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

Last updated: October 4, 2024
Sponsor: I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio
Overall Status: Active - Recruiting

Phase

N/A

Condition

Rheumatoid Arthritis

Joint Injuries

Psoriatic Arthritis

Treatment

Upadacitinib 15 MG [Rinvoq]

Clinical Study ID

NCT06630715
OPTIMA (L4182)
  • Ages > 18
  • All Genders

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.

Eligibility Criteria

Inclusion

The inclusion criteria for Psoriatic Arthritis patients are:

  1. Patients diagnosed with peripheral Psoriatic Arthritis according to the CASPARcriteria or with axial Psoriatic Arthritis according to ASAS criteria and with atleast one of the following:

  2. With active peripheral Psoriatic Arthritis regarding ongoing therapy in one ofthe following sites: MCP joints 1-5, proximal interphalangeal (PIP) joints ofhands 1-5, distal interphalangeal (DIP) joints of hands 2-5, wrists, elbows,knees and ankles/heels and feet, according to any of the following criteria:I) DAPSA ≥ 15 and joint inflammation according to the Global OMERACT-EULAR USscoring for synovitis and power Doppler (GLOESS) with a grade at patient level >3,2II) With a clinical enthesitis and an active enthesitis (positive power Dopplerof any grade), in the clinical symptomatic site, according to the OMERACT USdefinitionsIII) With active dactylitis (clinical diagnosis made by the physician at thetime of baseline visit) and a positive US dactylitis according to theDACTylitis glObal Sonographic (DACTOS) score >3IV) DAPSA ≥ 15 and tenosynovitis according to the OMERACT US scoring system fortenosynovitis with a grade >1

  3. With active axial PsA regarding ongoing therapy (ASDAS ≥ 2.1) and activesacroiliitis according to the ASAS MRI definitions

  4. Who are eligible according to the current guidelines/regulations to start treatmentwith UPA and present a favorable risk/benefit profile according to the clinician'sopinion for such treatment.

  5. Aged older than 18 years.

  6. Able to provide informed consent, according to requirements of local IRB/ethicscommittee.

The inclusion criteria for Rheumatoid Arthritis patients are:

  1. Patients diagnosed with RA according to the ACR/EULAR 2010 classification criteria

  2. With active Rheumatoid Arthritis according to the following criteria: DAS28-PCR >3.2, and the presence of at least one US finding of the following:

  3. Joint inflammation at hands and wrists according to the Global OMERACT-EULAR (GLOESS) US scoring for synovitis and power Doppler with a grade at patientlevel >2

  4. One tenosynovitis at hands or wrists, according to the OMERACT US scoringsystem for tenosynovitis with a grade >1

  5. Who are eligible according to the current guidelines/regulations to start treatmentwith Upadacitinib and present a favourable risk/benefit profile according to theclinician's opinion for such treatment.

  6. Aged older than 18 years.

  7. Able to provide informed consent, according to requirements of local IRB/ethicscommittee.

Exclusion

Exclusion Criteria:

  1. Patients with any contraindication to Upadacitinib:

  2. women who are pregnant or breastfeeding

  3. active infection

  4. evidence of tuberculosis infection

  5. known infection with human immunodeficiency virus or hepatitis B or C

  6. patients who have current malignancy or history of malignancy in the last 5years

  7. high cardiovascular risk

  8. high risk of venous thromboembolism

  9. patients with severe hepatic impairment

  10. Patients with associated fibromyalgia syndrome according to the 2016 ACR diagnosticcriteria

  11. Unable to provide informed consent, according to requirements of local IRB/ethicscommittee.

Study Design

Total Participants: 178
Treatment Group(s): 1
Primary Treatment: Upadacitinib 15 MG [Rinvoq]
Phase:
Study Start date:
July 23, 2024
Estimated Completion Date:
December 31, 2025

Study Description

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.

Connect with a study center

  • IRCCS Ospedale Galeazzi-Sant'Ambrogio,

    Milano, Mi 20157
    Italy

    Active - Recruiting

  • Ospedale Civile di Legnano

    LegNano, Milano 20025
    Italy

    Active - Recruiting

  • IRCCS Ospedale Humanitas

    Rozzano, Milano 20089
    Italy

    Active - Recruiting

  • IRCCS Policlinico San Donato

    San Donato, Milano 20097
    Italy

    Active - Recruiting

  • IRCCS San Gerardo

    Monza, Monza E Brianza 20900
    Italy

    Active - Recruiting

  • ASST Papa Giovanni XXIII

    Bergamo, 24127
    Italy

    Active - Recruiting

  • ASST Spedali Civili

    Brescia, 25153
    Italy

    Active - Recruiting

  • ASST Fatebenefratelli-Sacco Ospedale Luigi Sacco

    Milano,
    Italy

    Active - Recruiting

  • ASST Gaetano Pini CTO

    Milano, 20122
    Italy

    Active - Recruiting

  • ASST Grande Ospedale Metropolitano Niguarda

    Milano, 20162
    Italy

    Active - Recruiting

  • IRCCS Ospedale San Raffaele

    Milano, 20132
    Italy

    Active - Recruiting

  • Fondazione IRCCS Policlinico San Matteo

    Pavia, 27100
    Italy

    Active - Recruiting

  • IRCCS Istituti Clinici Scientifici Maugeri

    Pavia, 27100
    Italy

    Active - Recruiting

  • ASST Settelaghi - Ospedale di Circolo di Varese

    Varese, 21100
    Italy

    Active - Recruiting

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