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A Study to Evaluate the Safety and Efficacy of Obinutuzumab Compared With Placebo in Participants With Lupus Nephritis (LN)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02550652
Recruitment Status : Active, not recruiting
First Posted : September 15, 2015
Results First Posted : February 26, 2020
Last Update Posted : April 1, 2020
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Lupus Nephritis
Interventions Drug: Mycophenolate Mofetil/Mycophenolic Acid
Drug: Obinutuzumab
Other: Placebo
Drug: Methylprednisolone
Drug: Prednisone
Enrollment 126
Recruitment Details  
Pre-assignment Details A total of 126 patients were enrolled in the study however one patient randomized to obinutuzumab did not receive study treatment due to a positive pregnancy test, but prior to the first study drug infusion; therefore a total of 125 patients are included in the analysis.
Arm/Group Title OBINUTUZUMAB 1000MG and MMF PLACEBO and MMF
Hide Arm/Group Description Participants will receive 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 will be up titrated to a target dose of 2.0 - 2.5 grams per day (g/day) (or equivalent). Investigators, at their discretion, may 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 may receive 750-1000 mg methylprednisolone IV once daily for up to 3 days to treat underlying LN clinical activity. Participants will receive 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. Participants will receive 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 will be up titrated to a target dose of 2.0 - 2.5 g/day (or equivalent). Investigators, at their discretion, may 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 may receive 750-1000 mg methylprednisolone IV once daily for up to 3 days to treat underlying LN clinical activity. Participants will receive 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.
Period Title: Overall Study
Started 63 62
Completed 0 0
Not Completed 63 62
Reason Not Completed
Death             0             2
Lack of Efficacy             1             0
Withdrawal by Subject             3             4
Ongoing in study             59             56
Arm/Group Title OBINUTUZUMAB 1000MG and MMF PLACEBO and MMF Total
Hide Arm/Group Description Participants will receive 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 will be up titrated to a target dose of 2.0 - 2.5 grams per day (g/day) (or equivalent). Investigators, at their discretion, may 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 may receive 750-1000 mg methylprednisolone IV once daily for up to 3 days to treat underlying LN clinical activity. Participants will receive 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. Participants will receive 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 will be up titrated to a target dose of 2.0 - 2.5 g/day (or equivalent). Investigators, at their discretion, may 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 may receive 750-1000 mg methylprednisolone IV once daily for up to 3 days to treat underlying LN clinical activity. Participants will receive 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. Total of all reporting groups
Overall Number of Baseline Participants 63 62 125
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 63 participants 62 participants 125 participants
33.1  (9.8) 31.9  (10.1) 32.5  (9.9)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 63 participants 62 participants 125 participants
Female
55
  87.3%
51
  82.3%
106
  84.8%
Male
8
  12.7%
11
  17.7%
19
  15.2%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 63 participants 62 participants 125 participants
Hispanic Or Latino
42
  66.7%
49
  79.0%
91
  72.8%
Not Hispanic Or Latino
20
  31.7%
12
  19.4%
32
  25.6%
Not Stated
1
   1.6%
0
   0.0%
1
   0.8%
Unknown
0
   0.0%
1
   1.6%
1
   0.8%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 63 participants 62 participants 125 participants
American Indian or Alaska Native
11
  17.5%
17
  27.4%
28
  22.4%
Asian
3
   4.8%
2
   3.2%
5
   4.0%
Black or African American
6
   9.5%
5
   8.1%
11
   8.8%
Multiple
1
   1.6%
0
   0.0%
1
   0.8%
Native Hawaiian or other Pacific Islande
1
   1.6%
0
   0.0%
1
   0.8%
Unknown
13
  20.6%
12
  19.4%
25
  20.0%
White
28
  44.4%
26
  41.9%
54
  43.2%
Circulating CD19-Positive B-Cell Levels   [1] 
Mean (Standard Deviation)
Unit of measure:  cells/uL
Number Analyzed 48 participants 48 participants 96 participants
327.902  (330.562) 353.499  (454.165) 340.701  (395.314)
[1]
Measure Analysis Population Description: The number analyzed indicates the number of participants with non-missing results at baseline. Values below the level of quantification have been excluded from the analysis.
Region of Enrollment   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 62 participants 61 participants 123 participants
Asia
2
   3.2%
2
   3.3%
4
   3.3%
European Union
16
  25.8%
5
   8.2%
21
  17.1%
Latin America
37
  59.7%
46
  75.4%
83
  67.5%
United States
7
  11.3%
8
  13.1%
15
  12.2%
[1]
Measure Analysis Population Description: The number analyzed represents the number of patients contributing to summary statistics.
1.Primary Outcome
Title Percentage of Participants Who Achieve Protocol Defined Complete Renal Response (CRR) at Week 52
Hide Description Percentage of participants with normalization of serum creatinine, inactive urinary sediment (as evidenced by < 10 red blood cells (RBCs)/high-power field (HPF) and the absence of red cell casts) and urinary protein to creatinine ratio < 0.5. Normalization of serum creatinine is defined as serum creatinine ≤ the upper limit of normal (ULN) range of central laboratory values if baseline (Day 1) serum creatinine is above the ULN or serum creatinine ≤ 15% above baseline and ≤ the ULN range of central laboratory values if baseline (Day 1) serum creatinine is ≤ the ULN range of central laboratory values.
Time Frame From baseline to Week 52
Hide Outcome Measure Data
Hide Analysis 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.
Arm/Group Title OBINUTUZUMAB 1000MG and MMF PLACEBO and MMF
Hide Arm/Group Description:
Participants will receive 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 will be up titrated to a target dose of 2.0 - 2.5 grams per day (g/day) (or equivalent). Investigators, at their discretion, may 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 may receive 750-1000 mg methylprednisolone IV once daily for up to 3 days to treat underlying LN clinical activity. Participants will receive 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.
