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NCT02550652 · BASELINE

Baseline characteristics

A Study to Evaluate the Safety and Efficacy of Obinutuzumab Compared With Placebo in Participants With Lupus Nephritis (LN) · Source last updated 2024-08-27

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
      63
    2. group Id
      BG001
      value
      62
    3. group Id
      BG002
      value
      125
    units
    Participants
groups
  1. description
    Participants received obinutuzumab 1000 milligrams (mg) intravenous (IV) infusion on Days 1, 15, 168, and 182 along with MMF/MPA at a starting dose of 1500 mg/day (or equivalent) administered orally in 2 or 3 divided doses. MMF/MPA dose was up titrated to a target dose of 2.0 - 2.5 grams per day (g/day) (or equivalent). Investigators, at their discretion, could use MPA as a substitute for MMF, with a 360 mg dose being equivalent to a 500 mg dose of MMF. During screening or at randomization, if clinically indicated, participants could receive 1000 mg methylprednisolone IV once daily for up to 3 days to treat underlying LN clinical activity. Participants received 0.5 mg/kg oral prednisone, tapering this prednisone dose, per protocol, starting on Day 16 and reducing the prednisone dosage to 7.5 mg/day by Week 12.
    id
    BG000
    title
    OBINUTUZUMAB 1000MG and MMF
  2. description
    Participants received placebo matching to obinutuzumab IV infusion on Days 1, 15, 168, and 182 along with MMF/MPA at a starting dose of 1500 mg/day (or equivalent) administered orally in 2 or 3 divided doses. MMF/MPA dose was up titrated to a target dose of 2.0 - 2.5 g/day (or equivalent). Investigators, at their discretion, could use MPA as a substitute for MMF, with a 360 mg dose being equivalent to a 500 mg dose of MMF. During screening or at randomization, if clinically indicated, participants could receive 1000 mg methylprednisolone IV once daily for up to 3 days to treat underlying LN clinical activity. Participants received 0.5 mg/kg oral prednisone, tapering this prednisone dose, per protocol, starting on Day 16 and reducing the prednisone dosage to 7.5 mg/day by Week 12.
    id
    BG001
    title
    PLACEBO and MMF
  3. description
    Total of all reporting groups
    id
    BG002
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          9.8
          value
          33.1
        2. group Id
          BG001
          spread
          10.1
          value
          31.9
        3. group Id
          BG002
          spread
          9.9
          value
          32.5
      denoms
      1. counts
        1. group Id
          BG000
          value
          63
        2. group Id
          BG001
          value
          62
        3. group Id
          BG002
          value
          125
        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
          55
        2. group Id
          BG001
          value
          51
        3. group Id
          BG002
          value
          106
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          8
        2. group Id
          BG001
          value
          11
        3. group Id
          BG002
          value
          19
        title
        Male
      denoms
      1. counts
        1. group Id
          BG000
          value
          63
        2. group Id
          BG001
          value
          62
        3. group Id
          BG002
          value
          125
        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
          42
        2. group Id
          BG001
          value
          49
        3. group Id
          BG002
          value
          91
        title
        Hispanic Or Latino
      2. measurements
        1. group Id
          BG000
          value
          20
        2. group Id
          BG001
          value
          12
        3. group Id
          BG002
          value
          32
        title
        Not Hispanic Or Latino
      3. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
        title
        Not Stated
      4. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          1
        title
        Unknown
      denoms
      1. counts
        1. group Id
          BG000
          value
          63
        2. group Id
          BG001
          value
          62
        3. group Id
          BG002
          value
          125
        units
        Participants
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race/Ethnicity, Customized
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          11
        2. group Id
          BG001
          value
          17
        3. group Id
          BG002
          value
          28
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          5
        title
        Asian
      3. measurements
        1. group Id
          BG000
          value
          6
        2. group Id
          BG001
          value
          5
        3. group Id
          BG002
          value
          11
        title
        Black or African American
      4. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
        title
        Multiple
      5. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
        title
        Native Hawaiian or other Pacific Islande
      6. measurements
        1. group Id
          BG000
          value
          13
        2. group Id
          BG001
          value
          12
        3. group Id
          BG002
          value
          25
        title
        Unknown
      7. measurements
        1. group Id
          BG000
          value
          28
        2. group Id
          BG001
          value
          26
        3. group Id
          BG002
          value
          54
        title
        White
      denoms
      1. counts
        1. group Id
          BG000
          value
          63
        2. group Id
          BG001
          value
          62
        3. group Id
          BG002
          value
          125
        units
        Participants
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race/Ethnicity, Customized
    unit Of Measure
    Participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          331
          value
          328
        2. group Id
          BG001
          spread
          454
          value
          353
        3. group Id
          BG002
          spread
          395
          value
          341
      denoms
      1. counts
        1. group Id
          BG000
          value
          48
        2. group Id
          BG001
          value
          48
        3. group Id
          BG002
          value
          96
        units
        Participants
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    population Description
    The number analyzed indicates the number of participants with non-missing results at baseline. Values below the level of quantification have been excluded from the analysis.
