Phase
Condition
Joint Injuries
Musculoskeletal Diseases
Dermatomyositis (Connective Tissue Disease)
Treatment
Afimkibart
Placebo
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Has moderate to severe active RA defined by the presence of >=6 swollen joints and >=6 tender joints at screening and baseline (based on 66/68-joint count)
Diagnosis of RA for >=3 months and also fulfills the 2010 American College ofRheumatology (ACR)/European Alliance of Associations for Rheumatology (EULAR)classification criteria for RA
Demonstrated an inadequate response or loss of response to or intolerance to >=1conventional synthetic disease-modifying antirheumatic drug (csDMARD)
Exclusion
Exclusion Criteria:
Have failed more than two TNF inhibitors or JAK inhibitors
Class IV RA according to ACR revised response criteria (Hochberg et al. 1992)
Past or current use of other biologic disease-modifying antirheumatic drugs (bDMARDs) (excluding TNF inhibitors) or rituximab
Treatment with investigational therapy within 4 weeks or within 5 half-lives of theinvestigational therapy, whichever is longer, prior to initiation of studytreatment.
History of any arthritis with onset prior to age 17 years or current diagnosis ofinflammatory joint disease other than RA
Has been treated with intra-articular, intramuscular, intravenous, trigger point ortender point, intra-bursa, or intra-tendon sheath corticosteroids in the preceding 8weeks prior to the first dose of study drug
History of a severe allergic reaction or anaphylactic reaction or knownhypersensitivity to any component of the study drug (or its excipients) and/or otherproducts in the same class
Any major surgery within 6 weeks prior to screening or a major surgery plannedduring the study
Any serious, chronic and/or unstable pre-existing medical, psychiatric, or other-condition
History of malignancy, with the exception non-metastatic basal cell or cutaneoussquamous cell cancer adequately treated with electrodesiccation and curettage orresection or in situ cervical cancer adequately treated and cured
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
History of organ transplant
Any identified confirmed congenital or acquired immunodeficiency
Abnormal laboratory values and liver function test
Study Design
Connect with a study center
Centro Medico Arsema
Ciudad Autnoma de Buenos Aires, Buenos Aires C1427
ArgentinaActive - Recruiting
APRILLUS Asistencia e Investigacion
Buenos Aires, Ciudad Autonoma Buenos Aires C1406AGA
ArgentinaActive - Recruiting
Centro Privado de Medicina Familiar - Mind Out Research
Ciudad Autonoma Buenos Aires, C1417EYH
ArgentinaActive - Recruiting
HUB Erasme
Brussels, 1070
BelgiumActive - Recruiting
UZ Leuven
Leuven, 3000
BelgiumActive - Recruiting
L2IP ?Instituto de Pesquisas Clínicas Ltda.
Brasília, Federal District 70200-730
BrazilActive - Recruiting
IPC MT Instituto de Pesquisas Clinicas do Mato Grosso
Cuiab, Mato Grosso 78020-500
BrazilActive - Recruiting
Centro Mineiro de Pesquisa - CMIP
Juiz de Fora, Minas Gerais 36010-570
BrazilActive - Recruiting
Centro de Estudos em Terapias Inovadoras ? CETI
Curitiba, Paraná 80030-110
BrazilActive - Recruiting
Hospital So Lucas da PUCRS
Porto Alegre, Rio Grande do Sul 90610-000
BrazilActive - Recruiting
Hospital das Clínicas FMRP-USP
Ribeirão Preto, São Paulo 14048-900
BrazilActive - Recruiting
CEPIC - Centro Paulista de Investigao Clnica e Servios Mdicos
So Paulo, São Paulo 04266-010
BrazilActive - Recruiting
Bispebjerg og Frederiksberg Hospital
Frederiksberg, 2000
DenmarkActive - Recruiting
Bispebjerg og Frederiksberg Hospital
Frederiksberg 2621942, 2000
DenmarkSite Not Available
Sjllands Universitetshospital
Kge, 4600
DenmarkActive - Recruiting
CHU Strasbourg Hpital Hautepierre
Strasbourg, Bas Rhin 67091
FranceActive - Recruiting
Hopital de la Conception
