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

Primary Purpose

Lupus Nephritis

Status

Active

Phase

Phase 2

Locations

International

Study Type

Interventional

Intervention

Mycophenolate Mofetil/Mycophenolic Acid

Obinutuzumab

Placebo

Methylprednisolone

Prednisone

About this trial

This is an interventional treatment trial for Lupus Nephritis

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Univ of California, San Diego
Stanford University Medical Center
Emory Uni ; Division of Rheumatology
Suny Downstate Medical Center; Rheumatology
North Shore - Long Island Jewish Hospital Health System; Rheumatology & Allergy- Clinical Immunology
Columbia University Medical Center
Ohio State University; Division of Nephrology
Cemic; Haematology
CER San Juan Centro Polivalente de Asistencia e Investigacion Clinica
Organizacion Medica de Investigacion
Ser Servicos Especializados Em Reumatologia
Hospital das Clinicas - UFMG
Centro Mineiro de Pesquisa - CMIP
Instituto Scribner.
LMK Serviços Médicos S/S
Universidade Federal de Sao Paulo - UNIFES
Clinica De La Costa
Hospital Universitario San Ignacio
Riesgo De Fractura; Rheumatology
Hospital Pablo Tobon Uribe
Hospital Clinica Catolica
HOPITAL HENRI MONDOR; SERVICE DE Nephrologie
Hopital Claude Huriez; Internal Medicine
Hopital europeen Marseille; Service de medecine interne
Groupe Hospitalier Pitie-Salpetriere; Service de Medecine Interne Ii
Hopital Bichat Claude Bernard; Nephrologie
Hopital Rangueil; Service de Nephrologie & D'Immunologie Clinique
Rambam Medical Center; Rheumatology
Beilinson Medical Center; Rheumatology
Sheba Medical Center; Tel Hashomer
Ospedale San Giovanni Bosco; entro di Ricerche di Immunopatologia e Documentazione su Malattie Rare
Azienda Ospedaliera di Padova; Dipartimento di Medicina - UOC di Reumatologia
Unidad de Reumatologia Rehabilitacion Integral; Centro Medico Del Angel
Unidad de Investigacion en Enfermedades Cronico-Degenerativa; Reumatologia
Centro de Estudios de Investigacion Basica Y Clinica S.C.; Reumatologia
Instituto Nacional de Ciencias Médicas Y de La Nutricion Zubirán
Hospital General De Mexico; Rheumatology
Centro de Investigación Clínica de Morelia S.C.
Centro de Investigación de Tratamientos Innovadores de Sinaloa (CITI)
Trial Labs
Instituto de Ginecología y Reproducción
Centro de Investigación Delgado; Clinica Delgado
Centro de Investigaciones Medicas/Hospital Maria Auxiliadora
Hospital Nacional Cayetano Heredia; Rheumatology
Hospital Clinic i Provincial; Servicio de Nefrologia
Hospital Regional Universitario Carlos Haya; Servicio de Reumatologia

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Obinutuzumab

Placebo

Arm Description

Participants will receive obinutuzumab 1000 milligrams (mg) intravenous (IV) infusion on Days 1, 15, 168, and 182 along with MMF/MPA at a starting dose of 1500 mg/day (or equivalent) administered orally in 2 or 3 divided doses. MMF/MPA dose will be up titrated to a target dose of 2.0 - 2.5 grams per day (g/day) (or equivalent). Investigators, at their discretion, may use MPA as a substitute for MMF, with a 360 mg dose being equivalent to a 500 mg dose of MMF. During screening or at randomization, if clinically indicated, participants may receive 750-1000 mg methylprednisolone IV once daily for up to 3 days to treat underlying LN clinical activity. Participants will receive 0.5 mg/kg oral prednisone, tapering this prednisone dose, per protocol, starting on Day 16 and reducing the prednisone dosage to 7.5 mg/day by Week 12.

Participants will receive placebo matching to obinutuzumab IV infusion on Days 1, 15, 168, and 182 along with MMF/MPA at a starting dose of 1500 mg/day (or equivalent) administered orally in 2 or 3 divided doses. MMF/MPA dose will be up titrated to a target dose of 2.0 - 2.5 g/day (or equivalent). Investigators, at their discretion, may use MPA as a substitute for MMF, with a 360 mg dose being equivalent to a 500 mg dose of MMF. During screening or at randomization, if clinically indicated, participants may receive 750-1000 mg methylprednisolone IV once daily for up to 3 days to treat underlying LN clinical activity. Participants will receive 0.5 mg/kg oral prednisone, tapering this prednisone dose, per protocol, starting on Day 16 and reducing the prednisone dosage to 7.5 mg/day by Week 12.

