group Id
          BG002
          value
          52
        4. group Id
          BG003
          value
          50
        5. group Id
          BG004
          value
          98
        6. group Id
          BG005
          value
          301
        units
        Participants
      title
      India
    param Type
    NUMBER
    title
    Region of Enrollment
    unit Of Measure
    participants
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          3.885
          value
          5.45
        2. group Id
          BG001
          spread
          4.377
          value
          5.53
        3. group Id
          BG002
          spread
          4.466
          value
          5.28
        4. group Id
          BG003
          spread
          5.048
          value
          6.63
        5. group Id
          BG004
          spread
          4.283
          value
          5.40
        6. group Id
          BG005
          spread
          4.401
          value
          5.62
      denoms
      1. counts
        1. group Id
          BG000
          value
          49
        2. group Id
          BG001
          value
          52
        3. group Id
          BG002
          value
          52
        4. group Id
          BG003
          value
          50
        5. group Id
          BG004
          value
          98
        6. group Id
          BG005
          value
          301
        units
        Participants
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Duration of Rheumatoid Arthritis
    unit Of Measure
    years
  7. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          10.90
          value
          21.4
        2. group Id
          BG001
          spread
          12.60
          value
          23.0
        3. group Id
          BG002
          spread
          12.71
          value
          19.9
        4. group Id
          BG003
          spread
          13.76
          value
          24.4
        5. group Id
          BG004
          spread
          12.06
          value
          22.2
        6. group Id
          BG005
          spread
          12.38
          value
          22.2
      denoms
      1. counts
        1. group Id
          BG000
          value
          49
        2. group Id
          BG001
          value
          52
        3. group Id
          BG002
          value
          52
        4. group Id
          BG003
          value
          50
        5. group Id
          BG004
          value
          98
        6. group Id
          BG005
          value
          301
        units
        Participants
    description
    TJC is the number of tender and painful joints determined for each participant by examination of 68 joints. Joints were assessed by pressure and joint manipulation on physical examination. Participants were asked for pain sensations on these manipulations and watched for spontaneous pain reactions. Any positive response on pressure, movement, or both was translated into a single tender-versus-nontender dichotomy.
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Tender Joint Counts (TJC)
    unit Of Measure
    number of joints
  8. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          6.55
          value
          15.2
        2. group Id
          BG001
          spread
          9.32
          value
          17.0
        3. group Id
          BG002
          spread
          7.54
          value
          14.8
        4. group Id
          BG003
          spread
          7.92
          value
          16.1
        5. group Id
          BG004
          spread
          8.64
          value
          15.8
        6. group Id
          BG005
          spread
          8.13
          value
          15.8
      denoms
      1. counts
        1. group Id
          BG000
          value
          49
        2. group Id
          BG001
          value
          52
        3. group Id
          BG002
          value
          52
        4. group Id
          BG003
          value
          50
        5. group Id
          BG004
          value
          98
        6. group Id
          BG005
          value
          301
        units
        Participants
    description
    SJC is the number of swollen joints determined for each participant by examination of 66 joints. Joints were classified as either swollen or not swollen. Swelling was defined as palpable fluctuating synovitis of the joint.
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Swollen Joint Counts (SJC)
    unit Of Measure
    number of joints
  9. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          12.410
          value
          11.22
        2. group Id
          BG001
          spread
          22.111
          value
          12.02
        3. group Id
          BG002
          spread
          16.941
          value
          11.39
        4. group Id
          BG003
          spread
          15.602
          value
          14.32
        5. group Id
          BG004
          spread
          23.527
          value
          14.03
        6. group Id
          BG005
          spread
          19.402
          value
          12.81
      denoms
      1. counts
        1. group Id
          BG000
          value
          49
        2. group Id
          BG001
          value
          52
        3. group Id
          BG002
          value
          52
        4. group Id
          BG003
          value
          50
        5. group Id
          BG004
          value
          97
        6. group Id
          BG005
          value
          300
        units
        Participants
    description
    HsCRP is a laboratory analyte that is an indicator of inflammation. Decreases in hsCRP represent reductions in inflammation.
