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NCT06028438CompletedPhase 2

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

A Phase 2a Multicenter, Randomized, Double Blind, Parallel, Proof of Concept Study Evaluating the Efficacy and Safety of Nipocalimab and Certolizumab Combination Therapy in Participants With Active Rheumatoid Arthritis Despite Prior Treatment With Advanced Therapies (bDMARD or tsDMARD)

Source: ClinicalTrials.gov · Last updated 16 Oct 2025

Brief summary (registry, in English)

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

Status (registry)
Completed
Phase (registry)
Phase 2
Study type
Interventional
Enrollment
103 (actual)
First submitted
1 Sept 2023
Start date
15 Aug 2023
Primary completion date
29 Aug 2024
Lead sponsor
Janssen Research & Development, LLC
NCT number
NCT06028438
EU CT number
2023-504045-31-00

What you commit to

  • Study type: Interventional · Phase 2
  • Participants enrolled: 103
  • From 15 Aug 2023 to the primary completion date, 29 Aug 2024
  • 30 sites in 6 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • Has a confirmed or suspected clinical immunodeficiency syndrome not related to treatment of RA or has a family history of congenital or hereditary immunodeficiency unless confirmed absent
  • Has experienced myocardial infarction, unstable ischemic heart disease, or stroke less 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 optic neuritis

Other

  • Is (anatomically or functionally) asplenic

Who the study is looking for

  • Diagnosis of rheumatoid arthritis (RA) and meeting the 2010 American college of rheumatology (ACR) or European League Against Rheumatism (EULAR) criteria for RA for at least 3 months before screening
  • Has moderate to severe active RA as defined by persistent disease activity with at least 6 of 66 swollen joints and 6 of 68 tender joints at the time of screening and at 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 per deciliter (mg/dL) by the central laboratory at the time of screening
  • If has received prior biological disease-modifying antirheumatic drugs (bDMARDs) (or biosimilars) other than anti-tumor necrosis factor (anti-TNF) agent in RA, has demonstrated inadequate response (IR) or intolerance to the therapy based on one of the following:
    • IR to at least 1bDMARD (or the biosimilars) other than anti-TNF agents, as assessed by the treating physician, after at least 12 weeks of therapy including but not limited to abatacept, anakinra, tocilizumab, and sarilumab or at least 16 weeks of therapy with rituximab Documented IR may include inadequate improvement or loss in response after initial improvement in joint counts or other parameters of disease activity
    • Intolerance to bDMARD (or biosimilars) other than anti-TNF agent, as assessed by the treating physician. Documented intolerance includes side effects and injection 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 (including biosimilars), and/or
    • After at least 14 weeks dosage (example, at least 4 doses) of infliximab (including biosimilars) Documented IR may include inadequate improvement or loss in response after initial improvement in joint counts or other parameters of disease activity

Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (30)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Sanatorio Agote
Coordinator of this site? Confirm its status
Buenos AiresArgentinaUnknown status
Hospital Central Militar Cirujano Mayor Dr Cosme Argerich
Coordinator of this site? Confirm its status
Buenos AiresArgentinaUnknown status
Stat Research S.A.
Coordinator of this site? Confirm its status
Buenos AiresArgentinaUnknown status
Centro Privado de Medicina Familiar
Coordinator of this site? Confirm its status
Buenos AiresArgentinaUnknown status
ARCIS Salud SRL Aprillus asistencia e investigacion
Coordinator of this site? Confirm its status
CABAArgentinaUnknown status
Mautalen- Salud e Investigacion
Coordinator of this site? Confirm its status
CABAArgentinaUnknown status
Centro de Investigaciones Medicas Tucuman
Coordinator of this site? Confirm its status
San Miguel de TucumánArgentinaUnknown status
MVZ Rheumatologie und Autoimmunmedizin Hamburg GmbH
Coordinator of this site? Confirm its status
HamburgGermanyCompleted
Western General Hospital
Coordinator of this site? Confirm its status
EdinburghUnited KingdomUnknown status
Medway NHS Foundation Trust
Coordinator of this site? Confirm its status
GillinghamUnited KingdomUnknown status
Kings College Hospital
Coordinator of this site? Confirm its status
LondonUnited KingdomUnknown status
Budai Irgalmasrendi Korhaz Nonprofit Kft.
Coordinator of this site? Confirm its status
BudapestHungaryCompleted
Bekes Varmegyei Koezponti Korhaz
Coordinator of this site? Confirm its status
GyulaHungaryCompleted
Vasarhelyi Sarkanyfu Kft.
Coordinator of this site? Confirm its status
HódmezővásárhelyHungaryCompleted
Complex Rendelo Med Zrt.
Coordinator of this site? Confirm its status
SzékesfehérvárHungaryCompleted
Vital-Medicina Kft.
Coordinator of this site? Confirm its status
VeszpremHungaryCompleted
Szpital Uniwersytecki nr 2 im dr Jana Biziela w Bydgoszczy
Coordinator of this site? Confirm its status
BydgoszczPolandCompleted
NZOZ Lecznica MAK MED S C
Coordinator of this site? Confirm its status
NadarzynPolandCompleted
Klinika Reuma Park Sp. z o.o. S.K.
Coordinator of this site? Confirm its status
WarsawPolandCompleted
Medicover Integrated Clinical Services Sp. z o.o.
Coordinator of this site? Confirm its status
WarsawPolandCompleted
Graves Gilbert Clinic
Coordinator of this site? Confirm its status
Bowling GreenUnited StatesUnknown status
Bay Area Arthritis And Osteoporosis
Coordinator of this site? Confirm its status
BrandonUnited StatesUnknown status
Clinical Research of West Florida
Coordinator of this site? Confirm its status
ClearwaterUnited StatesUnknown status
Altoona Center For Clinical Research
Coordinator of this site? Confirm its status
DuncansvilleUnited StatesUnknown status
Newport Huntington Medical Group
Coordinator of this site? Confirm its status
Huntington BeachUnited StatesUnknown status
Atlanta Research Center for Rheumatology
Coordinator of this site? Confirm its status
MariettaUnited StatesUnknown status
SouthWest Rheumatology Research, LLC
Coordinator of this site? Confirm its status
MesquiteUnited StatesUnknown status
Arizona Arthritis and Rheumatology Research PLLC
Coordinator of this site? Confirm its status
PhoenixUnited StatesUnknown status
Integral Rheumatology And Immunology Specialists
Coordinator of this site? Confirm its status
PlantationUnited StatesUnknown status
Inland Rheumatology Clinical Trials Inc.
Coordinator of this site? Confirm its status
UplandUnited StatesUnknown status

Related publications

This page is information, not medical advice. Discuss any trial with your doctor.