Actively Recruiting

Age: 18Years +
All Genders
ID06630715

Efficacy of Upadacitinib in Psoriatic Arthritis and Rheumatoid Arthritis: The OPTIMA Study for Optimizing Imaging in Arthritis Follow-Up

Led by I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio · Updated on 2024-10-08

178

Participants Needed

14

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are investigating how imaging techniques like ultrasound and magnetic resonance imaging, along with clinical, laboratory, and patient-reported outcome measures, change over the first six months in people with active Psoriatic Arthritis or Rheumatoid Arthritis starting treatment with the drug Upadacitinib. This study focuses on understanding these changes in patients beginning this therapy to better monitor disease activity and treatment response. This observational study enrolls patients with active Psoriatic Arthritis or Rheumatoid Arthritis who are prescribed Upadacitinib by their doctors. Participants will be evaluated at treatment start and followed up at 2 weeks, 1 month, 3 months, and 6 months. Clinical assessments, laboratory tests, and ultrasound of affected joints will be done at each visit except the 2-week check. For those with axial disease, MRI scans will be performed at baseline and after 6 months if clinically indicated. During the study, data from clinical exams, lab tests, imaging, and patient questionnaires will be collected to measure disease activity and treatment effects. The main outcome is the change in ultrasound synovitis scores from baseline to 24 weeks. Other measures include various ultrasound scores, MRI indices, joint counts, inflammation markers, patient and physician assessments, and adverse events. This comprehensive follow-up aims to provide detailed information about disease progression and response to Upadacitinib over six months.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients diagnosed with peripheral Psoriatic Arthritis per CASPAR criteria or axial Psoriatic Arthritis per ASAS criteria with active disease
  • Active peripheral Psoriatic Arthritis with joint inflammation, enthesitis, dactylitis, or tenosynovitis as defined by specified clinical and ultrasound criteria
  • Active axial Psoriatic Arthritis with ASDAS score ≥ 2.1 and active sacroiliitis by MRI
  • Patients eligible for Upadacitinib treatment per guidelines and clinician opinion
  • Diagnosis of Rheumatoid Arthritis per ACR/EULAR 2010 criteria with active disease (DAS28-PCR > 3.2) and ultrasound evidence of synovitis or tenosynovitis
  • Patients eligible for Upadacitinib treatment per guidelines and clinician opinion
  • Adults aged 18 years or older
  • Able to provide informed consent according to local ethics requirements
Not Eligible

You will not qualify if you...

  • Pregnant or breastfeeding women
  • Active infections
  • Evidence of tuberculosis infection
  • Known infection with HIV, hepatitis B, or hepatitis C
  • Current malignancy or cancer history within last 5 years
  • High cardiovascular risk
  • High risk of venous thromboembolism
  • Severe liver impairment
  • Associated fibromyalgia syndrome per 2016 ACR criteria
  • Unable to provide informed consent according to local ethics requirements

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - Up to 24 weeks

Participants start Upadacitinib therapy and undergo standard clinical, laboratory, and imaging assessments to monitor disease activity and treatment effects.

1 baseline visit, 1 visit at 2 weeks, and 3 follow-up visits at approximately 1 month, 3 months, and 6 months after treatment initiation

Long-term Monitoring

Duration - 6 months

Participants with axial involvement may undergo MRI assessments at baseline and after 6 months to evaluate ongoing disease activity and treatment efficacy.

1 baseline MRI and 1 follow-up MRI at 6 months (if applicable)

Trial Site Locations

Total: 14 locations

1

Ospedale Civile di Legnano

Legnano, Milano, Italy, 20025

Actively Recruiting

2

IRCCS Ospedale Humanitas

Rozzano, Milano, Italy, 20089

Actively Recruiting

3

IRCCS Policlinico San Donato

San Donato, Milano, Italy, 20097

Actively Recruiting

4

IRCCS Ospedale Galeazzi-Sant'Ambrogio,

Milan, Mi, Italy, 20157

Actively Recruiting

5

IRCCS San Gerardo

Monza, Monza E Brianza, Italy, 20900

Actively Recruiting

6

ASST Papa Giovanni XXIII

Bergamo, Italy, 24127

Actively Recruiting

7

ASST Spedali Civili

Brescia, Italy, 25153

Actively Recruiting

8

ASST Gaetano Pini CTO

Milan, Italy, 20122

Actively Recruiting

9

IRCCS Ospedale San Raffaele

Milan, Italy, 20132

Actively Recruiting

10

ASST Grande Ospedale Metropolitano Niguarda

Milan, Italy, 20162

Actively Recruiting

11

ASST Fatebenefratelli-Sacco Ospedale Luigi Sacco

Milan, Italy

Actively Recruiting

12

Fondazione IRCCS Policlinico San Matteo

Pavia, Italy, 27100

Actively Recruiting

13

IRCCS Istituti Clinici Scientifici Maugeri

Pavia, Italy, 27100

Actively Recruiting

14

ASST Settelaghi - Ospedale di Circolo di Varese

Varese, Italy, 21100

Actively Recruiting

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Research Team

G

Georgios Filippou, MD

S

Silvia Sirotti, MD

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

2

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