    title
    Circulating CD19-Positive B-Cell Levels
    unit Of Measure
    cells/uL
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          4
        title
        Asia
      2. measurements
        1. group Id
          BG000
          value
          16
        2. group Id
          BG001
          value
          5
        3. group Id
          BG002
          value
          21
        title
        European Union
      3. measurements
        1. group Id
          BG000
          value
          37
        2. group Id
          BG001
          value
          46
        3. group Id
          BG002
          value
          83
        title
        Latin America
      4. measurements
        1. group Id
          BG000
          value
          7
        2. group Id
          BG001
          value
          8
        3. group Id
          BG002
          value
          15
        title
        United States
      denoms
      1. counts
        1. group Id
          BG000
          value
          62
        2. group Id
          BG001
          value
          61
        3. group Id
          BG002
          value
          123
        units
        Participants
    param Type
    COUNT_OF_PARTICIPANTS
    population Description
    The number analyzed represents the number of patients contributing to summary statistics.
    title
    Region of Enrollment
    unit Of Measure
    Participants
  7. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          14
        2. group Id
          BG001
          value
          17
        3. group Id
          BG002
          value
          31
      denoms
      1. counts
        1. group Id
          BG000
          value
          63
        2. group Id
          BG001
          value
          62
        3. group Id
          BG002
          value
          125
        units
        Participants
      title
      III
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          49
        2. group Id
          BG001
          value
          45
        3. group Id
          BG002
          value
          94
      denoms
      1. counts
        1. group Id
          BG000
          value
          63
        2. group Id
          BG001
          value
          62
        3. group Id
          BG002
          value
          125
        units
        Participants
      title
      IV
    description
    Participants were graded as Class III or Class IV using the classification by the International Society of Nephrology and the Renal Pathology Society (ISN/RPS): Class III Focal LN (\< 50% of glomeruli) III (A): active lesions III (A/C): active and chronic lesions III (C): chronic lesions Class IV Diffuse LN (≥50% glomeruli) Diffuse segmental (IV-S) or global (IV-G) LN IV (A): active lesions IV (A/C): active and chronic lesions IV (C): chronic lesions Stage IV is considered to have worse clinical outcome than stage III.
