A Randomized, Placebo-controlled, Multicenter, Study to Evaluate the Impact of Upadacitinib on Spondyloarthritis Outcomes in Patients with Active Psoriatic Arthritis (UP-SPOUT)

Conditions

Axial Spondyloarthritis, Psoriatic Arthritis

Brief summary

Change from baseline in the Total Spondyloarthritis Research Consortium of Canada (SPARCC) MRI inflammation score (for SIJ and spine) (combination of the 23-DVU SPARCC spine (range 0-414) and the SPARCC SIJ (range 0-72)) at 12 weeks of therapy with upadacitinib vs placebo in the DMARD-IR (conventional and/or biologic) subgroup

Detailed description

Change from baseline in Ankylosing Spondylitis Disease Activity Score (ASDAS-CRP) at Week 12 with upadacitinib vs placebo in the DMARD-IR (conventional and/or biologic) subgroup, Change from Baseline in BASDAI at Week 12 with upadacitinib vs placebo in the DMARD-IR (conventional and/or biologic) subgroup, Change from baseline in the Total Spondyloarthritis Research Consortium of Canada (SPARCC) MRI inflammation score (for SIJ and spine) (combination of the 23-DVU SPARCC spine (range 0-414) and the SPARCC SIJ (range 0-72)) at 12 weeks of therapy with upadacitinib vs placebo in the overall population (NSAID-IR, c-DMARD-IR and and bio-DMARD-IR), Change from baseline in Ankylosing Spondylitis Disease Activity Score (ASDAS-CRP) at Week 12 with upadacitinib vs placebo in the overall population (NSAID-IR, c-DMARD-IR and and bio-DMARD-IR), Change from Baseline in BASDAI at Week 12 with upadacitinib vs placebo in the overall population (NSAID-IR, c-DMARD-IR and and bio-DMARD-IR), Incidence of Adverse Events (AEs), AEs leading to withdrawal from study drug, and serious AEs (SAEs).

Related papers

No related papers found yet.

Interventions

DRUGMatching placebo (no active ingredients).

DRUGUpadacitinib

Eligibility

Sex/Gender

All

Age

18 Years to 64 Years

Design outcomes

Primary

Measure	Time frame
Change from baseline in the Total Spondyloarthritis Research Consortium of Canada (SPARCC) MRI inflammation score (for SIJ and spine) (combination of the 23-DVU SPARCC spine (range 0-414) and the SPARCC SIJ (range 0-72)) at 12 weeks of therapy with upadacitinib vs placebo in the DMARD-IR (conventional and/or biologic) subgroup	—

Secondary

Measure	Time frame
Change from baseline in Ankylosing Spondylitis Disease Activity Score (ASDAS-CRP) at Week 12 with upadacitinib vs placebo in the DMARD-IR (conventional and/or biologic) subgroup, Change from Baseline in BASDAI at Week 12 with upadacitinib vs placebo in the DMARD-IR (conventional and/or biologic) subgroup, Change from baseline in the Total Spondyloarthritis Research Consortium of Canada (SPARCC) MRI inflammation score (for SIJ and spine) (combination of the 23-DVU SPARCC spine (range 0-414) and the SPARCC SIJ (range 0-72)) at 12 weeks of therapy with upadacitinib vs placebo in the overall population (NSAID-IR, c-DMARD-IR and and bio-DMARD-IR), Change from baseline in Ankylosing Spondylitis Disease Activity Score (ASDAS-CRP) at Week 12 with upadacitinib vs placebo in the overall population (NSAID-IR, c-DMARD-IR and and bio-DMARD-IR), Change from Baseline in BASDAI at Week 12 with upadacitinib vs placebo in the overall population (NSAID-IR, c-DMARD-IR and and bio-DMARD-IR), Incidence of A	—

Measure

Time frame

Change from baseline in Ankylosing Spondylitis Disease Activity Score (ASDAS-CRP) at Week 12 with upadacitinib vs placebo in the DMARD-IR (conventional and/or biologic) subgroup, Change from Baseline in BASDAI at Week 12 with upadacitinib vs placebo in the DMARD-IR (conventional and/or biologic) subgroup, Change from baseline in the Total Spondyloarthritis Research Consortium of Canada (SPARCC) MRI inflammation score (for SIJ and spine) (combination of the 23-DVU SPARCC spine (range 0-414) and the SPARCC SIJ (range 0-72)) at 12 weeks of therapy with upadacitinib vs placebo in the overall population (NSAID-IR, c-DMARD-IR and and bio-DMARD-IR), Change from baseline in Ankylosing Spondylitis Disease Activity Score (ASDAS-CRP) at Week 12 with upadacitinib vs placebo in the overall population (NSAID-IR, c-DMARD-IR and and bio-DMARD-IR), Change from Baseline in BASDAI at Week 12 with upadacitinib vs placebo in the overall population (NSAID-IR, c-DMARD-IR and and bio-DMARD-IR), Incidence of A

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Countries

Belgium, Poland

Outcome results

None listed