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NCT02550652 · OUTCOME

Percent Change From Baseline in Circulating CD19-Positive B-Cell Levels

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.

Measure
MEAN
Unit
Percent change of cells/uL
Interval / dispersion
Standard Deviation
Time frame
Baseline, Week 2, Week 4, Week 12, Week 24, Week 52, Week 104, B Cell Follow-Up (Bcfu) at months 6, 12, 18, 24, 30, 36, 42 and 48

What was measured

CD19+ B cell is a B-lymphocyte with a transmembrane protein that is encoded by the gene CD19.

Analysis population: Modified intent-to-treat population will include all randomized participants who have received any amount of study drug. Participants who received an incorrect therapy were reported under the treatment arm to which they were randomized.

Groups in this outcome

OBINUTUZUMAB 1000MG and MMF

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.

PLACEBO and MMF

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.

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
OBINUTUZUMAB 1000MG and MMF63
PLACEBO and MMF62

Reported measurements

Week 2

Analysis denominator · Participants

GroupSource count
OBINUTUZUMAB 1000MG and MMF39
PLACEBO and MMF42
Values in Percent change of cells/uL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
OBINUTUZUMAB 1000MG and MMF-97.46912.899Not reportedNot reportedNot reported
PLACEBO and MMF39.293145.247Not reportedNot reportedNot reported
Week 4

Analysis denominator · Participants

GroupSource count
OBINUTUZUMAB 1000MG and MMF45
PLACEBO and MMF36
Values in Percent change of cells/uL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
OBINUTUZUMAB 1000MG and MMF-98.7775.235Not reportedNot reportedNot reported
PLACEBO and MMF-5.18678.469Not reportedNot reportedNot reported
Week 12

Analysis denominator · Participants

GroupSource count
OBINUTUZUMAB 1000MG and MMF41
PLACEBO and MMF45
Values in Percent change of cells/uL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
OBINUTUZUMAB 1000MG and MMF-97.04515.506Not reportedNot reportedNot reported
PLACEBO and MMF0.661134.421Not reportedNot reportedNot reported
Week 24

Analysis denominator · Participants

GroupSource count
OBINUTUZUMAB 1000MG and MMF42
PLACEBO and MMF37
Values in Percent change of cells/uL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
OBINUTUZUMAB 1000MG and MMF-96.62810.207Not reportedNot reportedNot reported
PLACEBO and MMF-11.44686.793Not reportedNot reportedNot reported
Week 52

Analysis denominator · Participants

GroupSource count
OBINUTUZUMAB 1000MG and MMF39
PLACEBO and MMF42
Values in Percent change of cells/uL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
OBINUTUZUMAB 1000MG and MMF-98.6205.677Not reportedNot reportedNot reported
PLACEBO and MMF37.695220.857Not reportedNot reportedNot reported
Week 104

Analysis denominator · Participants

GroupSource count
OBINUTUZUMAB 1000MG and MMF5
PLACEBO and MMF2
Values in Percent change of cells/uL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
OBINUTUZUMAB 1000MG and MMF77.123380.111Not reportedNot reportedNot reported
PLACEBO and MMF-76.05531.519Not reportedNot reportedNot reported
Bcfu Month 6

Analysis denominator · Participants

GroupSource count
OBINUTUZUMAB 1000MG and MMF13
PLACEBO and MMF5
Values in Percent change of cells/uL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
OBINUTUZUMAB 1000MG and MMF105.043402.281Not reportedNot reportedNot reported
PLACEBO and MMF-73.88919.755Not reportedNot reportedNot reported
Bcfu Month 12

Analysis denominator · Participants

GroupSource count
OBINUTUZUMAB 1000MG and MMF5
PLACEBO and MMF2
Values in Percent change of cells/uL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
OBINUTUZUMAB 1000MG and MMF77.123380.111Not reportedNot reportedNot reported
PLACEBO and MMF-76.05531.519Not reportedNot reportedNot reported
Bcfu Month 18

Analysis denominator · Participants

GroupSource count
OBINUTUZUMAB 1000MG and MMF3
PLACEBO and MMF1
Values in Percent change of cells/uL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
OBINUTUZUMAB 1000MG and MMF-83.15916.701Not reportedNot reportedNot reported
PLACEBO and MMF-11.418NANot reportedNot reportedThe standard deviation could not be derived from the data of 1 participant.
Bcfu Month 24

Analysis denominator · Participants

GroupSource count
OBINUTUZUMAB 1000MG and MMF2
PLACEBO and MMF0
Values in Percent change of cells/uL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
OBINUTUZUMAB 1000MG and MMF-93.6038.836Not reportedNot reportedNot reported
Bcfu Month 30

Analysis denominator · Participants

GroupSource count
OBINUTUZUMAB 1000MG and MMF3
PLACEBO and MMF0
Values in Percent change of cells/uL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
OBINUTUZUMAB 1000MG and MMF-59.95050.807Not reportedNot reportedNot reported
Bcfu Month 36

Analysis denominator · Participants

GroupSource count
OBINUTUZUMAB 1000MG and MMF2
PLACEBO and MMF0
Values in Percent change of cells/uL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
OBINUTUZUMAB 1000MG and MMF-99.1630.973Not reportedNot reportedNot reported
Bcfu Month 42

