A Study to Evaluate the Safety and Efficacy of Obinutuzum... | NCT02550652

ID	Type	Description	Link
2015-002022-39	EudraCT Number

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Obinutuzumab	Experimental	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.	Drug: Mycophenolate Mofetil/Mycophenolic Acid Drug: Obinutuzumab Drug: Methylprednisolone Drug: Prednisone
Placebo	Placebo Comparator	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.	Drug: Mycophenolate Mofetil/Mycophenolic Acid Other: Placebo Drug: Methylprednisolone Drug: Prednisone

Name	Type	Description	Arm Group Labels	Other Names
Mycophenolate Mofetil/Mycophenolic Acid	Drug	MMF/MPA will be administered as per schedule specified in the respective arm.	Obinutuzumab Placebo

Measure	Description	Time Frame
Percentage of Participants Who Achieve Protocol Defined Complete Renal Response (CRR) at Week 52	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 above the ULN range of central laboratory values.	From baseline to Week 52

Measure	Description	Time Frame
Percentage of Participants Who Achieve Protocol Defined Overall Response (OR) at Week 52	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.

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Diagnosis of Systemic Lupus Erythematosus (SLE), according to current American College of Rheumatology (ACR) criteria
Diagnosis of International Society of Nephrology/Renal Pathology Society (ISN/RPS) 2003 Class III or IV LN as evidenced by renal biopsy performed within 6 months prior to or during screening. Participants may co-exhibit Class V disease in addition to either Class III or Class IV disease
Proteinuria (urine protein to creatinine ratio) greater than (>) 1.0
For women who are not postmenopausal (greater than or equal to [>/=] 12 months of non-therapy-induced amenorrhea) or surgically sterile (absence of ovaries and/or uterus): agreement to remain abstinent or use two adequate methods of contraception, including at least one method with a failure rate of less than (<) 1 percent (%) per year, during the treatment period and for at least 18 months after the last dose of study drug
For men: agreement to remain abstinent or use a condom plus an additional contraceptive method that together result in a failure rate of <1% per year during the treatment period and for at least 12 months after the last dose of study drug and agreement to refrain from donating sperm during this same period

Exclusion Criteria:

Retinitis, poorly controlled seizure disorder, acute confusional state, myelitis, stroke or stroke syndrome, cerebellar ataxia, or dementia that is currently active and resulting from SLE
Presence of rapidly progressive glomerulonephritis
Severe renal impairment as defined by estimated Glomerular Filtration Rate (GFR) <30 milliliters per minute (mL/min) or the need for dialysis or renal transplant
Greater than 50% of glomeruli with sclerosis on renal biopsy
Treatment with cyclophosphamide or calcineurin inhibitors within the 3 months prior to randomization
Unstable disease with thrombocytopenia or at high risk for developing clinically significant bleeding or organ dysfunction requiring therapies such as plasmapheresis or acute blood or platelet transfusions
History of severe allergic or anaphylactic reactions to monoclonal antibodies or known hypersensitivity to any component of the obinutuzumab infusion
Significant or uncontrolled medical disease in any organ system not related to SLE or LN, which, in the investigator's opinion, would preclude participant participation
Concomitant chronic conditions, excluding SLE, (e.g., asthma, Crohn's disease) that required oral or systemic steroid use in the 52 weeks prior to screening
Previous treatment with an anti-cluster of differentiation (CD20)-targeted therapy within 12 months
Previous treatment with a biologic B-cell-targeted therapy (other than anti-CD20) within 6 months of randomization
Known intolerance to MMF or MPA

Name	Affiliation	Role
Clinical Trials	Hoffmann-La Roche	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Univ of California, San Diego		La Jolla	California	92093	United States
Stanford University Medical Center

PubMed Identifier	Type	Citation	Retractions
37947366	Derived	Rovin BH, Furie RA, Ross Terres JA, Giang S, Schindler T, Turchetta A, Garg JP, Pendergraft WF 3rd, Malvar A. Kidney Outcomes and Preservation of Kidney Function With Obinutuzumab in Patients With Lupus Nephritis: A Post Hoc Analysis of the NOBILITY Trial. Arthritis Rheumatol. 2024 Feb;76(2):247-254. doi: 10.1002/art.42734. Epub 2023 Nov 10.
34615636

ID	Title	Description
FG000	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.