Outcomes

Primary Outcome Measures

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 ≤ the ULN range of central laboratory values.

Secondary Outcome Measures

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.

Percentage of Participants With First Protocol Defined Overall Response Over the Course of 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.

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.

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.

Percentage of Participants With First Protocol Defined CRR Over the Course of 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.

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 antibodies targeting double stranded DNA.

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.

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.

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.

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.

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.

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.

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.

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

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

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.

Maximum Observed Plasma Concentration (Cmax) of Obinutuzumab

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

Systemic Clearance of Obinutuzumab

Volume of Distribution Under Steady State (Vss) of Obinutuzumab

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

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.

Full Information

NCT ID

NCT02550652

First Posted

September 14, 2015

Last Updated

July 27, 2023

Sponsor

Hoffmann-La Roche

1. Study Identification

Unique Protocol Identification Number

NCT02550652

Brief Title

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

Official Title

A Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study to Evaluate the Safety and Efficacy of Obinutuzumab in Patients With ISN/RPS 2003 Class III or IV Lupus Nephritis

Study Type

Interventional

2. Study Status

Record Verification Date

July 2023

Overall Recruitment Status

Active, not recruiting

Study Start Date

November 13, 2015 (Actual)

Primary Completion Date

January 15, 2019 (Actual)

Study Completion Date

October 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Hoffmann-La Roche

4. Oversight

5. Study Description

Brief Summary

This Phase II study will compare the efficacy and safety of obinutuzumab plus mycophenolate mofetil (MMF)/mycophenolic acid (MPA) with placebo plus MMF/MPA in participants with proliferative LN.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Lupus Nephritis

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

126 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Obinutuzumab

Arm Type

Experimental

Arm Description

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Intervention Type

Drug

Intervention Name(s)

Mycophenolate Mofetil/Mycophenolic Acid

Intervention Description

MMF/MPA will be administered as per schedule specified in the respective arm.

Intervention Type

Drug

Intervention Name(s)

Obinutuzumab

Other Intervention Name(s)

Gazyva, GA101, RO5072759

Intervention Description

Obinutuzumab will be administered as per schedule specified in the respective arm.

Intervention Type

Other

Intervention Name(s)

Placebo

Intervention Description

Placebo matching to obinutuzumab will be administered as per schedule specified in the respective arm.

Intervention Type

Drug

Intervention Name(s)

Methylprednisolone

Intervention Description

Methylprednisolone IV will be administered as per schedule specified in the respective arm.

Intervention Type

Drug

Intervention Name(s)

Prednisone

Intervention Description

Prednisone will be administered as per schedule specified in the respective arm.

Primary Outcome Measure Information:

Title

Percentage of Participants Who Achieve Protocol Defined Complete Renal Response (CRR) at Week 52

Description

Time Frame

From baseline to Week 52

Secondary Outcome Measure Information:

Title

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

Description

Time Frame

From baseline to Week 52

Title

Percentage of Participants With First Protocol Defined Overall Response Over the Course of 52 Weeks

Description

Time Frame

From baseline to Week 52

Title

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

Description

Time Frame

From baseline to Week 52

Title

Percentage of Participants Who Achieve Protocol Defined CRR at Week 24

Description

Time Frame

Week 24

Title

Percentage of Participants With First Protocol Defined CRR Over the Course of 52 Weeks

Description

Time Frame

From Baseline to Week 52

Title

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

Description

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

Time Frame

Baseline and Week 52

Title

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

Description

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

Time Frame

Baseline and Week 52

Title

Change From Baseline in C4 Levels at Week 52

Description

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

Time Frame

Baseline, Week 52

Title

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

Description

Time Frame

Week 52

Title

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

Description

Time Frame

Week 52

Title

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

Description

mCRR3 is defined by normalization of serum creatine as evidenced by serum creatinine ≤ the ULN range of central laboratory values and urinary protein to creatinine ratio < 0.5.

