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Efficacy Of Upadacitinib In Psoriatic Arthritis And Comparison To Rheumatoid Arthritis.
Sponsor: I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio
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
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