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Apr 18, 2023	Jul 31, 2024

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

Mean

Standard Deviation

Years

Title

Denominators

Categories

Title	Measurements
	OG00022 OG00114

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001		Cochran-Mantel-Haenszel		0.1145	Stratified by race (Afro Caribbean/African American vs. Others) and region (US vs. non-US sites). Statistically significant at pre-specified alpha of 20%.	Difference in Percentage of Participants	12.3			2-Sided	95	-3.4	28.1					Superiority
OG000 OG001

Secondary

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

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.

Posted

Count of Participants

Participants

From baseline to Week 52

ID	Title	Description
OG000	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.

Secondary

Time to OR Over 52 Weeks

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.

Posted

Count of Participants

Participants

From baseline to Week 52

ID	Title	Description
OG000	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.

Secondary

Percentage of Participants Who Achieve Protocol Defined Partial Renal Response (PRR) at Week 52

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.

Posted

Count of Participants

Participants

Week 52

ID	Title	Description
OG000	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.

Secondary

Percentage of Participants Who Achieve Protocol Defined CRR at Week 24

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.

Posted

Count of Participants

Participants

Week 24

ID	Title	Description
OG000	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.

Secondary

Time to CRR Over 52 Weeks

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.

Posted

Count of Participants

Participants

From Baseline to Week 52

ID	Title	Description
OG000	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.

Secondary

Change From Baseline in Anti-Double Stranded Deoxyribonucleic Acid (Anti-dsDNA) Antibody Levels at Week 52

Anti-dsDNA antibodies are a group of anti-nuclear autoantibodies targeting double stranded DNA.

Posted

Mean

Standard Deviation

log IU/mL

Baseline and Week 52

ID	Title	Description
OG000	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.
OG001	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.

Secondary

Change From Baseline in Complement Component 3 (C3) Levels at Week 52

Complement C3 is a blood test that reflects activation of complement pathway associated with immune deposition in certain autoimmune diseases.

Posted

Mean

Standard Deviation

g/L

Baseline and Week 52

ID	Title	Description
OG000	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.
OG001	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.

Secondary

Change From Baseline in C4 Levels at Week 52

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

Posted

Mean

Standard Deviation

g/L

Baseline, Week 52

ID	Title	Description
OG000	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.
OG001	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.

Secondary

Percentage of Participants Who Achieve Protocol Defined Modified CRR (mCRR1) at Week 52

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.

Posted

Count of Participants

Participants

Week 52

ID	Title	Description
OG000	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.

Secondary

Percentage of Participants Who Achieve Protocol Defined Second mCRR (mCRR2) at Week 52

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.

Posted

Count of Participants

Participants

Week 52

ID	Title	Description
OG000	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.

Secondary

Percentage of Participants Who Achieve Protocol Defined Third mCRR (mCRR3) at Week 52

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.

Posted

Count of Participants

Participants

Week 52

ID	Title	Description
OG000	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.
OG001	PLACEBO and MMF

Secondary

Percentage of Participants With Adverse Events (AEs)

An AE 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 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), Infections and Serious infections. The AEs reported do not include events after the receipt of rescue medications.

The safety population was defined as all participants who have received any amount of study medication. Participants are reported under the therapy they actually received.

Posted

Count of Participants

Participants

From baseline to approximately 7 years and 8 months

ID	Title	Description
OG000	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.

Secondary

Percentage of Participants With Adverse Events of Special Interest: Infusion Related Reactions, Grade 3 or Higher Infections, Drug-related Neutropenia and Drug-related Thrombocytopenia

Infusion related reaction is defined as any event reported within 24 hours of infusion and thought to be causally related to the investigational agent by the investigator. Grade 3 or higher infections include all events of Grade 3 to 5 under the SOC of infections and infestations. Drug-related neutropenia is defined as events in the Roche AE Grouped Term (AEGT) "Neutropenia and associated complications" and thought to be causally related to the investigational agent by the investigator. Drug-related thrombocytopenia is defined as events in the Standard MedDRA Query (SMQ) "Haematopoietic Thrombocytopenia narrow" and thought to be causally related to the investigational agent by the investigator.

