A Study to Evaluate the Nipocalimab and Certolizumab Combination Therapy in Participants With Active Rheumatoid Arthritis

Last updated: April 24, 2025
Sponsor: Janssen Research & Development, LLC
Overall Status: Completed

Phase

2

Condition

Joint Injuries

Rheumatoid Arthritis

Treatment

Nipocalimab

Certolizumab

Placebo

Clinical Study ID

NCT06028438
CR109343
80202135ARA2002
2023-504045-31-00
  • Ages 18-75
  • All Genders

Study Summary

The purpose of this study is to evaluate the efficacy of combination therapy with nipocalimab and certolizumab compared to certolizumab monotherapy.

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:

  1. 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

  2. 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:
  1. After at least 12 weeks dosage of etanercept, adalimumab, golimumab (includingbiosimilars), and/or

  2. 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

Total Participants: 103
Treatment Group(s): 3
Primary Treatment: Nipocalimab
Phase: 2
Study Start date:
August 15, 2023
Estimated Completion Date:
October 29, 2024

Connect with a study center

  • Centro Privado de Medicina Familiar

    Buenos Aires, C1417
    Argentina

    Site Not Available

  • Hospital Central Militar Cirujano Mayor Dr Cosme Argerich

    Buenos Aires, C1426BOR
    Argentina

    Site Not Available

  • Sanatorio Agote

    Buenos Aires, C1425EOE
    Argentina

    Site Not Available

  • ARCIS Salud SRL (Aprillus asistencia e investigacion)

    Caba, C1406AGA
    Argentina

    Active - Recruiting

  • ARCIS Salud SRL Aprillus asistencia e investigacion

    Caba, C1406AGA
    Argentina

    Site Not Available

  • Mautalen - Salud e Investigacion

    Caba, C1128AAF
    Argentina

    Site Not Available

  • Mautalen Salud e Investigacion

    Caba, C1128AAF
    Argentina

    Site Not Available

  • STAT Research S A

    Ciudad Autónoma de Buenos Aires, C1023AAB
    Argentina

    Site Not Available

  • STAT Research S.A.

    Ciudad Autónoma de Buenos Aires, C1023AAB
    Argentina

    Site Not Available

  • Centro de Investigaciones Medicas Tucuman

    San Miguel De Tucuman, T4000AXL
    Argentina

    Site Not Available

  • Hamburger Rheuma Forschungszentrum II

    Hamburg, 20095
    Germany

    Site Not Available

  • Rheumazentrum Ruhrgebiet

    Herne, 44649
    Germany

    Site Not Available

  • Rheumazentrum Ratingen

    Ratingen, 40878
    Germany

    Site Not Available

  • Budai Irgalmasrendi Korhaz

    Budapest, H-1027
    Hungary

    Site Not Available

  • Bekes Varmegyei Kozponti Korhaz Pandy Kalman Tagkorhaz

    Gyula, 5700
    Hungary

    Site Not Available

  • Porcika Klinika - Vasarhelyi Sarkanyfu Kft.

    Hodmezovasarhely, 6800
    Hungary

    Site Not Available

  • CMed Rehabilitacios es Diagnosztikai Kozpont

    Szekesfehervar, 8000
    Hungary

    Site Not Available

  • Vital Medical Center Orvosi es Fogaszati Kozpont

    Veszprem, 8200
    Hungary

    Site Not Available

  • Szpital Uniwersytecki nr 2 im dr Jana Biziela w Bydgoszczy

    Bydgoszcz, 85-168
    Poland

    Site Not Available

  • NZOZ Lecznica MAK MED S C

    Nadarzyn, 05 830
    Poland

    Site Not Available

  • NZOZ Lecznica MAK-MED. S.C.

    Nadarzyn, 05-830
    Poland

    Active - Recruiting

  • Centrum Medyczne Reuma Park

    Warszawa, 02 665
    Poland

    Site Not Available

  • MICS Centrum Medyczne Warszawa

    Warszawa, 00 874
    Poland

    Site Not Available

  • Western General Hospital

    Edinburgh, EH4 2XU
    United Kingdom

    Site Not Available

  • Medway NHS Foundation Trust

    Gillingham, ME7 5NY
    United Kingdom

    Site Not Available

  • King s College Hospital

    London, SE5 9RS
    United Kingdom

    Site Not Available

  • King's College Hospital

    London, SE5 9RS
    United Kingdom

    Active - Recruiting

  • Kings College Hospital

    London, SE5 9RS
    United Kingdom

    Site Not Available

  • Arizona Arthritis and Rheumatology Research PLLC

    Phoenix, Arizona 85032
    United States

    Site Not Available

  • Arizona Arthritis and Rheumatology Research, PLLC

    Phoenix, Arizona 85032
    United States

    Active - Recruiting

  • Newport Huntington Medical Group

    Huntington Beach, California 92648
    United States

    Site Not Available

  • Inland Rheumatology Clinical Trials Inc.

    Upland, California 91786
    United States

    Site Not Available

  • Bay Area Arthritis and Osteoporosis

    Brandon, Florida 33511
    United States

    Site Not Available

  • Clinical Research of West Florida

    Clearwater, Florida 33765
    United States

    Site Not Available

  • Integral Rheumatology & Immunology Specialists

    Plantation, Florida 33324
    United States

    Active - Recruiting

  • Integral Rheumatology And Immunology Specialists

    Plantation, Florida 33324
    United States

    Site Not Available

  • Atlanta Research Center for Rheumatology

    Marietta, Georgia 30060
    United States

    Site Not Available

  • Graves Gilbert Clinic

    Bowling Green, Kentucky 42101
    United States

    Site Not Available

  • Altoona Center For Clinical Research

    Duncansville, Pennsylvania 16635
    United States

    Site Not Available

  • Southwest Rheumatology Research LLC

    Mesquite, Texas 75150
    United States

    Site Not Available

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