Active Psoriatic Arthritis Axial Disease MedDRA version: 21.0 Level: LLT Classification code 10037160 Term: Psoriatic arthritis System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
Conditions
Sponsors
Janssen-Cilag International NV
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - 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
Exclusion criteria
Exclusion criteria: - 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. - To evaluate the safety of guselkumab in participants with active PsA. - 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
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Change from baseline in ASDAS-CRP at Week 24 - Change from baseline in Disease Activity Index for Psoriatic Arthritis at Week 24 - Change from baseline in Health Assessment Questionnaire – Disability Index at Week 24 - Proportion of participants with investigator’s global assessment 0/1 response at Week 24 among the participants with =3% BSA psoriatic involvement and an IGA score of =2 at baseline. - Change from baseline in Spondyloarthritis Research Consortium of Canada score for MRI sacroiliac joints at Week 24 - Proportion of participants who achieve a =50% improvement from baseline in BASDAI score at Week 24 - Proportion of participants who achieve ASDAS clinically important improvement at Week 24 - Proportion of participants who achieve ASAS 40 response at Week 24 - Proportion of participants who achieve ASDAS major improvement at Week 24 - Change from baseline in SPARCC score for MRI spine at Week 24 ;Timepoint(s) of evaluation of this end point: Week 24 | — |
Countries
Argentina, Australia, Bulgaria, Canada, Czechia, Czech Republic, Denmark, Germany, Hong Kong, Hungary, Israel, Italy, Malaysia, Poland, Portugal, Russian Federation, Spain, Taiwan, Türkiye, Ukraine, United Kingdom, United States
Contacts
Public ContactClinical Registry group
Janssen Biologics B.V.
Outcome results
None listed