The safety population was defined as all participants who have received any amount of study medication. Participants are reported under the therapy they actually received.

Posted

Count of Participants

Participants

From baseline to approximately 7 years and 8 months

ID	Title	Description
OG000	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.

Secondary

Percentage of Participants With Anti-Drug Antibody (ADA) to Obinutuzumab

Antibodies are a blood protein produced in response to and counteracting a specific antigen.

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

Posted

Count of Participants

Participants

From baseline to approximately 7 years and 8 months

ID	Title	Description
OG000	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.

Units	Counts
Participants

Secondary

Percent Change From Baseline in Circulating CD19-Positive B-Cell Levels

CD19+ B cell is a B-lymphocyte with a transmembrane protein that is encoded by the gene CD19.

Posted

Mean

Standard Deviation

Percent change of cells/uL

Baseline, Week 2, Week 4, Week 12, Week 24, Week 52, Week 104, B Cell Follow-Up (Bcfu) at months 6, 12, 18, 24, 30, 36, 42 and 48

ID	Title	Description
OG000	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.
OG001	PLACEBO and MMF

Secondary

Maximum Observed Plasma Concentration (Cmax) of Obinutuzumab

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

Posted

Mean

Standard Deviation

ug/mL

Week 0, Week 24, Week 52

ID	Title	Description
OG000	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.

Units	Counts
Participants	OG000

Secondary

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

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

Posted

Mean

Standard Deviation

ug/mL*day

Baseline to Week 52

ID	Title	Description
OG000	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.

Units	Counts
Participants	OG000

Secondary

Systemic Clearance of Obinutuzumab

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

Posted

Mean

Standard Deviation

L/day

Day 0, Week 24, Week 52

ID	Title	Description
OG000	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.

Units	Counts
Participants	OG000

Secondary

Volume of Distribution Under Steady State (Vss) of Obinutuzumab

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

Posted

Mean

Standard Deviation

Litre (L)

Day 0, Week 24, Week 52

ID	Title	Description
OG000	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.

Units	Counts
Participants	OG000

Secondary

Terminal Plasma Half-Life (t1/2) of Obinutuzumab

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

Posted

Mean

Standard Deviation

day

Day 0, Week 24, Week 52

ID	Title	Description
OG000	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.

Units	Counts
Participants	OG000

Secondary

Change From Baseline of Participant's Global Assessment of Disease Activity Visual Analog Scale (VAS) Score

Each VAS had a range from 0-100 with higher scores indicating greater symptom impact on global health status.

Posted

Mean

Standard Deviation

score on scale

Baseline (Day 1), Weeks 4, 12, 24, 36, 52

ID	Title	Description
OG000	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.
OG001	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.

