303
Participants
Start Date
October 26, 2021
Primary Completion Date
September 15, 2025
Study Completion Date
March 14, 2028
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.
Middlemore Hospital, Auckland
Dr Asokan Naidoo, Umhlanga
Mediclinic Vergelegen, Somerset West
Panorama Medical Center, Cape Town
Winelands Medical Research, Cape Town
Columbia University Medical Center, New York
Northwell Health Division of Rheumatology, Great Neck
Centro de Investigación y Tratamiento Reumatológico S.C., Mexico City
Clinica San Antonio;Investigaciones Trujillo S.A.C., Trujillo
Clinica Peruana Americana, Trujillo
Clínica San Juan Bautista CSJB, Lima
IRCCS S. Raffaele, Milan
Unidad de Reumatologia Rehabilitacion Integral, Mexicali
Centro de Investigacion Alberto Bazzoni S.A. de C.V., Torreón
Hospital General Universitario Gregorio Marañon, Madrid
Joint & Muscle Research Institute, Charlotte
Arthritis & Rheumatism, Aventura
Uni Di Padova, Padua
Pinnacle Research Group, Anniston
The Ohio State University Wexner Medical Center, Columbus
Azienda Ospedaliero-Universitaria Di Ferrara Arcispedale Santanna, Cona (Ferrara)
Paramount Medical Research & Consulting, LLC, Middleburg Heights
Clinical Research Institute of Michigan, LLC, Troy
Great Lakes Center of Rheumatology, Lansing
A.O. Universitaria Pisana, Pisa
"Hospital Universitario Dr. Jose Eleuterio Gonzalez", Monterrey
Unity Health - White County Medical Center- Rheumatology, Searcy
Ch Pitie Salpetriere, Paris
Precision Comprehensive Clinical Research Solutions, Colleyville
Prolato Clinical Research Center, Houston
Texas Arthritis Center, El Paso
Centro de Investigación de Tratamientos Innovadores de Sinaloa (CITI), Culiacán
University of Colorado Denver, Barbara Davis Center, Center For Clinical Research, Aurora
Providence Medical Foundation, Fullerton
Federal State Budgetary Scientific Institution Research Institute of Rheumatology V.A. Nasonova, Moscow
FGBU ?Federal Medical and Research Center named after V.A.Almazov? Russian Ministry of Health, Saint Petersburg
Republican clinical hospital named after G.G. Kuvatov, Ufa
Organizacion Medica de Investigacion, Buenos Aires
DOM Centro de Reumatología, Buenos Aires
Centro de Investigaciones Médicas Tucuman, San Miguel
Ser Servicos Especializados Em Reumatologia, Salvador
Hospital das Clinicas - UFMG, Belo Horizonte
Santa Casa de Misericordia, Belo Horizonte
Centro Mineiro de Pesquisa - CMIP, Juiz de Fora
Centro de Estudos em Terapias Inovadoras ? CETI, Curtiba
Hospital das Clinicas - FMUSP Ribeirao Preto, Ribeirão Preto
Centro Multidisciplinar de Estudos Clínicos - CEMEC*X*, São Bernardo do Campo
Revmatologicky Ustav, Prague
Policlinico Universitario Agostino Gemelli, Rome
Wellington Hospital, Wellington
Hogar Clínica San Juan de Dios, Arequipa
Instituto de Ginecología y Reproducción, Lima
Clinica El Golf, San Isidro
Szpital Uniwersytecki, Bydgoszcz
Medyczne Centrum Hetmanska, Poznan
Prywatna Praktyka Lekarska, Poznan
Ortopedyczno Rehab Szpital Klinic im Wiktora Degi UM, Poznan
MICS Centrum Medyczne Warszawa, Warsaw
REUMATOP Grzegorz Rozumek, Karin Pistorius Spó?ka Jawna, Wroc?aw
Emmed Research, Pretoria
Hospital Universitario Vall d'Hebron, Barcelona
Addenbrooke'S Hospital, Cambridge
Chapel Allerton Hospital, Leeds
Royal Free Hospital, London
Guy's Hospital, London
Manchester Royal Infirmary, Manchester
Hoffmann-La Roche
INDUSTRY