Time Frame

Week 52

Title

Percentage of Participants With Adverse Events (AEs)

Description

Time Frame

From Baseline up to Week 104

Title

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

Description

Time Frame

From baseline up to Week 104

Title

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

Description

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

Time Frame

From baseline up to Week 104

Title

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

Description

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

Time Frame

Baseline, Week 2, Week 4, Week 12, Week 24, Week 52

Title

Maximum Observed Plasma Concentration (Cmax) of Obinutuzumab

Time Frame

Week 0, Week 24, Week 52

Title

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

Time Frame

Week 0, Week 24, Week 52

Title

Systemic Clearance of Obinutuzumab

Time Frame

Day 0, Week 24, Week 52

Title

Volume of Distribution Under Steady State (Vss) of Obinutuzumab

Time Frame

Day 0, Week 24, Week 52

Title

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

Time Frame

Day 0, Week 24, Week 52

Title

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

Description

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

Time Frame

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Clinical Trials

Organizational Affiliation

Hoffmann-La Roche

Official's Role

Study Director

Facility Information:

Facility Name

Univ of California, San Diego

City

La Jolla

State/Province

California

ZIP/Postal Code

92093

Country

United States

Facility Name

Stanford University Medical Center

City

Palo Alto

State/Province

California

ZIP/Postal Code

94304

Country

United States

Facility Name

Emory Uni ; Division of Rheumatology

City

Atlanta

State/Province

Georgia

ZIP/Postal Code

30303

Country

United States

Facility Name

Suny Downstate Medical Center; Rheumatology

City

Brooklyn

State/Province

New York

ZIP/Postal Code

11203

Country

United States

Facility Name

North Shore - Long Island Jewish Hospital Health System; Rheumatology & Allergy- Clinical Immunology

City

Great Neck

State/Province

New York

ZIP/Postal Code

11021

Country

United States

Facility Name

Columbia University Medical Center

City

New York

State/Province

New York

ZIP/Postal Code

10032

Country

United States

Facility Name

Ohio State University; Division of Nephrology

City

Columbus

State/Province

Ohio

ZIP/Postal Code

43210

Country

United States

Facility Name

Cemic; Haematology

City

Buenos Aires

ZIP/Postal Code

C1431FWO

Country

Argentina

Facility Name

CER San Juan Centro Polivalente de Asistencia e Investigacion Clinica

City

San Juan

ZIP/Postal Code

J5400DIL

Country

Argentina

Facility Name

Organizacion Medica de Investigacion

City

San Nicolás

ZIP/Postal Code

C1015ABO

Country

Argentina

Facility Name

Ser Servicos Especializados Em Reumatologia

City

Salvador

State/Province

ZIP/Postal Code

40150-150

Country

Brazil

Facility Name

Hospital das Clinicas - UFMG

City

Belo Horizonte

State/Province

ZIP/Postal Code

31270-901

Country

Brazil

Facility Name

Centro Mineiro de Pesquisa - CMIP

City

Juiz de Fora

State/Province

ZIP/Postal Code

36010-570

Country

Brazil

Facility Name

Instituto Scribner.

City

Curitiba

State/Province

ZIP/Postal Code

80440-020

Country

Brazil

Facility Name

LMK Serviços Médicos S/S

City

Porto Alegre

State/Province

ZIP/Postal Code

90480-000

Country

Brazil

Facility Name

Universidade Federal de Sao Paulo - UNIFES

City

Sao Paulo

State/Province

ZIP/Postal Code

04026-000

Country

Brazil

Facility Name

Clinica De La Costa

City

Barranquilla

ZIP/Postal Code

080020

Country

Colombia

Facility Name

Hospital Universitario San Ignacio

City

Bogota

ZIP/Postal Code

000472

Country

Colombia

Facility Name

Riesgo De Fractura; Rheumatology

City

Bogota

Country

Colombia

Facility Name

Hospital Pablo Tobon Uribe

City

Medellin

ZIP/Postal Code

050034

Country

Colombia

Facility Name

Hospital Clinica Catolica

City

Goicoechea

ZIP/Postal Code

10801

Country

Costa Rica

Facility Name

HOPITAL HENRI MONDOR; SERVICE DE Nephrologie

City

Creteil

ZIP/Postal Code

94010

Country

France

Facility Name

Hopital Claude Huriez; Internal Medicine

City

Lille

ZIP/Postal Code

59037

Country

France

Facility Name

Hopital europeen Marseille; Service de medecine interne

City

Marseille

ZIP/Postal Code

13003

Country

France

Facility Name

Groupe Hospitalier Pitie-Salpetriere; Service de Medecine Interne Ii

City

Paris

ZIP/Postal Code

75651

Country

France

Facility Name

Hopital Bichat Claude Bernard; Nephrologie

City

Paris

ZIP/Postal Code

75877

Country

France

Facility Name

Hopital Rangueil; Service de Nephrologie & D'Immunologie Clinique

City

Toulouse

ZIP/Postal Code

31059

Country

France

Facility Name

Rambam Medical Center; Rheumatology

City

Haifa

ZIP/Postal Code

3109601

Country

Israel

Facility Name

Beilinson Medical Center; Rheumatology

City

Petach Tikva

ZIP/Postal Code

4941492

Country

Israel

Facility Name

Sheba Medical Center; Tel Hashomer

City

Ramat Gan

ZIP/Postal Code

5262100

Country

Israel

Facility Name

Ospedale San Giovanni Bosco; entro di Ricerche di Immunopatologia e Documentazione su Malattie Rare

