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| ID | Type | Description | Link |
|---|---|---|---|
| 2019-004034-42 | EudraCT Number | ||
| 2023-503628-22-00 | EU Trial (CTIS) Number |
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This study will evaluate the efficacy, safety, and pharmacokinetics of obinutuzumab compared with placebo in participants with International Society of Nephrology/Renal Pathology Society (ISN/RPS) 2003 class III or IV lupus nephritis (LN) when added on to standard-of-care therapy consisting of mycophenolate mofetil (MMF) and corticosteroids.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Obinutuzumab | Experimental | Participants will be randomized into 2 groups. Group 1 will receive obinutuzumab 1000 mg IV at baseline and Weeks 2, 24, 26, 50, and 52 plus MMF and oral prednisone. Group 2 receive obinutuzumab 1000 mg IV at baseline and Weeks 2, 24, 26, and 52 plus MMF and oral prednisone. Group 2 participants will receive a placebo infusion at their Week 50 visit. Participants with an adequate response at Week 76 will continue receiving blinded obinutuzumab infusions every 6 months starting at Week 80. Participants without an adequate response at Week 76 may be eligible for open-label obinutuzumab starting at Week 80. After study unblinding, participants may be eligible for further open-label obinutuzumab treatment. |
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| Placebo | Placebo Comparator | Placebo participants will receive obinutuzumab matched placebo at baseline and Weeks 2, 24, 26, 50, and 52 plus MMF and oral prednisone. Participants with an adequate response at Week 76 will continue receiving blinded obinutuzumab infusions every 6 months starting at Week 80. Participants without an adequate response at Week 76 may be eligible for open-label obinutuzumab starting at Week 80. After study unblinding, participants may be eligible for further open-label obinutuzumab treatment. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Obinutuzumab | Drug | Obinutuzumab will be administered by IV infusion at a dose of 1000 mg at Baseline and Weeks 2, 24, 26, 50 (group 2: placebo), and 52 and subsequently from Week 80 and every 6 months thereafter, based on response. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Complete Renal Response (CRR) | CRR was defined as an achievement of all the following criteria: urinary protein-to-creatinine ratio (UPCR) <0.5 gram/gram (g/g); estimated glomerular filtration rate (eGFR) >=85% of baseline, as calculated using the chronic kidney disease epidemiology collaboration (CKD-EPI) equation and no occurrence of intercurrent events of rescue therapy, treatment failure, death or early study withdrawal. Obinutuzumab and placebo were compared using Cochran-Mantel-Haenszel (CMH) test adjusting for the stratification factors region and race. Missing data was imputed by multiple imputations using fully conditional specification (FCS) predicted mean matching method. Percentage have been rounded off. | At Week 76 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Who Achieve CRR With Successful Prednisone Taper at Week 76 | CRR with successful prednisone was defined as the achievement of CRR at Week 76 with no receipt of prednisone >7.5 milligrams per day (mg/day) (or equivalent) from Week 64 through Week 76. CRR was defined as achievement of all the following criteria: UPCR <0.5 g/g; eGFR >=85% of baseline, as calculated using the CKD-EPI equation and no occurrence of intercurrent events of rescue therapy, treatment failure, death or early study withdrawal. Analysis was performed using CMH test adjusting for the stratification factors region and race. Missing data was imputed by multiple imputations using FCS predicted mean matching method. Percentage have been rounded off. |
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Key Inclusion Criteria:
Key Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama at Birmingham Medical Center | Birmingham | Alabama | 35233 | United States | ||
| Wallace Rheumatic Study Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39927615 | Derived | Furie RA, Rovin BH, Garg JP, Santiago MB, Aroca-Martinez G, Zuta Santillan AE, Alvarez D, Navarro Sandoval C, Lila AM, Tumlin JA, Saxena A, Irazoque Palazuelos F, Raghu H, Yoo B, Hassan I, Martins E, Sehgal H, Kirchner P, Ross Terres J, Omachi TA, Schindler T, Pendergraft WF 3rd, Malvar A; REGENCY Trial Investigators. Efficacy and Safety of Obinutuzumab in Active Lupus Nephritis. N Engl J Med. 2025 Apr 17;392(15):1471-1483. doi: 10.1056/NEJMoa2410965. Epub 2025 Feb 7. | |
| 37528520 |
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For eligible studies, qualified researchers may request access to individual patient level clinical data. See Roche's commitment to transparency of clinical study information here: https://go.roche.com/data\_sharing
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Participants were randomized in a 1:1 ratio to Obinutuzumab/placebo. As pre-specified in the statistical analysis plan (SAP), participant flow data for all participants randomized to 1 of the 2 dosing schedules of obinutuzumab (Groups 1 & 2) were reported in the combined obinutuzumab treatment group. This study is ongoing.
A total of 271 participants with International Society of Nephrology/ Renal Pathology Society (ISN/RPS) 2003 Class III or IV lupus nephritis (LN) treated with standard-of-care (SOC) therapy took part in the study across 72 sites in 15 countries.
This study consists of blinded treatment with obinutuzumab or placebo, followed by open-label treatment (OLT) with obinutuzumab.