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
NEUTROPENIA	Blood and lymphatic system disorders	MedDRA, v26.0	Systematic Assessment	EG0001 events1 affected64 at risk EG0011 events1 affected61 at risk
THROMBOCYTOPENIA	Blood and lymphatic system disorders	MedDRA, v26.0	Systematic Assessment	EG0000 events0 affected64 at risk EG0011 events1 affected61 at risk
CARDIAC FAILURE	Cardiac disorders	MedDRA, v26.0	Systematic Assessment	EG0000 events0 affected64 at risk EG0011 events1 affected61 at risk
INTESTINAL PERFORATION	Gastrointestinal disorders	MedDRA, v26.0	Systematic Assessment	EG0000 events0 affected64 at risk EG0011 events1 affected61 at risk
GENERAL PHYSICAL HEALTH DETERIORATION	General disorders	MedDRA, v26.0	Systematic Assessment	EG0000 events0 affected64 at risk EG0011 events1 affected61 at risk
PYREXIA	General disorders	MedDRA, v26.0	Systematic Assessment	EG0002 events2 affected64 at risk EG0012 events1 affected61 at risk
BRONCHIOLITIS	Infections and infestations	MedDRA, v26.0	Systematic Assessment	EG0000 events0 affected64 at risk EG0011 events1 affected61 at risk
CYTOMEGALOVIRUS CHORIORETINITIS	Infections and infestations	MedDRA, v26.0	Systematic Assessment	EG0000 events0 affected64 at risk EG0011 events1 affected61 at risk
CYTOMEGALOVIRUS MYOCARDITIS	Infections and infestations	MedDRA, v26.0	Systematic Assessment	EG0000 events0 affected64 at risk EG0011 events1 affected61 at risk
DISSEMINATED CYTOMEGALOVIRAL INFECTION	Infections and infestations	MedDRA, v26.0	Systematic Assessment	EG0000 events0 affected64 at risk EG0011 events1 affected61 at risk
ENDOMETRITIS BACTERIAL	Infections and infestations	MedDRA, v26.0	Systematic Assessment	EG0000 events0 affected64 at risk EG0011 events1 affected61 at risk
HERPES ZOSTER	Infections and infestations	MedDRA, v26.0	Systematic Assessment	EG0001 events1 affected64 at risk EG0013 events3 affected61 at risk
KLEBSIELLA BACTERAEMIA	Infections and infestations	MedDRA, v26.0	Systematic Assessment	EG0000 events0 affected64 at risk EG0011 events1 affected61 at risk
MENINGITIS CRYPTOCOCCAL	Infections and infestations	MedDRA, v26.0	Systematic Assessment	EG0000 events0 affected64 at risk EG0011 events1 affected61 at risk
ORAL CANDIDIASIS	Infections and infestations	MedDRA, v26.0	Systematic Assessment	EG0001 events1 affected64 at risk EG0010 events0 affected61 at risk
PNEUMONIA	Infections and infestations	MedDRA, v26.0	Systematic Assessment	EG0001 events1 affected64 at risk EG0011 events1 affected61 at risk
PYELONEPHRITIS	Infections and infestations	MedDRA, v26.0	Systematic Assessment	EG0000 events0 affected64 at risk EG0011 events1 affected61 at risk
URINARY TRACT INFECTION	Infections and infestations	MedDRA, v26.0	Systematic Assessment	EG0001 events1 affected64 at risk EG0011 events1 affected61 at risk
UROSEPSIS	Infections and infestations	MedDRA, v26.0	Systematic Assessment	EG0000 events0 affected64 at risk EG0011 events1 affected61 at risk
LUMBAR VERTEBRAL FRACTURE	Injury, poisoning and procedural complications	MedDRA, v26.0	Systematic Assessment	EG0000 events0 affected64 at risk EG0011 events1 affected61 at risk
ROAD TRAFFIC ACCIDENT	Injury, poisoning and procedural complications	MedDRA, v26.0	Systematic Assessment	EG0000 events0 affected64 at risk EG0011 events1 affected61 at risk
INFLUENZA A VIRUS TEST POSITIVE	Investigations	MedDRA, v26.0	Systematic Assessment	EG0001 events1 affected64 at risk EG0010 events0 affected61 at risk
WEIGHT INCREASED	Investigations	MedDRA, v26.0	Systematic Assessment	EG0000 events0 affected64 at risk EG0011 events1 affected61 at risk
HYPONATRAEMIA	Metabolism and nutrition disorders	MedDRA, v26.0	Systematic Assessment	EG0000 events0 affected64 at risk EG0011 events1 affected61 at risk
ARTHRALGIA	Musculoskeletal and connective tissue disorders	MedDRA, v26.0	Systematic Assessment	EG0001 events1 affected64 at risk EG0010 events0 affected61 at risk
ARTHRITIS	Musculoskeletal and connective tissue disorders	MedDRA, v26.0	Systematic Assessment	EG0000 events0 affected64 at risk EG0011 events1 affected61 at risk
SYSTEMIC LUPUS ERYTHEMATOSUS	Musculoskeletal and connective tissue disorders	MedDRA, v26.0	Systematic Assessment	EG0002 events2 affected64 at risk EG0012 events2 affected61 at risk
