Clinical trial NCT06028438: A Study to Evaluate the Nipocalimab and Certolizumab Combination Therapy in Participants With Active Rheumatoid Arthritis
Official title: 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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Arthritis, Rheumatoid
Lead sponsor: Janssen Research & Development, LLC
Sponsor class: INDUSTRY
First posted: 2023-09-08
Enrollment: 103
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


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

Primary outcomes:
measure: Change from Baseline in Disease Activity Index Score 28 Using C-reactive Protein (DAS28-CRP) at Week 12
timeFrame: Baseline, Week 12
Secondary outcomes:
measure: Percentage of Participants Achieving American College of Rheumatology (ACR) 20 Response at Week 12
timeFrame: At Week 12
measure: Percentage of Participants Achieving ACR 50 Response at Week 12
timeFrame: At Week 12
measure: Percentage of Participants Achieving ACR 70 Response at Week 12
timeFrame: At Week 12
measure: Percentage of Participants Achieving ACR90 Response at Week 12
timeFrame: At Week 12
measure: Percentage of Participants Achieving DAS28-CRP Remission at Week 12
timeFrame: At Week 12
measure: Percentage of Participants Achieving DAS28-CRP Low Disease Activity (LDA) at Week 12
timeFrame: At Week 12
measure: Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Week 12
timeFrame: Baseline, Week 12
measure: Change From Baseline in Clinical Disease Activity Index Score (CDAI) at Week 12
timeFrame: Baseline, Week 12
measure: Number of Participants With Treatment-emergent Adverse Events (TEAEs)
timeFrame: Up to Week 30
measure: Number of Participants With Treatment-emergent Serious Adverse Events (SAEs)
timeFrame: Up to Week 30
measure: Number of Participants With TEAEs Leading to Discontinuation of Study Intervention
timeFrame: Up to Week 30
measure: Number of Participants With Adverse Events of Special interests (AESIs)
timeFrame: Up to Week 30
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Arizona Arthritis and Rheumatology Research PLLC
state: Arizona
city: Huntington Beach
country: United States
facility: Newport Huntington Medical Group
state: California
city: Upland
country: United States
facility: Inland Rheumatology Clinical Trials Inc.
state: California
city: Brandon
country: United States
facility: Bay Area Arthritis and Osteoporosis
state: Florida
city: Clearwater
country: United States
facility: Clinical Research of West Florida
state: Florida
city: Plantation
country: United States
facility: Integral Rheumatology And Immunology Specialists
state: Florida
city: Marietta
country: United States
facility: Atlanta Research Center for Rheumatology
state: Georgia
city: Bowling Green
country: United States
facility: Graves Gilbert Clinic
state: Kentucky
city: Duncansville
country: United States
facility: Altoona Center For Clinical Research
state: Pennsylvania
city: Mesquite
country: United States
facility: Southwest Rheumatology Research LLC
state: Texas
city: Buenos Aires
country: Argentina
facility: Centro Privado de Medicina Familiar
city: Buenos Aires
country: Argentina
facility: Sanatorio Agote
city: Buenos Aires
country: Argentina
facility: Hospital Central Militar Cirujano Mayor Dr Cosme Argerich
city: Caba
country: Argentina
facility: Mautalen Salud e Investigacion
city: Caba
country: Argentina
facility: ARCIS Salud SRL Aprillus asistencia e investigacion
city: Ciudad Autónoma de Buenos Aires
country: Argentina
facility: STAT Research S A
city: San Miguel De Tucuman
country: Argentina
facility: Centro de Investigaciones Medicas Tucuman
city: Hamburg
country: Germany
facility: Hamburger Rheuma Forschungszentrum II
city: Herne
country: Germany
facility: Rheumazentrum Ruhrgebiet
city: Ratingen
country: Germany
facility: Rheumazentrum Ratingen
city: Budapest
country: Hungary
facility: Budai Irgalmasrendi Korhaz
city: Gyula
country: Hungary
facility: Bekes Varmegyei Kozponti Korhaz Pandy Kalman Tagkorhaz
city: Hodmezovasarhely
country: Hungary
facility: Porcika Klinika - Vasarhelyi Sarkanyfu Kft.
city: Szekesfehervar
country: Hungary
facility: CMed Rehabilitacios es Diagnosztikai Kozpont
city: Veszprem
country: Hungary
facility: Vital Medical Center Orvosi es Fogaszati Kozpont
city: Bydgoszcz
country: Poland
facility: Szpital Uniwersytecki nr 2 im dr Jana Biziela w Bydgoszczy
city: Nadarzyn
country: Poland
facility: NZOZ Lecznica MAK MED S C
city: Warszawa
country: Poland
facility: MICS Centrum Medyczne Warszawa
city: Warszawa
country: Poland
facility: Centrum Medyczne Reuma Park
city: Edinburgh
country: United Kingdom
facility: Western General Hospital
city: Gillingham
country: United Kingdom
facility: Medway NHS Foundation Trust
city: London
country: United Kingdom
facility: Kings College Hospital
Study officials:
affiliation: Janssen Research & Development, LLC
name: Janssen Research & Development, LLC Clinical Trial
role: STUDY_DIRECTOR
References: