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

Sponsor
I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio
Study ID
NCT06630715
Status
Recruiting
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Conditions

  • Psoriatic Arthritis (PsA
  • Rheumatoid Arthritis (RA

Eligibility Criteria

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

Interventions

Study Details

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.

Key Dates

Start date
Jul 23, 2024
Status verified
Sep 2024
Primary completion
Dec 31, 2025
Completion
Dec 31, 2025

Study Design

Enrollment
178 participants (estimated)

Arms

  • Arm: Rheumatoid Arthritis
    Patients diagnosed with RA according to the ACR/EULAR 2010 classification criteria with active disease starting Upadacitinib
  • Arm: Psoriatic Arthritis
    Patients diagnosed with peripheral Psoriatic Arthritis according to the CASPAR criteria or with axial Psoriatic Arthritis according to ASAS criteria with active disease starting Upadacitinib

Primary Outcome Measure

Difference between US synovitis score [ Time Frame: from baseline to 24 weeks ]

Central Contacts

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