Participants will receive 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 will be up titrated to a target dose of 2.0 - 2.5 g/day (or equivalent). Investigators, at their discretion, may 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 may receive 750-1000 mg methylprednisolone IV once daily for up to 3 days to treat underlying LN clinical activity. Participants will receive 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.
Overall Number of Participants Analyzed 63 62
Measure Type: Number
Unit of Measure: percentage of participants
34.9 22.6
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection OBINUTUZUMAB 1000MG and MMF, PLACEBO and MMF
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1145
Comments Stratified by race (Afro Caribbean/African American vs. Others) and region (US vs. non-US sites).
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Percentage of Participants
Estimated Value 12.3
Confidence Interval (2-Sided) 95%
-3.4 to 28.1
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Percentage of Participants Who Achieve Protocol Defined Overall Response (OR) at Week 52
Hide Description 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.
Time Frame From baseline to Week 52
Hide Outcome Measure Data
Hide Analysis 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.
Arm/Group Title OBINUTUZUMAB 1000MG and MMF PLACEBO and MMF
Hide Arm/Group Description:
Participants will receive 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 will be up titrated to a target dose of 2.0 - 2.5 grams per day (g/day) (or equivalent). Investigators, at their discretion, may 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 may receive 750-1000 mg methylprednisolone IV once daily for up to 3 days to treat underlying LN clinical activity. Participants will receive 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.
Participants will receive 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 will be up titrated to a target dose of 2.0 - 2.5 g/day (or equivalent). Investigators, at their discretion, may 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 may receive 750-1000 mg methylprednisolone IV once daily for up to 3 days to treat underlying LN clinical activity. Participants will receive 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.
Overall Number of Participants Analyzed 63 62
Measure Type: Number
Unit of Measure: percentage of participants
55.6 35.5
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection OBINUTUZUMAB 1000MG and MMF, PLACEBO and MMF
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0246
Comments Stratified by race (Afro Caribbean/African American vs. Others) and region (US vs. non-US sites).
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Percentage of Participants
Estimated Value 20.1
Confidence Interval 95%
3.0 to 37.2
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Percentage of Participants With First Protocol Defined Overall Response Over the Course of 52 Weeks
Hide Description OR includes both CRR and partial renal response(PRR). CRR as defined in the primary outcome measure above. PRR defined as 50% improvement in upcr, with one of these conditions met: 1. If baseline upcr is ≤3.0, then upcr of <1.0. 2. If baseline pcr is > 3.0, then upcr 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. Percentage of participants with response at various time points were measured using Kaplan Meier method.
Time Frame From baseline to Week 52 (up to approximately 38 months)
Hide Outcome Measure Data
Hide Analysis 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.
Arm/Group Title OBINUTUZUMAB 1000MG and MMF PLACEBO and MMF
Hide Arm/Group Description:
Participants will receive 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 will be up titrated to a target dose of 2.0 - 2.5 grams per day (g/day) (or equivalent). Investigators, at their discretion, may 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 may receive 750-1000 mg methylprednisolone IV once daily for up to 3 days to treat underlying LN clinical activity. Participants will receive 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.
Participants will receive 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 will be up titrated to a target dose of 2.0 - 2.5 g/day (or equivalent). Investigators, at their discretion, may 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 may receive 750-1000 mg methylprednisolone IV once daily for up to 3 days to treat underlying LN clinical activity. Participants will receive 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.
Overall Number of Participants Analyzed 63 62
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
Week 12 Number Analyzed 56 participants 60 participants
26
(15 to 37)
19
(10 to 29)
Week 24 Number Analyzed 33 participants 39 participants
57
(45 to 70)
41
(28 to 53)
Week 36 Number Analyzed 23 participants 30 participants
63
(50 to 75)
51
(38 to 64)
Week 52 Number Analyzed 13 participants 20 participants
75
(64 to 86)
58
(45 to 71)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection OBINUTUZUMAB 1000MG and MMF, PLACEBO and MMF
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0537
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
4.Secondary Outcome
Title Percentage of Participants Who Achieve Protocol Defined Partial Renal Response (PRR) at Week 52
Hide Description PRR defined as serum creatinine ≤15% above baseline value, no urinary red cell casts and either RBCs/HPF ≤ 50% above baseline or < 10 RBCs/HPF, 50% improvement in urine protein:creatinine ratio, with one of following conditions met: 1. If baseline urine protein:creatinine ratio is ≤ 3.0, then a urine protein:creatinine ratio of < 1.0. 2. If baseline protein:creatinine ratio is > 3.0, then a urine protein:creatinine ratio of < 3.0.
Time Frame From baseline to Week 52
Hide Outcome Measure Data
Hide Analysis 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.
Arm/Group Title OBINUTUZUMAB 1000MG and MMF PLACEBO and MMF
Hide Arm/Group Description:
Participants will receive 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 will be up titrated to a target dose of 2.0 - 2.5 grams per day (g/day) (or equivalent). Investigators, at their discretion, may 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 may receive 750-1000 mg methylprednisolone IV once daily for up to 3 days to treat underlying LN clinical activity. Participants will receive 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.
Participants will receive 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 will be up titrated to a target dose of 2.0 - 2.5 g/day (or equivalent). Investigators, at their discretion, may 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 may receive 750-1000 mg methylprednisolone IV once daily for up to 3 days to treat underlying LN clinical activity. Participants will receive 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.
Overall Number of Participants Analyzed 63 62
Measure Type: Number
Unit of Measure: percentage of participants
55.6 33.9
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection OBINUTUZUMAB 1000MG and MMF, PLACEBO and MMF
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0150
Comments Stratified by race (Afro Caribbean/African American vs. Others) and region (US vs. non-US sites).
