Phase
Condition
Rheumatoid Arthritis
Joint Injuries
Psoriatic Arthritis
Treatment
Upadacitinib 15 MG [Rinvoq]
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
The inclusion criteria for Psoriatic Arthritis patients are:
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:
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
With active axial PsA regarding ongoing therapy (ASDAS ≥ 2.1) and activesacroiliitis according to the ASAS MRI definitions
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.
Aged older than 18 years.
Able to provide informed consent, according to requirements of local IRB/ethicscommittee.
The inclusion criteria for Rheumatoid Arthritis patients are:
Patients diagnosed with RA according to the ACR/EULAR 2010 classification criteria
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:
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
One tenosynovitis at hands or wrists, according to the OMERACT US scoringsystem for tenosynovitis with a grade >1
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.
Aged older than 18 years.
Able to provide informed consent, according to requirements of local IRB/ethicscommittee.
Exclusion
Exclusion Criteria:
Patients with any contraindication to Upadacitinib:
women who are pregnant or breastfeeding
active infection
evidence of tuberculosis infection
known infection with human immunodeficiency virus or hepatitis B or C
patients who have current malignancy or history of malignancy in the last 5years
high cardiovascular risk
high risk of venous thromboembolism
patients with severe hepatic impairment
Patients with associated fibromyalgia syndrome according to the 2016 ACR diagnosticcriteria
Unable to provide informed consent, according to requirements of local IRB/ethicscommittee.
Study Design
Study Description
Connect with a study center
IRCCS Ospedale Galeazzi-Sant'Ambrogio,
Milano, Mi 20157
ItalyActive - Recruiting
Ospedale Civile di Legnano
LegNano, Milano 20025
ItalyActive - Recruiting
IRCCS Ospedale Humanitas
Rozzano, Milano 20089
ItalyActive - Recruiting
IRCCS Policlinico San Donato
San Donato, Milano 20097
ItalyActive - Recruiting
IRCCS San Gerardo
Monza, Monza E Brianza 20900
ItalyActive - Recruiting
ASST Papa Giovanni XXIII
Bergamo, 24127
ItalyActive - Recruiting
ASST Spedali Civili
Brescia, 25153
ItalyActive - Recruiting
ASST Fatebenefratelli-Sacco Ospedale Luigi Sacco
Milano,
ItalyActive - Recruiting
ASST Gaetano Pini CTO
Milano, 20122
ItalyActive - Recruiting
ASST Grande Ospedale Metropolitano Niguarda
Milano, 20162
ItalyActive - Recruiting
IRCCS Ospedale San Raffaele
Milano, 20132
ItalyActive - Recruiting
Fondazione IRCCS Policlinico San Matteo
Pavia, 27100
ItalyActive - Recruiting
IRCCS Istituti Clinici Scientifici Maugeri
Pavia, 27100
ItalyActive - Recruiting
ASST Settelaghi - Ospedale di Circolo di Varese
Varese, 21100
ItalyActive - Recruiting
Not the study for you?
Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.