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RECRUITING
NCT06630715

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

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

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

178

Start Date

2024-07-23

Completion Date

2025-12

Last Updated

2024-10-08

Healthy Volunteers

No

Interventions

DRUG

Upadacitinib 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