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| ID | Title | Description |
|---|---|---|
| FG000 | Obinutuzumab | Participants received obinutuzumab, 1000 milligrams (mg) as an intravenous (IV) infusion on Day 1 and Weeks 2, 24, 26, and either Weeks 50 and 52 or Week 52 only, along with mycophenolate mofetil (MMF) and SOC therapy. Placebo was administered at Week 50 for participants not treated with obinutuzumab. Participants with adequate response at Week 76 continued to receive obinutuzumab at Week 80 and every 6 months (Q6M) thereafter. The dose of MMF can be adjusted at the investigator's discretion beginning at Week 80. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Feb 7, 2024 | Aug 13, 2025 |
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| MMF | Drug | MMF willl be administered at a target dose of 2.0 - 2.5 g/day in divided doses through Week 80. |
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| Prednisone | Drug | Prednisone 0.5 mg/kg/day (maximum 60 mg/day) will be started on Day 2. Beginning on Day 15, prednisone will be tapered to 5 mg/day and continued until Week 80. |
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| Placebo | Drug | Placebo matching obinutuzumab will be administered by IV infusion at baseline and Weeks 0, 2, 24, 26, 50 and 52 and subsequently from Week 80 and every 6 months thereafter based on response. |
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| Methylprednisolone | Drug | Methylprednisolone 80 mg IV will be administered as predmedication prior to infusions. |
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| Acetaminophen | Drug | Acetaminophen 650-1000 mg will be administered as premedication prior to infusions. |
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| Diphenhydramine | Drug | Diphenhydramine 50 mg will be administered as premedication prior to infusions. |
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| At Week 76 |
| Percentage of Participants Who Achieve a Proteinuric Response | Proteinuric response was defined as an achievement of all the following criteria: UPCR <0.8 g/g and no occurrence of intercurrent events of rescue therapy, treatment failure, death or early study withdrawal. Analysis was performed using CMH test adjusting for the stratification factors region and race. Missing data was imputed by multiple imputations using FCS predicted mean matching method. Percentage have been rounded off. | At Week 76 |
| Mean Change in eGFR | Change in eGFR from baseline to Week 76 was analyzed using Analysis of Covariance (ANCOVA) model with covariates baseline eGFR and the stratification factors race and region. Death was considered as an intercurrent event which was handled under composite strategy by imputing data after death with 0. Missing data was imputed by multiple imputations using FCS predicted mean matching method. mL/min/1.73 m^2 = milliliters per minute per 1.73 square meters. Adjusted mean has been reported. | At Week 76 |
| Percentage of Participants Who Experience Death or Renal-related Events | Percentage of participants with death or renal-related events were defined as participants with one or more of the following events: Death; Treatment failure; Worsening proteinuria, defined as a confirmed ≥50% increase in UPCR to a value ≥3 g/g; Worsening eGFR, defined as a confirmed ≥30% decrease in eGFR to a value <60. Early study withdrawal due to lack of efficacy was an intercurrent event. Participants experiencing the intercurrent event were considered as participants with events under composite strategy. Analysis was performed using CMH test adjusting for the stratification factors region and race. Missing data was imputed by multiple imputations using FCS predicted mean matching method. Percentages have been rounded off. | From Day 1 to Week 76 |
| Percentage of Participants Who Achieve an Overall Renal Response (ORR) | ORR was defined as achievement of either CRR or PRR. CRR was defined as achievement of all of the criteria: UPCR <0.5 g/g; eGFR ≥85% of baseline, as calculated using the CKD-EPI equation. PRR was defined as achievement of all of the following criteria: ≥50% reduction in UPCR from baseline; UPCR <1 g/g (or <3 g/g if the baseline UPCR was ≥3 g/g); eGFR ≥85% of baseline, as calculated using the CKD-EPI equation and no occurrence of intercurrent events of rescue therapy, treatment failure, death or early study withdrawal. Analysis was performed using CMH test adjusting for the stratification factors region and race. Missing data was imputed by multiple imputations using FCS predicted mean matching method. Percentage have been rounded off. | At Week 50 |
| Change From Baseline in Fatigue Assessed Using Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Scale | The FACIT-F is a 13-item questionnaire that assesses self-reported fatigue and its impact upon daily activities and function. Participants scored each item on a 5-point scale: 0 (Not at all) to 4 (Very much). The sum of all responses resulted in the FACIT-F score of 0 (worse score) to 52 (better score). Higher scores indicate less fatigue. Change in FACIT-F score from baseline at Week 76 was analyzed using ANCOVA model with covariates baseline FACIT-F score and the stratification factors race and region. Death was considered as an intercurrent event which was handled under composite strategy by imputing FACIT-F score after death with 0. Missing data was imputed by multiple imputations using FCS predicted mean matching method. Adjusted mean has been reported. | At Week 76 |
| Change in Log-transformed Anti-double-stranded Deoxyribonucleic Acid (Anti-dsDNA) Titer | Anti-dsDNA are types of autoantibodies produced by the immune system and are indicators of lupus. Anti-dsDNA data was log-transformed before analysis. Missing data was imputed by multiple imputations using FCS predicted mean matching method. Analysis was performed using ANCOVA. Death was considered as an intercurrent event which was handled under composite strategy by imputing data after death with upper limit of quantification (ULOQ, 890 international units/milliliter [IU/mL]). Adjusted mean has been reported. | At Week 50 |
