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.
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.
| Facility | City | Region | Status |
|---|---|---|---|
| Pinnacle Research Group | Anniston | Alabama | |
| Unity Health - White County Medical Center- Rheumatology | Searcy | Arkansas | |
| Providence Medical Foundation | Fullerton | California | |
| Arthritis & Rheumatism | Aventura | Florida | |
| Great Lakes Center of Rheumatology | Lansing | Michigan | |
| Clinical Research Institute of Michigan, LLC | Troy | Michigan | |
| Northwell Health Division of Rheumatology | Great Neck | New York | |
| Columbia University Medical Center | New York | New York | |
| Joint & Muscle Research Institute | Charlotte | North Carolina | |
| The Ohio State University Wexner Medical Center | Columbus | Ohio | |
| Paramount Medical Research & Consulting, LLC | Middleburg Heights | Ohio | |
| Precision Comprehensive Clinical Research Solutions | Colleyville | Texas | |
| Texas Arthritis Center | El Paso | Texas | |
| Prolato Clinical Research Center | Houston | Texas | |
| 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 | |
| Hospital das Clinicas - UFMG | Belo Horizonte | Minas Gerais | |
| Santa Casa de Misericordia | Belo Horizonte | Minas Gerais | |
| Centro Mineiro de Pesquisa - CMIP | Juiz de Fora | Minas Gerais | |
| Centro de Estudos em Terapias Inovadoras ? CETI | Curtiba | Paraná | |
| Hospital das Clinicas - FMUSP Ribeirao Preto | Ribeirão Preto | São Paulo | |
| Centro Multidisciplinar de Estudos Clínicos - CEMEC*X* | São Bernardo do Campo | São Paulo | |
| Revmatologicky Ustav | Prague | Czechia | |
| Ch Pitie Salpetriere | Paris | France | |
| Policlinico Universitario Agostino Gemelli | Rome | Lazio | |
| IRCCS S. Raffaele | Milan | Lombardy | |
| A.O. Universitaria Pisana | Pisa | Tuscany | |
| Azienda Ospedaliero-Universitaria Di Ferrara Arcispedale Santanna | Cona (Ferrara) | Veneto | |
| Uni Di Padova | Padova | Veneto | |
| Centro de Investigacion Alberto Bazzoni S.A. de C.V. | Torreón | Coahuila | |
| Unidad de Reumatologia Rehabilitacion Integral | Mexicali | Estado de Baja California | |
| Centro de Investigación y Tratamiento Reumatológico S.C. | Mexico City | Mexico CITY (federal District) | |
| Hospital Universitario "Dr. Jose Eleuterio Gonzalez" | Monterrey | Nuevo León | |
| Centro de Investigación de Tratamientos Innovadores de Sinaloa (CITI) | Culiacán | Sinaloa | |
| 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 |
+ 24 more sites — see the full list on the official registry below.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT04963296 on ClinicalTrials.gov ↗ ← All trials in Spain