EPILEPSY	Nervous system disorders	MedDRA, v26.0	Systematic Assessment	EG0001 events1 affected64 at risk EG0010 events0 affected61 at risk
HEADACHE	Nervous system disorders	MedDRA, v26.0	Systematic Assessment	EG0000 events0 affected64 at risk EG0011 events1 affected61 at risk
IDIOPATHIC INTRACRANIAL HYPERTENSION	Nervous system disorders	MedDRA, v26.0	Systematic Assessment	EG0000 events0 affected64 at risk EG0011 events1 affected61 at risk
PSYCHOTIC DISORDER	Psychiatric disorders	MedDRA, v26.0	Systematic Assessment	EG0001 events1 affected64 at risk EG0010 events0 affected61 at risk
LUPUS NEPHRITIS	Renal and urinary disorders	MedDRA, v26.0	Systematic Assessment	EG0000 events0 affected64 at risk EG0011 events1 affected61 at risk
RENAL FAILURE	Renal and urinary disorders	MedDRA, v26.0	Systematic Assessment	EG0000 events0 affected64 at risk EG0012 events2 affected61 at risk
ASTHMA	Respiratory, thoracic and mediastinal disorders	MedDRA, v26.0	Systematic Assessment	EG0001 events1 affected64 at risk EG0010 events0 affected61 at risk
PULMONARY EMBOLISM	Respiratory, thoracic and mediastinal disorders	MedDRA, v26.0	Systematic Assessment	EG0001 events1 affected64 at risk EG0010 events0 affected61 at risk
HYPERTENSION	Vascular disorders	MedDRA, v26.0	Systematic Assessment	EG0000 events0 affected64 at risk EG0011 events1 affected61 at risk
SHOCK HAEMORRHAGIC	Vascular disorders	MedDRA, v26.0	Systematic Assessment	EG0001 events1 affected64 at risk EG0010 events0 affected61 at risk
LEUKOPENIA	Blood and lymphatic system disorders	MedDRA, v26.0	Systematic Assessment	EG0000 events0 affected64 at risk EG0011 events1 affected61 at risk
ABDOMINAL PAIN	Gastrointestinal disorders	MedDRA, v26.0	Systematic Assessment	EG0002 events2 affected64 at risk EG0010 events0 affected61 at risk
INTUSSUSCEPTION	Gastrointestinal disorders	MedDRA, v26.0	Systematic Assessment	EG0000 events0 affected64 at risk EG0011 events1 affected61 at risk
OESOPHAGEAL FISTULA	Gastrointestinal disorders	MedDRA, v26.0	Systematic Assessment	EG0001 events1 affected64 at risk EG0010 events0 affected61 at risk
UPPER GASTROINTESTINAL HAEMORRHAGE	Gastrointestinal disorders	MedDRA, v26.0	Systematic Assessment	EG0000 events0 affected64 at risk EG0011 events1 affected61 at risk
CHOLELITHIASIS	Hepatobiliary disorders	MedDRA, v26.0	Systematic Assessment	EG0001 events1 affected64 at risk EG0010 events0 affected61 at risk
HEPATITIS ACUTE	Hepatobiliary disorders	MedDRA, v26.0	Systematic Assessment	EG0000 events0 affected64 at risk EG0011 events1 affected61 at risk
APPENDICITIS	Infections and infestations	MedDRA, v26.0	Systematic Assessment	EG0000 events0 affected64 at risk EG0011 events1 affected61 at risk
PROGRESSIVE MULTIFOCAL LEUKOENCEPHALOPATHY	Infections and infestations	MedDRA, v26.0	Systematic Assessment	EG0000 events0 affected64 at risk EG0011 events1 affected61 at risk
RESPIRATORY TRACT INFECTION	Infections and infestations	MedDRA, v26.0	Systematic Assessment	EG0001 events1 affected64 at risk EG0010 events0 affected61 at risk
SEPSIS	Infections and infestations	MedDRA, v26.0	Systematic Assessment	EG0000 events0 affected64 at risk EG0012 events1 affected61 at risk
TUBERCULOSIS	Infections and infestations	MedDRA, v26.0	Systematic Assessment	EG0001 events1 affected64 at risk EG0010 events0 affected61 at risk
VARICELLA	Infections and infestations	MedDRA, v26.0	Systematic Assessment	EG0000 events0 affected64 at risk EG0011 events1 affected61 at risk
HEMIPARESIS	Nervous system disorders	MedDRA, v26.0	Systematic Assessment	EG0000 events0 affected64 at risk EG0011 events1 affected61 at risk
MYELITIS TRANSVERSE	Nervous system disorders	MedDRA, v26.0	Systematic Assessment	EG0001 events1 affected64 at risk EG0010 events0 affected61 at risk
SEIZURE	Nervous system disorders	MedDRA, v26.0	Systematic Assessment	EG0000 events0 affected64 at risk EG0011 events1 affected61 at risk
ABORTION SPONTANEOUS	Pregnancy, puerperium and perinatal conditions	MedDRA, v26.0	Systematic Assessment	EG0001 events1 affected64 at risk EG0010 events0 affected61 at risk
NEPHROPATHY TOXIC	Renal and urinary disorders	MedDRA, v26.0	Systematic Assessment	EG0000 events0 affected64 at risk EG0011 events1 affected61 at risk
RENAL IMPAIRMENT	Renal and urinary disorders	MedDRA, v26.0	Systematic Assessment	EG0000 events0 affected64 at risk EG0011 events1 affected61 at risk