| Change in Complement C3 | C3 is a marker of inflammation. Analysis was performed using ANCOVA. Death was considered as an intercurrent event which was handled under composite strategy by imputing data after death with lower limit of quantification (LLOQ)/2 under composite strategy. LLOQ at the central lab was set for C3 at 0.100 grams/liters (g/L). Missing data was imputed by multiple imputations using FCS predicted mean matching method. Adjusted mean has been reported. | At Week 50 |
| Change in Systematic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) | The SLEDAI-2K is a 24-item instrument that evaluates clinical symptoms and laboratory markers across nine organ systems and was used to capture changes in lupus-related disease activity. SLE manifestations are assessed by the clinician if present within the last 30 days and added to determine the total SLEDAI-2K score, which ranges from 0 to 105. Higher scores indicate increased disease activity. The analysis was performed using ANCOVA. Death was considered as an intercurrent event which was handled under composite strategy by imputing data after death with 105, the highest possible score. Missing data was imputed by multiple imputations using FCS predicted mean matching method. Adjusted mean has been reported. | At Week 76 |
| Time to Onset of CRR | CRR was defined as an achievement of all the following criteria: UPCR <0.5 g/g; eGFR >=85% of baseline, as calculated using the CKD-EPI equation and no occurrence of intercurrent events of rescue therapy, treatment failure, death or early study withdrawal. Participants who experienced the intercurrent events before achieving CRR as well as participants who completed 76-week treatment period without experiencing CRR were censored at Week 76. Summary statistics of time to onset of CRR are Kaplan-Meier estimates. A log-rank test was used to compare obinutuzumab and placebo. The median time to onset of CRR was greater than Week 76 due to considering the upper limit of the Week 76 analysis visit window in this analysis. The upper limit of the Week 76 visit window was 3 days prior to the next obinutuzumab or placebo infusion or 30 days beyond Week 76 whichever is shorter. | From baseline (Day 1) up to 80.3 weeks |
| Percentage of Participants Who Achieve CRR With Serum Creatinine Criteria | CRR with serum creatinine criteria was defined as achievement of all the following criteria: UPCR <0.5 g/g; Serum creatinine ≤ ULN, as determined by the central laboratory; serum creatinine not increased from baseline by > 25% and no occurrence of intercurrent events of rescue therapy, treatment failure, death or early study withdrawal. Analysis was performed using CMH test adjusting for the stratification factors region and race. Percentage have been rounded off. | At Week 76 |
| Number of Participants With Adverse Events (AEs) | An AE was 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 AE can therefore be any unfavorable and unintended sign (including abnormal laboratory values or abnormal clinical test results), symptoms, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. | Up to Week 76 |
| Number of Participants With Adverse Events of Special Interest (AESIs) | An AE was any untoward medical occurrence in participant administered a pharmaceutical product & which does not necessarily have to have a causal relationship with treatment. It can therefore be any unfavorable & unintended sign (including abnormal laboratory values/ abnormal clinical test results), symptoms, or disease temporally associated with use of pharmaceutical product, whether or not considered related to product. AESIs included potential drug-induced liver injury that include an elevated alanine transaminase (ALT) & aspartate aminotransferase (AST) in combination with either an elevated bilirubin or clinical jaundice defined by Hy's law; suspected transmission of an infectious agent by study drug; infusion-related reactions (IRRs); grade 3/higher infections; any hepatitis B reactivation and progressive multifocal leukoencephalopathy (PML); drug-related neutropenia; drug-related thrombocytopenia; gastrointestinal perforations and worsening of pre-existing cardiac conditions | Up to Week 76 |
| Number of Participants With Anti-Drug Antibodies (ADAs) Positive Post-Treatment | Determination of anti-obinutuzumab antibodies in serum samples were performed using a validated enzyme-linked Immunosorbent Assay (ELISA) method. Participants were considered to be ADA positive if they were ADA negative or have missing data at baseline but develop an ADA response following study drug exposure (treatment-induced ADA response), or if they were ADA positive at baseline and the titer of one or more post baseline samples was at least ≥ 4-fold greater than the titer of the baseline sample (treatment-enhanced ADA response). | Up to approximately 11 years |
| Total Peripheral B-Cell (CD19) Count | Up to approximately 11 years |
| Concentration of Obinutuzumab in Serum | Up to approximately 11 years |
| Beverly Hills |
| California |
| 90211 |
| United States |
| Kaiser Permanente - Fontana | Fontana | California | 92335 | United States |
| Kaiser Permanente - San Francisco Medical Center | San Francisco | California | 94118 | United States |
| Stanford University Medical Center | Stanford | California | 94305 | United States |
| Univ Colorado Health Sci Ctr | Aurora | Colorado | 80045 | United States |
| Yale Medical Group | New Haven | Connecticut | 06520 | United States |
| University of Miami Miller School of Medicine | Miami | Florida | 33136 | United States |
| Georgia Nephrology | Lawrenceville | Georgia | 30046 | United States |
| North Shore University Hospital | Manhasset | New York | 11030 | United States |
| NYU Langone Medical Center | New York | New York | 10016 | United States |
| Columbia University Medical Center | New York | New York | 10032 | United States |
| AD-CARE, University of Rochester Medical Center | Rochester | New York | 14620 | United States |
| The Ohio State University Wexner Medical Center | Columbus | Ohio | 43212 | United States |
| Oklahoma Medical Research Foundation | Oklahoma City | Oklahoma | 73104 | United States |
| University of Texas Southwestern | Dallas | Texas | 75390-8897 | United States |
| Southwest Rheumatology | Mesquite | Texas | 75150 | United States |