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Percentage of Participants
Estimated Value 21.7
Confidence Interval 95%
4.7 to 38.7
Estimation Comments [Not Specified]
5.Secondary Outcome
Title Percentage of Participants Who Achieve Protocol Defined CRR at Week 24
Hide Description CRR defined as normalization of serum creatinine, inactive urinary sediment (as evidenced by < 10 red blood cells (RBCs)/high-power field (HPF) and the absence of red cell casts) and urinary protein to creatinine ratio < 0.5. Normalization of serum creatinine is defined as serum creatinine ≤ the upper limit of normal (ULN) range of central laboratory values if baseline (Day 1) serum creatinine is above the ULN or serum creatinine ≤ 15% above baseline and ≤ the ULN range of central laboratory values if baseline (Day 1) serum creatinine is ≤ the ULN range of central laboratory values.
Time Frame Week 24
Hide Outcome Measure Data
Hide Analysis 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.
Arm/Group Title OBINUTUZUMAB 1000MG and MMF PLACEBO and MMF
Hide Arm/Group Description:
Participants will receive 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 will be up titrated to a target dose of 2.0 - 2.5 grams per day (g/day) (or equivalent). Investigators, at their discretion, may 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 may receive 750-1000 mg methylprednisolone IV once daily for up to 3 days to treat underlying LN clinical activity. Participants will receive 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.
Participants will receive 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 will be up titrated to a target dose of 2.0 - 2.5 g/day (or equivalent). Investigators, at their discretion, may 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 may receive 750-1000 mg methylprednisolone IV once daily for up to 3 days to treat underlying LN clinical activity. Participants will receive 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.
Overall Number of Participants Analyzed 63 62
Measure Type: Number
Unit of Measure: percentage of participants
23.8 24.2
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection OBINUTUZUMAB 1000MG and MMF, PLACEBO and MMF
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.9833
Comments Stratified by race (Afro Caribbean/African American vs. Others) and region (US vs. non-US sites).
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Percentage of Participants
Estimated Value 11.5
Confidence Interval (2-Sided) 95%
-15.4 to 14.6
Estimation Comments [Not Specified]
6.Secondary Outcome
Title Percentage of Participants With First Protocol Defined CRR Over the Course of 52 Weeks
Hide Description CRR included normalization of serum creatinine, inactive urinary sediment (as evidenced by < 10 RBCs/HPF and the absence of red cell casts) and urinary protein to creatinine ratio < 0.5. Normalization of serum creatinine is defined as serum creatinine ≤ the ULN range of central laboratory values if baseline serum creatinine is above the ULN or serum creatinine ≤ 15% above baseline and ≤ the ULN range of central laboratory values if baseline (Day 1) serum creatinine is ≤ the ULN range of central laboratory values. Percentage of participants with response at various time points were measured using Kaplan Meier method.
Time Frame From Baseline to Week 52
Hide Outcome Measure Data
Hide Analysis 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.
Arm/Group Title OBINUTUZUMAB 1000MG and MMF PLACEBO and MMF
Hide Arm/Group Description:
Participants will receive 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 will be up titrated to a target dose of 2.0 - 2.5 grams per day (g/day) (or equivalent). Investigators, at their discretion, may 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 may receive 750-1000 mg methylprednisolone IV once daily for up to 3 days to treat underlying LN clinical activity. Participants will receive 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.
Participants will receive 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 will be up titrated to a target dose of 2.0 - 2.5 g/day (or equivalent). Investigators, at their discretion, may 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 may receive 750-1000 mg methylprednisolone IV once daily for up to 3 days to treat underlying LN clinical activity. Participants will receive 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.
Overall Number of Participants Analyzed 63 62
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
Week 12 Number Analyzed 61 participants 61 participants
10
(2 to 17)
10
(2 to 17)
Week 24 Number Analyzed 48 participants 50 participants
26
(15 to 37)
28
(16 to 39)
Week 36 Number Analyzed 39 participants 39 participants
36
(24 to 48)
35
(23 to 47)
Week 52 Number Analyzed 26 participants 32 participants
50
(37 to 63)
40
(28 to 53)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection OBINUTUZUMAB 1000MG and MMF, PLACEBO and MMF
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2516
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
7.Secondary Outcome
Title Change From Baseline in Anti-Double Stranded Deoxyribonucleic Acid (Anti-dsDNA) Antibody Levels at Week 52
Hide Description Anti-dsDNA antibodies are a group of anti-nuclear antibodies targeting double stranded DNA.
Time Frame Baseline and Week 52
Hide Outcome Measure Data
Hide Analysis 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.
Arm/Group Title OBINUTUZUMAB 1000MG and MMF PLACEBO and MMF
Hide Arm/Group Description:
Participants will receive 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 will be up titrated to a target dose of 2.0 - 2.5 grams per day (g/day) (or equivalent). Investigators, at their discretion, may 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 may receive 750-1000 mg methylprednisolone IV once daily for up to 3 days to treat underlying LN clinical activity. Participants will receive 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.
Participants will receive 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 will be up titrated to a target dose of 2.0 - 2.5 g/day (or equivalent). Investigators, at their discretion, may 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 may receive 750-1000 mg methylprednisolone IV once daily for up to 3 days to treat underlying LN clinical activity. Participants will receive 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.
Overall Number of Participants Analyzed 63 62
Mean (Standard Deviation)
Unit of Measure: log IU/mL
-0.863  (1.157) -0.140  (1.125)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection OBINUTUZUMAB 1000MG and MMF, PLACEBO and MMF
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method ANCOVA
Comments Stratified by race (Afro Caribbean/African American vs. Others) and region (US vs. non-US sites).
Method of Estimation Estimation Parameter Difference in Adjusted Mean
Estimated Value -0.811
Confidence Interval (2-Sided) 95%
-1.142 to -0.48
Estimation Comments [Not Specified]
8.Secondary Outcome
Title Change From Baseline in Complement Component 3 (C3) Levels at Week 52
Hide Description Complement C3 is a blood test that reflects activation of complement pathway associated with immune deposition in certain autoimmune diseases.
