A Study Evaluating the Efficacy and Safety of Guselkumab Administered Subcutaneously in Participants With Active Psoriatic Arthritis
Completed · Phase 3 · Has a placebo group
Conditions studied: Arthritis, Psoriatic
In brief
The primary purpose of this study is to evaluate the efficacy of guselkumab treatment in participants with active psoriatic arthritis (PsA) by assessing the reduction in signs and symptoms of PsA.
Key facts
- Study ID
- NCT03158285
- Run by
- Janssen Research & Development, LLC
- People needed
- 741
- Starts
- 2017-07-12
- Expected to finish
- 2020-11-10
- Last updated by the study team
- 2026-06-02
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Have a diagnosis of Psoriatic Arthritis (PsA) for at least 6 months before the first administration of study agent and meet Classification criteria for Psoriatic Arthritis (CASPAR) at screening
- Have active PsA as defined by: at least 5 swollen joints and at least 5 tender joints at screening and at baseline, and CRP greater than or equal to (>=) 0.6 milligram per deciLitre (mg/dL) at screening from the central laboratory
- Have at least 1 of the PsA subsets: distal interphalangeal joint involvement, polyarticular arthritis with absence of rheumatoid nodules, arthritis mutilans, asymmetric peripheral arthritis, or spondylitis with peripheral arthritis (confirmation of sacroiliitis should be performed at the screening visit by a locally performed pelvic x-ray [single anterior-posterior view] unless a pelvic or SI joint x-ray or pelvic magnetic resonance imaging (MRI) has been previously performed. Results must be documented)
- Have active plaque psoriasis, with at least one psoriatic plaque of >= 2 centimeter (cm) diameter or nail changes consistent with psoriasis or documented history of plaque psoriasis
- Have active PsA despite previous non-biologic disease-modifying antirheumatic drug (DMARD), apremilast, and/or nonsteroidal anti-inflammatory drug (NSAID) therapy
You may not qualify if…
- Has other inflammatory diseases that might confound the evaluations or benefit of guselkumab therapy, including but not limited to rheumatoid arthritis (RA), axial spondyloarthritis (this does not include a primary diagnosis of PsA with spondylitis), systemic lupus erythematosus, or Lyme disease
- Has previously received any biologic treatment
- Has ever received tofacitinib, baricitinib, filgotinib, peficitinib (ASP015K), decernotinib (VX-509), or any other Janus kinase (JAK) inhibitor
- Has received any systemic immunosuppressants (eg, azathioprine, cyclosporine, 6 thioguanine, mercaptopurine, mycophenolate mofetil, hydroxyurea, tacrolimus) within 4 weeks of the first administration of study agent
- Is currently receiving 2 or more non-biologic DMARDs (other than methotrexate [MTX], sulfasalazine [SSZ], Hydroxychloroquine [HCQ], leflunomide [LEF]) including, but not limited to chloroquine, gold preparations, and penicillamine within 4 weeks before the first administration of study agent
- Has received apremilast within 4 weeks prior to the first administration of study agent
Where it is running
- Arizona Arthritis & Rheumatology Associates PC — Glendale, Arizona, United States
- Arizona Arthritis & Rheumatology Research, PLLC — Mesa, Arizona, United States
- Clinical Research Center of Connecticut — Danbury, Connecticut, United States
- Dawes Fretzin Clinical Research Group LLC — Indianapolis, Indiana, United States
- University of Michigan — Ann Arbor, Michigan, United States
- Arthritis Consultants — St Louis, Missouri, United States
- Austin Regional Clinic — Austin, Texas, United States
- Multiprofile Hospital for Active Treatment Plovdiv — Plovdiv, Bulgaria
- Multiprofile Hosptal for Active Treatment Eurohospital Plovdiv — Plovdiv, Bulgaria
- Medical Center Teodora — Rousse, Bulgaria
- Diagnostic Consulting Center No 17 — Sofia, Bulgaria
- Military Medical Academy — Sofia, Bulgaria
- Medical Centre Synexus — Sofia, Bulgaria
- MHAT-Targovishte, AD — Targovishte, Bulgaria
- Revmaclinic — Brno, Czechia
- Revmacentrum MUDr Mostera s r o — Brno-Židenice, Czechia
- MUDr Rosypalova s r o — Ostrava, Czechia
- Revmatologicky institut — Prague, Czechia
- Revmatologicka ambulance — Prague, Czechia
- Medical Plus S R O — Uherské Hradiště, Czechia
- PV Medical S R O — Zlín, Czechia
- Parnu Hospital — Pärnu, Estonia
- OU Innomedica — Tallinn, Estonia
- East Tallinn Central Hospital — Tallinn, Estonia
- Rheumatology Associates — Birmingham, Alabama, United States
Full record on ClinicalTrials.gov
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