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New combo therapy shows promise for Tough-to-Treat rheumatoid arthritis

NCT ID NCT06028438

Disease control Sponsor: Janssen Research & Development, LLC Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested whether adding nipocalimab to the standard drug certolizumab works better than certolizumab alone for people with active rheumatoid arthritis. It involved 103 adults who still had moderate to severe symptoms despite trying other advanced treatments. The main goal was to see if the combination reduced joint swelling and tenderness more effectively after 12 weeks.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

103 people

The number who actually took part.

Started

Aug 2023

Finished

Oct 2024

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 75 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

rheumatoid arthritis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Arthritis rheumatoid

Contacts and locations

Locations

  • ARCIS Salud SRL Aprillus asistencia e investigacion

    CABA, C1406AGA, Argentina

  • Altoona Center For Clinical Research

    Duncansville, Pennsylvania, 16635, United States

  • Arizona Arthritis and Rheumatology Research PLLC

    Phoenix, Arizona, 85032, United States

  • Atlanta Research Center for Rheumatology

    Marietta, Georgia, 30060, United States

  • Bay Area Arthritis and Osteoporosis

    Brandon, Florida, 33511, United States

  • Bekes Varmegyei Kozponti Korhaz Pandy Kalman Tagkorhaz

    Gyula, 5700, Hungary

  • Budai Irgalmasrendi Korhaz

    Budapest, H-1027, Hungary

  • CMed Rehabilitacios es Diagnosztikai Kozpont

    Székesfehérvár, 8000, Hungary

  • Centro Privado de Medicina Familiar

    Buenos Aires, C1417, Argentina

  • Centro de Investigaciones Medicas Tucuman

    San Miguel de Tucumán, T4000AXL, Argentina

  • Centrum Medyczne Reuma Park

    Warsaw, 02 665, Poland

  • Clinical Research of West Florida

    Clearwater, Florida, 33765, United States

  • Graves Gilbert Clinic

    Bowling Green, Kentucky, 42101, United States

  • Hamburger Rheuma Forschungszentrum II

    Hamburg, 20095, Germany

  • Hospital Central Militar Cirujano Mayor Dr Cosme Argerich

    Buenos Aires, C1426BOR, Argentina

  • Inland Rheumatology Clinical Trials Inc.

    Upland, California, 91786, United States

  • Integral Rheumatology And Immunology Specialists

    Plantation, Florida, 33324, United States

  • Kings College Hospital

    London, SE5 9RS, United Kingdom

  • MICS Centrum Medyczne Warszawa

    Warsaw, 00 874, Poland

  • Mautalen Salud e Investigacion

    CABA, C1128AAF, Argentina

  • Medway NHS Foundation Trust

    Gillingham, ME7 5NY, United Kingdom

  • NZOZ Lecznica MAK MED S C

    Nadarzyn, 05 830, Poland

  • Newport Huntington Medical Group

    Huntington Beach, California, 92648, United States

  • Porcika Klinika - Vasarhelyi Sarkanyfu Kft.

    Hódmezővásárhely, 6800, Hungary

  • Rheumazentrum Ratingen

    Ratingen, 40878, Germany

  • Rheumazentrum Ruhrgebiet

    Herne, 44649, Germany

  • STAT Research S A

    Buenos Aires, C1023AAB, Argentina

  • Sanatorio Agote

    Buenos Aires, C1425EOE, Argentina

  • Southwest Rheumatology Research LLC

    Mesquite, Texas, 75150, United States

  • Szpital Uniwersytecki nr 2 im dr Jana Biziela w Bydgoszczy

    Bydgoszcz, 85-168, Poland

  • Vital Medical Center Orvosi es Fogaszati Kozpont

    Veszprém, 8200, Hungary

  • Western General Hospital

    Edinburgh, EH4 2XU, United Kingdom

More trials for these conditions

Other studies related to the condition(s) this trial covers.