Analysis denominator · Participants

GroupSource count
OBINUTUZUMAB 1000MG and MMF1
PLACEBO and MMF0
Values in Percent change of cells/uL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
OBINUTUZUMAB 1000MG and MMF-99.084NANot reportedNot reportedThe standard deviation could not be derived from the data of 1 participant.
Bcfu Month 48

Analysis denominator · Participants

GroupSource count
OBINUTUZUMAB 1000MG and MMF1
PLACEBO and MMF0
Values in Percent change of cells/uL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
OBINUTUZUMAB 1000MG and MMF-99.851NANot reportedNot reportedThe standard deviation could not be derived from the data of 1 participant.
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        12.899
        value
        -97.469
      2. group Id
        OG001
        spread
        145.247
        value
        39.293
    denoms
    1. counts
      1. group Id
        OG000
        value
        39
      2. group Id
        OG001
        value
        42
      units
      Participants
    title
    Week 2
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        5.235
        value
        -98.777
      2. group Id
        OG001
        spread
        78.469
        value
        -5.186
    denoms
    1. counts
      1. group Id
        OG000
        value
        45
      2. group Id
        OG001
        value
        36
      units
      Participants
    title
    Week 4
  3. categories
    1. measurements
      1. group Id
        OG000
        spread
        15.506
        value
        -97.045
      2. group Id
        OG001
        spread
        134.421
        value
        0.661
    denoms
    1. counts
      1. group Id
        OG000
        value
        41
      2. group Id
        OG001
        value
        45
      units
      Participants
    title
    Week 12
  4. categories
    1. measurements
      1. group Id
        OG000
        spread
        10.207
        value
        -96.628
      2. group Id
        OG001
        spread
        86.793
        value
        -11.446
    denoms
    1. counts
      1. group Id
        OG000
        value
        42
      2. group Id
        OG001
        value
        37
      units
      Participants
    title
    Week 24
  5. categories
    1. measurements
      1. group Id
        OG000
        spread
        5.677
        value
        -98.620
      2. group Id
        OG001
        spread
        220.857
        value
        37.695
    denoms
    1. counts
      1. group Id
        OG000
        value
        39
      2. group Id
        OG001
        value
        42
      units
      Participants
    title
    Week 52
  6. categories
    1. measurements
      1. group Id
        OG000
        spread
        380.111
        value
        77.123
      2. group Id
        OG001
        spread
        31.519
        value
        -76.055
    denoms
    1. counts
      1. group Id
        OG000
        value
        5
      2. group Id
        OG001
        value
        2
      units
      Participants
    title
    Week 104
  7. categories
    1. measurements
      1. group Id
        OG000
        spread
        402.281
        value
        105.043
      2. group Id
        OG001
        spread
        19.755
        value
        -73.889
    denoms
    1. counts
      1. group Id
        OG000
        value
        13
      2. group Id
        OG001
        value
        5
      units
      Participants
    title
    Bcfu Month 6
  8. categories
    1. measurements
      1. group Id
        OG000
        spread
        380.111
        value
        77.123
      2. group Id
        OG001
        spread
        31.519
        value
        -76.055
    denoms
    1. counts
      1. group Id
        OG000
        value
        5
      2. group Id
        OG001
        value
        2
      units
      Participants
    title
    Bcfu Month 12
  9. categories
    1. measurements
      1. group Id
        OG000
        spread
        16.701
        value
        -83.159
      2. comment
        The standard deviation could not be derived from the data of 1 participant.
        group Id
        OG001
        spread
        NA
        value
        -11.418
    denoms
    1. counts
      1. group Id
        OG000
        value
        3
      2. group Id
        OG001
        value
        1
      units
      Participants
    title
    Bcfu Month 18
  10. categories
    1. measurements
      1. group Id
        OG000
        spread
        8.836
        value
        -93.603
    denoms
    1. counts
      1. group Id
        OG000
        value
        2
      2. group Id
        OG001
        value
        0
      units
      Participants
    title
    Bcfu Month 24
  11. categories
    1. measurements
      1. group Id
        OG000
        spread
        50.807
        value
        -59.950
    denoms
    1. counts
      1. group Id
        OG000
        value
        3
      2. group Id
        OG001
        value
        0
      units
      Participants
    title
    Bcfu Month 30
  12. categories
    1. measurements
      1. group Id
        OG000
        spread
        0.973
        value
        -99.163
    denoms
    1. counts
      1. group Id
        OG000
        value
        2
      2. group Id
        OG001
        value
        0
      units
      Participants
    title
    Bcfu Month 36
denoms
  1. counts
    1. group Id
      OG000
      value
      63
    2. group Id
      OG001
      value
      62
    units
    Participants
description
CD19+ B cell is a B-lymphocyte with a transmembrane protein that is encoded by the gene CD19.
dispersion Type
Standard Deviation
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
    OG000
    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
    OG001
    title
    PLACEBO and MMF
param Type
MEAN
population Description
Modified intent-to-treat population will include all randomized participants who have received any amount of study drug. Participants who received an incorrect therapy were reported under the treatment arm to which they were randomized.
reporting Status
POSTED
time Frame
Baseline, Week 2, Week 4, Week 12, Week 24, Week 52, Week 104, B Cell Follow-Up (Bcfu) at months 6, 12, 18, 24, 30, 36, 42 and 48
title
Percent Change From Baseline in Circulating CD19-Positive B-Cell Levels
type
SECONDARY
unit Of Measure
Percent change of cells/uL

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

Preserved source evidence · Not medical advice