A Proof-of-concept Study of the Efficacy and Safety of Nipocalimab in Participants With Active Rheumatoid Arthritis

Part of paid clinical trials in Glendale, Arizona.

Sponsor
Janssen Research & Development, LLC
Study ID
NCT04991753
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • Placebo — OTHER
    Placebo infusion will be administered intravenously.
  • Nipocalimab — DRUG
    Nipocalimab infusions will be administered intravenously.

Study Details

The purpose of this study is to evaluate the efficacy and safety of nipocalimab versus placebo in participants with moderate to severe active rheumatoid arthritis (RA).

Key Dates

Start date
Oct 14, 2021
Status verified
Aug 2025
Primary completion
Aug 10, 2022
Completion
Aug 10, 2022

Study Design

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

Arms

  • Placebo Comparator: Group 1: Placebo
    Participants will receive placebo intravenously (IV) every 2 weeks (q2w) through Week 10 along with standard-of-care background therapy.
  • Experimental: Group 2: Nipocalimab
    Participants will receive nipocalimab IV q2w through Week 10 along with standard-of-care background therapy.

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 (13)

FacilityCityStateZIPSite coordinators
Arizona Arthritis & Rheumatology Associates PCGlendaleArizona85306-
Arizona Arthritis & Rheumatology Research, PLLCMesaArizona85210-
Arizona Arthritis & Rheumatology Research, PLLCTucsonArizona85704-
Desert Medical AdvancesPalm DesertCalifornia92260-
Arthritis Care and Research Center Inc.: Smitha Reddy, MDPowayCalifornia92064-
TriWest Research Associates, LLCSan DiegoCalifornia92108-
Inland Rheumatology Clinical Trials, Inc.UplandCalifornia91786-
DJL Clinical Research, PLLCCharlotteNorth Carolina28210-
STAT Research, Inc.VandaliaOhio45377-
Low Country Rheumatology PASummervilleSouth Carolina29486-
West Tennessee Research InstituteJacksonTennessee38305-
Accurate Clinical Research, Inc.HoustonTexas77089-
Southwest Rheumatology Research LLCMesquiteTexas75150-

Related coverage on Hipa.ai

Find similar trials in Glendale, AZ

By condition
Rheumatoid arthritis
By specialty
RheumatologyAutoimmune diseaseMusculoskeletal disorders
By research site
Arizona Arthritis & Rheumatology Associates PC· Glendale, AZArizona Arthritis & Rheumatology Research, PLLC· Mesa, AZArizona Arthritis & Rheumatology Research, PLLC· Tucson, AZDesert Medical Advances· Palm Desert, CAArthritis Care and Research Center Inc.: Smitha Reddy, MD· Poway, CATriWest Research Associates, LLC· San Diego, CA

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