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A Study to Evaluate the Nipocalimab and Certolizumab Combination Therapy in Participants With Active Rheumatoid Arthritis | Clinical Trials | Clareo Health

COMPLETEDPHASE2

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)

NCT06028438•Janssen Research & Development, LLC

View on ClinicalTrials.gov

Summary

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

Eligibility

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

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

Locations (32)

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

Key Dates

Start Date

August 15, 2023

Primary Completion Date

August 29, 2024

Completion Date

October 29, 2024

Last Updated

October 16, 2025

Enrollment

103

ACTUAL participants

Conditions

Arthritis, Rheumatoid

Interventions

Placebo

DRUG

Nipocalimab

DRUG

Certolizumab

DRUG

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Arthritis, Rheumatoid

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RECRUITING

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Arthritis, RheumatoidPain

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RECRUITINGNA

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: October 16, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

The Reboot Study: A Safety Study of Abdominal Vagus Nerve Stimulation for Moderate to Severe Drug Refractory Rheumatoid Arthritis

Chronic Pain in Rheumatoid Arthritis

Fecal Microbial Transplantation for Rheumatoid Arthritis Trial

Progression of Bone Erosions in Rheumatoid Arthritis Assessed by HR-pQCT and Conventional X-ray

Study of LW402 Tablets in Moderate to Severe Rheumatoid Arthritis

A Proof-of-concept Study of the Efficacy and Safety of Nipocalimab in Participants With Active Rheumatoid Arthritis