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NCT02550652 · OUTCOME

Maximum Observed Plasma Concentration (Cmax) of Obinutuzumab

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
ug/mL
Interval / dispersion
Standard Deviation
Time frame
Week 0, Week 24, Week 52

Analysis population: Pharmacokinetic population included all patients randomized to and received any dose of obinutuzumab given as study medication.

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.

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

Reported measurements

Week 0-24
Values in ug/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
OBINUTUZUMAB 1000MG and MMF559112Not reportedNot reportedNot reported
Week 24-52
Values in ug/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
OBINUTUZUMAB 1000MG and MMF605115Not reportedNot reportedNot reported
Week 0-52
Values in ug/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
OBINUTUZUMAB 1000MG and MMF605115Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        112
        value
        559
    title
    Week 0-24
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        115
        value
        605
    title
    Week 24-52
  3. categories
    1. measurements
      1. group Id
        OG000
        spread
        115
        value
        605
    title
    Week 0-52
denoms
  1. counts
    1. group Id
      OG000
      value
      63
    units
    Participants
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
param Type
MEAN
population Description
Pharmacokinetic population included all patients randomized to and received any dose of obinutuzumab given as study medication.
reporting Status
POSTED
time Frame
Week 0, Week 24, Week 52
title
Maximum Observed Plasma Concentration (Cmax) of Obinutuzumab
type
SECONDARY
unit Of Measure
ug/mL

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

Preserved source evidence · Not medical advice