A Study to Evaluate the Impact of Upadacitinib on Spondyloarthritis Outcomes in Patients With Active Psoriatic Arthritis

Part of paid clinical trials in Cleveland, Ohio.

Sponsor
CARE ARTHRITIS LTD.
Study ID
NCT06454188
Phase
PHASE4
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

Study Details

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

Key Dates

Start date
Dec 3, 2024
Status verified
Mar 2026
Primary completion
Sep 30, 2028
Completion
Oct 31, 2028

Study Design

Enrollment
100 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Upadacitinib
    Participants randomized to this arm will receive Upadacitinib 15 mg tablets, once per day, for 12 weeks.
  • Placebo Comparator: Placebo
    Participants randomized to this arm will receive matching placebo tablets with no active ingredients, once per day, for 12 weeks.

Primary Outcome Measure

Change from baseline in the (SPARCC) MRI inflammation score (for SIJ and spine) at 12 weeks of therapy with upadacitinib vs placebo in the DMARD-IR (conventional and/or biologic) subgroup [ Time Frame: 12 weeks ]

Central Contacts

Locations (3)

FacilityCityStateZIPSite coordinators
University Hospitals Cleveland Medical CenterClevelandOhio44106
Lindsay Clinical Research Nurse Specialist
[email protected]
216-286-1246
Marina Magrey (PRINCIPAL_INVESTIGATOR)
Oregon Health and Science UniversityPortlandOregon97239
Study Coordinator
[email protected]
503-494-5742
Deodhar, Dr. (PRINCIPAL_INVESTIGATOR)
University of PennsylvaniaPhiladelphiaPennsylvania19104
Sarah Project Manager
[email protected]
(215) 614-1840
Alexis Ogdie (PRINCIPAL_INVESTIGATOR)

Find similar trials in Cleveland, OH

By condition
Psoriatic arthritis
By specialty
RheumatologyAutoimmune diseaseMusculoskeletal disorders
By research site
University Hospitals Cleveland Medical Center· Cleveland, OHOregon Health and Science University· Portland, ORUniversity of Pennsylvania· Philadelphia, PA

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