A Study Evaluating the Efficacy and Safety of Guselkumab Administered Subcutaneously in Participants With Active Psoriatic Arthritis Including Those Previously Treated With Biologic Anti -Tumor Necrosis Factor (TNF) Alpha Agent(s)

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

NCT03162796

Run by

Janssen Research & Development, LLC

People needed

383

Starts

2017-08-24

Expected to finish

2019-11-18

Last updated by the study team

2021-02-03

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 3 swollen joints and at least 3 tender joints at screening and at baseline; and C-reactive protein (CRP) greater than or equal to (>=) 0.3 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
• 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 drugs (DMARD), apremilast, and/or nonsteroidal anti-inflammatory drug (NSAID) therapy : Non-biologic DMARD therapy is defined as taking a non-biologic DMARD for at least 3 months or evidence of intolerance; Apremilast therapy is defined as taking apremilast at the marketed dose approved in the country where the study is being conducted for at least 4 months or evidence of intolerance; NSAID therapy is defined as taking an NSAID for at least 4 weeks or evidence of intolerance
• Participants may have been previously treated with up to 2 anti-TNF (tumor necrosis factor) alpha agents (approximately 30 percent [%] of the overall study population), and must document the reason for discontinuation

You may not qualify if…

• Has other inflammatory diseases that might confound the evaluations of 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 ever received more than 2 anti-TNFalpha agents
• Has previously received any biologic treatment (other than anti-TNF alpha agents), including, but not limited to ustekinumab, abatacept, secukinumab, tildrakizumab, ixekizumab, brodalumab, risankizumab, or other investigative biologic treatment
• Has previously received any systemic immunosuppressants (for example, azathioprine, cyclosporine, 6 thioguanine, mercaptopurine, mycophenolate mofetil, hydroxyurea, tacrolimus) within 4 weeks of the first administration of study agent
• Has received apremilast within 4 weeks prior to the first administration of study agent
• Has previously received tofacitinib, baricitinib, filgotinib, peficitinib (ASP015K), decernotinib (VX-509), or any other Janus kinase (JAK) inhibitor

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
• Arthritis and Osteoporosis Associates — Freehold, New Jersey, United States
• Austin Regional Clinic — Austin, Texas, United States
• Barwon Rheumatology Services — Geelong, Australia
• Southern Clinical Research — Hobart, Australia
• Liverpool Hospital — Liverpool, Australia
• Rheumatology Research Unit — Maroochydore, Australia
• Eastern Health - Box Hill Hospital — Melbourne, Australia
• Queen Elizabeth Hospital — Woodville South, Australia
• Eastern Regional Health Authority, St. Clare's Mercy Hospital — St. John's, Newfoundland and Labrador, Canada
• The Waterside Clinic — Barrie, Ontario, Canada
• Dermatrials Research — Hamilton, Ontario, Canada
• Skin Centre for Dermatology — Peterborough, Ontario, Canada
• K. Papp Clinical Research — Waterloo, Ontario, Canada
• G.R.M.O. (Groupe de recherche en maladies osseuses) Inc. — Québec, Canada
• Revmaclinic — Brno, Czechia
• MUDr. Rosypalova, s.r.o — Ostrava, Czechia
• Revmatologicky ustav — Prague, Czechia
• Revmatologicka ambulance — Prague, Czechia
• Rheumatology Associates — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.