Time Frame Baseline and Week 52
Hide Outcome Measure Data
Hide Analysis 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.
Arm/Group Title OBINUTUZUMAB 1000MG and MMF PLACEBO and MMF
Hide Arm/Group Description:
Participants will receive 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 will be up titrated to a target dose of 2.0 - 2.5 grams per day (g/day) (or equivalent). Investigators, at their discretion, may 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 may receive 750-1000 mg methylprednisolone IV once daily for up to 3 days to treat underlying LN clinical activity. Participants will receive 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.
Participants will receive 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 will be up titrated to a target dose of 2.0 - 2.5 g/day (or equivalent). Investigators, at their discretion, may 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 may receive 750-1000 mg methylprednisolone IV once daily for up to 3 days to treat underlying LN clinical activity. Participants will receive 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.
Overall Number of Participants Analyzed 63 62
Mean (Standard Deviation)
Unit of Measure: g/L
0.318  (0.295) 0.111  (0.265)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection OBINUTUZUMAB 1000MG and MMF, PLACEBO and MMF
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0002
Comments [Not Specified]
Method ANCOVA
Comments Stratified by race (Afro Caribbean/African American vs. Others) and region (US vs. non-US sites).
Method of Estimation Estimation Parameter Difference in Adjusted Mean
Estimated Value 0.178
Confidence Interval (2-Sided) 95%
0.086 to 0.27
Estimation Comments [Not Specified]
9.Secondary Outcome
Title Change From Baseline in C4 Levels at Week 52
Hide Description Complement C4 is a blood test that reflects activation of complement pathway associated with immune deposition in certain autoimmune diseases.
Time Frame Baseline, Week 52
Hide Outcome Measure Data
Hide Analysis 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.
Arm/Group Title OBINUTUZUMAB 1000MG and MMF PLACEBO and MMF
Hide Arm/Group Description:
Participants will receive 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 will be up titrated to a target dose of 2.0 - 2.5 grams per day (g/day) (or equivalent). Investigators, at their discretion, may 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 may receive 750-1000 mg methylprednisolone IV once daily for up to 3 days to treat underlying LN clinical activity. Participants will receive 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.
Participants will receive 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 will be up titrated to a target dose of 2.0 - 2.5 g/day (or equivalent). Investigators, at their discretion, may 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 may receive 750-1000 mg methylprednisolone IV once daily for up to 3 days to treat underlying LN clinical activity. Participants will receive 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.
Overall Number of Participants Analyzed 63 62
Mean (Standard Deviation)
Unit of Measure: g/L
0.099  (0.098) 0.004  (0.164)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection OBINUTUZUMAB 1000MG and MMF, PLACEBO and MMF
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method ANCOVA
Comments Stratified by race (Afro Caribbean/African American vs. Others) and region (US vs. non-US sites).
Method of Estimation Estimation Parameter Difference in Adjusted Mean
Estimated Value 0.085
Confidence Interval 95%
0.053 to 0.117
Estimation Comments [Not Specified]
10.Secondary Outcome
Title Percentage of Participants Who Achieve Protocol Defined Modified CRR (mCRR1) at Week 52
Hide Description mCRR1 has got two components only, i.e. serum Creatinine and urinary protein to creatinine ratio. mCRR1 is defined by attainment of normalization of serum creatinine as evidenced by 1.) serum creatinine ≤ the ULN range of central laboratory values if baseline (Day 1) serum creatinine is above the ULN or serum creatinine ≤15% above baseline and ≤ the ULN range of central laboratory values if baseline (Day 1) serum creatinine ≤ the ULN range of central laboratory values and 2.) Urinary protein to creatinine ratio <0.5.
Time Frame Week 52
Hide Outcome Measure Data
Hide Analysis 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.
Arm/Group Title OBINUTUZUMAB 1000MG and MMF PLACEBO and MMF
Hide Arm/Group Description:
Participants will receive 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 will be up titrated to a target dose of 2.0 - 2.5 grams per day (g/day) (or equivalent). Investigators, at their discretion, may 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 may receive 750-1000 mg methylprednisolone IV once daily for up to 3 days to treat underlying LN clinical activity. Participants will receive 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.
Participants will receive 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 will be up titrated to a target dose of 2.0 - 2.5 g/day (or equivalent). Investigators, at their discretion, may 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 may receive 750-1000 mg methylprednisolone IV once daily for up to 3 days to treat underlying LN clinical activity. Participants will receive 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.
Overall Number of Participants Analyzed 63 62
Measure Type: Number
Unit of Measure: percentage of participants
39.7 25.8
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection OBINUTUZUMAB 1000MG and MMF, PLACEBO and MMF
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0900
Comments Stratified by race (Afro Caribbean/African American vs. Others) and region (US vs. non-US sites).
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Percentage of Participants
Estimated Value 13.9
Confidence Interval 95%
-2.4 to 30.1
Estimation Comments [Not Specified]
11.Secondary Outcome
Title Percentage of Participants Who Achieve Protocol Defined Second mCRR (mCRR2) at Week 52
Hide Description mCRR2 is defined by normalization of serum creatinine, inactive urinary sediment (as evidenced by < 10 RBCs/HPF and the absence of red cell casts), and urinary protein to creatinine ratio <0.5. Normalization of serum creatinine as evidenced by the following: Serum creatinine ≤15% above baseline if baseline (Day 1) serum creatinine is above the normal range of the central laboratory values or ≤ the ULN range of central laboratory values if baseline (Day 1) serum creatinine is ≤ the ULN range of central laboratory values.
Time Frame Week 52
Hide Outcome Measure Data
Hide Analysis 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.