| University of Utah Health Science center | Salt Lake City | Utah | 84113 | United States |
| Organizacion Medica de Investigacion | Buenos Aires | C1015ABO | Argentina |
| DOM Centro de ReumatologÃa | Buenos Aires | C1111AAJ | Argentina |
| Sanatorio Allende | Córdoba | X5000JHQ | Argentina |
| Ser Servicos Especializados Em Reumatologia | Salvador | Estado de Bahia | 40150-150 | Brazil |
| Instituto Pro-Renal | Curitiba | Paraná | 80440-020 | Brazil |
| Hospital das Clinicas - FMUSP Ribeirao Preto | Ribeirão Preto | São Paulo | 14048-900 | Brazil |
| Centro Multidisciplinar de Estudos ClÃnicos - CEMEC*X* | Santo André | São Paulo | 09190-510 | Brazil |
| Hospital das Clinicas - FMUSP | São Paulo | São Paulo | 05403-000 | Brazil |
| Clinica De La Costa | Barranquilla | Colombia |
| Hospital Universitario San Ignacio | Bogotá | 000472 | Colombia |
| Hospital Pablo Tobon Uribe | MedellÃn | 050034 | Colombia |
| Hopital Henri Mondor | Créteil | 94010 | France |
| Hopital Claude Huriez | Lille | 59037 | France |
| Groupe Hospitalier Pitie-Salpetriere | Paris | 75651 | France |
| Hopital Bichat Claude Bernard | Paris | 75877 | France |
| Hopital Rangueil | Toulouse | 31059 | France |
| Charité Campus Mitte, Med.Klinik, Rheumatologie und Klinische Immunologie | Berlin | 10117 | Germany |
| Städtisches Klinik Dresden-Friedrichstadt | Dresden | 01067 | Germany |
| Universitätsklinikum "Carl Gustav Carus" | Dresden | 01307 | Germany |
| Universitätsklinikum Freiburg | Freiburg im Breisgau | 79106 | Germany |
| Universitaetsmedizin Johannes Gutenberg | Mainz | 55131 | Germany |
| Universitätskrankenhaus Tübingen | Tübingen | 72076 | Germany |
| Meir Medical Center | Kfar Saba | 4428164 | Israel |
| Rabin MC- Belinson campus | Petah Tikva | 49100 | Israel |
| Chaim Sheba Medical Center | Ramat Gan | 5262000 | Israel |
| Sourasky Medical Centre | Tel Aviv | 64239 | Israel |
| Policlinico di Bari | Bari | Apulia | 70124 | Italy |
| Ospedale Policlinico San Martino | Genoa | Liguria | 16132 | Italy |
| A.O. Spedali Civili Di Brescia-P.O. Spedali Civili | Brescia | Lombardy | 25123 | Italy |
| Azienda Ospedaliera Universitaria Careggi | Florence | Tuscany | 50141 | Italy |
| Azienda Ospedaliera di Padova | Padova | Veneto | 35128 | Italy |
| Centro de Investigación y Tratamiento Reumatológico S.C. | Mexico City | Mexico CITY (federal District) | 11850 | Mexico |
| Instituto Nacional de Ciencias Médicas Y de La Nutricion Zubirán | Mexico City | Mexico CITY (federal District) | Tlalpan 14000 | Mexico |
| Hospital Universitario | Monterrey | Nuevo León | 64460 | Mexico |
| Instituto Peruano del Hueso y la Articulación | Lima | 15046 | Peru |
| ClÃnica San Juan Bautista CSJB | Lima | 15431 | Peru |
| Instituto del Cerebro y la Columna Vertebral SAC | Lima | Lima 18 | Peru |
| Instituto de GinecologÃa y Reproducción | Lima | Peru |
| Hospital Nacional Cayetano Heredia | San MartÃn de Porres | 15102 | Peru |
| Uniwersytecki Szpital Kliniczny nr 4 w Lublinie | Lublin | 20-954 | Poland |
| Medyczne Centrum Hetmanska | Poznan | 60-218 | Poland |
| Ortopedyczno Rehab Szpital Klinic im Wiktora Degi UM | Poznan | 61-545 | Poland |
| Szpital Kliniczny Dzieciatka Jezus | Warsaw | 02-006 | Poland |
| Rheuma Medicus Zaklad Opieki Zdrowotnej | Warsaw | 02-118 | Poland |
| Narodowy Instytut Geriatrii, Reumatologii i Rehabilitacji im. Prof. Eleonory Reicher | Warsaw | 02-637 | Poland |
| Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wroclawiu | Wroclaw | 50-556 | Poland |
| Federal State Budgetary Scientific Institution Research Institute of Rheumatology V.A. Nasonova | Moscow | Moscow Oblast | 115522 | Russia |
| Federal Centre of Heart, Blood and Endocrinology n.a. V.A.Almazov | Saint Petersburg | Sankt-Peterburg | 197341 | Russia |
| ?Kazan (Privolzhsky) Federal University? | Kazan' | Tatarstan Republic | 420043 | Russia |
| SBEI HPE "The First St.Petersburg State Medical University n.a. acad. I.P.Pavlova"of MoH of RF | Saint Petersburg | 197022 | Russia |
| Groote Schuur Hospital and University of Cape Town | Cape Town | 7925 | South Africa |
| Hospital Universitario Vall d'Hebron | Barcelona | 08035 | Spain |
| Hospital Clinic i Provincial | Barcelona | 08036 | Spain |
| Hospital Ramon y Cajal | Madrid | 28034 | Spain |
| Hospital Universitario 12 de Octubre | Madrid | 28041 | Spain |
| Cambridge University Hospitals NHS Foundation Trust - Addenbrookes Hospital | Cambridge | CB2 0QQ | United Kingdom |
| Derived |
| Avasare R, Drexler Y, Caster DJ, Mitrofanova A, Jefferson JA. Management of Lupus Nephritis: New Treatments and Updated Guidelines. Kidney360. 2023 Oct 1;4(10):1503-1511. doi: 10.34067/KID.0000000000000230. |
| 33693991 | Derived | Dossier C, Hogan J. Response to Majeranowski. Pediatr Nephrol. 2021 Jun;36(6):1653. doi: 10.1007/s00467-021-04982-4. Epub 2021 Mar 10. No abstract available. |
| FG001 | Placebo | Participants received Obinutuzumab matching placebo as an IV infusion on Day 1 and Weeks 2, 24, 26, 50, and 52. Participants also received SOC therapy and MMF. Participants with adequate response at Week 76 continued to receive placebo at Week 80 and Q6M thereafter. The dose of MMF can be adjusted at the investigator's discretion beginning at Week 80. |
| Safety Population | Safety evaluable population included all participants who received any part of blinded infusion of Obinutuzumab/placebo & are grouped according to treatment they received. 3 participants from placebo arm were excluded from the safety analysis as they received no treatment post-randomization. 1 participant randomized to the placebo arm received obinutuzumab & was included in the obinutuzumab arm for safety analysis. |
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| Completed Week 76 Assessment |
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| COMPLETED |
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| NOT COMPLETED |
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Efficacy population included all randomized participants regardless of whether they received study drug. As pre-specified in the SAP, demographic and baseline characteristics were to be provided for obinutuzumab (combined treatment groups) and placebo groups.
