163
Participants
Start Date
September 21, 2021
Primary Completion Date
October 23, 2023
Study Completion Date
November 30, 2023
Placebo
Placebo infusion will be administered intravenously.
Nipocalimab
Nipocalimab dose 1 and dose 2 infusions will be administered intravenously.
Standard of Care Treatment
Standard of care treatment including ophthalmic drops, artificial tears and saliva, punctum plugs, and secretagogues, and/or one immunomodulator with or without low-dose glucocorticosteroids will be administered topically/orally.
Chang Gung Memorial Hospital Linkou Branch, Taoyuan District
Hosp. de Merida, Mérida
Charite Universitaetsmedizin Berlin, Berlin
Tri-Service General Hospital, Taipei
Hopital Saint Joseph, Marseille
Hosp Reina Sofia, Córdoba
Hosp Univ A Coruna, A Coruña
Altoona Center For Clinical Research, Duncansville
University of Pennsylvania, Philadelphia
Hamburger Rheuma Forschungszentrum II, Hamburg
IRCCS Ospedale San Raffaele, Milan
Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia Presidio Spedali Civili, Brescia
PMG Research of Salisbury, Salisbury
Columbia Arthritis Center, Columbia
University of Florida Health Jacksonville, Jacksonville
Omega Research Consultants, Orlando
Centre for Rheumatology, Immunology and Arthritis, Fort Lauderdale
Rheumatology Associates Of South Florida, Boca Raton
Bay Area Arthritis and Osteoporosis, Brandon
Anniston Medical Clinic, Anniston
Hosp Clinico Univ de Salamanca, Salamanca
Azienda Ospedaliera Universitaria Integrata Verona, Verona
Dr. Ramesh Gupta, Memphis
West Tennessee Research Institute, Jackson
CHU de Grenoble Hopital Albert Michallon, La Tronche
North Mississippi Medical Clinics, Tupelo
Hosp. Infanta Luisa, Seville
Uniklinik Köln, Cologne
University of Iowa Hospitals and Clinics, Iowa City
St. Paul Rheumatology P A, Eagan
Clinical Investigation Specialists, Gurnee
University of Kansas Medical Center, Kansas City
CHRU Hôpital de Hautepierre, Strasbourg
Centre Hospitalier Le Mans, Le Mans
Universitatsklinikum Tubingen, Tübingen
medius KLINIK KIRCHHEIM, Kirchheim unter Teck
Trinity Clinical Research, LLC, Carrollton
Hopital Pitie Salpetriere, Paris
Colorado Arthritis Associates, Denver
Denver Arthritis Clinic, Denver
Arizona Arthritis & Rheumatology Research, PLLC, Mesa
Arizona Arthritis and Rheumatology Research PLLC, Glendale
Azienda Ospedaliero Universitaria Policlinico Paolo Giaccone, Palermo
Inland Rheumatology Clinical Trials, Inc., Upland
St. Jude Heritage Medical Group, Fullerton
P.O. Vittorio Emanuele Azienda Ospedaliero Universitaria 'Policlinico Vittorio Emanuele', Catania
Austin Regional Clinic, Austin
Universitatsklinikum Carl Gustav Carus Dresden, Dresden
Tokyo Metropolitan Tama Medical Center, Fuchū
Nagasaki University Hospital, Nagasaki
Hokkaido University Hospital, Sapporo
St. Luke's International Hospital, Tokyo
Nihon University Itabashi Hospital, Tokyo
University of Tsukuba Hospital, Tsukuba
Medisch Centrum Leeuwarden, Leeuwarden
Erasmus Medisch Centrum, Rotterdam
Nasz Lekarz Przychodnie Medyczne, Bydgoszcz
Szpital Uniwersytecki nr 2 im dr Jana Biziela w Bydgoszczy, Bydgoszcz
Zespolu Opieki Zdrowotnej w Konskich, Gmina Końskie
Malopolskie Badania Kliniczne Sp z o o, Krakow
REUMED Zespol Poradni Specjalistycznych Filia nr 2, Lublin
Centrum Medyczne, Poznan
Medycyna Kliniczna, Warsaw
Narodowy Instytut Geriatrii Reumatologii i Rehabilitacji im prof dr hab med Eleonory Reicher, Warsaw
Centrum Medyczne AMED Targowek, Warsaw
Centrum Medyczne Oporow, Wroclaw
Instituto Portugues de Reumatologia, Lisbon
ULSAM, EPE - Hospital Conde de Bertiandos, Ponte de Lima
Corporacio Sanitari Parc Tauli, Sabadell
Janssen Research & Development, LLC
INDUSTRY