ACUTE RESPIRATORY FAILURE	Respiratory, thoracic and mediastinal disorders	MedDRA, v26.0	Systematic Assessment	EG0000 events0 affected64 at risk EG0011 events1 affected61 at risk
PLEURITIC PAIN	Respiratory, thoracic and mediastinal disorders	MedDRA, v26.0	Systematic Assessment	EG0000 events0 affected64 at risk EG0011 events1 affected61 at risk
PULMONARY ALVEOLAR HAEMORRHAGE	Respiratory, thoracic and mediastinal disorders	MedDRA, v26.0	Systematic Assessment	EG0001 events1 affected64 at risk EG0010 events0 affected61 at risk
RESPIRATORY FAILURE	Respiratory, thoracic and mediastinal disorders	MedDRA, v26.0	Systematic Assessment	EG0001 events1 affected64 at risk EG0010 events0 affected61 at risk
RASH	Skin and subcutaneous tissue disorders	MedDRA, v26.0	Systematic Assessment	EG0001 events1 affected64 at risk EG0010 events0 affected61 at risk
DEATH	General disorders	MedDRA, v26.0	Systematic Assessment	EG0001 events1 affected64 at risk EG0010 events0 affected61 at risk
PNEUMONIA ASPIRATION	Infections and infestations	MedDRA, v26.0	Systematic Assessment	EG0001 events1 affected64 at risk EG0010 events0 affected61 at risk
SUPERFICIAL VEIN THROMBOSIS	Vascular disorders	MedDRA, v26.0	Systematic Assessment	EG0000 events0 affected64 at risk EG0011 events1 affected61 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
ANAEMIA	Blood and lymphatic system disorders	MedDRA, v26.0	Systematic Assessment	EG0005 events5 affected64 at risk EG0016 events4 affected61 at risk
ABDOMINAL PAIN	Gastrointestinal disorders	MedDRA, v26.0	Systematic Assessment	EG0007 events5 affected64 at risk EG0013 events3 affected61 at risk
DIARRHOEA	Gastrointestinal disorders	MedDRA, v26.0	Systematic Assessment	EG0003 events3 affected64 at risk EG0015 events5 affected61 at risk
NAUSEA	Gastrointestinal disorders	MedDRA, v26.0	Systematic Assessment	EG0007 events6 affected64 at risk EG0013 events3 affected61 at risk
CHEST PAIN	General disorders	MedDRA, v26.0	Systematic Assessment	EG0000 events0 affected64 at risk EG0014 events4 affected61 at risk
BRONCHITIS	Infections and infestations	MedDRA, v26.0	Systematic Assessment	EG00015 events13 affected64 at risk EG0018 events5 affected61 at risk
CONJUNCTIVITIS	Infections and infestations	MedDRA, v26.0	Systematic Assessment	EG0006 events4 affected64 at risk EG0012 events2 affected61 at risk
GASTROENTERITIS	Infections and infestations	MedDRA, v26.0	Systematic Assessment	EG0004 events3 affected64 at risk EG0019 events6 affected61 at risk
HERPES ZOSTER	Infections and infestations	MedDRA, v26.0	Systematic Assessment	EG0006 events5 affected64 at risk EG0017 events6 affected61 at risk
INFLUENZA	Infections and infestations	MedDRA, v26.0	Systematic Assessment	EG0004 events4 affected64 at risk EG0013 events2 affected61 at risk
NASOPHARYNGITIS	Infections and infestations	MedDRA, v26.0	Systematic Assessment	EG0005 events5 affected64 at risk EG0018 events6 affected61 at risk
PHARYNGITIS	Infections and infestations	MedDRA, v26.0	Systematic Assessment	EG0008 events5 affected64 at risk EG0014 events4 affected61 at risk
UPPER RESPIRATORY TRACT INFECTION	Infections and infestations	MedDRA, v26.0	Systematic Assessment	EG0008 events6 affected64 at risk EG0016 events5 affected61 at risk
URINARY TRACT INFECTION	Infections and infestations	MedDRA, v26.0	Systematic Assessment	EG00019 events14 affected64 at risk EG00120 events12 affected61 at risk
INFUSION RELATED REACTION	Injury, poisoning and procedural complications	MedDRA, v26.0	Systematic Assessment	EG0007 events7 affected64 at risk EG0017 events6 affected61 at risk
HEADACHE	Nervous system disorders	MedDRA, v26.0	Systematic Assessment	EG0007 events5 affected64 at risk EG0013 events3 affected61 at risk
ANXIETY	Psychiatric disorders	MedDRA, v26.0	Systematic Assessment	EG0000 events0 affected64 at risk EG0014 events4 affected61 at risk
HYPERTENSION	Vascular disorders	MedDRA, v26.0	Systematic Assessment	EG0006 events6 affected64 at risk EG0012 events2 affected61 at risk
ARTHRALGIA	Musculoskeletal and connective tissue disorders	MedDRA, v26.0	Systematic Assessment	EG0006 events5 affected64 at risk EG0015 events4 affected61 at risk
INSOMNIA	Psychiatric disorders	MedDRA, v26.0	Systematic Assessment	EG0003 events3 affected64 at risk EG0014 events4 affected61 at risk