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| ID | Title | Description |
|---|---|---|
| BG000 | Obinutuzumab | Participants received obinutuzumab, 1000 mg as an IV infusion on Day 1 and Weeks 2, 24, 26, and either Weeks 50 and 52 or Week 52 only, along with MMF and SOC therapy. Placebo was administered at Week 50 for participants not treated with obinutuzumab. Participants with adequate response at Week 76 continued to receive obinutuzumab at Week 80 and Q6M thereafter. The dose of MMF can be adjusted at the investigator's discretion beginning at Week 80. |
| BG001 | Placebo | Participants received Obinutuzumab matching placebo as an IV infusion on Day 1 and Weeks 2, 24, 26, 50, and 52. Participants also received SOC therapy and MMF. Participants with adequate response at Week 76 continued to receive placebo at Week 80 and Q6M thereafter. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | Percentage of Participants With Complete Renal Response (CRR) | CRR was defined as an achievement of all the following criteria: urinary protein-to-creatinine ratio (UPCR) <0.5 gram/gram (g/g); estimated glomerular filtration rate (eGFR) >=85% of baseline, as calculated using the chronic kidney disease epidemiology collaboration (CKD-EPI) equation and no occurrence of intercurrent events of rescue therapy, treatment failure, death or early study withdrawal. Obinutuzumab and placebo were compared using Cochran-Mantel-Haenszel (CMH) test adjusting for the stratification factors region and race. Missing data was imputed by multiple imputations using fully conditional specification (FCS) predicted mean matching method. Percentage have been rounded off. | Efficacy population included all randomized participants regardless of whether they received study drug. As pre-specified in the SAP, all the endpoints were to be compared between the obinutuzumab (combined treatment groups) and placebo groups. | Posted | Number | 95% Confidence Interval | percentage of participants | At Week 76 |
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| Secondary | Percentage of Participants Who Achieve CRR With Successful Prednisone Taper at Week 76 | CRR with successful prednisone was defined as the achievement of CRR at Week 76 with no receipt of prednisone >7.5 milligrams per day (mg/day) (or equivalent) from Week 64 through Week 76. CRR was defined as achievement of all the following criteria: UPCR <0.5 g/g; eGFR >=85% of baseline, as calculated using the CKD-EPI equation and no occurrence of intercurrent events of rescue therapy, treatment failure, death or early study withdrawal. Analysis was performed using CMH test adjusting for the stratification factors region and race. Missing data was imputed by multiple imputations using FCS predicted mean matching method. Percentage have been rounded off. | Efficacy population included all randomized participants regardless of whether they received study drug. As pre-specified in the SAP, all the endpoints were to be compared between the obinutuzumab (combined treatment groups) and placebo groups. | Posted | Number | 95% Confidence Interval | percentage of participants | At Week 76 |
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| Secondary | Percentage of Participants Who Achieve a Proteinuric Response | Proteinuric response was defined as an achievement of all the following criteria: UPCR <0.8 g/g and no occurrence of intercurrent events of rescue therapy, treatment failure, death or early study withdrawal. Analysis was performed using CMH test adjusting for the stratification factors region and race. Missing data was imputed by multiple imputations using FCS predicted mean matching method. Percentage have been rounded off. | Efficacy population included all randomized participants regardless of whether they received study drug. As pre-specified in the SAP, all the endpoints were to be compared between the obinutuzumab (combined treatment groups) and placebo groups. | Posted | Number | 95% Confidence Interval | percentage of participants | At Week 76 |
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| Secondary | Mean Change in eGFR | Change in eGFR from baseline to Week 76 was analyzed using Analysis of Covariance (ANCOVA) model with covariates baseline eGFR and the stratification factors race and region. Death was considered as an intercurrent event which was handled under composite strategy by imputing data after death with 0. Missing data was imputed by multiple imputations using FCS predicted mean matching method. mL/min/1.73 m^2 = milliliters per minute per 1.73 square meters. Adjusted mean has been reported. | Efficacy population included all randomized participants regardless of whether they received study drug. As pre-specified in the SAP, all the endpoints were to be compared between the obinutuzumab (combined treatment groups) and placebo groups. | Posted | Mean | Standard Error | mL/min/1.73 m^2 | At Week 76 |
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| Secondary | Percentage of Participants Who Experience Death or Renal-related Events | Percentage of participants with death or renal-related events were defined as participants with one or more of the following events: Death; Treatment failure; Worsening proteinuria, defined as a confirmed ≥50% increase in UPCR to a value ≥3 g/g; Worsening eGFR, defined as a confirmed ≥30% decrease in eGFR to a value <60. Early study withdrawal due to lack of efficacy was an intercurrent event. Participants experiencing the intercurrent event were considered as participants with events under composite strategy. Analysis was performed using CMH test adjusting for the stratification factors region and race. Missing data was imputed by multiple imputations using FCS predicted mean matching method. Percentages have been rounded off. | Efficacy population included all randomized participants regardless of whether they received study drug. As pre-specified in the SAP, all the endpoints were to be compared between the obinutuzumab (combined treatment groups) and placebo groups. | Posted | Number | 95% Confidence Interval | percentage of participants | From Day 1 to Week 76 |
