NCT06028438CompletedPhase 2
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)
Source: ClinicalTrials.gov · Last updated 16 Oct 2025
Brief summary (registry, in English)
The purpose of this study is to evaluate the efficacy of combination therapy with nipocalimab and certolizumab compared to certolizumab monotherapy.
- Status (registry)
- Completed
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 103 (actual)
- First submitted
- 1 Sept 2023
- Start date
- 15 Aug 2023
- Primary completion date
- 29 Aug 2024
- Lead sponsor
- Janssen Research & Development, LLC
- Diseases
- Rheumatoid arthritis
- NCT number
- NCT06028438
- EU CT number
- 2023-504045-31-00
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 103
- From 15 Aug 2023 to the primary completion date, 29 Aug 2024
- 30 sites in 6 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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
- 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
Other
- Is (anatomically or functionally) asplenic
Who the study is looking for
- 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
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (30)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Sanatorio Agote Coordinator of this site? Confirm its status | Buenos Aires | Argentina | Unknown status |
| Hospital Central Militar Cirujano Mayor Dr Cosme Argerich Coordinator of this site? Confirm its status | Buenos Aires | Argentina | Unknown status |
| Stat Research S.A. Coordinator of this site? Confirm its status | Buenos Aires | Argentina | Unknown status |
| Centro Privado de Medicina Familiar Coordinator of this site? Confirm its status | Buenos Aires | Argentina | Unknown status |
| ARCIS Salud SRL Aprillus asistencia e investigacion Coordinator of this site? Confirm its status | CABA | Argentina | Unknown status |
| Mautalen- Salud e Investigacion Coordinator of this site? Confirm its status | CABA | Argentina | Unknown status |
| Centro de Investigaciones Medicas Tucuman Coordinator of this site? Confirm its status | San Miguel de Tucumán | Argentina | Unknown status |
| MVZ Rheumatologie und Autoimmunmedizin Hamburg GmbH Coordinator of this site? Confirm its status | Hamburg | Germany | Completed |
| Western General Hospital Coordinator of this site? Confirm its status | Edinburgh | United Kingdom | Unknown status |
| Medway NHS Foundation Trust Coordinator of this site? Confirm its status | Gillingham | United Kingdom | Unknown status |
| Kings College Hospital Coordinator of this site? Confirm its status | London | United Kingdom | Unknown status |
| Budai Irgalmasrendi Korhaz Nonprofit Kft. Coordinator of this site? Confirm its status | Budapest | Hungary | Completed |
| Bekes Varmegyei Koezponti Korhaz Coordinator of this site? Confirm its status | Gyula | Hungary | Completed |
| Vasarhelyi Sarkanyfu Kft. Coordinator of this site? Confirm its status | Hódmezővásárhely | Hungary | Completed |
| Complex Rendelo Med Zrt. Coordinator of this site? Confirm its status | Székesfehérvár | Hungary | Completed |
| Vital-Medicina Kft. Coordinator of this site? Confirm its status | Veszprem | Hungary | Completed |
| Szpital Uniwersytecki nr 2 im dr Jana Biziela w Bydgoszczy Coordinator of this site? Confirm its status | Bydgoszcz | Poland | Completed |
| NZOZ Lecznica MAK MED S C Coordinator of this site? Confirm its status | Nadarzyn | Poland | Completed |
| Klinika Reuma Park Sp. z o.o. S.K. Coordinator of this site? Confirm its status | Warsaw | Poland | Completed |
| Medicover Integrated Clinical Services Sp. z o.o. Coordinator of this site? Confirm its status | Warsaw | Poland | Completed |
| Graves Gilbert Clinic Coordinator of this site? Confirm its status | Bowling Green | United States | Unknown status |
| Bay Area Arthritis And Osteoporosis Coordinator of this site? Confirm its status | Brandon | United States | Unknown status |
| Clinical Research of West Florida Coordinator of this site? Confirm its status | Clearwater | United States | Unknown status |
| Altoona Center For Clinical Research Coordinator of this site? Confirm its status | Duncansville | United States | Unknown status |
| Newport Huntington Medical Group Coordinator of this site? Confirm its status | Huntington Beach | United States | Unknown status |
| Atlanta Research Center for Rheumatology Coordinator of this site? Confirm its status | Marietta | United States | Unknown status |
| SouthWest Rheumatology Research, LLC Coordinator of this site? Confirm its status | Mesquite | United States | Unknown status |
| Arizona Arthritis and Rheumatology Research PLLC Coordinator of this site? Confirm its status | Phoenix | United States | Unknown status |
| Integral Rheumatology And Immunology Specialists Coordinator of this site? Confirm its status | Plantation | United States | Unknown status |
| Inland Rheumatology Clinical Trials Inc. Coordinator of this site? Confirm its status | Upland | United States | Unknown status |
Related publications
This page is information, not medical advice. Discuss any trial with your doctor.