ID	Term
D005921	Glomerulonephritis
D009393	Nephritis
D007674	Kidney Diseases
D014570	Urologic Diseases
D052776	Female Urogenital Diseases
D005261	Female Urogenital Diseases and Pregnancy Complications
D000091642	Urogenital Diseases
D052801	Male Urogenital Diseases
D008180	Lupus Erythematosus, Systemic
D003240	Connective Tissue Diseases
D017437	Skin and Connective Tissue Diseases
D001327	Autoimmune Diseases
D007154	Immune System Diseases

ID	Term
D002208	Caproates
D000144	Acids, Acyclic
D002264	Carboxylic Acids
D009930	Organic Chemicals
D005227	Fatty Acids
D008055	Lipids
D011239	Prednisolone
D011246	Pregnadienetriols
D011245	Pregnadienes
D011278	Pregnanes
D013256	Steroids
D000072473	Fused-Ring Compounds
D011083	Polycyclic Compounds
D011244	Pregnadienediols

ID	Title	Description
BG000	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.
BG001	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.
BG002	Total	Total of all reporting groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	OBINUTUZUMAB 1000MG + 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.	1	64	17	64	51	64
EG001	PLACEBO + 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.	4	61	18	61	39	61

ID	Term
D009173	Mycophenolic Acid
C543332	obinutuzumab
D008775	Methylprednisolone
D011241	Prednisone