Phase
Condition
Dermatomyositis (Connective Tissue Disease)
Rheumatoid Arthritis
Arthritis And Arthritic Pain
Treatment
N/AClinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Diagnosis of adult-onset RA as defined by the ACR 2010 criteria, for at least 6 monthsbefore screening
Moderately to severely active RA as defined by at least 4/28 tender joints and atleast 4/28 swollen joints, and a DAS28 greater than or equal to (≥) 3.2
For Part 2 only: Active synovitis and/or osteitis as determined by contrast-enhancedmagnetic resonance imaging
Participants must be taking stable dose of anti-TNF-alpha therapies
Participants on stable oral glucocorticoids within 6 weeks of planned randomization
Participants taking non-steroidal anti-inflammatory drugs (NSAIDs) intermittently (upto 2-3 times weekly) for short-term relief of pain and participants on regular NSAIDuse (on stable dose for ≥ 4 weeks)
Exclusion
Exclusion Criteria:
Parenteral glucocorticoids administration (intramuscular, IV) of ≥50 mg within 6 weeksor less than or equal to (≤) 50 milligrams (mg) within 4 weeks prior to plannedrandomization, or scheduled parenteral administrations during the study
Joint(s) injected with intra-articular glucocorticoids or hyaluronic acid within 6weeks prior to planned randomization
Active inflammatory diseases of the joints not related to RA
Systemic autoimmune disease other than RA
Juvenile idiopathic arthritis or juvenile RA and/or RA developed before the age of 16
Active fibromyalgia that makes appropriate assessment of RA disease activitychallenging in the opinion of the Investigator
RA participants functional status class IV according to the ACR 1991 criteria
Participants with severe chronic or recurrent viral, bacterial, parasitic, or fungalinfections
History of active hepatitis B virus (HBV), hepatitis C virus (HCV), or humanimmunodeficiency virus (HIV) infection
Any identified confirmed congenital or acquired immunodeficiency
Abnormal laboratory values and liver function test
Myocardial infarction within less than 6 months prior to participation in the study
Severe central or peripheral nervous system diseases
Study Design
Connect with a study center
Organización medica de Investi
Cap fed, 1015
ArgentinaSite Not Available
Centro de Investigaciones Reumatologicas y Osteologicas
Ciudad Autonoma de Buenos Aires, 1111
ArgentinaSite Not Available
Instituto de Asistencia Reumatologica Integral
San Fernando, 1646
ArgentinaSite Not Available
Cer San Juan
San Juan, 5400
ArgentinaSite Not Available
Centro Medico Privado de Reumatologia; Reumathology
San Miguel, T4000AXL
ArgentinaSite Not Available
Medizinische Universität Wien, Allgemeines Krankenhaus der Stadt Wien
Wien, 1090
AustriaSite Not Available
Centro Integral de Reumatologia del Caribe SAS CIRCARIBE SAS
Barranquilla, 00000
ColombiaSite Not Available
Centro de Investigacion en Reumatologia y Especialdades Medicas SAS. CIREEM
Bogota, 110221
ColombiaSite Not Available
Fundación Instituto de Reumatología Fernando Chalem
Bogota, 111211
ColombiaSite Not Available
Riesgo de Fractura S.A.
Bogota, 110221
ColombiaSite Not Available
Riesgo de Fractura S.A.
Bogota D.C.,
ColombiaSite Not Available
Servimed S.A.S.
Bucaramanga, 680003
ColombiaSite Not Available
Clinica de Artritis Temprana S.A.
Cali, 00000
ColombiaSite Not Available
Healthy Medical Center SAS
Zipaquirá,
ColombiaSite Not Available
Revmatologicky Ustav
Praha, 128 50
Czech RepublicSite Not Available
MEDICAL PLUS, s.r.o.
