Clinical Trial

Efficacy Of Upadacitinib In Psoriatic Arthritis And Comparison To Rheumatoid Arthritis.

Study acronym: OPTIMA
Recruiting
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Record status
This record was last updated October 8, 2024 (before its estimated December 2025 completion). Its status may not reflect the trial's current state.
Summary
The general objective of the OPTIMA study is to assess the time course and interrelationship of imaging (ultrasound and magnetic resonance imaging), clinical, laboratory, and Patient Reported Outcome variables in patients with active Psoriatic Arthritis (any subset) and Rheumatoid Arthritis starting therapy with a Jak-Inhibitor (Upadacitinib), during the first 6 months of follow-up. Participants will be evaluated at the start of therapy with upadacitinib and during the follow-up visits at 2 weeks, 1, 3, and 6 months post-treatment initiation. At each visit (with the exception of the 2-weeks visit), data relating to the clinical evaluation, laboratory tests, and ultrasound of the affected joints will be collected according to standard clinical practice; questionnaires on disease activity will also be completed. In the case of axial involvement, a magnetic resonance imaging will be performed at baseline and after 6 months of therapy, only if required by the standard of care.
Trial Details
NCT Number NCT06630715
Lead Sponsor I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio
Conditions Rheumatoid Arthritis (RA, Psoriatic Arthritis (PsA
Enrollment 178 participants
Start Date 2024-07-23
Primary Completion 2025-12 (estimated)
Study Completion 2025-12 (estimated)
Updated on ClinicalTrials.gov 2024-10-08