Phase
Condition
Rheumatoid Arthritis
Arthritis And Arthritic Pain
Dermatomyositis (Connective Tissue Disease)
Treatment
Adalimumab
Abatacept
Methotrexate
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Early rheumatoid arthritis (RA), defined as symptoms of RA that started ≤ 12 monthsprior to screening and satisfied the American College of Rheumatology/EuropeanLeague Against Rheumatism (ACR/EULAR) 2010 criteria for the classification of RA atsome point during the 12-month period
Naïve to any targeted (biologic or nonbiologic) disease-modifying antirheumaticdrugs (DMARDs), conventional synthetic DMARDs other than methotrexate (MTX), orinvestigational therapies for RA
Treated with MTX for at least 12 weeks, with a stable dose of oral or parenteral MTXfor at least 4 weeks prior to randomization
Anti-cyclic citrullinated peptide-2 (Anti-CCP-2) test that is > 3× the upper limitof normal and are positive for rheumatoid factor (RF) according to central labtesting during screening
At least a Disease Activity Score 28-joint count calculated using C-reactive protein (DAS28-CRP) ≥ 3.2 at screening
At least 3 tender and at least 3 swollen joints at screening and at randomization
Exclusion
Exclusion Criteria:
Women who are breastfeeding
Autoimmune disease other than RA (e.g., psoriasis, systemic lupus erythematosus [SLE], vasculitis, seronegative spondyloarthritis, inflammatory bowel disease,Sjogren's syndrome) or currently active fibromyalgia
History of or current inflammatory joint disease other than RA (e.g., psoriaticarthritis, gout, reactive arthritis, Lyme disease)
At risk for tuberculosis
Recent acute infection
History of chronic or recurrent bacterial infection (e.g., chronic pyelonephritis,osteomyelitis, bronchiectasis)
History of infection of a joint prosthesis or artificial joint
History of systemic fungal infections (such as histoplasmosis, blastomycosis, orcoccidiomycosis)
History of primary immunodeficiency
Current clinical findings or a history of a demyelinating disorder
5 or more joints cannot be assessed for tenderness or swelling
Other protocol-defined inclusion/exclusion criteria apply
Study Design
Connect with a study center
Local Institution
C.a.b.a., Buenos Aires 1431
ArgentinaSite Not Available
Local Institution - 0012
Caba, Buenos Aires C1015ABO
ArgentinaSite Not Available
Local Institution - 0024
La Plata, Buenos Aires 1900
ArgentinaSite Not Available
Local Institution - 0016
Quilmes, Buenos Aires 1878
ArgentinaSite Not Available
Local Institution - 0014
San Isidro, Buenos Aires 1642
ArgentinaSite Not Available
Local Institution
DQG, Distrito Federal C1428
ArgentinaSite Not Available
Local Institution - 0057
San Miguel de Tucumán, Tucuman T4000
ArgentinaSite Not Available
Local Institution - 0015
Buenos Aires, 1431
ArgentinaSite Not Available
Local Institution - 0022
Buenos Aires, 1428
ArgentinaSite Not Available
Local Institution - 0023
Buenos Aires, 1428
ArgentinaSite Not Available
Local Institution - 0099
Cordoba, 0
ArgentinaSite Not Available
Local Institution - 0072
Botany, New South Wales 2019
AustraliaSite Not Available
Local Institution
Kogarah, New South Wales 2217
AustraliaSite Not Available
Local Institution - 0062
Paramatta, New South Wales 2150
AustraliaSite Not Available
Local Institution
Parramatta, New South Wales 2150
AustraliaSite Not Available
Local Institution - 0063
Maroochydore, Queensland 4558
AustraliaSite Not Available
Local Institution - 0102
Woodville South, South Australia 5011
AustraliaSite Not Available
Local Institution - 0064
Camberwell, Victoria 3124
AustraliaSite Not Available
Local Institution - 0065
Geelong, Victoria 3220
AustraliaSite Not Available
Local Institution - 0105
Ivanhoe, Victoria 3079
AustraliaSite Not Available
Local Institution - 0028
Brno, 638 00
CzechiaSite Not Available
Revmatologicky ustav
Praha, 12800
CzechiaSite Not Available
Local Institution - 0025
Praha 2, 12850
CzechiaSite Not Available
Local Institution - 0001
Montpellier, 34295
FranceSite Not Available
Local Institution - 0047
Rouen, 76031
FranceSite Not Available
Local Institution - 0035
Strasbourg, 67098
FranceSite Not Available
Local Institution - 0002
Toulouse, 31059
FranceSite Not Available
Local Institution - 0059
Berlin, 10117
GermanySite Not Available
Local Institution - 0055
Bonn, 53127
GermanySite Not Available
Local Institution - 0091
Freiburg, 79106
GermanySite Not Available
Local Institution
Freiburg im Breisgau, 79106
GermanySite Not Available
Local Institution - 0053
Hamburg, 20095
GermanySite Not Available
Local Institution - 0056
Planegg, 82152
GermanySite Not Available
Local Institution - 0083
Catania, 95121
ItalySite Not Available
POLICLINICO "G. RODOLICO"-Rheumatology
Catania, 95121
ItalySite Not Available
Fondazione IRCCS Policlinico San Matteo
Pavia, 27100
ItalySite Not Available
Local Institution - 0077
Pavia, 27100
ItalySite Not Available
Hospital Santa Maria della Misericordia in Perugia-Unit of Rheumatology, Department of Medicine and
Perugia, 06156
ItalySite Not Available
Local Institution - 0078
