Psoriatic ArthritisNCT05767814
Optimization of Psoriatic and Seronegative Rheumatoid Arthritis Patients Selection and Treatment Outcomes of Biologic Therapies.
An observational study of Psoriatic Arthritis and Rheumatoid Arthritis, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 2 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Psoriatic Arthritis, Rheumatoid Arthritis
- What is being tested?
- Phenotyping of synovial immune and stromal cells
- How many people
- 135 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 3 Oct 2019to 30 Sep 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Adult, Older adult
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
Who may be able to join
- 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
Who cannot join
- 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.
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- 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).
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
Italy1 site, 1 recruiting
- Recruiting
Division of Rheumatology
Rome, 00168
Stefano Alivernini, MD, PhD, 00390630154503, stefano.alivernini@policlinicogemelli.it
United Kingdom1 site
- Active, not recruiting
School of Immunity and Infection
Glasgow
About this study
Official title: 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.
- Conditions
- Psoriatic Arthritis, Rheumatoid Arthritis
- Being tested
- Phenotyping of synovial immune and stromal cells
- Keywords
- synovial tissue
- Medical subject headings
- Arthritis, Psoriatic, Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Phenotyping of synovial immune and stromal cellsOther
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.
| Study group | Role | What they receive |
|---|---|---|
| PsO patients at risk of PsA development | Not described Receives: Other: Phenotyping of synovial immune and stromal cells | |
| naive to treatment PsA | Not described Receives: Other: Phenotyping of synovial immune and stromal cells | |
| TNF-inhibitor resistant PsA | Not described Receives: Other: Phenotyping of synovial immune and stromal cells | |
| IL-17-inhibitor resistant PsA | Not described Receives: Other: Phenotyping of synovial immune and stromal cells | |
| TNF-inhibitor induced remission PsA | Not described Receives: Other: Phenotyping of synovial immune and stromal cells | |
| IL-17-inhibitor induced remission PsA | Not described Receives: Other: Phenotyping of synovial immune and stromal cells | |
| c-DMARDs resistant PsA | Not described Receives: Other: Phenotyping of synovial immune and stromal cells | |
| c-DMARDs resistant RA | Not described Receives: Other: Phenotyping of synovial immune and stromal cells |
What is being measured
The primary outcome is the main question the study is designed to answer.
Minimal Disease Activity status achievement
This outcome will be recorded for all study cohorts
Measured: 6 months
PsA development (Fulfilment of the CASPAR criteria)
This outcome will be recorded only for PsO patient with arthralgia at risk of PsA development
Measured: 12 months
Remission maintenance
This outcome will be recorded only for PsA patients in sustained remission
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2023
- Study start3 Oct 2019
- Primary completion31 Aug 2023 (estimated)
- Study completion30 Sep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Psoriatic ArthritisStudies of the same condition, open and under way.
- More trials run by Fondazione Policlinico Universitario Agostino Gemelli IRCCSThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case crossover
- Time perspective
- Prospective
- Enrolment
- 135 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alivernini Stefano, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05767814
- Sponsor's protocol ID
- 2784
- Status last verified
- Mar 2023
- First submitted
- 2 Mar 2023
- Last updated
- 14 Mar 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Ultrasonographic and Tissue Biomarkers in Optimization of Psoriatic and Seronegative Rheumatoid Arthritis Patients Selection and Treatment Outcomes of Biologic Therapies.
- ClinicalTrials.gov ID
- NCT05767814
- Acronym / sponsor ID
- 2784
- Conditions
- Psoriatic Arthritis, Rheumatoid Arthritis
- Keywords
- synovial tissue
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 135 participants (estimated)
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSUniversity, hospital or other
- Study start
- 3 Oct 2019 (actual)
- Primary completion
- 31 Aug 2023 (estimated)
- Study completion
- 30 Sep 2024 (estimated)
- First posted
- 14 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case crossover
- Time perspective
- Prospective
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| PsO patients at risk of PsA development | – | Other: Phenotyping of synovial immune and stromal cells |
| naive to treatment PsA | – | Other: Phenotyping of synovial immune and stromal cells |
| TNF-inhibitor resistant PsA | – | Other: Phenotyping of synovial immune and stromal cells |
| IL-17-inhibitor resistant PsA | – | Other: Phenotyping of synovial immune and stromal cells |
| TNF-inhibitor induced remission PsA | – | Other: Phenotyping of synovial immune and stromal cells |
| IL-17-inhibitor induced remission PsA | – | Other: Phenotyping of synovial immune and stromal cells |
| c-DMARDs resistant PsA | – | Other: Phenotyping of synovial immune and stromal cells |
| c-DMARDs resistant RA | – | Other: Phenotyping of synovial immune and stromal cells |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (6 listed)
- 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)
Key exclusion criteria (14 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Phenotyping of synovial immune and stromal cellsGenerate 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. | Other | 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 |
Primary outcome
Minimal Disease Activity status achievement
Time frame: 6 months
This outcome will be recorded for all study cohorts
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
Remission maintenance
Time frame: 12 months
This outcome will be recorded only for PsA patients in sustained remission
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Psoriatic Arthritis and Rheumatoid Arthritis, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Italy, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Stefano Alivernini, MD, PhD (00390630154503, stefano.alivernini@policlinicogemelli.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Minimal Disease Activity status achievement (time frame: 6 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Mar 2023.