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| Secondary | Percentage of Participants Who Achieve an Overall Renal Response (ORR) | ORR was defined as achievement of either CRR or PRR. CRR was defined as achievement of all of the criteria: UPCR <0.5 g/g; eGFR ≥85% of baseline, as calculated using the CKD-EPI equation. PRR was defined as achievement of all of the following criteria: ≥50% reduction in UPCR from baseline; UPCR <1 g/g (or <3 g/g if the baseline UPCR was ≥3 g/g); eGFR ≥85% of baseline, as calculated using the CKD-EPI equation and no occurrence of intercurrent events of rescue therapy, treatment failure, death or early study withdrawal. Analysis was performed using CMH test adjusting for the stratification factors region and race. Missing data was imputed by multiple imputations using FCS predicted mean matching method. Percentage have been rounded off. | Efficacy population included all randomized participants regardless of whether they received study drug. As pre-specified in the SAP, all the endpoints were to be compared between the obinutuzumab (combined treatment groups) and placebo groups. | Posted | Number | 95% Confidence Interval | percentage of participants | At Week 50 |
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| Secondary | Change From Baseline in Fatigue Assessed Using Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Scale | The FACIT-F is a 13-item questionnaire that assesses self-reported fatigue and its impact upon daily activities and function. Participants scored each item on a 5-point scale: 0 (Not at all) to 4 (Very much). The sum of all responses resulted in the FACIT-F score of 0 (worse score) to 52 (better score). Higher scores indicate less fatigue. Change in FACIT-F score from baseline at Week 76 was analyzed using ANCOVA model with covariates baseline FACIT-F score and the stratification factors race and region. Death was considered as an intercurrent event which was handled under composite strategy by imputing FACIT-F score after death with 0. Missing data was imputed by multiple imputations using FCS predicted mean matching method. Adjusted mean has been reported. | Efficacy population included all randomized participants regardless of whether they received study drug. As pre-specified in the SAP, all the endpoints were to be compared between the obinutuzumab (combined treatment groups) and placebo groups. | Posted | Mean | Standard Error | score on a scale | At Week 76 |
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| Secondary | Change in Log-transformed Anti-double-stranded Deoxyribonucleic Acid (Anti-dsDNA) Titer | Anti-dsDNA are types of autoantibodies produced by the immune system and are indicators of lupus. Anti-dsDNA data was log-transformed before analysis. Missing data was imputed by multiple imputations using FCS predicted mean matching method. Analysis was performed using ANCOVA. Death was considered as an intercurrent event which was handled under composite strategy by imputing data after death with upper limit of quantification (ULOQ, 890 international units/milliliter [IU/mL]). Adjusted mean has been reported. | Efficacy population included all randomized participants regardless of whether they received study drug. As pre-specified in the SAP, all the endpoints were to be compared between the obinutuzumab (combined treatment groups) and placebo groups. | Posted | Mean | Standard Error | Log (IU/mL) | At Week 50 |
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| Secondary | Change in Complement C3 | C3 is a marker of inflammation. Analysis was performed using ANCOVA. Death was considered as an intercurrent event which was handled under composite strategy by imputing data after death with lower limit of quantification (LLOQ)/2 under composite strategy. LLOQ at the central lab was set for C3 at 0.100 grams/liters (g/L). Missing data was imputed by multiple imputations using FCS predicted mean matching method. Adjusted mean has been reported. | Efficacy population included all randomized participants regardless of whether they received study drug. As pre-specified in the SAP, all the endpoints were to be compared between the obinutuzumab (combined treatment groups) and placebo groups. | Posted | Mean | Standard Error | g/L | At Week 50 |
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| Secondary | Change in Systematic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) | The SLEDAI-2K is a 24-item instrument that evaluates clinical symptoms and laboratory markers across nine organ systems and was used to capture changes in lupus-related disease activity. SLE manifestations are assessed by the clinician if present within the last 30 days and added to determine the total SLEDAI-2K score, which ranges from 0 to 105. Higher scores indicate increased disease activity. The analysis was performed using ANCOVA. Death was considered as an intercurrent event which was handled under composite strategy by imputing data after death with 105, the highest possible score. Missing data was imputed by multiple imputations using FCS predicted mean matching method. Adjusted mean has been reported. | Efficacy population included all randomized participants regardless of whether they received study drug. As pre-specified in the SAP, all the endpoints were to be compared between the obinutuzumab (combined treatment groups) and placebo groups. | Posted | Mean | Standard Error | score on a scale | At Week 76 |
