RecruitingNCT06630715

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

Efficacy Of Upadacitinib In Psoriatic Arthritis And Comparison To Rheumatoid Arthritis. OPTimising IMAging For The Use In The Follow-Up Of Arthritis: The OPTIMA Study


Sponsor

I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio

Enrollment

178 participants

Start Date

Jul 23, 2024

Study Type

OBSERVATIONAL

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is looking at how well a drug called upadacitinib works in real-world patients with psoriatic arthritis (joint inflammation related to psoriasis), and comparing its effects to patients with rheumatoid arthritis taking the same drug. **You may be eligible if...** - You have been diagnosed with psoriatic arthritis OR rheumatoid arthritis - You have active joint inflammation confirmed by clinical exam and ultrasound - Your doctor has decided it is appropriate for you to start upadacitinib - You are over 18 years old **You may NOT be eligible if...** - You have any contraindication to upadacitinib (such as active serious infection, active TB, HIV, hepatitis B or C, significant heart disease, recent cancer, or are pregnant/breastfeeding) - You have fibromyalgia - You are unable to provide informed consent Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGUpadacitinib 15 MG [Rinvoq]

15 mg/ day


Locations(14)

Ospedale Civile di Legnano

Legnano, Milano, Italy

IRCCS Ospedale Humanitas

Rozzano, Milano, Italy

IRCCS Policlinico San Donato

San Donato, Milano, Italy

IRCCS Ospedale Galeazzi-Sant'Ambrogio,

Milan, Mi, Italy

IRCCS San Gerardo

Monza, Monza E Brianza, Italy

ASST Papa Giovanni XXIII

Bergamo, Italy

ASST Spedali Civili

Brescia, Italy

ASST Gaetano Pini CTO

Milan, Italy

IRCCS Ospedale San Raffaele

Milan, Italy

ASST Grande Ospedale Metropolitano Niguarda

Milan, Italy

ASST Fatebenefratelli-Sacco Ospedale Luigi Sacco

Milan, Italy

Fondazione IRCCS Policlinico San Matteo

Pavia, Italy

IRCCS Istituti Clinici Scientifici Maugeri

Pavia, Italy

ASST Settelaghi - Ospedale di Circolo di Varese

Varese, Italy

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NCT06630715