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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Rheumatoid Arthritis | Patients diagnosed with RA according to the ACR/EULAR 2010 classification criteria with active disease starting Upadacitinib |
| |
| Psoriatic Arthritis | Patients diagnosed with peripheral Psoriatic Arthritis according to the CASPAR criteria or with axial Psoriatic Arthritis according to ASAS criteria with active disease starting Upadacitinib |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Upadacitinib 15 MG [Rinvoq] | Drug | 15 mg/ day |
|
| Measure | Description | Time Frame |
|---|---|---|
| Difference between US synovitis score | Difference between US synovitis score from baseline to 24 weeks in patients with active synovitis | from baseline to 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Difference between US dactylitis score | Difference between US dactylitis score (DACTOS) from baseline to 24 weeks in patients with active dactylitis | from baseline to 24 weeks |
| Difference between US tenosynovitis score |
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The inclusion criteria for Psoriatic Arthritis patients are:
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:
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
With active axial PsA regarding ongoing therapy (ASDAS ≥ 2.1) and active sacroiliitis according to the ASAS MRI definitions
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.
Aged older than 18 years.
Able to provide informed consent, according to requirements of local IRB/ethics committee.
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:
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.
Aged older than 18 years.
Able to provide informed consent, according to requirements of local IRB/ethics committee.
Exclusion Criteria:
Patients with any contraindication to Upadacitinib:
Patients with associated fibromyalgia syndrome according to the 2016 ACR diagnostic criteria
Unable to provide informed consent, according to requirements of local IRB/ethics committee.
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Patients with active Psoriatic Arthritis and patients with active Rheumatoid Arthritis who will start therapy with upadacitinib
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Georgios Filippou, MD | Contact | 0039 0283502707 | georgios.filippou@grupposandonato.it | |
| Silvia Sirotti, MD | Contact | 0039 0283502708 | silvia.sirotti@grupposandonato.it |
| Name | Affiliation | Role |
|---|---|---|
| Georgios Filippou, MD | Università degli Studi di Milano / IRCCS Ospedale Galeazzi-Sant'Ambrogio | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ospedale Civile di Legnano | Recruiting | Legnano | Milano | 20025 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32911127 | Background | Albano D, Bignone R, Chianca V, Cuocolo R, Messina C, Sconfienza LM, Ciccia F, Brunetti A, Midiri M, Galia M. T2 mapping of the sacroiliac joints in patients with axial spondyloarthritis. Eur J Radiol. 2020 Oct;131:109246. doi: 10.1016/j.ejrad.2020.109246. Epub 2020 Aug 29. | |
| 16208659 | Background | Maksymowych WP, Inman RD, Salonen D, Dhillon SS, Williams M, Stone M, Conner-Spady B, Palsat J, Lambert RG. Spondyloarthritis research Consortium of Canada magnetic resonance imaging index for assessment of sacroiliac joint inflammation in ankylosing spondylitis. Arthritis Rheum. 2005 Oct 15;53(5):703-9. doi: 10.1002/art.21445. |
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Difference between US tenosynovitis score from baseline to 24 weeks in patients with active tenosynovitis
| from baseline to 24 weeks |
| Difference between US enthesitis score | Difference between US enthesitis score from baseline to 24 weeks in patients with active enthesitis | from baseline to 24 weeks |
| Difference between US peritendonitis score | Difference between US peritendonitis score from baseline to 24 weeks in patients with peritendonitis | from baseline to 24 weeks |