Arm/Group Title OBINUTUZUMAB 1000MG and MMF PLACEBO and MMF
Hide Arm/Group Description:
Participants will receive 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 will be up titrated to a target dose of 2.0 - 2.5 grams per day (g/day) (or equivalent). Investigators, at their discretion, may 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 may receive 750-1000 mg methylprednisolone IV once daily for up to 3 days to treat underlying LN clinical activity. Participants will receive 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.
Participants will receive 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 will be up titrated to a target dose of 2.0 - 2.5 g/day (or equivalent). Investigators, at their discretion, may 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 may receive 750-1000 mg methylprednisolone IV once daily for up to 3 days to treat underlying LN clinical activity. Participants will receive 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.
Overall Number of Participants Analyzed 63 62
Measure Type: Number
Unit of Measure: percentage of participants
44.4 33.9
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection OBINUTUZUMAB 1000MG and MMF, PLACEBO and MMF
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1838
Comments Stratified by race (Afro Caribbean/African American vs. Others) and region (US vs. non-US sites).
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Percentage of Participants
Estimated Value 10.6
Confidence Interval (2-Sided) 95%
-6.4 to 27.6
Estimation Comments [Not Specified]
12.Secondary Outcome
Title Percentage of Participants Who Achieve Protocol Defined Third mCRR (mCRR3) at Week 52
Hide Description mCRR3 is defined by normalization of serum creatine as evidenced by serum creatinine ≤ the ULN range of central laboratory values and urinary protein to creatinine ratio < 0.5.
Time Frame Week 52
Hide Outcome Measure Data
Hide Analysis 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.
Arm/Group Title OBINUTUZUMAB 1000MG and MMF PLACEBO and MMF
Hide Arm/Group Description:
Participants will receive 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 will be up titrated to a target dose of 2.0 - 2.5 grams per day (g/day) (or equivalent). Investigators, at their discretion, may 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 may receive 750-1000 mg methylprednisolone IV once daily for up to 3 days to treat underlying LN clinical activity. Participants will receive 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.
Participants will receive 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 will be up titrated to a target dose of 2.0 - 2.5 g/day (or equivalent). Investigators, at their discretion, may 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 may receive 750-1000 mg methylprednisolone IV once daily for up to 3 days to treat underlying LN clinical activity. Participants will receive 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.
Overall Number of Participants Analyzed 63 62
Measure Type: Number
Unit of Measure: percentage of participants
46.0 38.7
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection OBINUTUZUMAB 1000MG and MMF, PLACEBO and MMF
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3726
Comments Stratified by race (Afro Caribbean/African American vs. Others) and region (US vs. non-US sites).
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Percentage of Participants
Estimated Value 7.3
Confidence Interval (2-Sided) 95%
-10.0 to 24.6
Estimation Comments [Not Specified]
13.Secondary Outcome
Title Percentage of Participants With Adverse Events
Hide Description An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events. AEs, including AEs of Special Interest and AEs of Particular Interest, were reported based on the national cancer institute common terminology criteria for AEs, Version 4.0 (NCI-CTCAE, v4.0). Reported are the number of subjects with AEs, Grade 3-5 AEs, and Serious Adverse Events (SAEs).
Time Frame From Baseline up to Week 52 (up to approximately 38 months)
Hide Outcome Measure Data
Hide Analysis Population Description
The safety population was defined as all participants who have received at least one dose of study medication.
Arm/Group Title OBINUTUZUMAB 1000MG and MMF PLACEBO and MMF
Hide Arm/Group Description:
Participants will receive 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 will be up titrated to a target dose of 2.0 - 2.5 grams per day (g/day) (or equivalent). Investigators, at their discretion, may 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 may receive 750-1000 mg methylprednisolone IV once daily for up to 3 days to treat underlying LN clinical activity. Participants will receive 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.
Participants will receive 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 will be up titrated to a target dose of 2.0 - 2.5 g/day (or equivalent). Investigators, at their discretion, may 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 may receive 750-1000 mg methylprednisolone IV once daily for up to 3 days to treat underlying LN clinical activity. Participants will receive 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.
Overall Number of Participants Analyzed 64 61
Measure Type: Number
Unit of Measure: percentage of participants
Adverse Events 85.9 85.2
Serious Adverse Events 14.1 21.3
Grade 3-5 Infections 1.6 18.0
14.Secondary Outcome
Title Percentage of Participants With Adverse Events of Special Interest: Infusion Related Reactions, Infections, Thrombocytopenia and Neutropenia
Hide Description Neutropenia is defined as low neutrophil count (ANC <1.0 x 109/L). Infusion related reaction is defined as a type of hypersensitivity reaction (pruritus, chills, diaphoresis, fever) that develops during or shortly after administration of a drug. Thrombocytopenia is defined as deficiency of platelets (<150 x 10^9/L) in the blood. Infections include all events of infections under the SOC of infections and infestations in this study.
Time Frame From baseline to Week 52 (up to approximately 38 months)
Hide Outcome Measure Data
Hide Analysis Population Description
The safety population was defined as all participants who have received at least one dose of study medication.
Arm/Group Title OBINUTUZUMAB 1000MG and MMF PLACEBO and MMF
Hide Arm/Group Description:
Participants will receive 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 will be up titrated to a target dose of 2.0 - 2.5 grams per day (g/day) (or equivalent). Investigators, at their discretion, may 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 may receive 750-1000 mg methylprednisolone IV once daily for up to 3 days to treat underlying LN clinical activity. Participants will receive 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.
Participants will receive 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 will be up titrated to a target dose of 2.0 - 2.5 g/day (or equivalent). Investigators, at their discretion, may 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 may receive 750-1000 mg methylprednisolone IV once daily for up to 3 days to treat underlying LN clinical activity. Participants will receive 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.