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    population Description
    All randomized participants who received at least one dose of study drug and had evaluable hsCRP data at baseline.
    title
    High Sensitivity C-Reactive Protein (hsCRP)
    unit Of Measure
    milligrams/liter (mg/L)
  10. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          17.57
          value
          38.2
        2. group Id
          BG001
          spread
          14.62
          value
          36.5
        3. group Id
          BG002
          spread
          17.16
          value
          35.4
        4. group Id
          BG003
          spread
          18.17
          value
          43.3
        5. group Id
          BG004
          spread
          20.94
          value
          39.9
        6. group Id
          BG005
          spread
          18.39
          value
          38.8
      denoms
      1. counts
        1. group Id
          BG000
          value
          49
        2. group Id
          BG001
          value
          52
        3. group Id
          BG002
          value
          52
        4. group Id
          BG003
          value
          50
        5. group Id
          BG004
          value
          98
        6. group Id
          BG005
          value
          301
        units
        Participants
    description
    ESR is a laboratory analyte that is an indicator of inflammation. Decreases represent reductions in inflammation.
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Erythrocyte Sedimentation Rate (ESR)
    unit Of Measure
    millimeters/hour (mm/hr)
population Description
All randomized participants who received at least 1 dose of study drug.
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      49
    2. group Id
      BG001
      value
      52
    3. group Id
      BG002
      value
      52
    4. group Id
      BG003
      value
      50
    5. group Id
      BG004
      value
      98
    6. group Id
      BG005
      value
      301
    units
    Participants
groups
  1. description
    Administered orally QD for initial 12 weeks (Part A) followed by randomization to either 4 mg QD or 2 mg BID for an additional 12 weeks (Part B). After 24 weeks of treatment, participants were eligible to participate in an open-label extension period (Part C). Part C: 4 mg or 8 mg administered orally QD for 52 weeks. After 76 weeks of treatment, participants were eligible to participate in an additional open-label extension period (Part D). Part D: 4 mg administered orally QD for 52 additional weeks. MTX was administered orally as background therapy.
    id
    BG000
    title
    1 mg LY3009104
  2. description
    Administered orally QD for 24 weeks (Parts A and B). After 24 weeks of treatment, participants were eligible to participate in an open-label extension period (Part C). Part C: 4 mg or 8 mg administered orally QD for 52 weeks. After 76 weeks of treatment, participants were eligible to participate in an additional open-label extension period (Part D). Part D: 4 mg administered orally QD for 52 additional weeks. MTX was administered orally as background therapy.
    id
    BG001
    title
    2 mg LY3009104
  3. description
    Administered orally QD for 24 weeks (Parts A and B). After 24 weeks of treatment, participants were eligible to participate in an open-label extension period (Part C). Part C: 4 mg or 8 mg administered orally QD for 52 weeks. After 76 weeks of treatment, participants were eligible to participate in an additional open-label extension period (Part D). Part D: 4 mg administered orally QD for 52 additional weeks. MTX was administered orally as background therapy.
    id
    BG002
    title
    4 mg LY3009104
  4. description
    Administered orally QD for 24 weeks (Parts A and B). After 24 weeks of treatment, participants were eligible to participate in an open-label extension period (Part C). Part C: 8 mg administered orally QD for 52 weeks. After 76 weeks of treatment, participants were eligible to participate in an additional open-label extension period (Part D). Part D: 4 mg administered orally QD for 52 additional weeks. MTX was administered orally as background therapy.
    id
    BG003
    title
    8 mg LY3009104
  5. description
    Placebo administered orally QD for initial 12 weeks (Part A) followed by randomization to either 4 mg QD or 2 mg BID for an additional 12 weeks (Part B). After 24 weeks of treatment, participants were eligible to participate in an open-label extension period (Part C). Part C: 4 mg or 8 mg administered orally QD for 52 weeks. After 76 weeks of treatment participants were eligible to participate in an additional open-label extension period (Part D). Part D: 4 mg administered orally QD for 52 additional weeks. MTX was administered orally as background therapy.
