Guselkumab versus Placebo for the Treatment of Psoriatic Arthritis Axial Disease in Bio-naive Participants
- Conditions
- Active Psoriatic Arthritis Axial DiseaseMedDRA version: 21.0Level: LLTClassification code 10037160Term: Psoriatic arthritisSystem Organ Class: 100000004859Therapeutic area: Diseases [C] - Immune System Diseases [C20]
- Registration Number
- EUCTR2021-000465-32-ES
- Lead Sponsor
- Janssen-Cilag International NV
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 405
- Be at least 18 years of age.
- 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 criteria 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 =0.3 mg/dL at screening from the central laboratory.
- Have a BASDAI score of at least 4.
- Have magnetic resonance imaging-confirmed PsA axial disease (positive MRI spine and/or SI joints, shown by a SPARCC score of =3 in either the spine or the sacroiliac joints).
- Have a spinal pain score of at least 4.
For the complete overview of the inclusion criteria, please refer to section 5.1 of the protocol
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 365
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 40
- Has other inflammatory diseases that might confound the evaluations of benefit of guselkumab therapy, including but not limited to rheumatoid arthritis, ankylosing spondylitis/non-radiographic-axial spondyloarthritis, systemic lupus erythematosus, or Lyme disease.
- Has previously received any biologic treatment including, but not limited to, guselkumab, ustekinumab, secukinumab, tildrakizumab, ixekizumab, brodalumab, risankizumab or other investigative biologic treatment.
- Has ever received a Janus kinase inhibitor including but not limited to tofacitinib, baricitinib, filgotinib, peficitinib, decernotinib, upadacitinib or any other investigational JAK inhibitor.
- Has received any systemic immunosuppressants within 4 weeks of the first administration of study intervention.
- Has received apremilast within 4 weeks prior to 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.
For the complete overview of the exclusion criteria, please refer to section 5.2 of the protocol
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 PsA axial disease by assessing reduction in axial symptoms.;Secondary Objective: - To evaluate the efficacy of guselkumab on additional measures of axial symptoms, reduction in axial inflammation, and other signs and symptoms of PsA, psoriasis, and participant well-being.<br>- To evaluate the safety of guselkumab in participants with active PsA.<br>- To evaluate the pharmacokinetics and immunogenicity of guselkumab in participants with active PsA.;Primary end point(s): Change from baseline in BASDAI at Week 24.;Timepoint(s) of evaluation of this end point: Week 24
- Secondary Outcome Measures
Name Time Method