About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
With active axial PsA regarding ongoing therapy (ASDAS ≥ 2.1) and active sacroiliitis according to the ASAS MRI definitions
Who are eligible according to the current guidelines/regulations to start treatment with UPA and present a favorable risk/benefit profile according to the clinician's opinion for such treatment.
Aged older than 18 years.
Able to provide informed consent, according to requirements of local IRB/ethics committee.
Disqualifiers
women who are pregnant or breastfeeding
active infection
evidence of tuberculosis infection
known infection with human immunodeficiency virus or hepatitis B or C
Trial population
Patients with active Psoriatic Arthritis and patients with active Rheumatoid Arthritis who will start therapy with upadacitinib
Trial design
Cohort
Prospective
Treatments tested in this trial
Upadacitinib 15 MG [Rinvoq]
Drug15 mg/ day
Treatment groups
Trial outcomes
Primary outcomes
Difference between US synovitis score
Difference between US synovitis score from baseline to 24 weeks in patients with active synovitis
Secondary outcomes
Difference between US dactylitis score
Difference between US dactylitis score (DACTOS) from baseline to 24 weeks in patients with active dactylitis
Difference between US tenosynovitis score
Difference between US tenosynovitis score from baseline to 24 weeks in patients with active tenosynovitis
Difference between US enthesitis score
Difference between US enthesitis score from baseline to 24 weeks in patients with active enthesitis
Difference between US peritendonitis score
Difference between US peritendonitis score from baseline to 24 weeks in patients with peritendonitis
Sponsors and contacts
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