UnknownNot Applicable

Optimization of Psoriatic and Seronegative Rheumatoid Arthritis Patients Selection and Treatment Outcomes of Biologic Therapies.

Italy, United Kingdom135 participantsStarted 2019-10-03

Plain-language summary

Different classes of biological targeted therapies (b-DMARDs) are available for psoriatic arthritis (PsA) and seronegative rheumatoid arthritis (RA) (TNF inhibitors, anti-IL23, anti-IL17). A variable percentage of subjects, however, does not respond the first b-DMARD. Musculoskeletal ultrasound (US) and synovial tissue analysis could provide useful information on the top of clinical variables to predict response. The primary aim of this project is to create a global single-cell RNA sequencing atlas of PsA synovitis and to evaluate the predictive value of clinical, US and synovial variables (inflammatory cells and synovial tissue-single cell signature) on disease trajectory outcome and treatment response. Patients with PsA or seronegative RA at different disease stages will be enrolled. Clinical and US examination will be performed at baseline, 3, 6 and 12 months, while synovial biopsy at baseline and 6 months. The optimal combination of clinical, US and synovial variables to stratify treatment response will be developed. The sensitivity to change of US and synovial variables and their evaluation in patients achieving clinical remission will also be considered as secondary aims. The expected results will help the optimisation of treatment strategies in patients with PsA and seronegative RA.

Who can participate

Age range18 Years – 75 Years

SexALL

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Inclusion Criteria: * Patients fulfilling the CASPAR classification Criteria for PsA * Patients fulfilling the 2010 ACR/EULAR classification criteria for RA * Clinically active arthritis, with at least one joint clinically involved; * Subject eligible to treatment (c-or b-DMARD) as indicated by the treating rheumatologist according to usual clinical practice * Subjects with PsA in sustained clinical and ultrasound remission (MDA) * Patients with PsO and arthralgia Exclusion Criteria: * Severe and uncontrolled infections such as sepsis and opportunistic infections. * Patients who are currently included in any interventional clinical trial in PsA or RA. * Patients treated with more than one biologics. * Subjects who are impaired, incapacitated, or incapable of completing study-related assessments * Subjects with active vasculitis of a major organ system, with the exception of rheumatoid nodules. * Subjects with current symptoms of severe, progressive, or uncontrolled renal, hepatic, hematologic, gastrointestinal, pulmonary, cardiac, neurologic, or cerebral disease, whether or not related to RA or PsA and which, in the opinion of the investigator, might place a subject at unacceptable risk for participation in the study. * Female subjects who have had a breast cancer screening that is suspicious for malignancy and in whom the possibility of malignancy cannot be reasonably excluded by additional clinical, laboratory, or other diagnostic evaluations. * Subjects with a history o…

What they're measuring

Minimal Disease Activity status achievement

Timeframe: 6 months

PsA development (Fulfilment of the CASPAR criteria)

Timeframe: 12 months

Remission maintenance

Timeframe: 12 months

Trial details

NCT IDNCT05767814

SponsorFondazione Policlinico Universitario Agostino Gemelli IRCCS

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2023-08-31

Contact for this trial

Stefano Alivernini, MD, PhD

00390630154503 stefano.alivernini@policlinicogemelli.it