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

PHASE2CompletedINTERVENTIONAL
Enrollment

126

Participants

Timeline

Start Date

November 13, 2015

Primary Completion Date

January 15, 2019

Study Completion Date

August 2, 2023

Conditions
Lupus Nephritis
Interventions
DRUG

Mycophenolate Mofetil/Mycophenolic Acid

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

DRUG

Obinutuzumab

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

OTHER

Placebo

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

DRUG

Methylprednisolone

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

DRUG

Prednisone

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

Trial Locations (46)

6726

Hospital General De Mexico; Rheumatology, Mexico City

10032

Columbia University Medical Center, New York

10154

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

10801

Hospital Clinica Catolica, Guadalupe

11021

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

11203

Suny Downstate Medical Center; Rheumatology, Brooklyn

13003

Hopital europeen Marseille; Service de medecine interne, Marseille

15074

Centro de Investigación Delgado; Clinica Delgado, Miraflores

15102

Hospital Nacional Cayetano Heredia; Rheumatology, San Martín de Porres

15801

Centro de Investigaciones Medicas/Hospital Maria Auxiliadora, San Juán de Miraflores

21100

Unidad de Reumatologia Rehabilitacion Integral; Centro Medico Del Angel, Mexicali

29009

Hospital Regional Universitario Carlos Haya; Servicio de Reumatologia, Málaga

30303

Emory Uni ; Division of Rheumatology, Atlanta

31059

Hopital Rangueil; Service de Nephrologie & D'Immunologie Clinique, Toulouse

35128

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

43210

Ohio State University; Division of Nephrology, Columbus

44620

Unidad de Investigacion en Enfermedades Cronico-Degenerativa; Reumatologia, Guadalajara

44690

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

58070

Centro de Investigación Clínica de Morelia S.C., Morelia

59037

Hopital Claude Huriez; Internal Medicine, Lille

75651

Groupe Hospitalier Pitie-Salpetriere; Service de Medecine Interne Ii, Paris

75877

Hopital Bichat Claude Bernard; Nephrologie, Paris

80000

Centro de Investigación de Tratamientos Innovadores de Sinaloa (CITI), Culiacán

92093

Univ of California, San Diego, La Jolla

94010

HOPITAL HENRI MONDOR; SERVICE DE Nephrologie, Créteil

94304

Stanford University Medical Center, Palo Alto

3109601

Rambam Medical Center; Rheumatology, Haifa

4941492

Beilinson Medical Center; Rheumatology, Petah Tikva

5262100

Sheba Medical Center; Tel Hashomer, Ramat Gan

C1431FWO

Cemic; Haematology, Buenos Aires

J5400DIL

CER San Juan Centro Polivalente de Asistencia e Investigacion Clinica, San Juan

C1015ABO

Organizacion Medica de Investigacion, San Nicolás

40150-150

Ser Servicos Especializados Em Reumatologia, Salvador

31270-901

Hospital das Clinicas - UFMG, Belo Horizonte

36010-570

Centro Mineiro de Pesquisa - CMIP, Juiz de Fora

80440-020

Instituto Scribner., Curitiba

90480-000

LMK Serviços Médicos S/S, Porto Alegre

04026-000

Universidade Federal de Sao Paulo - UNIFES, São Paulo

080020

Clinica De La Costa, Barranquilla

000472

Hospital Universitario San Ignacio, Bogotá

Unknown

Riesgo De Fractura; Rheumatology, Bogotá

Instituto de Ginecología y Reproducción, Lima

050034

Hospital Pablo Tobon Uribe, Medellín

Tlalpan 14000

Instituto Nacional de Ciencias Médicas Y de La Nutricion Zubirán, Mexico City

0801

Trial Labs, Panama City

08036

Hospital Clinic i Provincial; Servicio de Nefrologia, Barcelona

All Listed Sponsors
lead

Hoffmann-La Roche

INDUSTRY

NCT02550652 - A Study to Evaluate the Safety and Efficacy of Obinutuzumab Compared With Placebo in Participants With Lupus Nephritis (LN) | Biotech Hunter | Biotech Hunter