City

Torino

State/Province

Piemonte

ZIP/Postal Code

10154

Country

Italy

Facility Name

Azienda Ospedaliera di Padova; Dipartimento di Medicina - UOC di Reumatologia

City

Padova

State/Province

Veneto

ZIP/Postal Code

35128

Country

Italy

Facility Name

Unidad de Reumatologia Rehabilitacion Integral; Centro Medico Del Angel

City

Mexicali

State/Province

BAJA California

ZIP/Postal Code

21100

Country

Mexico

Facility Name

Unidad de Investigacion en Enfermedades Cronico-Degenerativa; Reumatologia

City

Guadalajara

State/Province

Jalisco

ZIP/Postal Code

44620

Country

Mexico

Facility Name

Centro de Estudios de Investigacion Basica Y Clinica S.C.; Reumatologia

City

Guadalajara

State/Province

Jalisco

ZIP/Postal Code

44690

Country

Mexico

Facility Name

Instituto Nacional de Ciencias Médicas Y de La Nutricion Zubirán

City

Mexico City

State/Province

Mexico CITY (federal District)

ZIP/Postal Code

Tlalpan 14000

Country

Mexico

Facility Name

Hospital General De Mexico; Rheumatology

City

Mexico, D.F.

State/Province

Mexico CITY (federal District)

ZIP/Postal Code

6726

Country

Mexico

Facility Name

Centro de Investigación Clínica de Morelia S.C.

City

Morelia

State/Province

Michoacan

ZIP/Postal Code

58070

Country

Mexico

Facility Name

Centro de Investigación de Tratamientos Innovadores de Sinaloa (CITI)

City

Culiacán Rosales

State/Province

Sinaloa

ZIP/Postal Code

80000

Country

Mexico

Facility Name

Trial Labs

City

Panama

ZIP/Postal Code

0801

Country

Panama

Facility Name

Instituto de Ginecología y Reproducción

City

Lima

Country

Peru

Facility Name

Centro de Investigación Delgado; Clinica Delgado

City

Miraflores

ZIP/Postal Code

15074

Country

Peru

Facility Name

Centro de Investigaciones Medicas/Hospital Maria Auxiliadora

City

San Juan de Miraflores

ZIP/Postal Code

15801

Country

Peru

Facility Name

Hospital Nacional Cayetano Heredia; Rheumatology

City

San Martin de Porres

ZIP/Postal Code

15102

Country

Peru

Facility Name

Hospital Clinic i Provincial; Servicio de Nefrologia

City

Barcelona

ZIP/Postal Code

08036

Country

Spain

Facility Name

Hospital Regional Universitario Carlos Haya; Servicio de Reumatologia

City

Malaga

ZIP/Postal Code

29009

Country

Spain

12. IPD Sharing Statement

Plan to Share IPD

IPD Sharing Plan Description

Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.clinicalstudydatarequest.com). Further details on Roche's criteria for eligible studies are available here (https://clinicalstudydatarequest.com/Study-Sponsors/Study-Sponsors-Roche.aspx). For further details on Roche's Global Policy on Sharing of Clinical Study Information and how to request access to related clinical study documents, see here (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm).

Citations:

PubMed Identifier

34615636

Citation

Furie RA, Aroca G, Cascino MD, Garg JP, Rovin BH, Alvarez A, Fragoso-Loyo H, Zuta-Santillan E, Schindler T, Brunetta P, Looney CM, Hassan I, Malvar A. B-cell depletion with obinutuzumab for the treatment of proliferative lupus nephritis: a randomised, double-blind, placebo-controlled trial. Ann Rheum Dis. 2022 Jan;81(1):100-107. doi: 10.1136/annrheumdis-2021-220920. Epub 2021 Oct 6.

Results Reference

derived

PubMed Identifier

33693991

Citation

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.

Results Reference

derived

Learn more about this trial

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

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