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

Completed · Phase 2 · Has a placebo group

Conditions studied: Arthritis, Rheumatoid

In brief

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

Key facts

Study ID

NCT06028438

Run by

Janssen Research & Development, LLC

People needed

103

Starts

2023-08-15

Expected to finish

2024-10-29

Last updated by the study team

2025-10-16

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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
• Is (anatomically or functionally) asplenic
• 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

Where it is running

• Arizona Arthritis and Rheumatology Research PLLC — Phoenix, Arizona, United States
• Newport Huntington Medical Group — Huntington Beach, California, United States
• Inland Rheumatology Clinical Trials Inc. — Upland, California, United States
• Bay Area Arthritis and Osteoporosis — Brandon, Florida, United States
• Clinical Research of West Florida — Clearwater, Florida, United States
• Integral Rheumatology And Immunology Specialists — Plantation, Florida, United States
• Atlanta Research Center for Rheumatology — Marietta, Georgia, United States
• Graves Gilbert Clinic — Bowling Green, Kentucky, United States
• Altoona Center For Clinical Research — Duncansville, Pennsylvania, United States
• Southwest Rheumatology Research LLC — Mesquite, Texas, United States
• STAT Research S A — Buenos Aires, Argentina
• Centro Privado de Medicina Familiar — Buenos Aires, Argentina
• Sanatorio Agote — Buenos Aires, Argentina
• Hospital Central Militar Cirujano Mayor Dr Cosme Argerich — Buenos Aires, Argentina
• Mautalen Salud e Investigacion — CABA, Argentina
• ARCIS Salud SRL Aprillus asistencia e investigacion — CABA, Argentina
• Centro de Investigaciones Medicas Tucuman — San Miguel de Tucumán, Argentina
• Hamburger Rheuma Forschungszentrum II — Hamburg, Germany
• Rheumazentrum Ruhrgebiet — Herne, Germany
• Rheumazentrum Ratingen — Ratingen, Germany
• Budai Irgalmasrendi Korhaz — Budapest, Hungary
• Bekes Varmegyei Kozponti Korhaz Pandy Kalman Tagkorhaz — Gyula, Hungary
• Porcika Klinika - Vasarhelyi Sarkanyfu Kft. — Hódmezővásárhely, Hungary
• CMed Rehabilitacios es Diagnosztikai Kozpont — Székesfehérvár, Hungary
• Vital Medical Center Orvosi es Fogaszati Kozpont — Veszprém, Hungary

Full record on ClinicalTrials.gov

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