Marseille, Bouches-du-Rhne 13005
FranceActive - Recruiting
Hopital Lapeyronie
Montpellier, Herault 34295
FranceActive - Recruiting
Hopital Purpan
Toulouse, Lot Et Garonne 31059
FranceActive - Recruiting
Hpital Cochin
Paris 2988507, Paris 75014
FranceSite Not Available
Hpital Cochin
Paris, 75014
FranceActive - Recruiting
Rheumazentrum Ruhrgebiet
Herne, North Rhine-Westphalia 44649
GermanyActive - Recruiting
Städtisches Klinik Dresden-Friedrichstadt
Dresden, Saxony 01067
GermanyActive - Recruiting
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Rome, Lazio 00168
ItalyActive - Recruiting
Nzoz Bif-Med
Bytom, 41-902
PolandActive - Recruiting
Nzoz Bif-Med
Bytom 3101950, 41-902
PolandSite Not Available
Centrum Kliniczno-Badawcze J. Brzezicki, B. Górnikiewicz-Brzezicka Lekarze Spó?ka Partne
Elbl?g, 82-300
PolandActive - Recruiting
Malopolskie Badania Kliniczne
Krakow, 30-002
PolandActive - Recruiting
Zespol Poradni Specjalistycznych REUMED
Lublin, 20-607
PolandActive - Recruiting
Zespol Poradni Specjalistycznych REUMED
Lublin 765876, 20-607
PolandSite Not Available
Twoja Przychodnia NCM
Nowa Sól, 67-100
PolandActive - Recruiting
Centrum Medyczne Reuma Park
Warsaw, 02-665
PolandActive - Recruiting
Narodowy Instytut Geriatrii, Reumatologii i Rehabilitacji im. Prof. Eleonory Reicher
Warsaw, 02-637
PolandActive - Recruiting
Reumatop Spolka Jawna
Wroclaw, 52-210
PolandActive - Recruiting
Reumatop Spolka Jawna
Wroclaw 3081368, 52-210
PolandSite Not Available
Hospital Regional Universitario de Malaga
Málaga, 29009
SpainActive - Recruiting
Hospital Universitario Virgen Macarena
Seville, 41009
SpainActive - Recruiting
Doncaster Royal Infirmary
Doncaster, South Yorkshire DN2 5LT
United KingdomActive - Recruiting
North Tyneside General Hospital
Newcastle upon Tyne, Tyne & Wear NE29 8NH
United KingdomActive - Recruiting
Barnet Hospital
Barnet, EN5 3DJ
United KingdomActive - Recruiting
SunValley Arthritis Center Ltd.
Peoria, Arizona 85381
United StatesActive - Recruiting
SunValley Arthritis Center Ltd.
Peoria 5308480, Arizona 5551752 85381
United StatesSite Not Available
Inland Rheumatology Clinical Trials Incorporated
Upland, California 91786
United StatesActive - Recruiting
Inland Rheumatology Clinical Trials Incorporated
Upland 5404915, California 5332921 91786
United StatesSite Not Available
West Broward Rheumatology Associates, Inc.
Tamarac, Florida 33321
United StatesActive - Recruiting
West Broward Rheumatology Associates, Inc.
Tamarac 4174738, Florida 4155751 33321
United StatesSite Not Available
Willow Rheumatology and Wellness PLLC
Willowbrook, Illinois 60527
United StatesActive - Recruiting
Accurate Clinical Research Inc.
Lake Charles, Louisiana 70605
United StatesActive - Recruiting
Accurate Clinical Research Inc.
Lake Charles 4330236, Louisiana 4331987 70605
United StatesSite Not Available
Ohio State University Wexner Medical Center
Columbus, Ohio 43203
United StatesActive - Recruiting
Altoona Center For Clinical Research
Duncansville, Pennsylvania 16635
United StatesActive - Recruiting
Altoona Center For Clinical Research
Duncansville 5187508, Pennsylvania 6254927 16635
United StatesSite Not Available
Accurate Clinical Management
Houston, Texas 77089
United StatesActive - Recruiting
DM Clinical Research
Tomball, Texas 77375
United StatesActive - Recruiting
Accurate Clinical Management
Houston 4699066, Texas 4736286 77089
United StatesSite Not Available
DM Clinical Research
Tomball 4737094, Texas 4736286 77375
United StatesSite Not Available
Tidewater Clinical Research
Chesapeake, Virginia 23320
United StatesActive - Recruiting
Rheumatic Disease Center
Glendale, Wisconsin 53217
United StatesActive - Recruiting
Rheumatic Disease Center
Glendale 5254404, Wisconsin 5279468 53217
United StatesSite Not Available

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