NCT04186871
Recruiting
December 5, 2019
May 5, 2022
Brief summary:
The purpose of this study is to evaluate the safety and effectiveness of treatment with branebrutinib treatment in participants with active systemic Lupus Erythematosus (SLE) or Primary Sjögren's Syndrome (pSS), or branebrutinib treatment followed by open-label abatacept treatment in study participants with active Rheumatoid Arthritis (RA).
N/A
Arm | Intervention/treatment |
---|---|
Experimental: Primary Sjögren's Syndrome (pSS): branebrutinib |
Drug: branebrutinib Specified dose on specified days |
Experimental: Rheumatoid Arthritis (RA): branebrutinib followed by abatacept |
Drug: branebrutinib Specified dose on specified days Drug: abatacept Specified dose on specified days |
Experimental: Systemic Lupus Erythematosus (SLE): branebrutinib |
Drug: branebrutinib Specified dose on specified days |
Placebo Comparator: RA: placebo followed by abatacept |
Drug: abatacept Specified dose on specified days Drug: branebrutinib placebo Specified dose on specified days |
Placebo Comparator: SLE: placebo |
Drug: branebrutinib placebo Specified dose on specified days |
Placebo Comparator: pSS: placebo |
Drug: branebrutinib placebo Specified dose on specified days |
Inclusion Criteria: Sub-study for Systemic Lupus Erythematosus (SLE) Active SLE as defined by the Systemic Lupus Erythematosus International Collaborating Clinics (SLICC) classification Diagnosed with SLE more than 24 weeks before screening visit Sub-study for primary Sjögren's Syndrome (pSS) Moderate to severe pSS, meeting ACR-EULAR classification criteria Sub-study for active Rheumatoid Arthritis (RA) Moderate to severe adult-onset RA ACR global functional status class I to III Women and men must agree to follow instructions for methods of contraception. Exclusion Criteria: Sub-study for SLE Certain other autoimmune diseases and overlap syndromes Sub-study for pSS Certain other immune-mediated diseases, active fibromyalgia, or other medical conditions Sub-study for RA Diagnosis with juvenile arthritis or idiopathic arthritis before age 16 For all sub-studies: History of any significant drug allergy Active infection, significant concurrent medical condition, or clinically significant abnormalities Other protocol defined inclusion/exclusion criteria could apply
Contact: BMS Study Connect Contact Center www.BMSStudyConnect.com 855-907-3286 Clinical.Trials@bms.com
Contact: First line of the email MUST contain NCT # and Site #.
United States, Arizona
Arizona Arthritis and Rheumatology Research
Phoenix
United States, California
Medvin Clinical Research - Covina Office
Covina
United States, California
Encino Research Center
Encino
United States, California
Local Institution
Los Angeles
United States, California
TriWest Research Associates
San Diego
United States, California
Inland Rheumatology and Osteoporosis Medical Group
Upland
United States, Florida
Local Institution
Brandon
United States, Florida
Local Institution
Clearwater
United States, Florida
Omega Research Consultants - DeBary
DeBary
United States, Florida
Local Institution
Fort Lauderdale
United States, Florida
Local Institution
Gainesville
United States, Florida
Benidecto Fernandez MD PA
Hialeah
United States, Florida
Local Institution
Jacksonville
United States, Florida
Local Institution
Miami
United States, Florida
Integral Rheumatology & Immunology Specialists
Plantation
United States, Florida
Local Institution
Tampa
United States, Georgia
Local Institution
Atlanta
United States, Georgia
North Georgia Rheumatology Group-Lawrenceville
Lawrenceville
United States, Illinois
Clinical Investigation Specialists - Gurnee
Skokie
United States, Indiana
Local Institution
Evansville
United States, Kentucky
Local Institution
Lexington
United States, Louisiana
Local Institution
Lake Charles
United States, Louisiana
Arthritis and Diabetes Clinic
Monroe
United States, Michigan
University of Michigan Medical Center
Ann Arbor
United States, Michigan
Local Institution
Detroit
United States, Michigan
AA Medical Research Center-Grand Blanc
Grand Blanc
United States, Missouri
West County Rheumatology
Saint Louis
United States, Missouri
Arthritis Consultants
Saint Louis
United States, Montana
Local Institution
Kalispell
United States, Nebraska
Arthritis Center of Nebraska
Lincoln
United States, Nevada
Innovative Health Research
Las Vegas
United States, New York
