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

NCT06630715 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 178

Last updated 2024-10-08

No results posted yet for this study

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.

Conditions

  • Rheumatoid Arthritis (RA
  • Psoriatic Arthritis (PsA

Interventions

DRUG

Upadacitinib 15 MG [Rinvoq]

15 mg/ day

Sponsors & Collaborators

  • I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio

    lead OTHER

Principal Investigators

  • Georgios Filippou, MD · Università degli Studi di Milano / IRCCS Ospedale Galeazzi-Sant'Ambrogio

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-07-23
Primary Completion
2025-12-31
Completion
2025-12-31

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06630715 on ClinicalTrials.gov