| Difference between SPARCC MRI index | Difference between SPARCC MRI index from baseline to 24 weeks in patients with active sacroiliitis in PsA | from baseline to 24 weeks |
| Difference between T2 mapping scores | Difference between T2 mapping scores from baseline to 24 weeks in patients with active sacroiliitis in PsA | from baseline to 24 weeks |
| Difference between SJC66 | Difference between SJC66 from baseline to 24 weeks in PsA and RA | from baseline to 24 weeks |
| Difference between TJC68 | Difference between TJC68 from baseline to 24 weeks in PsA and RA | from baseline to 24 weeks |
| Difference between the SPARCC score | Difference between the SPARCC score from baseline to and 24 weeks in PsA | from baseline to and 24 weeks |
| Difference between the dactylitis count | Difference between the dactylitis count from baseline to and 24 weeks in PsA | from baseline to 24 weeks |
| Prevalence of BSA = 0 | Prevalence of BSA = 0 after 24 weeks in PsA | after 24 weeks |
| Difference between CRP levels | Difference between CRP levels from baseline to and 24 weeks in PsA and RA | from baseline to and 24 weeks |
| Difference between HAQ score | Difference between HAQ score from baseline to and 24 weeks in PsA and RA | from baseline to and 24 weeks |
| Difference between Physician's Global Assessment of Disease Activity VAS | Difference between Physician's Global Assessment of Disease Activity VAS from baseline to and 24 weeks in PsA and RA | from baseline to and 24 weeks |
| Difference between VAS pain | Difference between VAS pain from baseline to and 24 weeks in PsA and RA | from baseline to and 24 weeks |
| Difference between GH-VAS | Difference between GH-VAS from baseline to and 24 weeks in PsA and RA | from baseline to 24 weeks |
| Difference between ASDAS levels | Difference between ASDAS levels from baseline to and 24 weeks in PsA | from baseline to 24 weeks |
| Prevalence of MDA | Prevalence of MDA at 24 weeks in PsA | at 24 weeks |
| Difference between DAS28 levels | Difference between DAS28 levels at baseline and 24 weeks in PsA and RA | baseline and 24 weeks |
| Time to remission | Time to remission in PsA and RA up to 2 weeks | up to 2 weeks |
| Adverse events | Adverse events from baseline and 24 weeks | from baseline and 24 weeks |
| IRCCS Ospedale Humanitas | Recruiting | Rozzano | Milano | 20089 | Italy |
|
| IRCCS Policlinico San Donato | Recruiting | San Donato | Milano | 20097 | Italy |
|
| IRCCS Ospedale Galeazzi-Sant'Ambrogio, | Recruiting | Milan | Mi | 20157 | Italy |
|
| IRCCS San Gerardo | Recruiting | Monza | Monza E Brianza | 20900 | Italy |
|
| ASST Papa Giovanni XXIII | Recruiting | Bergamo | 24127 | Italy |
|
| ASST Spedali Civili | Recruiting | Brescia | 25153 | Italy |
|
| ASST Gaetano Pini CTO | Recruiting | Milan | 20122 | Italy |
|
| IRCCS Ospedale San Raffaele | Recruiting | Milan | 20132 | Italy |
|
| ASST Grande Ospedale Metropolitano Niguarda | Recruiting | Milan | 20162 | Italy |
|
| ASST Fatebenefratelli-Sacco Ospedale Luigi Sacco | Recruiting | Milan | Italy |
|
| Fondazione IRCCS Policlinico San Matteo | Recruiting | Pavia | 27100 | Italy |
|
| IRCCS Istituti Clinici Scientifici Maugeri | Recruiting | Pavia | 27100 | Italy |
|
| ASST Settelaghi - Ospedale di Circolo di Varese | Recruiting | Varese | 21100 | Italy |
|
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| ID | Term |
|---|---|
| D001172 | Arthritis, Rheumatoid |
| D015535 | Arthritis, Psoriatic |
| C563250 | Salivary Gland Adenoma, Pleomorphic |
| D013585 | Synovitis |
| D058566 | Sacroiliitis |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D025242 | Spondylarthropathies |
| D025241 | Spondylarthritis |
| D013166 | Spondylitis |
| D013122 | Spinal Diseases |
| D001847 | Bone Diseases |
| D011565 | Psoriasis |
| D017444 | Skin Diseases, Papulosquamous |
| D012871 | Skin Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C000613732 | upadacitinib |
Not provided
Not provided
Not provided