Phase
Condition
Arthritis And Arthritic Pain
Rheumatoid Arthritis
Dermatomyositis (Connective Tissue Disease)
Treatment
Placebo
IMVT-1402
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Diagnosis of 'definite RA' according to the 2010 ACR/ European Alliance ofAssociations for Rheumatology (EULAR) Rheumatoid Arthritis Classification Criteria.
Greater than or equal to 6/68 TJC and ≥ 6/66 SJC at both Screening and Baselinevisits.
C-reactive protein ≥ 1.5 × upper limit of normal (ULN) at Screening Visit.
DAS28-CRP > 4.1 at the Screening Visit.
Elevated immunoglobulin G (IgG) + ACPA at the Screening Visit.
Inadequate response to at least 2 classes of biologic/targeted synthetic DMARDs.
Additional inclusion criteria are defined in the protocol.
Exclusion
Exclusion Criteria:
Have received rituximab and experienced insufficient efficacy or loss of efficacy
History of any chronic inflammatory arthritis with onset prior to age 18 or historyof acute inflammatory joint disease of different origin from RA.
Active malignancy or history of malignancy within 5 years prior to Screening Visit.
Medical history of primary immunodeficiency, T cell or humoral, including commonvariable immunodeficiency.
Used any non-immunosuppressive Fc-based therapeutic protein (e.g., mAb or Fc-fusionprotein) within 4 weeks prior to or at Screening Visit.
Used any anti-FcRn treatment within 2 months prior to or at Screening Visit or havea documented history of non-response to prior anti-FcRn treatment.
Other, more specific exclusion criteria are defined in the protocol.
Study Design
Study Description
Connect with a study center
Site Number - 5602
Plovdiv, 4004
BulgariaSite Not Available
Site Number - 5603
Plovdiv, 4000
BulgariaSite Not Available
Site Number - 5605
Plovdiv, 4002
BulgariaSite Not Available
Site Number - 5604
Ruse, 7000
BulgariaSite Not Available
Site Number - 5606
Sevlievo, 5400
BulgariaSite Not Available
Site Number - 5600
Sofia, 1336
BulgariaSite Not Available
Site Number - 5601
Sofia, 1680
BulgariaSite Not Available
Site Number - 3204
Brno, 638 00
CzechiaSite Not Available
Site Number - 3202
Ostrava, 702 00
CzechiaSite Not Available
Site Number - 3203
Praha 2 Nové Město, 128 50
CzechiaSite Not Available
Site Number - 3201
Uherské Hradiště, 686 01
CzechiaSite Not Available
Site Number - 3200
Zlín, 760 01
CzechiaSite Not Available
Site Number - 8000
Tbilisi, 0159
GeorgiaSite Not Available
Site Number - 8001
Tbilisi, 0160
GeorgiaSite Not Available
Site Number - 8002
Tbilisi, 0102
GeorgiaSite Not Available
Site Number - 8003
Tbilisi, 0186
GeorgiaSite Not Available
Site Number - 6500
Hamburg, 20095
GermanySite Not Available
Site Number - 6501
Ratingen, 40878
GermanySite Not Available
Site Number - 7554
Budapest, 1027
HungarySite Not Available
Site Number - 7555
Budapest, 1027
HungarySite Not Available
Site Number - 7550
Hódmezővásárhely, 6800
HungarySite Not Available
Site Number - 7553
Kecskemét, 6000
HungarySite Not Available
Site Number - 7551
Székesfehérvár, 8000
HungarySite Not Available
Site Number - 7552
Veszprém, 8200
HungarySite Not Available
Site Number - 3001
Białystok, 15-077
PolandSite Not Available
Site Number - 3005
Białystok, 15-879
PolandSite Not Available
Site Number - 3007
Elbląg, 82-300
PolandSite Not Available
Site Number - 3006
Nadarzyn, 05-830
PolandSite Not Available
Site Number - 3000
Poznań, 61-397
PolandSite Not Available
Site Number - 3008
