Guselkumab vs Golimumab in PsA TNF Inadequate Responder Patients

Part of paid clinical trials in Loxahatchee Groves, Florida.

Sponsor
University of Pennsylvania
Study ID
NCT05669833
Phase
PHASE3
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • Guselkumab — DRUG
    Guselkumab (GUS) subcutaneous injection
  • Golimumab — DRUG
    Golimumab (GOL) subcutaneous injection

Study Details

The trial is an open-label randomized study that will examine whether switching to a selective IL23 inhibitor (guselkumab) is more effective than switching to a second TNFi (golimumab) among patients with PsA who have an inadequate response to a TNFi.

Key Dates

Start date
Jul 14, 2023
Status verified
Oct 2025
Primary completion
Oct 31, 2026
Completion
Oct 31, 2026

Study Design

Enrollment
63 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Guselkumab 100mg q4w
    Guselkumab (GUS) 100mg every 4 weeks
  • Experimental: Guselkumab 100mg q8w
    Guselkumab (GUS) 100mg every 8 weeks
  • Active Comparator: Golimumab 50mg q4w
    Golimumab (GOL) 50mg every 4 weeks

Primary Outcome Measure

Achievement of cDAPSA low disease activity [ Time Frame: 12 Months ]

Central Contacts

Locations (14)

FacilityCityStateZIPSite coordinators
Family Arthritis CenterLoxahatchee GrovesFlorida33470
Veronika Solomon
[email protected]
Howard Busch, DO (PRINCIPAL_INVESTIGATOR)
Healing RheumatologyPlant CityFlorida33563
Veronika Solomon
[email protected]
Gina Prakash, MD (PRINCIPAL_INVESTIGATOR)
Southwest Florida RheumatologyRiverviewFlorida33569
Veronika Solomon
[email protected]
Shanmugapriya Reddy, MD (PRINCIPAL_INVESTIGATOR)
Parris and AssociatesLilburnGeorgia30047
Veronika Solomon
[email protected]
Glenn Parris, MD (PRINCIPAL_INVESTIGATOR)
University of Massachusetts Chan Medical SchoolWorcesterMassachusetts01655
Study Coordinator
[email protected]
774-455-3528
Karen Salomon-Escoto, MD (PRINCIPAL_INVESTIGATOR)
University of Nebraska Medical CenterOmahaNebraska68198
Study Coordinator
[email protected]
Ted Mikuls, MD (PRINCIPAL_INVESTIGATOR)
New York UniversityNew YorkNew York10016
Study Coordinator
[email protected]
646-501-7379
Soumya Reddy, MD (PRINCIPAL_INVESTIGATOR)
Cincy ArthritisBlue AshOhio45242
Veronika Solomon
[email protected]
Tara Adhikari, MD (PRINCIPAL_INVESTIGATOR)
Southern Ohio RheumatologyWheelersburgOhio45694
Veronika Solomon
[email protected]
Rajesh Kataria, MD (PRINCIPAL_INVESTIGATOR)
Hospital at the University of PennsylvaniaPhiladelphiaPennsylvania19104
Sarah Gillespie, MS
[email protected]
215-614-1840
[email protected]
Alexis Ogdie-Beatty, MD, MSCE (PRINCIPAL_INVESTIGATOR)
Cumberland RheumatologyCrossvilleTennessee38555
Veronika Solomon
[email protected]
Sivalingam Kanagasegar, MD (PRINCIPAL_INVESTIGATOR)
Heritage Rheumatology and Arthritis CareColleyvilleTexas76034
Veronika Solomon
[email protected]
Dhiman Basu, MD (PRINCIPAL_INVESTIGATOR)
Texas Arthritis CenterEl PasoTexas79902
Veronika Solomon
[email protected]
Sanjay Chabra, MD (PRINCIPAL_INVESTIGATOR)
University of UtahSalt Lake CityUtah84132
Study Coordinator
[email protected]
801-585-0797
Jessica Walsh, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Loxahatchee Groves, FL

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Psoriatic arthritis
By specialty
RheumatologyAutoimmune diseaseMusculoskeletal disorders
By research site
Family Arthritis Center· Loxahatchee Groves, FLHealing Rheumatology· Plant City, FLSouthwest Florida Rheumatology· Riverview, FLParris and Associates· Lilburn, GAUniversity of Massachusetts Chan Medical School· Worcester, MAUniversity of Nebraska Medical Center· Omaha, NE

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