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

Part of paid clinical trials in Phoenix, Arizona.

Sponsor
Janssen Research & Development, LLC
Study ID
NCT06028438
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Placebo — DRUG
    Placebo will be administered intravenously.
  • Nipocalimab — DRUG
    Nipocalimab will be administered intravenously.
  • Certolizumab — DRUG
    Certolizumab will be administered subcutaneously.

Study Details

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

Key Dates

Start date
Aug 15, 2023
Status verified
Sep 2025
Primary completion
Aug 29, 2024
Completion
Oct 29, 2024

Study Design

Enrollment
103 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Certolizumab + Placebo
    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.
  • Experimental: Certolizumab + Nipocalimab
    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.

Primary Outcome Measure

Change From Baseline in Disease Activity Index Score 28 Using C-reactive Protein (DAS28-CRP) at Week 12 [ Time Frame: Baseline (Week 0), Week 12 ]

Locations (10)

FacilityCityStateZIPSite coordinators
Arizona Arthritis and Rheumatology Research PLLCPhoenixArizona85032-
Newport Huntington Medical GroupHuntington BeachCalifornia92648-
Inland Rheumatology Clinical Trials Inc.UplandCalifornia91786-
Bay Area Arthritis and OsteoporosisBrandonFlorida33511-
Clinical Research of West FloridaClearwaterFlorida33765-
Integral Rheumatology And Immunology SpecialistsPlantationFlorida33324-
Atlanta Research Center for RheumatologyMariettaGeorgia30060-
Graves Gilbert ClinicBowling GreenKentucky42101-
Altoona Center For Clinical ResearchDuncansvillePennsylvania16635-
Southwest Rheumatology Research LLCMesquiteTexas75150-

Related coverage on Hipa.ai

Find similar trials in Phoenix, AZ

By condition
Rheumatoid arthritis
By specialty
RheumatologyAutoimmune diseaseMusculoskeletal disorders
By research site
Arizona Arthritis and Rheumatology Research PLLC· Phoenix, AZNewport Huntington Medical Group· Huntington Beach, CAInland Rheumatology Clinical Trials Inc.· Upland, CABay Area Arthritis and Osteoporosis· Brandon, FLClinical Research of West Florida· Clearwater, FLIntegral Rheumatology And Immunology Specialists· Plantation, FL

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