NCT02550652 · OUTCOME

Percentage of Participants Who Achieve Protocol Defined Overall Response (OR) 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: COUNT_OF_PARTICIPANTS
Unit: Participants
Interval / dispersion: Not reported
Time frame: From baseline to Week 52

What was measured

OR includes both CRR and partial renal response (PRR). CRR as defined in the primary outcome measure above. PRR defined as 50% improvement in urine protein:creatinine ratio, with one of following conditions met: 1. If baseline urine protein:creatinine ratio is ≤ 3.0, then urine protein:creatinine ratio of \<1.0. 2. If baseline protein:creatinine ratio is \> 3.0, then urine protein:creatinine ratio of \<3.0, serum creatinine ≤15% above baseline value, and no urinary red cell casts and either RBCs/HPF ≤50% above baseline or \<10 RBCs/HPF.

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 Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
OBINUTUZUMAB 1000MG and MMF	35	Not reported	Not reported	Not reported	Not reported
PLACEBO and MMF	22	Not reported	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
3.0
ci Pct Value
95
ci Upper Limit
37.2
group Ids
OG000
OG001
non Inferiority Type
SUPERIORITY
p Value
0.0246
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 Percentage of Participants
param Value
20.1
statistical Method
Cochran-Mantel-Haenszel
ci Lower Limit
8.9
ci Num Sides
TWO_SIDED
ci Pct Value
80
ci Upper Limit
31.3
group Ids
OG000
OG001
non Inferiority Type
SUPERIORITY
p Value
0.0246
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 Percentage of Participants
param Value
20.1
statistical Method
Cochran-Mantel-Haenszel

Complete source fields

analyses

ci Lower Limit
3.0
ci Pct Value
95
ci Upper Limit
37.2
group Ids
OG000
OG001
non Inferiority Type
SUPERIORITY
p Value
0.0246
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 Percentage of Participants
param Value
20.1
statistical Method
Cochran-Mantel-Haenszel
ci Lower Limit
8.9
ci Num Sides
TWO_SIDED
ci Pct Value
80
ci Upper Limit
31.3
group Ids
OG000
OG001
non Inferiority Type
SUPERIORITY
p Value
0.0246
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 Percentage of Participants
param Value
20.1
statistical Method
Cochran-Mantel-Haenszel

classes

categories
measurements
group Id
OG000
value
35
group Id
OG001
value
22

denoms

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

description

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

COUNT_OF_PARTICIPANTS

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

From baseline to Week 52

title

Percentage of Participants Who Achieve Protocol Defined Overall Response (OR) at Week 52

type

SECONDARY

unit Of Measure

Participants

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Preserved source evidence · Not medical advice