    id
    BG004
    title
    Placebo
  6. description
    Total of all reporting groups
    id
    BG005
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          11.07
          value
          53.1
        2. group Id
          BG001
          spread
          13.12
          value
          50.7
        3. group Id
          BG002
          spread
          10.42
          value
          52.5
        4. group Id
          BG003
          spread
          10.91
          value
          52.7
        5. group Id
          BG004
          spread
          12.15
          value
          49.2
        6. group Id
          BG005
          spread
          11.71
          value
          51.2
      denoms
      1. counts
        1. group Id
          BG000
          value
          49
        2. group Id
          BG001
          value
          52
        3. group Id
          BG002
          value
          52
        4. group Id
          BG003
          value
          50
        5. group Id
          BG004
          value
          98
        6. group Id
          BG005
          value
          301
        units
        Participants
    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
          42
        2. group Id
          BG001
          value
          44
        3. group Id
          BG002
          value
          37
        4. group Id
          BG003
          value
          41
        5. group Id
          BG004
          value
          85
        6. group Id
          BG005
          value
          249
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          7
        2. group Id
          BG001
          value
          8
        3. group Id
          BG002
          value
          15
        4. group Id
          BG003
          value
          9
        5. group Id
          BG004
          value
          13
        6. group Id
          BG005
          value
          52
        title
        Male
      denoms
      1. counts
        1. group Id
          BG000
          value
          49
        2. group Id
          BG001
          value
          52
        3. group Id
          BG002
          value
          52
        4. group Id
          BG003
          value
          50
        5. group Id
          BG004
          value
          98
        6. group Id
          BG005
          value
          301
        units
        Participants
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Sex: Female, Male
    unit Of Measure
    Participants
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          10
        2. group Id
          BG001
          value
          7
        3. group Id
          BG002
          value
          12
        4. group Id
          BG003
          value
          11
        5. group Id
          BG004
          value
          16
        6. group Id
          BG005
          value
          56
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          36
        2. group Id
          BG001
          value
          41
        3. group Id
          BG002
          value
          36
        4. group Id
          BG003
          value
          36
        5. group Id
          BG004
          value
          78
        6. group Id
          BG005
          value
          227
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          4
        4. group Id
          BG003
          value
          3
        5. group Id
          BG004
          value
          4
        6. group Id
          BG005
          value
          18
        title
        Unknown or Not Reported
      denoms
      1. counts
        1. group Id
          BG000
          value
          49
        2. group Id
          BG001
          value
          52
        3. group Id
          BG002
          value
          52
        4. group Id
          BG003
          value
          50
        5. group Id
          BG004
          value
          98
        6. group Id
          BG005
          value
          301
        units
        Participants
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Ethnicity (NIH/OMB)
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          4
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          3
        4. group Id
          BG003
          value
          2
        5. group Id
          BG004
          value
          7
        6. group Id
          BG005
          value
          19
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          8
        2. group Id
          BG001
          value
          8
        3. group Id
          BG002
          value
          7
        4. group Id
          BG003
          value
          9
        5. group Id
          BG004
          value
          15
        6. group Id
          BG005
          value
          47
        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
          1
        3. group Id
          BG002
          value
          2
        4. group Id
          BG003
          value
          2
        5. group Id
          BG004
          value
          6
        6. group Id
          BG005
          value
          11
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          37
        2. group Id
          BG001
          value
          40
        3. group Id
          BG002
          value
          40
        4. group Id
          BG003
          value
          37
        5. group Id
          BG004
          value
          70
        6. group Id
          BG005
          value
          224
        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
      denoms
      1. counts
        1. group Id
          BG000
          value
          49
        2. group Id
          BG001
          value
          52
        3. group Id
          BG002
          value
          52
        4. group Id
          BG003
          value
          50
        5. group Id
          BG004
          value
          98
        6. group Id
          BG005
          value
          301
        units
        Participants
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race (NIH/OMB)
    unit Of Measure
    Participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          16
        2. group Id
          BG001
          value
          16
        3. group Id
          BG002
          value
          16
        4. group Id
          BG003
          value
          16
        5. group Id
          BG004
          value
          31
        6. group Id
          BG005
          value
          95
      denoms
      1. counts
        1. group Id
          BG000
          value
          49
        2. group Id
          BG001
          value
          52
        3. group Id
          BG002
          value
          52
        4. group Id
          BG003
          value
          50
        5. group Id
          BG004
          value
          98
        6. group Id
          BG005
          value
          301
        units
        Participants
      title
      United States
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          3
        4. group Id
          BG003
          value
          2
        5. group Id
          BG004
          value
          2
        6. group Id
          BG005
          value
          13
      denoms
      1. counts
        1. group Id
          BG000
          value
          49
        2. group Id
          BG001
          value
          52
        3. group Id
          BG002
          value
          52
        4. group Id
          BG003
          value
          50
        5. group Id
          BG004
          value
          98
        6. group Id
          BG005
          value
          301
        units
        Participants
      title
      Hungary
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          4
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          6
        4. group Id
          BG003
          value
          3
        5. group Id
          BG004
          value
          7
        6. group Id
          BG005
          value
          23
      denoms
      1. counts
