NCT02550652 · OUTCOME

Change From Baseline in C4 Levels at Week 52

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: g/L
Interval / dispersion: Standard Deviation
Time frame: Baseline, Week 52

What was measured

Complement C4 is a blood test that reflects activation of complement pathway associated with immune deposition in certain autoimmune diseases.

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

Group	Source count
OBINUTUZUMAB 1000MG and MMF	63
PLACEBO and MMF	62

Reported measurements

Source class 1

Values in g/L · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
OBINUTUZUMAB 1000MG and MMF	0.101	0.117	Not reported	Not reported	Not reported
PLACEBO and MMF	0.004	0.164	Not reported	Not reported	Not reported

Source statistical analyses

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

ci Lower Limit
0.052
ci Pct Value
95
ci Upper Limit
0.124
group Ids
OG000
OG001
non Inferiority Type
SUPERIORITY
p Value
<0.0001
param Type
Difference in Adjusted Mean
param Value
0.088
statistical Comment
Stratified by race (Afro Caribbean/African American vs. Others) and region (US vs. non-US sites).
statistical Method
ANCOVA
ci Lower Limit
0.065
ci Num Sides
TWO_SIDED
ci Pct Value
80
ci Upper Limit
0.112
group Ids
OG000
OG001
non Inferiority Type
SUPERIORITY
p Value
<0.0001
p Value Comment
Stratified by race (Afro Caribbean/African American vs. Others) and region (US vs. non-US sites). Statistically significant at pre-specified alpha of 20%.
param Type
Difference in Adjusted Mean
param Value
0.088
statistical Method
ANCOVA

Complete source fields

analyses

ci Lower Limit
0.052
ci Pct Value
95
ci Upper Limit
0.124
group Ids
OG000
OG001
non Inferiority Type
SUPERIORITY
p Value
<0.0001
param Type
Difference in Adjusted Mean
param Value
0.088
statistical Comment
Stratified by race (Afro Caribbean/African American vs. Others) and region (US vs. non-US sites).
statistical Method
ANCOVA
ci Lower Limit
0.065
ci Num Sides
TWO_SIDED
ci Pct Value
80
ci Upper Limit
0.112
group Ids
OG000
OG001
non Inferiority Type
SUPERIORITY
p Value
<0.0001
p Value Comment
Stratified by race (Afro Caribbean/African American vs. Others) and region (US vs. non-US sites). Statistically significant at pre-specified alpha of 20%.
param Type
Difference in Adjusted Mean
param Value
0.088
statistical Method
ANCOVA

classes

categories
measurements
group Id
OG000
spread
0.117
value
0.101
group Id
OG001
spread
0.164
value
0.004

denoms

counts
group Id
OG000
value
63
group Id
OG001
value
62
units
Participants

description

Complement C4 is a blood test that reflects activation of complement pathway associated with immune deposition in certain autoimmune diseases.

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
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 52

title

Change From Baseline in C4 Levels at Week 52

type

SECONDARY

unit Of Measure

g/L

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

Preserved source evidence · Not medical advice