Uherske Hradiste,
Czech RepublicSite Not Available
Charité Research Organisation GmbH
Berlin, 10117
GermanySite Not Available
Praxis Dres. Jung
Deggingen,
GermanySite Not Available
Centro Clinico de Especialidades Medicas
Ciudad De Guatemala, 01011
GuatemalaSite Not Available
Centro de Estudio y Tratamiento de Enfermedades Reumaticas
Guatemala,
GuatemalaSite Not Available
Clinica Privada de Reumatologia Dr. Henry Briones Alvarado
Guatemala,
GuatemalaSite Not Available
Azienda Ospedaliera Città della Salute e della Scienza di Torino; Radiology
Torino, Abruzzo 10126
ItalySite Not Available
Azienda Ospedaliero-Universitaria Policlinico S. Orsola Malpighi; U.O. Malattie Infettive
Bologna, Emilia-Romagna 40138
ItalySite Not Available
Azienda Ospedaliero - Universitaria Policlinico - Vittorio Emanuele
Catania, Sicilia 95123
ItalySite Not Available
Azienda Ospedaliero Universitaria Careggi - SOD Reumatologia
Firenze, Toscana 50134
ItalySite Not Available
Centro de Investigacion del Noroeste SC
Tijuana, BAJA California 22010
MexicoSite Not Available
Investigacion y Biomedicina de Chihuahua, Sociedad Civil
Chichuahua, Chihuahua 31000
MexicoSite Not Available
Centro Integral en Reumatología S.A. de C.V. (CIRSA)
Guadalajara, Jalisco 44160
MexicoSite Not Available
Centro Médico de las Américas
Merida, Yucatan
MexicoSite Not Available
Unidad de Atencion Medica e Investigacion en Salud (UNAMIS)
Mérida, Yucatan 97070
MexicoSite Not Available
Javier Orozco Private Practice
Guadalajara, 44650
MexicoSite Not Available
Centro de Investigación; Artritis y Osteoporosis S.C.
Mexicali, 21200
MexicoSite Not Available
Hospital Angeles Lindavista
Mexico, 07760
MexicoSite Not Available
Hospital Universitario "Dr. Jose Eleuterio Gonzalez"
Monterrey, 64460
MexicoSite Not Available
Policlinica Medica de Queretaro S.C.
Queretaro, 76000
MexicoSite Not Available
Hogar Clínica San Juan de Dios
Arequipa,
PeruSite Not Available
Hospital Nacional Almanzor Aguinaga Asenjo; Unidad De Investigacion Del Servicio De Oncologia Medica
Chiclayo, CIX
PeruSite Not Available
Clinica Internacional Sede Lima
LIma, Lima 01
PeruSite Not Available
Hospital Guillermo Almenara Irigoyen Hospital Guillermo Almenara Irigoyen Hospital Guillermo Almen
La Victoria, Lima 13
PeruSite Not Available
Clinica Internacional, Sede San Borja; Unidad de Investigacion de Clínica Internacional
Lima, Lima 41
PeruSite Not Available
Instituto de Ginecología y Reproducción
Lima,
PeruSite Not Available
Niepubliczny Zakład Opieki Zdrowotnej "Vesalius" Sp. z o.o.
Krakw, 31-216
PolandSite Not Available
Medyczne Centrum Hetmanska
Poznan, 60-218
PolandSite Not Available
Samodzielny Publiczny Szpital Kliniczny nr 1 im. prof.Tadeusza Sokolowskiego
Szczecin, 71-242
PolandSite Not Available
Reumatika - Centrum Reumatologii Niepubliczny Zakład Opieki Zdrowotnej
Warszawa, 02-653
PolandSite Not Available
Hospital Universitario Marques de Valdecilla; Servicio de Reumatologia
Santander, Cantabria 39008
SpainSite Not Available
Complexo Hospitalario Universitario A Coruña; Servicio de Reumatología
A Coruña, LA Coruña 15006
SpainSite Not Available
Hospital de Basurto; Servicio de Reumatologia
Bilbao, Vizcaya 48013
SpainSite Not Available
Hospital General Universitario Gregorio Marañon; Servicio de Reumatología
Madrid, 28007
SpainSite Not Available
Hospital Universitario 12 de Octubre
Madrid, 28041
SpainSite Not Available
Hospital Universitario de la Princesa; Servicio de Reumatologia
Madrid, 28006
SpainSite Not Available
Hospital Regional Universitario Carlos Haya; Servicio de Psiquiatria
Malaga, 29010
SpainSite Not Available
Hospital Universitario Reina Sofía; Servicio de Aparato Digestivo
Murcia, 30003
SpainSite Not Available
New Queen Elizabeth Hospital Birmingham
Birmingham, B15 2WB
United KingdomSite Not Available
Cambridge University Hospitals NHS Foundation Trust
Cambridge, CB2 0QQ
United KingdomSite Not Available
Glasgow Royal Infirmary
Glasgow, G4 0SF
United KingdomSite Not Available
Barts Hospital; Department of Rheumatology
London, E1 4DG
United KingdomSite Not Available
Guys and St Thomas NHS Foundation Trust, Guys Hospital
London, SE1 9RT
United KingdomSite Not Available
Manchester Royal Infirmary; Kellgren Centre for Rheumatology
Manchester, M13 9WL
United KingdomSite Not Available
Newcastle U. Medical School; Institute of Cellular Medicine
Newcastle,
United KingdomSite Not Available
University of Oxford, Botnar Research Centre
Oxford,
United KingdomSite Not Available
Derriford Hospital
Plymouth, PL6 8DH
United KingdomSite Not Available
Lister Hospital; Rheumatology Dept
Stevenage, SG1 4AB
United KingdomSite Not Available
Pinnacle Research Group; Llc, Central
Anniston, Alabama 36207
United StatesSite Not Available
Arizona Arthritis & Rheumatology Associates, P.C.