        1. group Id
          BG000
          value
          49
        2. group Id
          BG001
          value
          52
        3. group Id
          BG002
          value
          52
        4. group Id
          BG003
          value
          50
        5. group Id
          BG004
          value
          98
        6. group Id
          BG005
          value
          301
        units
        Participants
      title
      Czech Republic
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          7
        2. group Id
          BG001
          value
          8
        3. group Id
          BG002
          value
          8
        4. group Id
          BG003
          value
          8
        5. group Id
          BG004
          value
          16
        6. group Id
          BG005
          value
          47
      denoms
      1. counts
        1. group Id
          BG000
          value
          49
        2. group Id
          BG001
          value
          52
        3. group Id
          BG002
          value
          52
        4. group Id
          BG003
          value
          50
        5. group Id
          BG004
          value
          98
        6. group Id
          BG005
          value
          301
        units
        Participants
      title
      Mexico
    5. categories
      1. measurements
        1. group Id
          BG000
          value
          4
        2. group Id
          BG001
          value
          5
        3. group Id
          BG002
          value
          6
        4. group Id
          BG003
          value
          7
        5. group Id
          BG004
          value
          11
        6. group Id
          BG005
          value
          33
      denoms
      1. counts
        1. group Id
          BG000
          value
          49
        2. group Id
          BG001
          value
          52
        3. group Id
          BG002
          value
          52
        4. group Id
          BG003
          value
          50
        5. group Id
          BG004
          value
          98
        6. group Id
          BG005
          value
          301
        units
        Participants
      title
      Poland
    6. categories
      1. measurements
        1. group Id
          BG000
          value
          6
        2. group Id
          BG001
          value
          6
        3. group Id
          BG002
          value
          5
        4. group Id
          BG003
          value
          3
        5. group Id
          BG004
          value
          9
        6. group Id
          BG005
          value
          29
      denoms
      1. counts
        1. group Id
          BG000
          value
          49
        2. group Id
          BG001
          value
          52
        3. group Id
          BG002
          value
          52
        4. group Id
          BG003
          value
          50
        5. group Id
          BG004
          value
          98
        6. group Id
          BG005
          value
          301
        units
        Participants
      title
      Ukraine
    7. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          1
        5. group Id
          BG004
          value
          5
        6. group Id
          BG005
          value
          7
      denoms
      1. counts
        1. group Id
          BG000
          value
          49
        2. group Id
          BG001
          value
          52
        3. group Id
          BG002
          value
          52
        4. group Id
          BG003
          value
          50
        5. group Id
          BG004
          value
          98
        6. group Id
          BG005
          value
          301
        units
        Participants
      title
      Croatia
    8. categories
      1. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          3
        5. group Id
          BG004
          value
          3
        6. group Id
          BG005
          value
          11
      denoms
      1. counts
        1. group Id
          BG000
          value
          49
        2. group Id
          BG001
          value
          52
        3. group Id
          BG002
          value
          52
        4. group Id
          BG003
          value
          50
        5. group Id
          BG004
          value
          98
        6. group Id
          BG005
          value
          301
        units
        Participants
      title
      Romania
    9. categories
      1. measurements
        1. group Id
          BG000
          value
          7
        2. group Id
          BG001
          value
          8
        3. group Id
          BG002
          value
          7
        4. group Id
          BG003
          value
          7
        5. group Id
          BG004
          value
          14
        6. group Id
          BG005
          value
          43
      denoms
      1. counts
        1. group Id
          BG000
          value
          49
        2. group Id
          BG001
          value
          52
        3. group Id
          BG002
          value
          52
        4. group Id
          BG003
          value
          50
        5. group Id
          BG004
          value
          98
        6. group Id
          BG005
          value
          301
        units
        Participants
      title
      India
    param Type
    NUMBER
    title
    Region of Enrollment
    unit Of Measure
    participants
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          3.885
          value
          5.45
        2. group Id
          BG001
          spread
          4.377
          value
          5.53
        3. group Id
          BG002
          spread
          4.466
          value
          5.28
        4. group Id
          BG003
          spread
          5.048
          value
          6.63
        5. group Id
          BG004
          spread
          4.283
          value
          5.40
        6. group Id
          BG005
          spread
          4.401
          value
          5.62
      denoms
      1. counts
        1. group Id
          BG000
          value
          49
        2. group Id
          BG001
          value
          52
        3. group Id
          BG002
          value
          52
        4. group Id
          BG003
          value
          50
        5. group Id
          BG004
          value
          98
        6. group Id
          BG005
          value
          301
        units
        Participants
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Duration of Rheumatoid Arthritis
    unit Of Measure
    years
  7. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          10.90
          value
          21.4
        2. group Id
          BG001
          spread
          12.60
          value
          23.0
        3. group Id
          BG002
          spread
          12.71
          value
          19.9
        4. group Id
          BG003
          spread
          13.76
          value
          24.4
        5. group Id
          BG004
          spread
          12.06
          value
          22.2
        6. group Id
          BG005
          spread
          12.38
          value
          22.2
      denoms
      1. counts
        1. group Id
          BG000
          value
          49
        2. group Id
          BG001
          value
          52
        3. group Id
          BG002
          value
          52
        4. group Id
          BG003
          value
          50
        5. group Id
          BG004
          value
          98
        6. group Id
          BG005
          value
          301
        units
        Participants
    description
    TJC is the number of tender and painful joints determined for each participant by examination of 68 joints. Joints were assessed by pressure and joint manipulation on physical examination. Participants were asked for pain sensations on these manipulations and watched for spontaneous pain reactions. Any positive response on pressure, movement, or both was translated into a single tender-versus-nontender dichotomy.