    param Type
    NUMBER
    title
    Lupus Nephritis (LN) Biopsy Class
    unit Of Measure
    Participants
  8. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          2.66
          value
          3.32
        2. group Id
          BG001
          spread
          2.46
          value
          2.93
        3. group Id
          BG002
          spread
          2.56
          value
          3.12
      denoms
      1. counts
        1. group Id
          BG000
          value
          60
        2. group Id
          BG001
          value
          60
        3. group Id
          BG002
          value
          120
        units
        Participants
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    population Description
    Due to a central lab error, uPCR was not available for the first 5 patients at baseline
    title
    Urine Protein Creatinine Ratio (UPCR)
    unit Of Measure
    mg/mg
  9. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          0.34
          value
          0.87
        2. group Id
          BG001
          spread
          0.32
          value
          0.8
        3. group Id
          BG002
          spread
          0.34
          value
          0.84
      denoms
      1. counts
        1. group Id
          BG000
          value
          63
        2. group Id
          BG001
          value
          62
        3. group Id
          BG002
          value
          125
        units
        Participants
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Serum creatinine
    unit Of Measure
    (mg/dL)
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      63
    2. group Id
      BG001
      value
      62
    3. group Id
      BG002
      value
      125
    units
    Participants
groups
  1. description
    Participants received obinutuzumab 1000 milligrams (mg) intravenous (IV) infusion on Days 1, 15, 168, and 182 along with MMF/MPA at a starting dose of 1500 mg/day (or equivalent) administered orally in 2 or 3 divided doses. MMF/MPA dose was up titrated to a target dose of 2.0 - 2.5 grams per day (g/day) (or equivalent). Investigators, at their discretion, could use MPA as a substitute for MMF, with a 360 mg dose being equivalent to a 500 mg dose of MMF. During screening or at randomization, if clinically indicated, participants could receive 1000 mg methylprednisolone IV once daily for up to 3 days to treat underlying LN clinical activity. Participants received 0.5 mg/kg oral prednisone, tapering this prednisone dose, per protocol, starting on Day 16 and reducing the prednisone dosage to 7.5 mg/day by Week 12.
    id
    BG000
    title
    OBINUTUZUMAB 1000MG and MMF
  2. description
    Participants received placebo matching to obinutuzumab IV infusion on Days 1, 15, 168, and 182 along with MMF/MPA at a starting dose of 1500 mg/day (or equivalent) administered orally in 2 or 3 divided doses. MMF/MPA dose was up titrated to a target dose of 2.0 - 2.5 g/day (or equivalent). Investigators, at their discretion, could use MPA as a substitute for MMF, with a 360 mg dose being equivalent to a 500 mg dose of MMF. During screening or at randomization, if clinically indicated, participants could receive 1000 mg methylprednisolone IV once daily for up to 3 days to treat underlying LN clinical activity. Participants received 0.5 mg/kg oral prednisone, tapering this prednisone dose, per protocol, starting on Day 16 and reducing the prednisone dosage to 7.5 mg/day by Week 12.
    id
    BG001
    title
    PLACEBO and MMF
  3. description
    Total of all reporting groups
    id
    BG002
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          9.8
          value
          33.1
        2. group Id
          BG001
          spread
          10.1
          value
          31.9
        3. group Id
          BG002
          spread
          9.9
          value
          32.5
      denoms
      1. counts
        1. group Id
          BG000
          value
          63
        2. group Id
          BG001
          value
          62
        3. group Id
          BG002
          value
          125
        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
          55
        2. group Id
          BG001
          value
          51
        3. group Id
          BG002
          value
          106
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          8
        2. group Id
          BG001
          value
          11
        3. group Id
          BG002
          value
          19
        title
        Male
      denoms
      1. counts
        1. group Id
          BG000
          value
          63
        2. group Id
          BG001
          value
          62
        3. group Id
          BG002
          value
          125
        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
          42
        2. group Id
          BG001
          value
          49
        3. group Id
          BG002
          value
          91
        title
        Hispanic Or Latino
      2. measurements
        1. group Id
          BG000
          value
          20
        2. group Id
          BG001
          value
          12
        3. group Id
          BG002
          value
          32
        title
        Not Hispanic Or Latino
      3. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
        title
        Not Stated
      4. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          1
        title
        Unknown
      denoms
      1. counts
        1. group Id
          BG000
          value
          63
        2. group Id
          BG001
          value
          62
        3. group Id
          BG002
          value
          125
        units
        Participants
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race/Ethnicity, Customized
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          11
        2. group Id
          BG001
          value
          17
        3. group Id
          BG002
          value
          28
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          5
        title
        Asian
      3. measurements
        1. group Id
          BG000
          value
          6
        2. group Id
          BG001
          value
          5
        3. group Id
          BG002
          value
          11
        title
        Black or African American
      4. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
        title
        Multiple
      5. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
        title
        Native Hawaiian or other Pacific Islande
      6. measurements
        1. group Id
          BG000
          value
          13
        2. group Id
          BG001
          value
          12
        3. group Id
          BG002
          value
          25
        title
        Unknown
      7. measurements
        1. group Id
          BG000
          value
          28
        2. group Id
          BG001
          value
          26
        3. group Id
          BG002
          value
          54
        title
        White
      denoms
      1. counts
        1. group Id
          BG000
          value
          63
        2. group Id
          BG001
          value
          62
        3. group Id
          BG002
          value
          125
        units
        Participants
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race/Ethnicity, Customized
    unit Of Measure
    Participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          331
          value
          328
        2. group Id
          BG001
          spread
          454
          value
          353
        3. group Id
          BG002
          spread
          395
          value
          341
      denoms
      1. counts
        1. group Id
          BG000
          value
          48
        2. group Id
          BG001
          value
          48
        3. group Id
          BG002
          value
          96
        units
        Participants
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    population Description
    The number analyzed indicates the number of participants with non-missing results at baseline. Values below the level of quantification have been excluded from the analysis.