Overall Number of Participants Analyzed 64 61
Measure Type: Number
Unit of Measure: percentage of participants
Infusion Related Reactions 15.6 9.8
Infections 64.1 59.0
Thrombocytopenia 0 0
Neutropenia 4.7 1.6
15.Secondary Outcome
Title Percentage of Participants With Anti-Drug Antibody (ADA) to Obinutuzumab
Hide Description Antibodies are a blood protein produced in response to and counteracting a specific antigen.
Time Frame From baseline to Week 52 (up to approximately 38 months)
Hide Outcome Measure Data
Hide Analysis Population Description
The safety population was defined as all participants who have received at least one dose of study medication.
Arm/Group Title OBINUTUZUMAB 1000MG and MMF
Hide Arm/Group Description:
Participants will receive 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 will be up titrated to a target dose of 2.0 - 2.5 grams per day (g/day) (or equivalent). Investigators, at their discretion, may 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 may receive 750-1000 mg methylprednisolone IV once daily for up to 3 days to treat underlying LN clinical activity. Participants will receive 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.
Overall Number of Participants Analyzed 64
Measure Type: Number
Unit of Measure: percentage of participants
9.38
16.Secondary Outcome
Title Percent Change From Baseline in Circulating CD19-Positive B-Cell Levels
Hide Description CD19+ B cell is a transmembrane protein that is encoded by the gene CD19.
Time Frame Baseline, Week 2, Week 4, Week 12, Week 24, Week 52
Hide Outcome Measure Data
Hide Analysis 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.
Arm/Group Title OBINUTUZUMAB 1000MG and MMF PLACEBO and MMF
Hide Arm/Group Description:
Participants will receive 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 will be up titrated to a target dose of 2.0 - 2.5 grams per day (g/day) (or equivalent). Investigators, at their discretion, may 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 may receive 750-1000 mg methylprednisolone IV once daily for up to 3 days to treat underlying LN clinical activity. Participants will receive 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.
Participants will receive 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 will be up titrated to a target dose of 2.0 - 2.5 g/day (or equivalent). Investigators, at their discretion, may 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 may receive 750-1000 mg methylprednisolone IV once daily for up to 3 days to treat underlying LN clinical activity. Participants will receive 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.
Overall Number of Participants Analyzed 63 62
Mean (Standard Deviation)
Unit of Measure: Percent change of cells/uL
Week 2 Number Analyzed 39 participants 42 participants
-97.469  (12.899) 39.293  (145.247)
Week 4 Number Analyzed 45 participants 36 participants
-98.777  (5.235) -5.186  (78.469)
Week 12 Number Analyzed 41 participants 45 participants
-97.045  (15.506) 0.661  (134.421)
Week 24 Number Analyzed 42 participants 37 participants
-96.628  (10.207) -11.446  (86.793)
Week 52 Number Analyzed 39 participants 42 participants
-98.620  (5.677) 37.695  (220.857)
17.Secondary Outcome
Title Maximum Observed Plasma Concentration (Cmax) of Obinutuzumab
Hide Description [Not Specified]
Time Frame Week 0, Week 24, Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
Pharmacokinetic population included all patients randomized to and received any dose of obinutuzumab given as study medication.
Arm/Group Title OBINUTUZUMAB 1000MG and MMF
Hide Arm/Group Description:
Participants will receive 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 will be up titrated to a target dose of 2.0 - 2.5 grams per day (g/day) (or equivalent). Investigators, at their discretion, may 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 may receive 750-1000 mg methylprednisolone IV once daily for up to 3 days to treat underlying LN clinical activity. Participants will receive 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.
Overall Number of Participants Analyzed 64
Mean (Standard Deviation)
Unit of Measure: ug/mL
Week 0-24 559  (112)
Week 24-52 605  (115)
Week 0-52 605  (115)
18.Secondary Outcome
Title Area Under the Plasma Concentration Versus Time Curve (AUC) of Obinutuzumab
Hide Description [Not Specified]
Time Frame Week 0, Week 24, Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
Pharmacokinetic population included all patients randomized to and received any dose of obinutuzumab given as study medication.
Arm/Group Title OBINUTUZUMAB 1000MG and MMF
Hide Arm/Group Description:
Participants will receive 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 will be up titrated to a target dose of 2.0 - 2.5 grams per day (g/day) (or equivalent). Investigators, at their discretion, may 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 may receive 750-1000 mg methylprednisolone IV once daily for up to 3 days to treat underlying LN clinical activity. Participants will receive 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.
Overall Number of Participants Analyzed 64
Mean (Standard Deviation)
Unit of Measure: ug/mL*day
Week 0-24 10595  (4016)
Week 24-52 15811  (5543)
Week 0-52 26406  (9027)
19.Secondary Outcome
Title Systemic Clearance of Obinutuzumab
Hide Description [Not Specified]
Time Frame Day 0, Week 24, Week 52
Hide Outcome Measure Data
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Pharmacokinetic population included all patients randomized to and received any dose of obinutuzumab given as study medication.
Arm/Group Title OBINUTUZUMAB 1000MG and MMF
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Participants will receive 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 will be up titrated to a target dose of 2.0 - 2.5 grams per day (g/day) (or equivalent). Investigators, at their discretion, may 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 may receive 750-1000 mg methylprednisolone IV once daily for up to 3 days to treat underlying LN clinical activity. Participants will receive 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.
Overall Number of Participants Analyzed 64
Mean (Standard Deviation)
Unit of Measure: L/day
Day 0 0.255  (0.136)
Week 24 0.147  (0.0564)
Week 52 0.137  (0.0535)
20.Secondary Outcome
Title Volume of Distribution Under Steady State (Vss) of Obinutuzumab
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Time Frame Day 0, Week 24, Week 52
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Pharmacokinetic population included all patients randomized to and received any dose of obinutuzumab given as study medication.
