TrialPath
Recruiting

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

NCT06630715 · I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio
In plain English

Click the button to translate this study into plain language — what it is, who qualifies, and what participation looks like.

Official title
Efficacy Of Upadacitinib In Psoriatic Arthritis And Comparison To Rheumatoid Arthritis. OPTimising IMAging For The Use In The Follow-Up Of Arthritis: The OPTIMA Study
About this study
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.
Eligibility criteria
The inclusion criteria for Psoriatic Arthritis patients are: 1. 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: 1. 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 2. With active axial PsA regarding ongoing therapy (ASDAS ≥ 2.1) and active sacroiliitis according to the ASAS MRI definitions 2. 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. 3. Aged older than 18 years. 4. Able to provide informed consent, according to requirements of local IRB/ethics committee. 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: 1. 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 2. One tenosynovitis at hands or wrists, according to the OMERACT US scoring system for tenosynovitis with a grade \>1 3. 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. 4. Aged older than 18 years. 5. Able to provide informed consent, according to requirements of local IRB/ethics committee. Exclusion Criteria: 1. Patients with any contraindication to Upadacitinib: 1. women who are pregnant or breastfeeding 2. active infection 3. evidence of tuberculosis infection 4. known infection with human immunodeficiency virus or hepatitis B or C 5. patients who have current malignancy or history of malignancy in the last 5 years 6. high cardiovascular risk 7. high risk of venous thromboembolism 8. patients with severe hepatic impairment 2. Patients with associated fibromyalgia syndrome according to the 2016 ACR diagnostic criteria 3. Unable to provide informed consent, according to requirements of local IRB/ethics committee.
Study design
Enrollment target: 178 participants
Age groups: adult, older_adult
Timeline
Starts: 2024-07-23
Estimated completion: 2025-12
Last updated: 2024-10-08
Interventions
Drug: Upadacitinib 15 MG [Rinvoq]
Primary outcomes
  • Difference between US synovitis score (from baseline to 24 weeks)
Sponsor
I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio · other
Contacts & investigators
ContactGeorgios Filippou, MD · contact · georgios.filippou@grupposandonato.it · 0039 0283502707
ContactSilvia Sirotti, MD · contact · silvia.sirotti@grupposandonato.it · 0039 0283502708
InvestigatorGeorgios Filippou, MD · principal_investigator, Università degli Studi di Milano / IRCCS Ospedale Galeazzi-Sant'Ambrogio
All locations (14)
Ospedale Civile di LegnanoRecruiting
Legnano, Milano, Italy
IRCCS Ospedale HumanitasRecruiting
Rozzano, Milano, Italy
IRCCS Policlinico San DonatoRecruiting
San Donato, Milano, Italy
IRCCS Ospedale Galeazzi-Sant'Ambrogio,Recruiting
Milan, Mi, Italy
IRCCS San GerardoRecruiting
Monza, Monza E Brianza, Italy
ASST Papa Giovanni XXIIIRecruiting
Bergamo, Italy
ASST Spedali CiviliRecruiting
Brescia, Italy
ASST Gaetano Pini CTORecruiting
Milan, Italy
IRCCS Ospedale San RaffaeleRecruiting
Milan, Italy
ASST Grande Ospedale Metropolitano NiguardaRecruiting
Milan, Italy
ASST Fatebenefratelli-Sacco Ospedale Luigi SaccoRecruiting
Milan, Italy
Fondazione IRCCS Policlinico San MatteoRecruiting
Pavia, Italy
IRCCS Istituti Clinici Scientifici MaugeriRecruiting
Pavia, Italy
ASST Settelaghi - Ospedale di Circolo di VareseRecruiting
Varese, Italy
Efficacy Of Upadacitinib In Psoriatic Arthritis And Comparison To Rheumatoid Arthritis. · TrialPath