Phase
Condition
Joint Injuries
Rheumatoid Arthritis
Treatment
Nipocalimab
Certolizumab
Placebo
Clinical Study ID
Ages 18-75 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Diagnosis of rheumatoid arthritis (RA) and meeting the 2010 American college ofrheumatology (ACR) or European League Against Rheumatism (EULAR) criteria for RA forat least 3 months before screening
Has moderate to severe active RA as defined by persistent disease activity with atleast 6 of 66 swollen joints and 6 of 68 tender joints at the time of screening andat baseline
Is positive for anti-citrullinated protein antibodies (ACPA) or rheumatoid factor (RF) by the central laboratory at the time of screening
Has C-reactive protein (CRP) greater than or equal to (>=) 0.3 milligram perdeciliter (mg/dL) by the central laboratory at the time of screening
If has received prior biological disease-modifying antirheumatic drugs (bDMARDs) (orbiosimilars) other than anti-tumor necrosis factor (anti-TNF) agent in RA, hasdemonstrated inadequate response (IR) or intolerance to the therapy based on one ofthe following:
IR to at least 1bDMARD (or the biosimilars) other than anti-TNF agents, asassessed by the treating physician, after at least 12 weeks of therapyincluding but not limited to abatacept, anakinra, tocilizumab, and sarilumab orat least 16 weeks of therapy with rituximab Documented IR may includeinadequate improvement or loss in response after initial improvement in jointcounts or other parameters of disease activity
Intolerance to bDMARD (or biosimilars) other than anti-TNF agent, as assessedby the treating physician. Documented intolerance includes side effects andinjection or infusion reactions
- If has received prior anti-TNF agent (including biosimilars), has demonstrated IR to >=1 anti-TNF agent (including biosimilars), as assessed by the treating physician:
After at least 12 weeks dosage of etanercept, adalimumab, golimumab (includingbiosimilars), and/or
After at least 14 weeks dosage (example, at least 4 doses) of infliximab (including biosimilars) Documented IR may include inadequate improvement orloss in response after initial improvement in joint counts or other parametersof disease activity
Exclusion
Exclusion Criteria:
Has a confirmed or suspected clinical immunodeficiency syndrome not related totreatment of RA or has a family history of congenital or hereditary immunodeficiencyunless confirmed absent
Is (anatomically or functionally) asplenic
Has experienced myocardial infarction, unstable ischemic heart disease, or strokeless than or equal to (<=) 12 weeks of screening
Has a diagnosis of congestive heart failure including medically controlled,asymptomatic congestive heart failure
Has a history of known demyelinating disease such as multiple sclerosis or opticneuritis
Study Design
Connect with a study center
Centro Privado de Medicina Familiar
Buenos Aires, C1417
ArgentinaSite Not Available
Hospital Central Militar Cirujano Mayor Dr Cosme Argerich
Buenos Aires, C1426BOR
ArgentinaSite Not Available
Sanatorio Agote
Buenos Aires, C1425EOE
ArgentinaSite Not Available
ARCIS Salud SRL (Aprillus asistencia e investigacion)
Caba, C1406AGA
ArgentinaActive - Recruiting
ARCIS Salud SRL Aprillus asistencia e investigacion
Caba, C1406AGA
ArgentinaSite Not Available
Mautalen - Salud e Investigacion
Caba, C1128AAF
ArgentinaSite Not Available
Mautalen Salud e Investigacion
Caba, C1128AAF
ArgentinaSite Not Available
STAT Research S A
Ciudad Autónoma de Buenos Aires, C1023AAB
ArgentinaSite Not Available
STAT Research S.A.
Ciudad Autónoma de Buenos Aires, C1023AAB
ArgentinaSite Not Available
Centro de Investigaciones Medicas Tucuman
San Miguel De Tucuman, T4000AXL
ArgentinaSite Not Available
Hamburger Rheuma Forschungszentrum II
Hamburg, 20095
GermanySite Not Available
Rheumazentrum Ruhrgebiet
Herne, 44649
GermanySite Not Available
Rheumazentrum Ratingen
Ratingen, 40878
GermanySite Not Available
Budai Irgalmasrendi Korhaz
Budapest, H-1027
HungarySite Not Available
Bekes Varmegyei Kozponti Korhaz Pandy Kalman Tagkorhaz
Gyula, 5700
HungarySite Not Available
Porcika Klinika - Vasarhelyi Sarkanyfu Kft.
Hodmezovasarhely, 6800
HungarySite Not Available
CMed Rehabilitacios es Diagnosztikai Kozpont
Szekesfehervar, 8000
HungarySite Not Available
Vital Medical Center Orvosi es Fogaszati Kozpont
Veszprem, 8200
HungarySite Not Available
Szpital Uniwersytecki nr 2 im dr Jana Biziela w Bydgoszczy
Bydgoszcz, 85-168
PolandSite Not Available
NZOZ Lecznica MAK MED S C
Nadarzyn, 05 830
PolandSite Not Available
NZOZ Lecznica MAK-MED. S.C.
Nadarzyn, 05-830
PolandActive - Recruiting
Centrum Medyczne Reuma Park
Warszawa, 02 665
PolandSite Not Available
MICS Centrum Medyczne Warszawa
Warszawa, 00 874
PolandSite Not Available
Western General Hospital
Edinburgh, EH4 2XU
United KingdomSite Not Available
Medway NHS Foundation Trust
Gillingham, ME7 5NY
United KingdomSite Not Available
King s College Hospital
London, SE5 9RS
United KingdomSite Not Available
King's College Hospital
London, SE5 9RS
United KingdomActive - Recruiting
Kings College Hospital
London, SE5 9RS
United KingdomSite Not Available
Arizona Arthritis and Rheumatology Research PLLC
Phoenix, Arizona 85032
United StatesSite Not Available
Arizona Arthritis and Rheumatology Research, PLLC
Phoenix, Arizona 85032
United StatesActive - Recruiting
Newport Huntington Medical Group
Huntington Beach, California 92648
United StatesSite Not Available
Inland Rheumatology Clinical Trials Inc.
Upland, California 91786
United StatesSite Not Available
Bay Area Arthritis and Osteoporosis
Brandon, Florida 33511
United StatesSite Not Available
Clinical Research of West Florida
Clearwater, Florida 33765
United StatesSite Not Available
Integral Rheumatology & Immunology Specialists
Plantation, Florida 33324
United StatesActive - Recruiting
Integral Rheumatology And Immunology Specialists
Plantation, Florida 33324
United StatesSite Not Available
Atlanta Research Center for Rheumatology
Marietta, Georgia 30060
United StatesSite Not Available
Graves Gilbert Clinic
Bowling Green, Kentucky 42101
United StatesSite Not Available
Altoona Center For Clinical Research
Duncansville, Pennsylvania 16635
United StatesSite Not Available
Southwest Rheumatology Research LLC
Mesquite, Texas 75150
United StatesSite Not Available
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