Arm/Group Title OBINUTUZUMAB 1000MG and MMF
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Participants will receive 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 will be up titrated to a target dose of 2.0 - 2.5 grams per day (g/day) (or equivalent). Investigators, at their discretion, may 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 may receive 750-1000 mg methylprednisolone IV once daily for up to 3 days to treat underlying LN clinical activity. Participants will receive 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.
Overall Number of Participants Analyzed 64
Mean (Standard Deviation)
Unit of Measure: L
Day 0 3.67  (0.591)
Week 24 3.67  (0.591)
Week 52 3.67  (0.591)
21.Secondary Outcome
Title Terminal Plasma Half-Life (t1/2) of Obinutuzumab
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Time Frame Day 0, Week 24, Week 52
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Pharmacokinetic population included all patients randomized to and received any dose of obinutuzumab given as study medication.
Arm/Group Title OBINUTUZUMAB 1000MG and MMF
Hide Arm/Group Description:
Participants will receive 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 will be up titrated to a target dose of 2.0 - 2.5 grams per day (g/day) (or equivalent). Investigators, at their discretion, may 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 may receive 750-1000 mg methylprednisolone IV once daily for up to 3 days to treat underlying LN clinical activity. Participants will receive 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.
Overall Number of Participants Analyzed 64
Mean (Standard Deviation)
Unit of Measure: day
Day 0 13.1  (3.7)
Week 24 20.5  (5.6)
Week 52 22.1  (6.7)
22.Secondary Outcome
Title Change From Baseline of Participant's Global Assessment of Disease Activity Visual Analog Scale (VAS) Score
Hide Description Each VAS had a range from 0-100 with higher scores indicating greater symptom impact on global health status.
Time Frame Baseline (Day 1), Weeks 4, 12, 24, 36, 52/early termination
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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.
Arm/Group Title OBINUTUZUMAB 1000MG and MMF PLACEBO and MMF
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Participants will receive 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 will be up titrated to a target dose of 2.0 - 2.5 grams per day (g/day) (or equivalent). Investigators, at their discretion, may 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 may receive 750-1000 mg methylprednisolone IV once daily for up to 3 days to treat underlying LN clinical activity. Participants will receive 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.
Participants will receive 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 will be up titrated to a target dose of 2.0 - 2.5 g/day (or equivalent). Investigators, at their discretion, may 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 may receive 750-1000 mg methylprednisolone IV once daily for up to 3 days to treat underlying LN clinical activity. Participants will receive 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.
Overall Number of Participants Analyzed 63 62
Mean (Standard Deviation)
Unit of Measure: score on scale
Baseline Number Analyzed 58 participants 60 participants
41.3  (25.59) 39.4  (24.76)
Week 4 Number Analyzed 55 participants 57 participants
-14.4  (18.28) -8.7  (22.69)
Week 12 Number Analyzed 57 participants 60 participants
-19.9  (25.07) -11.6  (25.22)
Week 24 Number Analyzed 54 participants 56 participants
-25.1  (25.26) -20.8  (24.74)
Week 36 Number Analyzed 54 participants 57 participants
-24.8  (25.71) -19.6  (25.04)
Week 52 Number Analyzed 54 participants 56 participants
-25.4  (26.49) -23.3  (25.76)
Time Frame From baseline to Week 52 (approximately 38 months)
Adverse Event Reporting Description The safety population was defined as all participants who have received at least one dose of study medication.
 
Arm/Group Title OBINUTUZUMAB 1000MG and MMF PLACEBO and MMF
Hide Arm/Group Description Participants will receive 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 will be up titrated to a target dose of 2.0 - 2.5 grams per day (g/day) (or equivalent). Investigators, at their discretion, may 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 may receive 750-1000 mg methylprednisolone IV once daily for up to 3 days to treat underlying LN clinical activity. Participants will receive 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. Participants will receive 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 will be up titrated to a target dose of 2.0 - 2.5 g/day (or equivalent). Investigators, at their discretion, may 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 may receive 750-1000 mg methylprednisolone IV once daily for up to 3 days to treat underlying LN clinical activity. Participants will receive 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.