Local Institution
Brooklyn
United States, New York
Local Institution
Manhasset
United States, New York
Local Institution
New York
United States, North Carolina
Joint Muscle Medical Care and Research Institute - Lilington Office
Charlotte
United States, North Carolina
PMG Research of Salisbury
Salisbury
United States, North Dakota
Local Institution
Minot
United States, Oklahoma
Health Research of Oklahoma
Oklahoma City
United States, Oklahoma
Lynn Health Science Institute
Oklahoma City
United States, Oklahoma
Local Institution
Tulsa
United States, Pennsylvania
Altoona Center for Clinical Research
Duncansville
United States, South Carolina
Arthritis and Osteoporosis Center - Orangeburg
Orangeburg
United States, South Carolina
Low Country Rheumatology
Summerville
United States, Tennessee
West Tennessee Research Institute
Jackson
United States, Tennessee
Office of Ramesh C. Gupta, MD
Memphis
United States, Texas
Local Institution
Austin
United States, Texas
Precision Comprehensive Clinical Research Solutions
Colleyville
United States, Texas
Local Institution
Dallas
United States, Texas
Local Institution
Houston
United States, Texas
Biopharma Informatic - Houston
Houston
United States, Texas
Local Institution
League City
United States, Texas
Southwest Rheumatology Research
Mesquite
United States, Texas
Trinity Universal Research
Plano
United States, Texas
Sun Research Institute
San Antonio
United States, Texas
Local Institution
Waco
United States, Washington
Arthritis Northwest
Spokane
Argentina, Buenos Aires
Local Institution - 0065
Ciudad Autonoma de Buenos Aires
Argentina, Tucuman
Centro Medico Privado de Reumatologia
San Miguel De Tucum
Argentina
Local Institution - 0066
San Juan
Belgium
Universitair Ziekenhuis Gent
Gent
Belgium
Universitair Ziekenhuis Leuven Multidisciplinair Borstcentrum
Leuven
Belgium
Local Institution
Liege
France
Local Institution - 0075
Brest
France
Local Institution
Le Kremlin-Bicetre
France
Hopital Europeen Marseille
Marseille
France
Hopital Lapeyronie
Montpellier Cedex 5
France
Local Institution
Strasbourg Cedex
Germany
Local Institution - 0038
Berlin
Germany
Local Institution - 0049
Freiburg
Germany
Rheumazentrum Ruhrgebiet
Herne
Germany
Uniklinik Koln
Koln
Germany
Klinikum der Ludwig Maximillians Universitat Munchen
Munchen
Mexico, Coahuila
Local Institution
Saltillo
Mexico, Distrito Federal
Local Institution
Mexico City
Mexico, Distrito Federal
Local Institution
Mexico
Mexico, Jalisco
Centro Integral de Reumatologia
Guadalajara
Mexico, Jalisco
Clinica de Investigacion en Reumatologia y Obesidad
Guadalajara
Mexico, Jalisco
Local Institution
Guadalajara
Mexico, Jalisco
Local Institution
Zapopan
Mexico, Morelos
Local Institution
Cuernavaca
Mexico, Yucatan
Local Institution
Merida
Mexico, Yucatan
Local Institution
Merida
Mexico, Yucatan
Local Institution
Merida
Mexico
Local Institution
San Luis Potosi
Mexico
Centro de Alta Especialidad en Reumatologia e Investigacion del Potosi
San Luis Potosi
Mexico
Local Institution - 0059
San Luis Potosi
Netherlands
Local Institution
Amsterdam
Netherlands
Universitair Medisch Centrum Groningen
Groningen
Poland
ClinicMed Daniluk Nowak Spolka Jawna
Bialystok
Poland
Local Institution - 0089
Bydgoszcz
Poland
Local Institution - 0072
Bydgoszcz
Poland
Ambulatorium Sp. z o.o. Elblag
Elblag
Poland
Centrum Kliniczno Badawcze J Brzezicki B Gornikiewicz Brzezicka Lekarze Spolka Partnerska
Elblag
Poland
Local Institution
Krakow
Poland
Local Institution
Poznan
Poland
Local Institution - 0011
Poznan
Poland
Nasz Lekarz Osrodek Badan Klinicznych - Torun
Torun
Poland
Medycyna Kliniczna Marzena Waszczak - Jeka
Warszawa
Poland
Local Institution - 0033
Warszawa
Poland
ETG - Warszawa
Warszawa
Poland
Local Institution - 0026
Warszawa
Spain
Complejo Hospitalario Universitario A Coruna
A Coru
Spain
Hospital Universitari Vall dHebron
Barcelona
Spain
Hospital Regional Universitario de Malaga Hospital General
Malaga
Spain
Local Institution - 0018
Sevilla
Spain
Hospital Clinico Universitario de Valencia
Valencia
United Kingdom
Local Institution
Harlow
United Kingdom
Local Institution
Hull
United Kingdom
The Leeds Teaching Hospitals NHS Trust
Leeds
United Kingdom
Local Institution
London
United Kingdom
Guys and Saint Thomas NHS Foundation Trust
London
United Kingdom
University Hospital Southampton NHS Foundation Trust
Southampton
Bristol-Myers Squibb
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb