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A Study of the Efficacy and Safety of Guselkumab in Participants with Active Psoriatic Arthritis
EU CTIS ID: 2023-504734-21-00
What this study is testing
To evaluate the efficacy of guselkumab treatment in participants with active psoriatic arthritis (PsA) by assessing the reduction in signs and symptoms of PsA.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Be at least 18 years of age (or the legal age of consent in the jurisdiction in which the study is taking place)
- If currently using non-biologic DMARDs (limited to MTX, SSZ, HCQ, or LEF), participants should have started treatment at least 3 months and the dose must be stable for at least 4 weeks before first administration of study intervention and should have no serious toxic side effects attributable to the non-biologic DMARD. If currently not using MTX, SSZ, or HCQ, must not have received for at least 4 weeks before first administration of study intervention. If currently not using LEF, must not have received for at least 12 weeks before first administration of study intervention. a.If using MTX, the route of administration and dose must be stable and the dose must be ≤25 mg/week. b.If receiving SSZ, the dose must be ≤3g/day. c.If receiving HCQ, the dose must be ≤400 mg/day. d.If receiving LEF, the dose must be ≤20 mg/day.
- Have active plaque psoriasis, with at least one psoriatic plaque of ≥ 2cm diameter and/or nail changes consistent with psoriasis.
- If using NSAIDs or other analgesics for PsA at baseline, participants must be on a stable dose for at least 2 weeks prior to the first administration of study intervention. If currently not using NSAIDs or other analgesics for PsA, must not have received NSAIDs or other analgesics for PsA within 2 weeks prior to the first administration of study intervention.
- If using oral corticosteroids at baseline, participants must be on a stable dose equivalent to ≤10 mg of prednisone/day for at least 2 weeks prior to the first administration of study intervention. If not currently using oral corticosteroids, the participant must not have received oral corticosteroids within 2 weeks prior to the first administration of study intervention.
- Have active PsA despite previous non-biologic DMARD, apremilast, and/or NSAID therapy.
You likely can't join if
- Has known allergies, hypersensitivity, or intolerance to study intervention or its excipients.
- Has other inflammatory diseases that might confound the evaluations of benefit of guselkumab therapy, including but not limited to RA, axial spondyloarthritis (AS)/non-radiographic axial spondyloarthritis (nr- axSpA), systemic lupus erythematosus, or Lyme disease (confirmed by Western blot).
- Has the arthritis mutilans subset of PsA.
- Has previously received any biologic treatment including, but not limited to, guselkumab, ustekinumab, secukinumab, anti-TNFα agents (such as adalimumab, etanercept, infliximab, golimumab SC or intravenous (IV), certolizumab pegol, or their respective biosimilars), tildrakizumab, ixekizumab, brodalumab, risankizumab or other investigative biologic treatment for PsA or psoriasis.
- Has ever received tofacitinib, baricitinib, filgotinib, peficitinib, decernotinib, upadacitinib 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 intervention.
See the full eligibility criteria
Who can join
- Be at least 18 years of age (or the legal age of consent in the jurisdiction in which the study is taking place)
- If currently using non-biologic DMARDs (limited to MTX, SSZ, HCQ, or LEF), participants should have started treatment at least 3 months and the dose must be stable for at least 4 weeks before first administration of study intervention and should have no serious toxic side effects attributable to the non-biologic DMARD. If currently not using MTX, SSZ, or HCQ, must not have received for at least 4 weeks before first administration of study intervention. If currently not using LEF, must not have received for at least 12 weeks before first administration of study intervention. a.If using MTX, the route of administration and dose must be stable and the dose must be ≤25 mg/week. b.If receiving SSZ, the dose must be ≤3g/day. c.If receiving HCQ, the dose must be ≤400 mg/day. d.If receiving LEF, the dose must be ≤20 mg/day.
- Have active plaque psoriasis, with at least one psoriatic plaque of ≥ 2cm diameter and/or nail changes consistent with psoriasis.
- If using NSAIDs or other analgesics for PsA at baseline, participants must be on a stable dose for at least 2 weeks prior to the first administration of study intervention. If currently not using NSAIDs or other analgesics for PsA, must not have received NSAIDs or other analgesics for PsA within 2 weeks prior to the first administration of study intervention.
- If using oral corticosteroids at baseline, participants must be on a stable dose equivalent to ≤10 mg of prednisone/day for at least 2 weeks prior to the first administration of study intervention. If not currently using oral corticosteroids, the participant must not have received oral corticosteroids within 2 weeks prior to the first administration of study intervention.
- Have active PsA despite previous non-biologic DMARD, apremilast, and/or NSAID therapy.
- Have a diagnosis of PsA for at least 6 months prior to the first administration of study intervention and meet ClASsification criteria for Psoriatic ARthritis (CASPAR) criteria at screening.
- Have active PsA as defined by: a. At least three swollen joints and three tender joints at screening and at baseline -AND- b. CRP ≥ 0.3 mg/dL at screening from the central laboratory.
- Have ≥2 joints with erosions on baseline radiographs of the hands and feet as determined by central read.
- 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.
What rules you out
- Has known allergies, hypersensitivity, or intolerance to study intervention or its excipients.
- Has other inflammatory diseases that might confound the evaluations of benefit of guselkumab therapy, including but not limited to RA, axial spondyloarthritis (AS)/non-radiographic axial spondyloarthritis (nr- axSpA), systemic lupus erythematosus, or Lyme disease (confirmed by Western blot).
- Has the arthritis mutilans subset of PsA.
- Has previously received any biologic treatment including, but not limited to, guselkumab, ustekinumab, secukinumab, anti-TNFα agents (such as adalimumab, etanercept, infliximab, golimumab SC or intravenous (IV), certolizumab pegol, or their respective biosimilars), tildrakizumab, ixekizumab, brodalumab, risankizumab or other investigative biologic treatment for PsA or psoriasis.
- Has ever received tofacitinib, baricitinib, filgotinib, peficitinib, decernotinib, upadacitinib 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 intervention.
- Has received non-biologic DMARDs other than MTX, SSZ, HCQ, LEF, within 4 weeks before the first administration of study intervention.
- Is receiving 3 or more non-biologic DMARDs specified in Table 3 at baseline. Note: participants cannot be on concomitant MTX and LEF.
- Has received phototherapy or any systemic medications/treatments that could affect psoriasis evaluations (including, but not limited to, retinoids, 1,25-dihydroxy vitamin D3 and analogues, psoralens, fumaric acid derivatives, with the exception of those in Table 3) within 4 weeks of the first administration of study intervention.
The study team makes the final eligibility decision.
Where it's taking place
- Turkey
- Korea, Republic of
- Ukraine
- United States
- Malaysia
- Russian Federation
- Canada
- Australia
- Georgia
- China
- Israel
- Bosnia and Herzegovina
- Philippines
- Serbia
- Belarus
- Taiwan
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Turkey; Korea, Republic of; Ukraine; United States; Malaysia; Russian Federation and 10 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.