All-Cause Mortality
OBINUTUZUMAB 1000MG and MMF PLACEBO and MMF
Affected / at Risk (%) Affected / at Risk (%)
Total   0/64 (0.00%)      2/61 (3.28%)    
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OBINUTUZUMAB 1000MG and MMF PLACEBO and MMF
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   9/64 (14.06%)      13/61 (21.31%)    
Blood and lymphatic system disorders     
NEUTROPENIA  1  1/64 (1.56%)  1 0/61 (0.00%)  0
THROMBOCYTOPENIA  1  0/64 (0.00%)  0 1/61 (1.64%)  1
Cardiac disorders     
CARDIAC FAILURE  1  0/64 (0.00%)  0 1/61 (1.64%)  1
Gastrointestinal disorders     
INTESTINAL PERFORATION  1  0/64 (0.00%)  0 1/61 (1.64%)  1
General disorders     
GENERAL PHYSICAL HEALTH DETERIORATION  1  0/64 (0.00%)  0 1/61 (1.64%)  1
PYREXIA  1  1/64 (1.56%)  1 1/61 (1.64%)  2
Infections and infestations     
BRONCHIOLITIS  1  0/64 (0.00%)  0 1/61 (1.64%)  1
CYTOMEGALOVIRUS CHORIORETINITIS  1  0/64 (0.00%)  0 1/61 (1.64%)  1
CYTOMEGALOVIRUS MYOCARDITIS  1  0/64 (0.00%)  0 1/61 (1.64%)  1
DISSEMINATED CYTOMEGALOVIRAL INFECTION  1  0/64 (0.00%)  0 1/61 (1.64%)  1
ENDOMETRITIS BACTERIAL  1  0/64 (0.00%)  0 1/61 (1.64%)  1
HERPES ZOSTER  1  0/64 (0.00%)  0 3/61 (4.92%)  3
KLEBSIELLA BACTERAEMIA  1  0/64 (0.00%)  0 1/61 (1.64%)  1
MENINGITIS CRYPTOCOCCAL  1  0/64 (0.00%)  0 1/61 (1.64%)  1
ORAL CANDIDIASIS  1  1/64 (1.56%)  1 0/61 (0.00%)  0
PNEUMONIA  1  0/64 (0.00%)  0 1/61 (1.64%)  1
PYELONEPHRITIS  1  0/64 (0.00%)  0 1/61 (1.64%)  1
URINARY TRACT INFECTION  1  1/64 (1.56%)  1 0/61 (0.00%)  0
UROSEPSIS  1  0/64 (0.00%)  0 1/61 (1.64%)  1
Injury, poisoning and procedural complications     
LUMBAR VERTEBRAL FRACTURE  1  0/64 (0.00%)  0 1/61 (1.64%)  1
ROAD TRAFFIC ACCIDENT  1  0/64 (0.00%)  0 1/61 (1.64%)  1
Investigations     
INFLUENZA A VIRUS TEST POSITIVE  1  1/64 (1.56%)  1 0/61 (0.00%)  0
WEIGHT INCREASED  1  0/64 (0.00%)  0 1/61 (1.64%)  1
Metabolism and nutrition disorders     
HYPONATRAEMIA  1  0/64 (0.00%)  0 1/61 (1.64%)  1
Musculoskeletal and connective tissue disorders     
ARTHRALGIA  1  1/64 (1.56%)  1 0/61 (0.00%)  0
ARTHRITIS  1  0/64 (0.00%)  0 1/61 (1.64%)  1
SYSTEMIC LUPUS ERYTHEMATOSUS  1  2/64 (3.13%)  2 1/61 (1.64%)  1
Nervous system disorders     
EPILEPSY  1  1/64 (1.56%)  1 0/61 (0.00%)  0
HEADACHE  1  0/64 (0.00%)  0 1/61 (1.64%)  1
IDIOPATHIC INTRACRANIAL HYPERTENSION  1  0/64 (0.00%)  0 1/61 (1.64%)  1
TOXIC ENCEPHALOPATHY  1  0/64 (0.00%)  0 1/61 (1.64%)  1
Psychiatric disorders     
PSYCHOTIC DISORDER  1  1/64 (1.56%)  1 0/61 (0.00%)  0
Renal and urinary disorders     
LUPUS NEPHRITIS  1  0/64 (0.00%)  0 1/61 (1.64%)  1
RENAL FAILURE  1  0/64 (0.00%)  0 1/61 (1.64%)  1
Respiratory, thoracic and mediastinal disorders     
ASTHMA  1  1/64 (1.56%)  1 0/61 (0.00%)  0
PULMONARY EMBOLISM  1  1/64 (1.56%)  1 0/61 (0.00%)  0
Vascular disorders     
HYPERTENSION  1  0/64 (0.00%)  0 1/61 (1.64%)  1
SHOCK HAEMORRHAGIC  1  1/64 (1.56%)  1 0/61 (0.00%)  0
1
Term from vocabulary, MedDRA, V21.1
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
OBINUTUZUMAB 1000MG and MMF PLACEBO and MMF
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   45/64 (70.31%)      31/61 (50.82%)    
Blood and lymphatic system disorders     
ANAEMIA  1  4/64 (6.25%)  4 1/61 (1.64%)  2
Gastrointestinal disorders     
ABDOMINAL PAIN  1  4/64 (6.25%)  5 3/61 (4.92%)  3
DIARRHOEA  1  2/64 (3.13%)  2 5/61 (8.20%)  5
NAUSEA  1  5/64 (7.81%)  5 3/61 (4.92%)  3
General disorders     
CHEST PAIN  1  0/64 (0.00%)  0 4/61 (6.56%)  4
Infections and infestations     
BRONCHITIS  1  12/64 (18.75%)  14 4/61 (6.56%)  6
CONJUNCTIVITIS  1  4/64 (6.25%)  6 1/61 (1.64%)  1
GASTROENTERITIS  1  3/64 (4.69%)  4 6/61 (9.84%)  7
HERPES ZOSTER  1  5/64 (7.81%)  6 5/61 (8.20%)  6
INFLUENZA  1  4/64 (6.25%)  4 1/61 (1.64%)  1
NASOPHARYNGITIS  1  3/64 (4.69%)  3 4/61 (6.56%)  4
PHARYNGITIS  1  5/64 (7.81%)  6 2/61 (3.28%)  2
UPPER RESPIRATORY TRACT INFECTION  1  5/64 (7.81%)  6 5/61 (8.20%)  6
URINARY TRACT INFECTION  1  9/64 (14.06%)  11 8/61 (13.11%)  11
Injury, poisoning and procedural complications     
INFUSION RELATED REACTION  1  7/64 (10.94%)  7 6/61 (9.84%)  7
Nervous system disorders     
HEADACHE  1  5/64 (7.81%)  5 3/61 (4.92%)  3
Psychiatric disorders     
ANXIETY  1  0/64 (0.00%)  0 4/61 (6.56%)  4
Vascular disorders     
HYPERTENSION  1  6/64 (9.38%)  6 1/61 (1.64%)  1
1
Term from vocabulary, MedDRA, V21.1
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor’s intellectual property rights.
Results Point of Contact
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Name/Title: Medical Communications
Organization: Genentech
Phone: 800-821-8590
EMail: genentech@druginfo.com
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Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT02550652    
Other Study ID Numbers: WA29748
2015-002022-39 ( EudraCT Number )
First Submitted: September 14, 2015
First Posted: September 15, 2015
Results First Submitted: January 14, 2020
Results First Posted: February 26, 2020
Last Update Posted: April 1, 2020