Guselkumab in Active Psoriatic Arthritis Participants With Inadequate Response/Intolerance to One Prior Anti-TNF Alpha Agent

Ведущий спонсор: Janssen Research & Development, LLC

The purpose of this study is to evaluate the efficacy of guselkumab treatment in participants with active psoriatic arthritis (PsA) and inadequate response (IR) and/or intolerance to a prior anti-tumor necrosis factor (TNF) by assessing the reduction in signs and symptoms of PsA.

• Arthritis, Psoriatic

Тип вмешательства: Drug

Название вмешательства: Guselkumab

Описание: Participants will receive guselkumab as SC injection.

Тип вмешательства: Drug

Название вмешательства: Placebo

Описание: Participants will receive matching placebo as SC injection.

Критерии:

Inclusion Criteria: - Have a diagnosis of active 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 milligrams per deciliter (mg/dL) at screening from the central laboratory - Have at least one of the following PsA subsets: distal interphalangeal joint involvement, polyarticular arthritis with absence of rheumatoid nodules, asymmetric peripheral arthritis, or spondylitis with peripheral arthritis - Have active plaque psoriasis, with at least one psoriatic plaque of >= 2 centimeters (cm) diameter and/or nail changes consistent with psoriasis, or documented history of plaque psoriasis - Have an inadequate response and/or intolerance to anti-tumor necrosis factor alpha (TNF alpha) therapy, defined as presence of active PsA despite previous treatment with one prior anti-TNF alpha agent Exclusion Criteria: - Has other inflammatory diseases that might confound the evaluations of benefit of guselkumab therapy in the treatment of PsA, including but not limited to rheumatoid arthritis, ankylosing spondylitis/nonradiographic axial spondyloarthritis, systemic lupus erythematosus, or Lyme disease - Has received more than 1 prior anti-tumor necrosis factor (TNF) alpha agent (or biosimilars) - Has ever received Janus kinase (JAK) inhibitor including but not limited to tofacitinib, baricitinib, filgotinib, peficitinib, decernotinib, upadacitinib or any other investigational JAK inhibitor - Has received any systemic immunosuppressants (example, azathioprine, cyclosporine, 6 thioguanine, mercaptopurine, mycophenolate mofetil, hydroxyurea, tacrolimus) within 4 weeks of the first administration of study intervention - Has known allergies, hypersensitivity, or intolerance to guselkumab or its excipients - Has a history of chronic or recurrent infectious disease, including but not limited to chronic renal infection, chronic chest infection (example, bronchiectasis), recurrent urinary tract infection (example, recurrent pyelonephritis or chronic non-remitting cystitis), fungal infection (example, mucocutaneous candidiasis), or open, draining, or infected skin wounds or ulcers

Пол:

All

Минимальный возраст:

18 Years

Максимальный возраст:

N/A

Здоровые волонтеры:

No

Фамилия: Study Contact

Телефон: 844-434-4210

Australia

Bulgaria

Czechia

Hungary

Israel

Malaysia

Poland

Puerto Rico

Russian Federation

Turkey

Ukraine

United States

2022-01-01

Тип: Sponsor

• Arthritis
• Arthritis, Psoriatic

Метка: Group 1: Guselkumab and Placebo

Тип: Experimental

Описание: Participants will receive guselkumab and placebo subcutaneously (SC) to maintain the blind.

Метка: Group 2: Guselkumab

Тип: Experimental

Описание: Participants will receive guselkumab SC.

Метка: Group 3: Placebo Followed by Guselkumab

Тип: Experimental

Описание: Participants will receive placebo SC and will cross over to receive guselkumab SC.

Распределение: Randomized

Модель вмешательства: Parallel Assignment

Первичное назначение: Treatment

Маскировка: Double (Participant, Investigator)