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

March 2, 2023 updated by: Alivernini Stefano, Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Role of Ultrasonographic and Tissue Biomarkers in Optimization of Psoriatic and Seronegative Rheumatoid Arthritis Patients Selection and Treatment Outcomes of Biologic Therapies.

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

135

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

  1. PsO with arthralgia (at risk of PsA)
  2. Naïve-to treatment active early PsA
  3. Established PsA with active disease: non-responders to TNFi
  4. Established PsA with active disease: non-responders to IL-17i
  5. PsA in remission induced by TNFi
  6. PsA in remission induced by IL-17i
  7. Established PsA with active disease: non-responders to cDMARDs
  8. Established RA with active disease: non-responders to cDMARDs

Description

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 of cancer in the last 5 years, other than non-melanoma skin cell cancers cured by local resection or carcinoma in situ. Existing non-melanoma skin cell cancers should be removed, the lesion site healed, and residual cancer ruled out before administration of the study drug.
  • Subjects who currently abuse drugs or alcohol.
  • Subjects with evidence (as assessed by the investigator) of active or latent bacterial or viral infections at the time of potential enrollment, including subjects with evidence of human immunodeficiency virus (HIV) detected during screening.
  • Subjects with herpes zoster or cytomegalovirus (CMV) that resolved less than 2 months before the informed consent document was signed.
  • Subjects who have received any live vaccines within 3 months of the anticipated first dose of study medication.
  • Subjects with any serious bacterial infection within the last 3 months, unless treated and resolved with antibiotics, or any chronic bacterial infection (eg, chronic pyelonephritis, osteomyelitis, or bronchiectasis).
  • Subjects at risk for tuberculosis (TB). Specifically excluded from this study will be subjects with a history of active TB within the last 3 years, even if it was treated; a history of active TB greater than 3 years ago, unless there is documentation that the prior anti-TB treatment was appropriate in duration and type; current clinical, radiographic, or laboratory evidence of active TB; and latent TB that was not successfully treated (≥ 4 weeks).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
PsO patients at risk of PsA development
Other: Phenotyping of synovial immune and stromal cells
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.
naive to treatment PsA
Other: Phenotyping of synovial immune and stromal cells
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.
TNF-inhibitor resistant PsA
Other: Phenotyping of synovial immune and stromal cells
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.
IL-17-inhibitor resistant PsA
Other: Phenotyping of synovial immune and stromal cells
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.
TNF-inhibitor induced remission PsA
Other: Phenotyping of synovial immune and stromal cells
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.
IL-17-inhibitor induced remission PsA
Other: Phenotyping of synovial immune and stromal cells
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.
c-DMARDs resistant PsA
Other: Phenotyping of synovial immune and stromal cells
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.
c-DMARDs resistant RA
Other: Phenotyping of synovial immune and stromal cells
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Minimal Disease Activity status achievement
Time Frame: 6 months
This outcome will be recorded for all study cohorts
6 months
PsA development (Fulfilment of the CASPAR criteria)
Time Frame: 12 months
This outcome will be recorded only for PsO patient with arthralgia at risk of PsA development
12 months
Remission maintenance
Time Frame: 12 months
This outcome will be recorded only for PsA patients in sustained remission
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 3, 2019

Primary Completion (Anticipated)

August 31, 2023

Study Completion (Anticipated)

September 30, 2024

Study Registration Dates

First Submitted

March 2, 2023

First Submitted That Met QC Criteria

March 2, 2023

First Posted (Actual)

March 14, 2023

Study Record Updates

Last Update Posted (Actual)

March 14, 2023

Last Update Submitted That Met QC Criteria

March 2, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2784

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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