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.
This is a multicentric prospective observational study in which consecutive patients diagnosed with Psoriatic Arthritis (any subset) and Rheumatoid Arthritis, that according to clinicians' evaluation should be treated with Upadacitinib therapy, will be recruited from the outpatient clinic of the Rheumatology Department of the centers included in the study. The investigators will enroll consecutive patients with Psoriatic Arthritis and Rheumatoid Arthritis with active disease and fulfilling the inclusion and exclusion criteria, from the outpatient clinic of the Rheumatology Units of the participating centers. Written informed consent will be obtained prior to the beginning of the study. All patients, in line with clinical routine practice, will undergo a standard clinical, laboratory, and imaging assessment in order to define the disease activity according to standardized disease activity indexes, at baseline and during the first 3 follow-up visits. For patients starting new treatments for Psoriatic Arthritis and Rheumatoid Arthritis, the follow-up visits are generally scheduled after 1 month (± 1 week), 3 months (± 2 weeks), and 6 months (± 4 weeks) post-treatment initiation, in accordance with international guidelines and local protocols. In case of suspicion of axial involvement, an MRI of the sacroiliac joints will be performed at baseline and, in case of positivity, will be repeated after 6 months (±1 month) in order to assess disease activity at the spine and the treatment efficacy. Regarding the Patient Reported Outcome, the investigators will assess these during the scheduled visits, and two weeks after the initiation of treatment to evaluate earlier pain and functional improvement. The Patient Reported Outcome assessment at two weeks will be administered in a paper form to participants during the baseline visit, and subsequently participants will return these during the first follow-up visit. The data for the study will be retrieved from the medical records of participants and recorded into an appositely created electronic case report form.
Study Type
OBSERVATIONAL
Enrollment
178
15 mg/ day
Ospedale Civile di Legnano
Legnano, Milano, Italy
RECRUITINGIRCCS Ospedale Humanitas
Rozzano, Milano, Italy
RECRUITINGIRCCS Policlinico San Donato
San Donato, Milano, Italy
RECRUITINGIRCCS Ospedale Galeazzi-Sant'Ambrogio,
Milan, Mi, Italy
RECRUITINGIRCCS San Gerardo
Monza, Monza E Brianza, Italy
RECRUITINGASST Papa Giovanni XXIII
Bergamo, Italy
RECRUITINGASST Spedali Civili
Brescia, Italy
RECRUITINGASST Gaetano Pini CTO
Milan, Italy
RECRUITINGIRCCS Ospedale San Raffaele
Milan, Italy
RECRUITINGASST Grande Ospedale Metropolitano Niguarda
Milan, Italy
RECRUITING...and 4 more locations
Difference between US synovitis score
Difference between US synovitis score from baseline to 24 weeks in patients with active synovitis
Time frame: from baseline to 24 weeks
Difference between US dactylitis score
Difference between US dactylitis score (DACTOS) from baseline to 24 weeks in patients with active dactylitis
Time frame: from baseline to 24 weeks
Difference between US tenosynovitis score
Difference between US tenosynovitis score from baseline to 24 weeks in patients with active tenosynovitis
Time frame: from baseline to 24 weeks
Difference between US enthesitis score
Difference between US enthesitis score from baseline to 24 weeks in patients with active enthesitis
Time frame: from baseline to 24 weeks
Difference between US peritendonitis score
Difference between US peritendonitis score from baseline to 24 weeks in patients with peritendonitis
Time frame: from baseline to 24 weeks
Difference between SPARCC MRI index
Difference between SPARCC MRI index from baseline to 24 weeks in patients with active sacroiliitis in PsA
Time frame: from baseline to 24 weeks
Difference between T2 mapping scores
Difference between T2 mapping scores from baseline to 24 weeks in patients with active sacroiliitis in PsA
Time frame: from baseline to 24 weeks
Difference between SJC66
Difference between SJC66 from baseline to 24 weeks in PsA and RA
Time frame: from baseline to 24 weeks
Difference between TJC68
Difference between TJC68 from baseline to 24 weeks in PsA and RA
Time frame: from baseline to 24 weeks
Difference between the SPARCC score
Difference between the SPARCC score from baseline to and 24 weeks in PsA
Time frame: from baseline to and 24 weeks
Difference between the dactylitis count
Difference between the dactylitis count from baseline to and 24 weeks in PsA
Time frame: from baseline to 24 weeks
Prevalence of BSA = 0
Prevalence of BSA = 0 after 24 weeks in PsA
Time frame: after 24 weeks
Difference between CRP levels
Difference between CRP levels from baseline to and 24 weeks in PsA and RA
Time frame: from baseline to and 24 weeks
Difference between HAQ score
Difference between HAQ score from baseline to and 24 weeks in PsA and RA
Time frame: from baseline to and 24 weeks
Difference between Physician's Global Assessment of Disease Activity VAS
Difference between Physician's Global Assessment of Disease Activity VAS from baseline to and 24 weeks in PsA and RA
Time frame: from baseline to and 24 weeks
Difference between VAS pain
Difference between VAS pain from baseline to and 24 weeks in PsA and RA
Time frame: from baseline to and 24 weeks
Difference between GH-VAS
Difference between GH-VAS from baseline to and 24 weeks in PsA and RA
Time frame: from baseline to 24 weeks
Difference between ASDAS levels
Difference between ASDAS levels from baseline to and 24 weeks in PsA
Time frame: from baseline to 24 weeks
Prevalence of MDA
Prevalence of MDA at 24 weeks in PsA
Time frame: at 24 weeks
Difference between DAS28 levels
Difference between DAS28 levels at baseline and 24 weeks in PsA and RA
Time frame: baseline and 24 weeks
Time to remission
Time to remission in PsA and RA up to 2 weeks
Time frame: up to 2 weeks
Adverse events
Adverse events from baseline and 24 weeks
Time frame: from baseline and 24 weeks
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