A Study of the Efficacy and Safety of Guselkumab in Participants with Active Psoriatic Arthritis
- Conditions
- Psoriatic arthritis (PsA)MedDRA version: 21.0Level: LLTClassification code 10037160Term: Psoriatic arthritisSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disordersTherapeutic area: Diseases [C] - Immune System Diseases [C20]
- Registration Number
- EUCTR2020-004981-20-BG
- Lead Sponsor
- Janssen-Cilag International NV
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 950
1.Be at least 18 years of age (or the legal age of consent in the jurisdiction in which the study is taking place).
2.Have active PsA despite previous non-biologic DMARD, apremilast, and/or NSAID therapy.
3.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.
4.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.
NOTE: A one-time repeat assessment of CRP level is allowed during the 6-week screening phase and the investigator may consider the participant eligible if the test result is within acceptable range on repeat testing in the central laboratory.
5.Have =2 joints with erosions on baseline radiographs of the hands and feet as determined by central read.
6.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.
7.Have active plaque psoriasis, with at least one psoriatic plaque of =2cm diameter and/or nail changes consistent with psoriasis.
8.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.
9.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.
10.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.
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 893
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 57
1.Has known allergies, hypersensitivity, or intolerance to study intervention or its excipients.
2.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).
3.Has the arthritis mutilans subset of PsA.
4.Has previously received any biologic treatment including, but not limited to, guselkumab, ustekinumab, secukinumab, anti-TNFa 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.
5.Has ever received tofacitinib, baricitinib, filgotinib, peficitinib, decernotinib, upadacitinib or any other Janus kinase (JAK) inhibitor.
6.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.
7.Has received non-biologic DMARDs other than MTX, SSZ, HCQ, LEF, within 4 weeks before the first administration of study intervention.
8.Is receiving 3 or more non-biologic DMARDs specified in Table 3 at baseline. Note: participants cannot be on concomitant MTX and LEF.
9.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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To evaluate the efficacy of guselkumab treatment in participants with active psoriatic arthritis (PsA) by assessing the reduction in signs and symptoms of PsA.;Secondary Objective: •To evaluate the inhibition of progression of structural damage in participants with active PsA.<br>•To evaluate the safety in participants with active PsA.<br>•To evaluate the pharmacokinetics (PK) and immunogenicity in participants with active PsA.;Primary end point(s): •Proportion of participants with 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): •Change from baseline in PsA modified van der Heijde-Sharp (vdH-S) score<br>•Frequency and type of adverse events (AEs), serious adverse events (SAEs), reasonably related AEs, AEs leading to discontinuation of study intervention, infections and injection-site reactions. <br>•Laboratory abnormalities (chemistry, hematology), maximum toxicity (Common Terminology Criteria for Adverse Events [CTCAE 5.0]) grades.<br>•Serum guselkumab concentration.<br>•Incidence of antibodies to guselkumab.<br>;Timepoint(s) of evaluation of this end point: Week 24 and visit over time through week 156 or 168