    title
    Circulating CD19-Positive B-Cell Levels
    unit Of Measure
    cells/uL
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          4
        title
        Asia
      2. measurements
        1. group Id
          BG000
          value
          16
        2. group Id
          BG001
          value
          5
        3. group Id
          BG002
          value
          21
        title
        European Union
      3. measurements
        1. group Id
          BG000
          value
          37
        2. group Id
          BG001
          value
          46
        3. group Id
          BG002
          value
          83
        title
        Latin America
      4. measurements
        1. group Id
          BG000
          value
          7
        2. group Id
          BG001
          value
          8
        3. group Id
          BG002
          value
          15
        title
        United States
      denoms
      1. counts
        1. group Id
          BG000
          value
          62
        2. group Id
          BG001
          value
          61
        3. group Id
          BG002
          value
          123
        units
        Participants
    param Type
    COUNT_OF_PARTICIPANTS
    population Description
    The number analyzed represents the number of patients contributing to summary statistics.
    title
    Region of Enrollment
    unit Of Measure
    Participants
  7. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          14
        2. group Id
          BG001
          value
          17
        3. group Id
          BG002
          value
          31
      denoms
      1. counts
        1. group Id
          BG000
          value
          63
        2. group Id
          BG001
          value
          62
        3. group Id
          BG002
          value
          125
        units
        Participants
      title
      III
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          49
        2. group Id
          BG001
          value
          45
        3. group Id
          BG002
          value
          94
      denoms
      1. counts
        1. group Id
          BG000
          value
          63
        2. group Id
          BG001
          value
          62
        3. group Id
          BG002
          value
          125
        units
        Participants
      title
      IV
    description
    Participants were graded as Class III or Class IV using the classification by the International Society of Nephrology and the Renal Pathology Society (ISN/RPS): Class III Focal LN (\< 50% of glomeruli) III (A): active lesions III (A/C): active and chronic lesions III (C): chronic lesions Class IV Diffuse LN (≥50% glomeruli) Diffuse segmental (IV-S) or global (IV-G) LN IV (A): active lesions IV (A/C): active and chronic lesions IV (C): chronic lesions Stage IV is considered to have worse clinical outcome than stage III.
    param Type
    NUMBER
    title
    Lupus Nephritis (LN) Biopsy Class
    unit Of Measure
    Participants
  8. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          2.66
          value
          3.32
        2. group Id
          BG001
          spread
          2.46
          value
          2.93
        3. group Id
          BG002
          spread
          2.56
          value
          3.12
      denoms
      1. counts
        1. group Id
          BG000
          value
          60
        2. group Id
          BG001
          value
          60
        3. group Id
          BG002
          value
          120
        units
        Participants
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    population Description
    Due to a central lab error, uPCR was not available for the first 5 patients at baseline
    title
    Urine Protein Creatinine Ratio (UPCR)
    unit Of Measure
    mg/mg
  9. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          0.34
          value
          0.87
        2. group Id
          BG001
          spread
          0.32
          value
          0.8
        3. group Id
          BG002
          spread
          0.34
          value
          0.84
      denoms
      1. counts
        1. group Id
          BG000
          value
          63
        2. group Id
          BG001
          value
          62
        3. group Id
          BG002
          value
          125
        units
        Participants
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Serum creatinine
    unit Of Measure
    (mg/dL)

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Preserved source evidence · Not medical advice