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NCT04221477 · OUTCOME

Change in Log-transformed Anti-double-stranded Deoxyribonucleic Acid (Anti-dsDNA) Titer

A Study to Evaluate the Efficacy and Safety of Obinutuzumab in Participants With ISN/RPS 2003 Class III or IV Lupus Nephritis · Source last updated 2026-07-21

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure
MEAN
Unit
Log (IU/mL)
Interval / dispersion
Standard Error
Time frame
At Week 50

What was measured

Anti-dsDNA are types of autoantibodies produced by the immune system and are indicators of lupus. Anti-dsDNA data was log-transformed before analysis. Missing data was imputed by multiple imputations using FCS predicted mean matching method. Analysis was performed using ANCOVA. Death was considered as an intercurrent event which was handled under composite strategy by imputing data after death with upper limit of quantification (ULOQ, 890 international units/milliliter \[IU/mL\]). Adjusted mean has been reported.

Analysis population: Efficacy population included all randomized participants regardless of whether they received study drug. As pre-specified in the SAP, all the endpoints were to be compared between the obinutuzumab (combined treatment groups) and placebo groups.

Groups in this outcome

Obinutuzumab

Participants received obinutuzumab, 1000 mg as an IV infusion on Day 1 and Weeks 2, 24, 26, and either Weeks 50 and 52 or Week 52 only, along with MMF and SOC therapy. Placebo was administered at Week 50 for participants not treated with obinutuzumab. Participants with adequate response at Week 76 continued to receive obinutuzumab at Week 80 and Q6M thereafter. The dose of MMF can be adjusted at the investigator's discretion beginning at Week 80.

Placebo

Participants received Obinutuzumab matching placebo as an IV infusion on Day 1 and Weeks 2, 24, 26, 50, and 52. Participants also received SOC therapy and MMF. Participants with adequate response at Week 76 continued to receive placebo at Week 80 and Q6M thereafter.

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

Analysis denominator · Participants

GroupSource count
Obinutuzumab135
Placebo136

Reported measurements

Source class 1
Values in Log (IU/mL) · Interval/dispersion: Standard Error
GroupValueSpreadLowerUpperComment
Obinutuzumab-0.380.100Not reportedNot reportedNot reported
Placebo-0.010.099Not reportedNot reportedNot reported

Source statistical analyses

Group order, estimate direction, methods and comments are retained. No treatment ranking is inferred.

  1. ci Lower Limit
    -0.57
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    -0.16
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.0006
    p Value Comment
    Not type I error controlled.
    param Type
    Difference in Adjusted Means
    param Value
    -0.36
    statistical Method
    ANCOVA
Complete source fields
analyses
  1. ci Lower Limit
    -0.57
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    -0.16
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.0006
    p Value Comment
    Not type I error controlled.
    param Type
    Difference in Adjusted Means
    param Value
    -0.36
    statistical Method
    ANCOVA
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        0.100
        value
        -0.38
      2. group Id
        OG001
        spread
        0.099
        value
        -0.01
denoms
  1. counts
    1. group Id
      OG000
      value
      135
    2. group Id
      OG001
      value
      136
    units
    Participants
description
Anti-dsDNA are types of autoantibodies produced by the immune system and are indicators of lupus. Anti-dsDNA data was log-transformed before analysis. Missing data was imputed by multiple imputations using FCS predicted mean matching method. Analysis was performed using ANCOVA. Death was considered as an intercurrent event which was handled under composite strategy by imputing data after death with upper limit of quantification (ULOQ, 890 international units/milliliter \[IU/mL\]). Adjusted mean has been reported.
dispersion Type
Standard Error
groups
  1. description
    Participants received obinutuzumab, 1000 mg as an IV infusion on Day 1 and Weeks 2, 24, 26, and either Weeks 50 and 52 or Week 52 only, along with MMF and SOC therapy. Placebo was administered at Week 50 for participants not treated with obinutuzumab. Participants with adequate response at Week 76 continued to receive obinutuzumab at Week 80 and Q6M thereafter. The dose of MMF can be adjusted at the investigator's discretion beginning at Week 80.
    id
    OG000
    title
    Obinutuzumab
  2. description
    Participants received Obinutuzumab matching placebo as an IV infusion on Day 1 and Weeks 2, 24, 26, 50, and 52. Participants also received SOC therapy and MMF. Participants with adequate response at Week 76 continued to receive placebo at Week 80 and Q6M thereafter.
    id
    OG001
    title
    Placebo
param Type
MEAN
population Description
Efficacy population included all randomized participants regardless of whether they received study drug. As pre-specified in the SAP, all the endpoints were to be compared between the obinutuzumab (combined treatment groups) and placebo groups.
reporting Status
POSTED
time Frame
At Week 50
title
Change in Log-transformed Anti-double-stranded Deoxyribonucleic Acid (Anti-dsDNA) Titer
type
SECONDARY
unit Of Measure
Log (IU/mL)

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

Preserved source evidence · Not medical advice