A phase 3 study of Guselkumab in Subjects with Active Psoriatic Arthritis

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 245

Inclusion Criteria

1. Be a man or a woman at least 18 years of age
2. Have a diagnosis of PsA for at least 6 months before the first administration of study intervention and meet Classification criteria for Psoriatic ARthritis at screening.
3. Have active PsA as defined by at least 3 swollen joints and at least 3 tender joints at screening and at baseline.
4. 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.
5. Have active plaque psoriasis, with at least one psoriatic plaque of =2 cm diameter or nail changes consistent with psoriasis or documented history of plaque psoriasis.
6. Have an inadequate response to anti-TNFa therapy, defined as presence of active PsA despite previous treatment with either 1 or 2 anti-TNFa agents and either of the following:
a. Lack of benefit of an anti-TNFa therapy, as documented in the patient history by the treating physician, after at least 12 weeks of etanercept, adalimumab, golimumab, or certolizumab pegol therapy (or biosimilar) and/or at least a 14-week dosage regimen (ie, at least 4 doses) of infliximab (or biosimilar). Documented lack of benefit may include inadequate improvement in joint counts, physical function, or disease activity
b. Intolerance to an anti-TNFa therapy, as documented in the patient history by the treating physician, to etanercept, adalimumab, golimumab, certolizumab pegol, or infliximab (or biosimilars)

For a complete overview of the inclusion criteria please refer to protocol section 5.1 (pages 25-29)
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 221
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 24

Exclusion Criteria

1. Has other inflammatory diseases that might confound the evaluations of benefit of guselkumab therapy, including but not limited to RA, axial spondyloarthritis, systemic lupus erythematosus, or Lyme disease
2. Has ever received more than 2 anti-TNFa agents
3. Has received an anti-TNFa agent (see page 30 of the protocol for a description of the anti-TNFa agents)
4. Has previously been treated with guselkumab.
5. Has previously received any biologic treatment, including, but not limited to ustekinumab, abatacept, secukinumab, tildrakizumab, ixekizumab, brodalumab, risankizumab, or other investigative biologic treatment.

For a complete overview of the exclusion criteria please refer to protocol section 5.2 (pages 30-33)

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To evaluate guselkumab efficacy vs placebo in patients with active psoriatic arthritis (PsA) and an inadequate response to anti-TNFa therapy by assessing the reduction in signs and symptoms of joint disease.;Secondary Objective: - Efficacy in improving physical function<br>- Efficacy in improving general and disease-specific health-related quality of life and patient-reported health outcomes<br>- Efficacy in improving psoriatic skin lesions<br>- Safety;Primary end point(s): The Proportion of participants who achieve an American College of Rheumatology (ACR) 20 response ;Timepoint(s) of evaluation of this end point: Week 24

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): 1. Change from baseline in Health Assessment Questionnaire-Disability Index score <br>2. Proportion of participants who achieve an ACR 50 response <br>3. Change from baseline in 36-item short form health survey Physical Component Summary score<br>4. Proportion of participants who achieve Psoriatic Area and Severity Index 100 response among participants with =3% body surface area psoriatic involvement and an Investigator’s Global Assessment score of =2 at baseline;Timepoint(s) of evaluation of this end point: Week 24

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