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

NCT06028438 | Completed Phase 2 Results DMC FDA Drug

• 3 other identifiers: CR1093432023-504045-31-0080202135ARA2002
• Study Type: interventional
• Target: 103
• Locations: 6 countries
• Sites: 32

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

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in Disease Activity Index Score 28 Using C-reactive Protein (DAS28-CRP) at Week 12

  Change from baseline in DAS28-CRP at Week 12 were reported. The DAS28 is a composite index used to assess rheumatoid arthritis disease activity, calculated based on the tender joint count (out of 28 evaluated joints), swollen joint count (out of 28 evaluated joints), Patient's Global Assessment of Disease Activity, and C-reactive protein (CRP; in milligrams per liter \[mg/L\]). The set of 28 joint count was based on evaluation of the shoulder, elbow, wrist, metacarpophalangeal (MCP) MCP1 to MCP5, proximal interphalangeal (PIP) PIP1 to PIP5 joints of both the upper right extremity and the upper left extremity as well as the knee joints of lower right and lower left extremities. Score on the DAS28 ranged from 0 to 10, where higher scores indicated more disease activity. Negative changes from baseline indicated improvement of arthritis.

  Baseline (Week 0), Week 12

Secondary Outcomes (8)

• Percentage of Participants Who Achieved American College of Rheumatology (ACR) Response 20 at Week 12

  Week 12

• Percentage of Participants Who Achieved American College of Rheumatology (ACR) 50 Response at Week 12

  Week 12

• Percentage of Participants Who Achieved American College of Rheumatology (ACR) 70 Response at Week 12

  Week 12

• Percentage of Participants Who Achieved American College of Rheumatology (ACR) 90 Response at Week 12

  Week 12

• Percentage of Participants Who Achieved Disease Activity Index Score 28 Using C-reactive Protein (DAS28-CRP) Remission at Week 12

  Week 12

Study Arms (2)

Certolizumab + Placebo

ACTIVE COMPARATOR

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.

Drug: Placebo; Drug: Certolizumab

Certolizumab + Nipocalimab

EXPERIMENTAL

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.

Drug: Nipocalimab; Drug: Certolizumab

Interventions

Placebo DRUG

Placebo will be administered intravenously.

Certolizumab + Placebo

Nipocalimab DRUG

Nipocalimab will be administered intravenously.

Also known as: JNJ-80202135, M281

Certolizumab + Nipocalimab

Certolizumab DRUG

Certolizumab will be administered subcutaneously.

Also known as: Cimzia

Certolizumab + Nipocalimab; Certolizumab + Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Janssen Research & Development, LLC: lead

Study Sites (32)

Arizona Arthritis and Rheumatology Research PLLC

Phoenix, Arizona, 85032, United States

Location

Newport Huntington Medical Group

Huntington Beach, California, 92648, United States

Location

Inland Rheumatology Clinical Trials Inc.

Upland, California, 91786, United States

Location

Bay Area Arthritis and Osteoporosis

Brandon, Florida, 33511, United States

Location

Clinical Research of West Florida

Clearwater, Florida, 33765, United States

Location

Integral Rheumatology And Immunology Specialists

Plantation, Florida, 33324, United States

Location

Atlanta Research Center for Rheumatology

Marietta, Georgia, 30060, United States

Location

Graves Gilbert Clinic

Bowling Green, Kentucky, 42101, United States

Location

Altoona Center For Clinical Research

Duncansville, Pennsylvania, 16635, United States

Location

Southwest Rheumatology Research LLC

Mesquite, Texas, 75150, United States

Location

STAT Research S A

Buenos Aires, C1023AAB, Argentina

Location

Centro Privado de Medicina Familiar

Buenos Aires, C1417, Argentina

Location

Sanatorio Agote

Buenos Aires, C1425EOE, Argentina

Location

Hospital Central Militar Cirujano Mayor Dr Cosme Argerich

Buenos Aires, C1426BOR, Argentina

Location

Mautalen Salud e Investigacion

CABA, C1128AAF, Argentina

Location

ARCIS Salud SRL Aprillus asistencia e investigacion

CABA, C1406AGA, Argentina

Location

Centro de Investigaciones Medicas Tucuman

San Miguel de Tucumán, T4000AXL, Argentina

Location

Hamburger Rheuma Forschungszentrum II

Hamburg, 20095, Germany

Location

Rheumazentrum Ruhrgebiet

Herne, 44649, Germany

Location

Rheumazentrum Ratingen

Ratingen, 40878, Germany

Location

Budai Irgalmasrendi Korhaz

Budapest, H-1027, Hungary

Location

Bekes Varmegyei Kozponti Korhaz Pandy Kalman Tagkorhaz

Gyula, 5700, Hungary

Location

Porcika Klinika - Vasarhelyi Sarkanyfu Kft.

Hódmezővásárhely, 6800, Hungary

Location

CMed Rehabilitacios es Diagnosztikai Kozpont

Székesfehérvár, 8000, Hungary

Location

Vital Medical Center Orvosi es Fogaszati Kozpont

Veszprém, 8200, Hungary

Location

Szpital Uniwersytecki nr 2 im dr Jana Biziela w Bydgoszczy

Bydgoszcz, 85-168, Poland

Location

NZOZ Lecznica MAK MED S C

Nadarzyn, 05 830, Poland

Location

MICS Centrum Medyczne Warszawa

Warsaw, 00 874, Poland

Location

Centrum Medyczne Reuma Park

Warsaw, 02 665, Poland

Location

Western General Hospital

Edinburgh, EH4 2XU, United Kingdom

Location

Medway NHS Foundation Trust

Gillingham, ME7 5NY, United Kingdom

Location

Kings College Hospital

London, SE5 9RS, United Kingdom

Location

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

Certolizumab Pegol

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Polyethylene Glycols; Polymers; Macromolecular Substances; Immunoglobulin Fab Fragments; Immunoglobulin Fragments; Peptide Fragments; Peptides; Amino Acids, Peptides, and Proteins; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Serum Globulins; Globulins

Results Point of Contact

• Title: Medical Director Rheumatology
• Organization: Janssen Research & Development

ClinicalTrialDisclosure@its.jnj.com

844-434-4210

Study Officials

• Janssen Research & Development, LLC Clinical Trial

  Janssen Research & Development, LLC

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 1, 2023
• First Posted: September 8, 2023
• Study Start: August 15, 2023
• Primary Completion: August 29, 2024
• Study Completion: October 29, 2024
• Last Updated: October 16, 2025
• Results First Posted: October 16, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share

Locations

PL (4); HU (5); GB (3); US (10); DE (3); AR (7)