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

NCT ID: NCT06028438

Last Updated: 2025-10-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 103 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-08-15
• Study Completion Date: 2024-10-29

Brief Summary

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

Conditions

Arthritis, Rheumatoid

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Certolizumab + Placebo

Participants will receive placebo intravenously (IV) and certolizumab dose 1 subcutaneously at Week 0, 2, and 4 followed by placebo IV and certolizumab dose 2 subcutaneously at Weeks 6 to 22.

Group Type: ACTIVE_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo will be administered intravenously.

Certolizumab

Intervention Type: DRUG

Certolizumab will be administered subcutaneously.

Certolizumab + Nipocalimab

Participants will receive nipocalimab IV and certolizumab dose 1 subcutaneously at Week 0, 2, and 4 followed by nipocalimab IV and certolizumab dose 2 subcutaneously at Weeks 6 to 22.

Group Type: EXPERIMENTAL

Nipocalimab

Intervention Type: DRUG

Nipocalimab will be administered intravenously.

Certolizumab

Intervention Type: DRUG

Certolizumab will be administered subcutaneously.

Interventions

Placebo

Placebo will be administered intravenously.

Intervention Type: DRUG

Nipocalimab

Nipocalimab will be administered intravenously.

Intervention Type: DRUG

Certolizumab

Certolizumab will be administered subcutaneously.

Intervention Type: DRUG

Other Intervention Names

JNJ-80202135; M281; Cimzia

Eligibility Criteria

Inclusion Criteria

• 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:

1. 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

2. 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:

1. After at least 12 weeks dosage of etanercept, adalimumab, golimumab (including biosimilars), and/or

2. 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

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Janssen Research & Development, LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Janssen Research & Development, LLC Clinical Trial

Role: STUDY_DIRECTOR

Janssen Research & Development, LLC

Locations

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

Szpital Uniwersytecki nr 2 im dr Jana Biziela w Bydgoszczy

Bydgoszcz, , Poland

NZOZ Lecznica MAK MED S C

Nadarzyn, , Poland

MICS Centrum Medyczne Warszawa

Warsaw, , Poland

Centrum Medyczne Reuma Park

Warsaw, , Poland

Western General Hospital

Edinburgh, , United Kingdom

Medway NHS Foundation Trust

Gillingham, , United Kingdom

Kings College Hospital

London, , United Kingdom

Countries

United States; Argentina; Germany; Hungary; Poland; United Kingdom

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

2023-504045-31-00

Identifier Type: REGISTRY

Identifier Source: secondary_id

80202135ARA2002

Identifier Type: OTHER

Identifier Source: secondary_id

CR109343

Identifier Type: -

Identifier Source: org_study_id