Glendale, Arizona 85306
United StatesSite Not Available
Arizona Arthritis and Rheuma
Mesa, Arizona 85202
United StatesSite Not Available
Arizona Arthritis & Rheumatology Research, PLLC
Phoenix, Arizona 85037
United StatesSite Not Available
Medvin Clinical Research
Covina, California 91723
United StatesSite Not Available
University of California San Diego
La Jolla, California 92093
United StatesSite Not Available
Advanced Medical Research, LLC
Lakewood, California 90712
United StatesSite Not Available
Stanford hospital & Clinics; Investigational Drug Services
Stanford, California 94304
United StatesSite Not Available
Omega Research Consultants LLC
DeBary, Florida 32713-1817
United StatesSite Not Available
San Marcus Research Clinic, Inc.
Hialeah, Florida 33015-5110
United StatesSite Not Available
Millenium Research
Ormond Beach, Florida 32174
United StatesSite Not Available
Alastair C. Kennedy, M.D., P.A.
Vero Beach, Florida 32960-4891
United StatesSite Not Available
Ochsner Clin Foundatn; Clin Res
Baton Rouge, Louisiana 70809
United StatesSite Not Available
Clinical Pharmacology Study Group
Worcester, Massachusetts 01610
United StatesSite Not Available
Shores Rheumatology PC
Saint Clair Shores, Michigan 48080
United StatesSite Not Available
Jackson Arthritis Clinic
Flowood, Mississippi 39232
United StatesSite Not Available
Arthritis & Osteoporosis Associates
Freehold, New Jersey
United StatesSite Not Available
Atlantic Coast Rheumatology
Toms River, New Jersey 08755
United StatesSite Not Available
Ocean Rheumatology
Toms River, New Jersey 08775
United StatesSite Not Available
Albuquerque Center For Rheumatology
Albuquerque, New Mexico 87102
United StatesSite Not Available
Albuquerque Clinical Trials
Albuquerque, New Mexico 87102
United StatesSite Not Available
Saint Lawrence Health System; Rheumatology
Canton, New York 13617
United StatesSite Not Available
Paramount Medical Research
Middleburg Heights, Ohio 44130
United StatesSite Not Available
Oklahoma Center For Arthritis Therapy & Research
Tulsa, Oklahoma 74104
United StatesSite Not Available
Altoona Center For Clinical Research
Duncansville, Pennsylvania 16635
United StatesSite Not Available
Advanced Rheumatology & Arthritis Research Center
Wexford, Pennsylvania 15090
United StatesSite Not Available
Low Country Rheumatology, PA
Charleston, South Carolina 29406
United StatesSite Not Available
Columbia Arthritis Center (Partnership Practice)
Columbia, South Carolina 29204
United StatesSite Not Available
West Tennessee Research Institute
Jackson, Tennessee 38305
United StatesSite Not Available
Adriana Pop-Moody MD Clinic PA
Corpus Christi, Texas 78404
United StatesSite Not Available
Metroplex Clinical Research
Dallas, Texas 75231
United StatesSite Not Available
Accurate Clinical Research
Houston, Texas 77089
United StatesSite Not Available
Pioneer Research Solutions
Houston, Texas 077099
United StatesSite Not Available
Southwest Rheumatology
Mesquite, Texas 75150
United StatesSite Not Available
Accurate Clinical Research, Inc
Stafford, Texas 77477
United StatesSite Not Available

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