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| Secondary | Time to Onset of CRR | CRR was defined as an achievement of all the following criteria: UPCR <0.5 g/g; eGFR >=85% of baseline, as calculated using the CKD-EPI equation and no occurrence of intercurrent events of rescue therapy, treatment failure, death or early study withdrawal. Participants who experienced the intercurrent events before achieving CRR as well as participants who completed 76-week treatment period without experiencing CRR were censored at Week 76. Summary statistics of time to onset of CRR are Kaplan-Meier estimates. A log-rank test was used to compare obinutuzumab and placebo. The median time to onset of CRR was greater than Week 76 due to considering the upper limit of the Week 76 analysis visit window in this analysis. The upper limit of the Week 76 visit window was 3 days prior to the next obinutuzumab or placebo infusion or 30 days beyond Week 76 whichever is shorter. | Efficacy population included all randomized participants regardless of whether they received study drug. As pre-specified in the SAP, all the endpoints were to be compared between the obinutuzumab (combined treatment groups) and placebo groups. | Posted | Median | 95% Confidence Interval | weeks | From baseline (Day 1) up to 80.3 weeks |
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| Secondary | Percentage of Participants Who Achieve CRR With Serum Creatinine Criteria | CRR with serum creatinine criteria was defined as achievement of all the following criteria: UPCR <0.5 g/g; Serum creatinine ≤ ULN, as determined by the central laboratory; serum creatinine not increased from baseline by > 25% and no occurrence of intercurrent events of rescue therapy, treatment failure, death or early study withdrawal. Analysis was performed using CMH test adjusting for the stratification factors region and race. Percentage have been rounded off. | Efficacy population included all randomized participants regardless of whether they received study drug. As pre-specified in the SAP, all the endpoints were to be compared between the obinutuzumab (combined treatment groups) and placebo groups. | Posted | Number | 95% Confidence Interval | percentage of participants | At Week 76 |
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| Secondary | Number of Participants With Adverse Events (AEs) | An AE was 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 AE can therefore be any unfavorable and unintended sign (including abnormal laboratory values or abnormal clinical test results), symptoms, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. | Safety evaluable population included all participants who received any part of blinded infusion of obinutuzumab or placebo and were grouped according to the treatment they actually received rather than the treatment assigned. As pre-specified in the SAP, safety data were to be provided for obinutuzumab (combined treatment groups) and placebo groups. | Posted | Count of Participants | Participants | Up to Week 76 |
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| Secondary | Number of Participants With Adverse Events of Special Interest (AESIs) | An AE was any untoward medical occurrence in participant administered a pharmaceutical product & which does not necessarily have to have a causal relationship with treatment. It can therefore be any unfavorable & unintended sign (including abnormal laboratory values/ abnormal clinical test results), symptoms, or disease temporally associated with use of pharmaceutical product, whether or not considered related to product. AESIs included potential drug-induced liver injury that include an elevated alanine transaminase (ALT) & aspartate aminotransferase (AST) in combination with either an elevated bilirubin or clinical jaundice defined by Hy's law; suspected transmission of an infectious agent by study drug; infusion-related reactions (IRRs); grade 3/higher infections; any hepatitis B reactivation and progressive multifocal leukoencephalopathy (PML); drug-related neutropenia; drug-related thrombocytopenia; gastrointestinal perforations and worsening of pre-existing cardiac conditions | Safety evaluable population included all participants who received any part of blinded infusion of obinutuzumab or placebo and were grouped according to the treatment they actually received rather than the treatment assigned. As pre-specified in the SAP, safety data were to be provided for obinutuzumab (combined treatment groups) and placebo groups. | Posted | Count of Participants | Participants | Up to Week 76 |
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| Secondary | Number of Participants With Anti-Drug Antibodies (ADAs) Positive Post-Treatment | Determination of anti-obinutuzumab antibodies in serum samples were performed using a validated enzyme-linked Immunosorbent Assay (ELISA) method. Participants were considered to be ADA positive if they were ADA negative or have missing data at baseline but develop an ADA response following study drug exposure (treatment-induced ADA response), or if they were ADA positive at baseline and the titer of one or more post baseline samples was at least ≥ 4-fold greater than the titer of the baseline sample (treatment-enhanced ADA response). | Not Posted | Feb 2029 | Up to approximately 11 years | Participants | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Total Peripheral B-Cell (CD19) Count | Not Posted | Feb 2032 | Up to approximately 11 years | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Concentration of Obinutuzumab in Serum | Not Posted | Feb 2032 | Up to approximately 11 years | Participants |
Up to Week 76 Data collected up to the primary completion date (Up to Week 76) is reported. Data collection post Week 76 is still ongoing. Final data will be reported 1 year after the study completion date. As pre-specified in the SAP, safety data were to be provided for obinutuzumab (combined treatment groups) and placebo groups. AE data were collected for all Obinutuzumab participants together, without regard to or information of the specific Obinutuzumab group participants they were part of.
Safety evaluable population=all participants who received any part of blinded infusion of Obinutuzumab/placebo & are grouped according to treatment they received. 3 participants from placebo arm did not receive treatment & were excluded from the safety analysis. 1 participant randomized to placebo arm received obinutuzumab & was included in obinutuzumab arm for safety analysis. Includes AEs until point of rescue for participants who received rescue therapy (except corticosteroid-only rescue).
