40
Participants
Start Date
May 12, 2022
Primary Completion Date
August 31, 2027
Study Completion Date
September 28, 2029
Obinutuzumab
Obinutuzumab will be administered by IV infusion at a dose of 1000 mg on Day 1, Day 14, Week 24, Week 26 and Week 52.
Placebo
Placebo matching obinutuzumab will be administered by IV on Day 1, Day 14, Week 24, Week 26 and Week 52.
Mycophenolate Mofetil
Mycophenolate Mofetil (MMF) will be taken by home administration orally at a target dose of 1200 mg/m\^2/day to a maximum of 2.5g/day from baseline (Day 1) onwards.
Acetaminophen/paracetamol
Acetaminophen 1000 mg will be administered as pre-medication prior to infusions.
Diphenhydramine hydrochloride (HCl)
Diphenhydramine HCl 50 mg will be administered as pre-medication prior to infusions.
Methylprednisolone
Methylprednisolone 80 mg IV will be administered as pre-medication prior to infusions.
Prednisone
Oral prednisone or equivalent corticosteroid will be taken by home administration daily to a maximum dose of 60mg/day followed by a guided taper to 5mg/day or less by Week 24.
RECRUITING
Panaroma Medical Center, Panorama
WITHDRAWN
Red Cross War Memorial Children?s Hospital, Cape Town
WITHDRAWN
Groote Schuur Hospital, Cape Town
RECRUITING
Cohen Children's Medical Center of New York, Queens
RECRUITING
IRCCS G. Gaslini, Genoa
WITHDRAWN
Chldren?s Hospital of Philadelphia, Philadelphia
RECRUITING
Clinica Pediatrica II De Marchi, Milan
RECRUITING
Hospital Ramon y Cajal, Madrid
RECRUITING
Hospital de La Paz, Madrid
RECRUITING
Emory Children's Center, Atlanta
RECRUITING
CHU de Toulouse - Hôpital des Enfants, Toulouse
RECRUITING
CREA Hospital Mexico Americano, Guadalajara
RECRUITING
Cincinnati Childrens Hospital, Cincinnati
RECRUITING
Hospital Universitario la Fe: Servicio de Reumatologia Pediatrica, Valencia
RECRUITING
Indiana University Health University Hospital, Indianapolis
RECRUITING
Hospital Universitario Dr. Jose Eleuterio Gonzalez, Monterrey
RECRUITING
Louisiana State University, Shreveport
RECRUITING
Hôpital Robert Debré, Paris
RECRUITING
Hop Necker Enfants Malades, Paris
WITHDRAWN
Texas Arthritis Center, El Paso
RECRUITING
Children's Hospital Colorado, Anchutz Medical Campus, Aurora
RECRUITING
Loma Linda University health, Loma Linda
RECRUITING
UCSF Benioff Childrens Hospital, San Francisco
RECRUITING
CH de Bicêtre, Le Kremlin-Bicêtre
WITHDRAWN
Saint-Petersburg State, St-peterburg
RECRUITING
Hackensack University Medical Center, Hackensack
RECRUITING
Ser Servicos Especializados Em Reumatologia, Salvador
RECRUITING
Centro de Pesquisa São Lucas, Campinas
RECRUITING
Hospital das Clinicas - FMUSP, São Paulo
ACTIVE_NOT_RECRUITING
Universidade Federal de Sao Paulo - UNIFES, São Paulo
RECRUITING
The Hospital for Sick Children, Toronto
RECRUITING
Hospital Sainte-Justine, Montreal
RECRUITING
Ospedale Pediatrico Bambino Gesu, Rome
RECRUITING
Clinstile S.A de C.V., Mexico City
ACTIVE_NOT_RECRUITING
Instituto de Ginecología y Reproducción, Lima
ACTIVE_NOT_RECRUITING
Clinica El Golf, San Isidro
RECRUITING
Uniwersyteckie Centrum Kliniczne, Gdansk
WITHDRAWN
Szpital Specjalistyczny dla Dzieci i Doroslych, Torun
RECRUITING
Hospital Sant Joan De Deu, Esplugas de Llobregat
WITHDRAWN
Royal Hospital For Children, Glasgow
RECRUITING
Alder Hey Childrens Hospital, Liverpool
RECRUITING
Great Ormond Street Hospital for Children, London
Collaborators (1)
Genentech, Inc.
INDUSTRY
Hoffmann-La Roche
INDUSTRY