Actively Recruiting
Efficacy Of Upadacitinib In Psoriatic Arthritis And Comparison To Rheumatoid Arthritis.
Led by I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio · Updated on 2024-10-08
178
Participants Needed
14
Research Sites
70 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Efficacy Of Upadacitinib In Psoriatic Arthritis And Comparison To Rheumatoid Arthritis.
Who Can Participate
Eligibility Criteria
You may qualify if you...
The inclusion criteria for Psoriatic Arthritis patients are:
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Patients diagnosed with peripheral Psoriatic Arthritis according to the CASPAR criteria or with axial Psoriatic Arthritis according to ASAS criteria and with at least one of the following:
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With active peripheral Psoriatic Arthritis regarding ongoing therapy in one of the following sites: MCP joints 1-5, proximal interphalangeal (PIP) joints of hands 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 US scoring for synovitis and power Doppler (GLOESS) with a grade at patient level >3,2
II) With a clinical enthesitis and an active enthesitis (positive power Doppler of any grade), in the clinical symptomatic site, according to the OMERACT US definitions
III) With active dactylitis (clinical diagnosis made by the physician at the time of baseline visit) and a positive US dactylitis according to the DACTylitis glObal Sonographic (DACTOS) score >3
IV) DAPSA ≥ 15 and tenosynovitis according to the OMERACT US scoring system for tenosynovitis with a grade >1
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With active axial PsA regarding ongoing therapy (ASDAS ≥ 2.1) and active sacroiliitis according to the ASAS MRI definitions
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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.
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Aged older than 18 years.
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Able to provide informed consent, according to requirements of local IRB/ethics committee.
The inclusion criteria for Rheumatoid Arthritis patients are:
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Patients diagnosed with RA according to the ACR/EULAR 2010 classification criteria
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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 patient level >2
- One tenosynovitis at hands or wrists, according to the OMERACT US scoring system for tenosynovitis with a grade >1
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Who are eligible according to the current guidelines/regulations to start treatment with Upadacitinib and present a favourable risk/benefit profile according to the clinician's opinion for such treatment.
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Aged older than 18 years.
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Able to provide informed consent, according to requirements of local IRB/ethics committee.
Exclusion Criteria:
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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 5 years
- high cardiovascular risk
- high risk of venous thromboembolism
- patients with severe hepatic impairment
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Patients with associated fibromyalgia syndrome according to the 2016 ACR diagnostic criteria
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Unable to provide informed consent, according to requirements of local IRB/ethics committee.
You will not qualify if you...
History of severe allergic reactions to study medication Currently pregnant or breastfeeding Recent participation in another clinical trial within the last 30 days Presence of uncontrolled medical conditions that could affect safety
AI-Screening
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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
Research Team
G
Georgios Filippou, MD
CONTACT
S
Silvia Sirotti, MD
CONTACT
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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