NCT02550652 · OUTCOME

Area Under the Plasma Concentration Versus Time Curve (AUC) 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*day
Interval / dispersion: Standard Deviation
Time frame: Baseline to 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

Group	Source count
OBINUTUZUMAB 1000MG and MMF	63

Reported measurements

Week 0-24

Values in ug/mL*day · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
OBINUTUZUMAB 1000MG and MMF	10595	4016	Not reported	Not reported	Not reported

Week 24-52

Values in ug/mL*day · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
OBINUTUZUMAB 1000MG and MMF	15811	5543	Not reported	Not reported	Not reported

Week 0-52

Values in ug/mL*day · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
OBINUTUZUMAB 1000MG and MMF	26406	9027	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
spread
4016
value
10595
title
Week 0-24
categories
measurements
group Id
OG000
spread
5543
value
15811
title
Week 24-52
categories
measurements
group Id
OG000
spread
9027
value
26406
title
Week 0-52

denoms

counts
group Id
OG000
value
63
units
Participants

dispersion Type

Standard Deviation

groups

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

Baseline to Week 52

title

Area Under the Plasma Concentration Versus Time Curve (AUC) of Obinutuzumab

type

SECONDARY

unit Of Measure

ug/mL*day

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

Preserved source evidence · Not medical advice