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Obinutuzumab | Participants received obinutuzumab, 1000 mg as an IV infusion on Day 1 and Weeks 2, 24, 26, and either Weeks 50 and 52 or Week 52 only, along with MMF and SOC therapy. Placebo was administered at Week 50 for participants not treated with obinutuzumab. Participants with adequate response at Week 76 continued to receive obinutuzumab at Week 80 and Q6M thereafter. The dose of MMF can be adjusted at the investigator's discretion beginning at Week 80. | 5 | 136 | 44 | 136 | 107 | 136 |
| EG001 | Placebo | Participants received Obinutuzumab matching placebo as an IV infusion on Day 1 and Weeks 2, 24, 26, 50, and 52. Participants also received SOC therapy and MMF. Participants with adequate response at Week 76 continued to receive placebo at Week 80 and Q6M thereafter. | 4 | 132 | 24 | 132 | 94 | 132 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Acute coronary syndrome | Cardiac disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Pericardial effusion | Cardiac disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Scintillating scotoma | Eye disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Anal inflammation | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Gastric ulcer haemorrhage | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Gastritis erosive | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Large intestinal stenosis | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Small intestinal obstruction | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Cholecystitis | Hepatobiliary disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Cholecystitis acute | Hepatobiliary disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Bacterial diarrhoea | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Bacterial infection | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| COVID-19 pneumonia | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Device related bacteraemia | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Gastroenteritis viral | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Herpes zoster | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Peritonsillar abscess | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Pneumonia bacterial | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Post-acute COVID-19 syndrome | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Pyelonephritis | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Pyelonephritis acute | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Respiratory tract infection | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Tooth abscess | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Urethritis | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Urosepsis | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Craniocerebral injury | Injury, poisoning and procedural complications | MedDRA 27.0 | Systematic Assessment |
| |
| Infusion related reaction | Injury, poisoning and procedural complications | MedDRA 27.0 | Systematic Assessment |
| |
| Joint dislocation | Injury, poisoning and procedural complications | MedDRA 27.0 | Systematic Assessment |
| |
| Radius fracture | Injury, poisoning and procedural complications | MedDRA 27.0 | Systematic Assessment |
| |
| Tendon rupture | Injury, poisoning and procedural complications | MedDRA 27.0 | Systematic Assessment |
| |
| Neutrophil count decreased | Investigations | MedDRA 27.0 | Systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA 27.0 | Systematic Assessment |
| |
| Intervertebral disc disorder | Musculoskeletal and connective tissue disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Intervertebral disc protrusion | Musculoskeletal and connective tissue disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Osteonecrosis | Musculoskeletal and connective tissue disorders | MedDRA 27.0 | Systematic Assessment |
| |
| B-cell lymphoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 27.0 | Systematic Assessment |
| |
| Vulvovaginal warts | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 27.0 | Systematic Assessment |
| |
| Autoimmune encephalopathy | Nervous system disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Nephrotic syndrome | Renal and urinary disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Proteinuria | Renal and urinary disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Cervical dysplasia | Reproductive system and breast disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Organising pneumonia | Respiratory, thoracic and mediastinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Hypertensive urgency | Vascular disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Peripheral venous disease | Vascular disorders | MedDRA 27.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Herpes zoster | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Infusion related reaction | Injury, poisoning and procedural complications | MedDRA 27.0 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 27.0 | Systematic Assessment |
|
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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Communications | Hoffmann-La Roche | 800 821-8590 | genentech@druginfo.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jul 19, 2024 | Aug 13, 2025 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D008181 | Lupus Nephritis |
| 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 |
Not provided
Not provided
| ID | Term |
|---|---|
| C543332 | obinutuzumab |
| D011241 | Prednisone |
| D008775 | Methylprednisolone |
| D000082 | Acetaminophen |
| D004155 | Diphenhydramine |
| ID | Term |
|---|---|
| D011244 | Pregnadienediols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D011239 | Prednisolone |
| D011246 | Pregnadienetriols |
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
| D000588 | Amines |
| D005021 | Ethylamines |
| D001559 | Benzhydryl Compounds |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
Not provided
Not provided
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Placebo |
Participants received Obinutuzumab matching placebo as an IV infusion on Day 1 and Weeks 2, 24, 26, 50, and 52. Participants also received SOC therapy and MMF. Participants with adequate response at Week 76 continued to receive placebo at Week 80 and Q6M thereafter. |
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| OG001 |
| Placebo |
Participants received Obinutuzumab matching placebo as an IV infusion on Day 1 and Weeks 2, 24, 26, 50, and 52. Participants also received SOC therapy and MMF. Participants with adequate response at Week 76 continued to receive placebo at Week 80 and Q6M thereafter. |
|
|
|
| OG001 |
| Placebo |
Participants received Obinutuzumab matching placebo as an IV infusion on Day 1 and Weeks 2, 24, 26, 50, and 52. Participants also received SOC therapy and MMF. Participants with adequate response at Week 76 continued to receive placebo at Week 80 and Q6M thereafter. |
|
|
|
| OG001 | Placebo | Participants received Obinutuzumab matching placebo as an IV infusion on Day 1 and Weeks 2, 24, 26, 50, and 52. Participants also received SOC therapy and MMF. Participants with adequate response at Week 76 continued to receive placebo at Week 80 and Q6M thereafter. |
|
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|
|
|
|
|
|
|
| Placebo |
Participants received Obinutuzumab matching placebo as an IV infusion on Day 1 and Weeks 2, 24, 26, 50, and 52. Participants also received SOC therapy and MMF. Participants with adequate response at Week 76 continued to receive placebo at Week 80 and Q6M thereafter. |
|
|
|
| OG001 | Placebo | Participants received Obinutuzumab matching placebo as an IV infusion on Day 1 and Weeks 2, 24, 26, 50, and 52. Participants also received SOC therapy and MMF. Participants with adequate response at Week 76 continued to receive placebo at Week 80 and Q6M thereafter. |
|
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|
| OG001 | Placebo | Participants received Obinutuzumab matching placebo as an IV infusion on Day 1 and Weeks 2, 24, 26, 50, and 52. Participants also received SOC therapy and MMF. Participants with adequate response at Week 76 continued to receive placebo at Week 80 and Q6M thereafter. |
|
|