Perugia, 06156
ItalySite Not Available
Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Università Cattolica del Sacro Cuore
Roma, 00168
ItalySite Not Available
Local Institution - 0100
Roma, 00168
ItalySite Not Available
Local Institution
Rome, 00168
ItalySite Not Available
Local Institution - 0093
Nagoya, Aichi 457-8511
JapanSite Not Available
Local Institution - 0079
Kitakyushu, Fukuoka 807-8556
JapanSite Not Available
Local Institution
Kitakyushu-shi, Fukuoka 8078556
JapanSite Not Available
Local Institution - 0110
Sapporo, Hokkaido 0608648
JapanSite Not Available
Local Institution
Sendai, Miyagi 9808574
JapanSite Not Available
Local Institution - 0046
Sendai-shi, Miyagi 980-8574
JapanSite Not Available
Local Institution - 0112
Sasebo, Nagasaki 857-1195
JapanSite Not Available
Local Institution
Kawagoe, Saitama 3508550
JapanSite Not Available
Local Institution - 0090
Kawagoe, Saitama 350-8550
JapanSite Not Available
Local Institution - 0090
Kawagoe-shi, Saitama 3508550
JapanSite Not Available
Local Institution - 0089
Chuo-ku, Tokyo 1048560
JapanSite Not Available
Local Institution
Shinjuku-ku, Tokyo 1600016
JapanSite Not Available
Local Institution - 0093
Aichi, 457-8511
JapanSite Not Available
Local Institution - 0010
Tokyo, 1600035
JapanSite Not Available
Local Institution - 0089
Tokyo, 104-8560
JapanSite Not Available
Local Institution - 0006
Cdmx, Distrito Federal 11850
MexicoSite Not Available
Local Institution
Mexico, Distrito Federal 11850
MexicoSite Not Available
Local Institution - 0008
Mexico City, Distrito Federal 14080
MexicoSite Not Available
Local Institution - 0017
Guadalajara, Jalisco 44650
MexicoSite Not Available
Local Institution - 0117
Guadalajara, Jalisco 44650
MexicoSite Not Available
Local Institution - 0118
San Luis Potosí, SAN LUIS Potosi 78200
MexicoSite Not Available
Local Institution
Merida, Yucatan 97070
MexicoSite Not Available
Local Institution - 0005
Mérida, Yucatán 97070
MexicoSite Not Available
Local Institution - 0009
Chihuahua, 31000
MexicoSite Not Available
Local Institution
San Luis Potosi, 78200
MexicoSite Not Available
Local Institution - 0020
Torun, Kujawsko-pomorskie 87-100
PolandSite Not Available
Local Institution
Bydgoszcz, 85-168
PolandSite Not Available
Local Institution - 0124
Bydgoszcz, 85-168
PolandSite Not Available
Local Institution - 0019
Elblag, 82-300
PolandSite Not Available
Local Institution
A Coruna, 15006
SpainSite Not Available
Local Institution - 0004
A Coruña, 15006
SpainSite Not Available
Local Institution - 0003
Madrid, 28046
SpainSite Not Available
Local Institution - 0085
Santander, 39008
SpainSite Not Available
Local Institution - 0049
Basel, 4031
SwitzerlandSite Not Available
Local Institution - 0052
St. Gallen, 9007
SwitzerlandSite Not Available
Local Institution
Kaohsiung, 803
TaiwanSite Not Available
Local Institution - 0098
Kaohsiung Niao Sung Dist, 83301
TaiwanSite Not Available
Local Institution - 0104
New Taipei City, 220
TaiwanSite Not Available
Local Institution - 0096
Taichung, 40447
TaiwanSite Not Available
Local Institution - 0095
Taichung City, 402
TaiwanSite Not Available
Local Institution - 0120
Tainan, 704
TaiwanSite Not Available
Local Institution - 0111
Cannock, Staffordshire WS11 5XY
United KingdomSite Not Available
Local Institution
Greater London, London, SE1 1UL
United KingdomSite Not Available
Local Institution - 0060
Hull, HU3 2JZ
United KingdomSite Not Available
Local Institution - 0114
London, SE1 9RT
United KingdomSite Not Available
Local Institution
Wolverhampton, WV10 0QP
United KingdomSite Not Available
Local Institution - 0036
Fullerton, California 92835
United StatesSite Not Available
Local Institution - 0086
Los Alamitos, California 90720
United StatesSite Not Available
Local Institution - 0041
Aurora, Colorado 80045
United StatesSite Not Available
Local Institution - 0058
Cumberland, Maryland 21502
United StatesSite Not Available
Local Institution - 0038
Hagerstown, Maryland 21740
United StatesSite Not Available
Local Institution - 0084
Eagan, Minnesota 55121
United StatesSite Not Available
Local Institution
Saint Louis, Missouri 63141
United StatesSite Not Available
Local Institution
Lincoln, Nebraska 68516
United StatesSite Not Available
Local Institution - 0040
Freehold, New Jersey 07728
United StatesSite Not Available
NYU Langone Ambulatory Care Brooklyn Heights
Brooklyn, New York 11201
United StatesSite Not Available
Local Institution - 0082
Wilmington, North Carolina 28401
United StatesSite Not Available
Local Institution - 0127
Portland, Oregon 97239
United StatesSite Not Available
Local Institution - 0031
Duncansville, Pennsylvania 16635
United StatesSite Not Available
Local Institution - 0034
Jackson, Tennessee 38305
United StatesSite Not Available
Local Institution - 0044
Dallas, Texas 75231
United StatesSite Not Available
Local Institution
Glendale, Wisconsin 53217
United StatesSite Not Available
Local Institution - 0119
Milwaukee, Wisconsin 53217
United StatesSite Not Available
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