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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorI.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio

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 volunteers

Qualifiers

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

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Upadacitinib 15 MG [Rinvoq]

    Drug

    15 mg/ day

Treatment groups

178 Participants
are divided into 2 treatment groups
Group A: Rheumatoid Arthritis1 intervention
Group B: Psoriatic Arthritis1 intervention

Trial outcomes

Primary outcomes

1

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

Secondary outcomes

1

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
2

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
3

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
4

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

Other outcomes

Sponsors and contacts

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