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A Study to Evaluate the Efficacy and Safety of Obinutuzumab in Participants With Systemic Lupus Erythematosus
Sponsor: Hoffmann-La Roche
Summary
This parallel-group, double-blind, placebo-controlled study will evaluate the efficacy and safety of obinutuzumab versus placebo in participants with active, autoantibody-positive systemic lupus erythematosus (SLE) who are treated with standard-of-care therapy.
Official title: A Phase III, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study To Evaluate The Efficacy And Safety of Obinutuzumab in Patients With Systemic Lupus Erythematosus
Key Details
Gender
All
Age Range
18 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
303
Start Date
2021-10-26
Completion Date
2028-03-14
Last Updated
2026-04-06
Healthy Volunteers
No
Conditions
Interventions
Obinutuzumab
Obinutuzumab will be administered by IV infusion at a dose of 1000 mg on Day 1 and at Weeks 2, 24 and 26.
Placebo
Placebo matching obinutuzumab will be administered by IV on Day 1 and at Weeks 2, 24 and 26.
Acetaminophen/Paracetamol
Acetaminophen 650-1000 mg will be administered as premedication prior to infusions.
Diphenhydramine hydrochloride
Diphenhydramine 50 mg will be administered as premedication prior to infusions.
Methylprednisolone
Methylprednisolone 80 mg IV will be administered as premedication prior to infusions.
Locations (64)
Pinnacle Research Group
Anniston, Alabama, United States
Unity Health - White County Medical Center- Rheumatology
Searcy, Arkansas, United States
Providence Medical Foundation
Fullerton, California, United States
Arthritis & Rheumatism
Aventura, Florida, United States
Great Lakes Center of Rheumatology
Lansing, Michigan, United States
Clinical Research Institute of Michigan, LLC
Troy, Michigan, United States
Northwell Health Division of Rheumatology
Great Neck, New York, United States
Columbia University Medical Center
New York, New York, United States
Joint & Muscle Research Institute
Charlotte, North Carolina, United States
The Ohio State University Wexner Medical Center
Columbus, Ohio, United States
Paramount Medical Research & Consulting, LLC
Middleburg Heights, Ohio, United States
Precision Comprehensive Clinical Research Solutions
Colleyville, Texas, United States
Texas Arthritis Center
El Paso, Texas, United States
Prolato Clinical Research Center
Houston, Texas, United States
Organizacion Medica de Investigacion
Buenos Aires, Argentina
DOM Centro de Reumatología
Buenos Aires, Argentina
Centro de Investigaciones Médicas Tucuman
San Miguel, Argentina
Ser Servicos Especializados Em Reumatologia
Salvador, Estado de Bahia, Brazil
Hospital das Clinicas - UFMG
Belo Horizonte, Minas Gerais, Brazil
Santa Casa de Misericordia
Belo Horizonte, Minas Gerais, Brazil
Centro Mineiro de Pesquisa - CMIP
Juiz de Fora, Minas Gerais, Brazil
Centro de Estudos em Terapias Inovadoras ? CETI
Curtiba, Paraná, Brazil
Hospital das Clinicas - FMUSP Ribeirao Preto
Ribeirão Preto, São Paulo, Brazil
Centro Multidisciplinar de Estudos Clínicos - CEMEC*X*
São Bernardo do Campo, São Paulo, Brazil
Revmatologicky Ustav
Prague, Czechia
Ch Pitie Salpetriere
Paris, France
Policlinico Universitario Agostino Gemelli
Rome, Lazio, Italy
IRCCS S. Raffaele
Milan, Lombardy, Italy
A.O. Universitaria Pisana
Pisa, Tuscany, Italy
Azienda Ospedaliero-Universitaria Di Ferrara Arcispedale Santanna
Cona (Ferrara), Veneto, Italy
Uni Di Padova
Padova, Veneto, Italy
Centro de Investigacion Alberto Bazzoni S.A. de C.V.
Torreón, Coahuila, Mexico
Unidad de Reumatologia Rehabilitacion Integral
Mexicali, Estado de Baja California, Mexico
Centro de Investigación y Tratamiento Reumatológico S.C.
Mexico City, Mexico CITY (federal District), Mexico
Hospital Universitario "Dr. Jose Eleuterio Gonzalez"
Monterrey, Nuevo León, Mexico
Centro de Investigación de Tratamientos Innovadores de Sinaloa (CITI)
Culiacán, Sinaloa, Mexico
Middlemore Hospital
Auckland, New Zealand
Wellington Hospital
Wellington, New Zealand
Hogar Clínica San Juan de Dios
Arequipa, Peru
Clínica San Juan Bautista CSJB
Lima, Peru
Instituto de Ginecología y Reproducción
Lima, Peru
Clinica El Golf
San Isidro, Peru
Clinica San Antonio;Investigaciones Trujillo S.A.C.
Trujillo, Peru
Szpital Uniwersytecki
Bydgoszcz, Poland
Medyczne Centrum Hetmanska
Poznan, Poland
Prywatna Praktyka Lekarska
Poznan, Poland
Ortopedyczno Rehab Szpital Klinic im Wiktora Degi UM
Poznan, Poland
MICS Centrum Medyczne Warszawa
Warsaw, Poland
Rheuma Medicus Zaklad Opieki Zdrowotnej
Warsaw, Poland
REUMATOP Grzegorz Rozumek, Karin Pistorius Spó?ka Jawna
Wroc?aw, Poland
Republican clinical hospital named after G.G. Kuvatov
Ufa, Bashkortostan Republic, Russia
Federal State Budgetary Scientific Institution Research Institute of Rheumatology V.A. Nasonova
Moscow, Moscow Oblast, Russia
FGBU ?Federal Medical and Research Center named after V.A.Almazov? Russian Ministry of Health
Saint Petersburg, Sankt-Peterburg, Russia
Panorama Medical Center
Cape Town, South Africa
Winelands Medical Research
Cape Town, South Africa
Emmed Research
Pretoria, South Africa
Dr Asokan Naidoo
Umhlanga, South Africa
Hospital Universitario Vall d'Hebron
Barcelona, Spain
Hospital General Universitario Gregorio Marañon
Madrid, Spain
Addenbrooke'S Hospital
Cambridge, United Kingdom
Chapel Allerton Hospital
Leeds, United Kingdom
Royal Free Hospital
London, United Kingdom
Guy's Hospital
London, United Kingdom
Manchester Royal Infirmary
Manchester, United Kingdom