271
Participants
Start Date
August 10, 2020
Primary Completion Date
August 15, 2024
Study Completion Date
February 28, 2028
Obinutuzumab
Obinutuzumab will be administered by IV infusion at a dose of 1000 mg at Baseline and Weeks 2, 24, 26, 50 (group 2: placebo), and 52 and subsequently from Week 80 and every 6 months thereafter, based on response.
MMF
MMF willl be administered at a target dose of 2.0 - 2.5 g/day in divided doses through Week 80.
Prednisone
Prednisone 0.5 mg/kg/day (maximum 60 mg/day) will be started on Day 2. Beginning on Day 15, prednisone will be tapered to 5 mg/day and continued until Week 80.
Placebo
Placebo matching obinutuzumab will be administered by IV infusion at baseline and Weeks 0, 2, 24, 26, 50 and 52 and subsequently from Week 80 and every 6 months thereafter based on response.
Methylprednisolone
Methylprednisolone 80 mg IV will be administered as predmedication prior to infusions.
Acetaminophen
Acetaminophen 650-1000 mg will be administered as premedication prior to infusions.
Diphenhydramine
Diphenhydramine 50 mg will be administered as premedication prior to infusions.
Groote Schuur Hospital and University of Cape Town, Cape Town
NYU Langone Medical Center, New York
Columbia University Medical Center, New York
Charité Campus Mitte, Med.Klinik, Rheumatologie und Klinische Immunologie, Berlin
North Shore University Hospital, Manhasset
Centro de Investigación y Tratamiento Reumatológico S.C., Mexico City
AD-CARE, University of Rochester Medical Center, Rochester
Instituto Peruano del Hueso y la Articulación, Lima
Hospital Nacional Cayetano Heredia, San Martín de Porres
Clínica San Juan Bautista CSJB, Lima
Ospedale Policlinico San Martino, Genoa
A.O. Spedali Civili Di Brescia-P.O. Spedali Civili, Brescia
Hospital Ramon y Cajal, Madrid
Hospital Universitario 12 de Octubre, Madrid
Georgia Nephrology, Lawrenceville
Hopital Rangueil, Toulouse
University of Miami Miller School of Medicine, Miami
Azienda Ospedaliera di Padova, Padua
University of Alabama at Birmingham Medical Center, Birmingham
The Ohio State University Wexner Medical Center, Columbus
Rabin MC- Belinson campus, Petah Tikva
Azienda Ospedaliera Universitaria Careggi, Florence
Universitaetsmedizin Johannes Gutenberg, Mainz
Hopital Claude Huriez, Lille
Sourasky Medical Centre, Tel Aviv
Hospital Universitario, Monterrey
Policlinico di Bari, Bari
Universitätskrankenhaus Tübingen, Tübingen
Oklahoma Medical Research Foundation, Oklahoma City
Southwest Rheumatology, Mesquite
Groupe Hospitalier Pitie-Salpetriere, Paris
Hopital Bichat Claude Bernard, Paris
Universitätsklinikum Freiburg, Freiburg im Breisgau
Univ Colorado Health Sci Ctr, Aurora
University of Utah Health Science center, Salt Lake City
Wallace Rheumatic Study Center, Beverly Hills
Kaiser Permanente - Fontana, Fontana
Hopital Henri Mondor, Créteil
Kaiser Permanente - San Francisco Medical Center, San Francisco
Stanford University Medical Center, Stanford
Federal State Budgetary Scientific Institution Research Institute of Rheumatology V.A. Nasonova, Moscow
"SBEI HPE The First St.Petersburg State Medical University n.a. acad. I.P.Pavlovaof MoH of RF", Saint Petersburg
Federal Centre of Heart, Blood and Endocrinology n.a. V.A.Almazov, Saint Petersburg
?Kazan (Privolzhsky) Federal University?, Kazan'
Meir Medical Center, Kfar Saba
Chaim Sheba Medical Center, Ramat Gan
University of Texas Southwestern, Dallas
Organizacion Medica de Investigacion, Buenos Aires
DOM Centro de Reumatología, Buenos Aires
Sanatorio Allende, Córdoba
Ser Servicos Especializados Em Reumatologia, Salvador
Instituto Pro-Renal, Curitiba
Hospital das Clinicas - FMUSP Ribeirao Preto, Ribeirão Preto
Centro Multidisciplinar de Estudos Clínicos - CEMEC*X*, Santo André
Hospital das Clinicas - FMUSP, São Paulo
Clinica De La Costa, Barranquilla
Instituto de Ginecología y Reproducción, Lima
Hospital Universitario San Ignacio, Bogotá
Hospital Pablo Tobon Uribe, Medellín
Städtisches Klinik Dresden-Friedrichstadt, Dresden
"Universitätsklinikum Carl Gustav Carus", Dresden
Instituto Nacional de Ciencias Médicas Y de La Nutricion Zubirán, Mexico City
Instituto del Cerebro y la Columna Vertebral SAC, Lima
Uniwersytecki Szpital Kliniczny nr 4 w Lublinie, Lublin
Medyczne Centrum Hetmanska, Poznan
Ortopedyczno Rehab Szpital Klinic im Wiktora Degi UM, Poznan
Szpital Kliniczny Dzieciatka Jezus, Warsaw
Rheuma Medicus Zaklad Opieki Zdrowotnej, Warsaw
Narodowy Instytut Geriatrii, Reumatologii i Rehabilitacji im. Prof. Eleonory Reicher, Warsaw
Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wroclawiu, Wroclaw
Hospital Universitario Vall d'Hebron, Barcelona
Hospital Clinic i Provincial, Barcelona
Cambridge University Hospitals NHS Foundation Trust - Addenbrookes Hospital, Cambridge
Hoffmann-La Roche
INDUSTRY