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Tender Joint Counts (TJC)
    unit Of Measure
    number of joints
  8. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          6.55
          value
          15.2
        2. group Id
          BG001
          spread
          9.32
          value
          17.0
        3. group Id
          BG002
          spread
          7.54
          value
          14.8
        4. group Id
          BG003
          spread
          7.92
          value
          16.1
        5. group Id
          BG004
          spread
          8.64
          value
          15.8
        6. group Id
          BG005
          spread
          8.13
          value
          15.8
      denoms
      1. counts
        1. group Id
          BG000
          value
          49
        2. group Id
          BG001
          value
          52
        3. group Id
          BG002
          value
          52
        4. group Id
          BG003
          value
          50
        5. group Id
          BG004
          value
          98
        6. group Id
          BG005
          value
          301
        units
        Participants
    description
    SJC is the number of swollen joints determined for each participant by examination of 66 joints. Joints were classified as either swollen or not swollen. Swelling was defined as palpable fluctuating synovitis of the joint.
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Swollen Joint Counts (SJC)
    unit Of Measure
    number of joints
  9. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          12.410
          value
          11.22
        2. group Id
          BG001
          spread
          22.111
          value
          12.02
        3. group Id
          BG002
          spread
          16.941
          value
          11.39
        4. group Id
          BG003
          spread
          15.602
          value
          14.32
        5. group Id
          BG004
          spread
          23.527
          value
          14.03
        6. group Id
          BG005
          spread
          19.402
          value
          12.81
      denoms
      1. counts
        1. group Id
          BG000
          value
          49
        2. group Id
          BG001
          value
          52
        3. group Id
          BG002
          value
          52
        4. group Id
          BG003
          value
          50
        5. group Id
          BG004
          value
          97
        6. group Id
          BG005
          value
          300
        units
        Participants
    description
    HsCRP is a laboratory analyte that is an indicator of inflammation. Decreases in hsCRP represent reductions in inflammation.
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    population Description
    All randomized participants who received at least one dose of study drug and had evaluable hsCRP data at baseline.
    title
    High Sensitivity C-Reactive Protein (hsCRP)
    unit Of Measure
    milligrams/liter (mg/L)
  10. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          17.57
          value
          38.2
        2. group Id
          BG001
          spread
          14.62
          value
          36.5
        3. group Id
          BG002
          spread
          17.16
          value
          35.4
        4. group Id
          BG003
          spread
          18.17
          value
          43.3
        5. group Id
          BG004
          spread
          20.94
          value
          39.9
        6. group Id
          BG005
          spread
          18.39
          value
          38.8
      denoms
      1. counts
        1. group Id
          BG000
          value
          49
        2. group Id
          BG001
          value
          52
        3. group Id
          BG002
          value
          52
        4. group Id
          BG003
          value
          50
        5. group Id
          BG004
          value
          98
        6. group Id
          BG005
          value
          301
        units
        Participants
    description
    ESR is a laboratory analyte that is an indicator of inflammation. Decreases represent reductions in inflammation.
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Erythrocyte Sedimentation Rate (ESR)
    unit Of Measure
    millimeters/hour (mm/hr)
population Description
All randomized participants who received at least 1 dose of study drug.

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Preserved source evidence · Not medical advice