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Contact Information:

Stefano Alivernini, MD, PhD 00390630154503
stefano.alivernini@policlinicogemelli.it


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Be Part of Research - Trial Details - Optimization of Psoriatic and Seronegative Rheumatoid Arthritis Patients Selection and Treatment Outcomes of Biologic Therapies.
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Optimization of Psoriatic and Seronegative Rheumatoid Arthritis Patients Selection and Treatment Outcomes of Biologic Therapies.

Recruiting

Open to: ALL

Age: 18.0 - 75.0

Glasgow

Medical Conditions

Arthritis
Arthritis, Rheumatoid
Arthritis, Psoriatic

This information is provided directly by researchers, and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information. In some summaries, you may come across links to external websites. These websites will have more information to help you better understand the study.


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.

Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.  

The recruitment start and end dates are as follows:

Oct 2019 Aug 2023

OBSERVATIONAL

Intervention Type : OTHER
Intervention Description : Generate a comprehensive cellular and molecular atlas of PsA by CITE-Seq (single cell protein and transcriptomics) and spatial transcriptomics of synovium of PsO at risk of developing PsA and PsA patients across different disease stages.

Intervention Arm Group : IL-17-inhibitor induced remission PsA;IL-17-inhibitor resistant PsA;PsO patients at risk of PsA development;TNF-inhibitor induced remission PsA;TNF-inhibitor resistant PsA;c-DMARDs resistant PsA;c-DMARDs resistant RA;naive to treatment PsA;



You can take part if:



You may not be able to take part if:


This is in the inclusion criteria above


Below are the locations for where you can take part in the trial. Please note that not all sites may be open.

  • School of Immunity and Infection
    Glasgow

Stefano Alivernini, MD, PhD 00390630154503
stefano.alivernini@policlinicogemelli.it



The study is sponsored by Fondazione Policlinico Universitario Agostino Gemelli IRCCS




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Read full details for Trial ID: NCT05767814
Last updated 02 March 2023

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