Poznań, 60-848
PolandSite Not Available
Site Number - 3003
Sochaczew, 96-500
PolandSite Not Available
Site Number - 3004
Warszawa, 02-665
PolandSite Not Available
Site Number - 3002
Wrocław, 53-673
PolandSite Not Available
Site Number - 1011
San Juan, 918
Puerto RicoSite Not Available
Site Number - 7500
Braşov, 500283
RomaniaSite Not Available
Site Number - 7501
Râmnicu Vâlcea, 240636
RomaniaSite Not Available
Site Number - 7101
Bilbao, 48013
SpainSite Not Available
Site Number - 7102
Málaga, 29009
SpainSite Not Available
Site Number - 7100
Sevilla, 41009
SpainSite Not Available
Site Number - 7000
Edinburgh, EH4 2XU
United KingdomSite Not Available
Site Number - 7001
London, SE5 9RJ
United KingdomSite Not Available
Site Number -7002
North Shields, NE29 8NH
United KingdomSite Not Available
Site Number - 7003
Wolverhampton, WV10 0QP
United KingdomSite Not Available
Site Number - 1003
Anniston, Alabama 36207
United StatesActive - Recruiting
Site Number - 1018
Mesa, Arizona 85210
United StatesActive - Recruiting
Site Number - 1019
Sun City, Arizona 85351
United StatesActive - Recruiting
Site Number - 1022
Covina, California 91722
United StatesActive - Recruiting
Site Number - 1032
Fresno, California 93710
United StatesSite Not Available
Site Number - 1028
San Leandro, California 94578
United StatesActive - Recruiting
Site Number - 1024
Temecula, California 92592
United StatesActive - Recruiting
Site Number - 1033
Tujunga, California 91042
United StatesSite Not Available
Site Number - 1023
Whittier, California 90602
United StatesActive - Recruiting
Site Number - 1020
Denver, Colorado 80230
United StatesActive - Recruiting
Site Number - 1015
Jupiter, Florida 33458
United StatesActive - Recruiting
Site Number - 1002
Miami, Florida 33143
United StatesActive - Recruiting
Site Number - 1027
Plantation, Florida 33324
United StatesSite Not Available
Site Number - 1005
Winter Park, Florida 32789
United StatesActive - Recruiting
Site Number - 1012
Zephyrhills, Florida 33542
United StatesActive - Recruiting
Site Number - 1001
Gainesville, Georgia 30501
United StatesActive - Recruiting
Site Number - 1006
Cumberland, Maryland 21502
United StatesActive - Recruiting
Site Number - 1007
Hagerstown, Maryland 21740
United StatesActive - Recruiting
Site Number - 1008
Worcester, Massachusetts 01655
United StatesSite Not Available
Site Number - 1009
Lansing, Michigan 48911
United StatesSite Not Available
Site Number - 1021
Saint Clair Shores, Michigan 48081
United StatesActive - Recruiting
Site Number - 1030
Kansas City, Missouri 64151
United StatesSite Not Available
Site Number - 1010
Summit, New Jersey 07901
United StatesActive - Recruiting
Site Number - 1004
Charlotte, North Carolina 28207
United StatesActive - Recruiting
Site Number - 1000
Duncansville, Pennsylvania 16635
United StatesActive - Recruiting
Site Number - 1016
Jackson, Tennessee 38305
United StatesActive - Recruiting
Site Number - 1026
Memphis, Tennessee 38119
United StatesActive - Recruiting
Site Number -1029
Murfreesboro, Tennessee 37128
United StatesSite Not Available
Site Number - 1017
Colleyville, Texas 76034
United StatesActive - Recruiting
Site Number - 1014
Mesquite, Texas 75150
United StatesActive - Recruiting
Site Number - 1013
Tomball, Texas 77375
United StatesActive - Recruiting
Site Number - 1025
Tomball, Texas 77377
United StatesActive - Recruiting
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