Rheumatoid ArthritisNCT05767801
Synovial Tissue and Blood Signature of Rheumatoid Arthritis Patients With Disease Flare After Treatment Discontinuation for Sustained Remission.
An observational study of Rheumatoid Arthritis, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 3 sites in Italy.
Trial summary
Flares of immune-mediated inflammatory diseases, as Rheumatoid Arthritis (RA), are a major burden for patients in routine care. They occur unpredictably, adding to the physical and psychological burden of the condition. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Rheumatoid Arthritis
- What is being tested?
- Evaluation of subclinical inflammation
- Type of treatment
- Surgery or procedure
- How many people
- 200 participants
- Where
- 3 sitesItaly
- Study dates
- 15 Nov 2019to 14 Mar 2023
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients with Rheumatoid Arthritis in stable remission (DAS<1.6 for at least 6 months) and under treatment with stable dose of conventional, synthetic or biological DMARDs. All patients at the time of enrolment must fulfil the ultrasound criteria of Power Doppler negativity of knee, wrist, II-V MCP and II-V MTP bilaterally and any other reported painful joint not included in the screening ultrasound protocol.
Who may be able to join
- Diagnosis of RA following the 2010 ACR/EULAR classification criteria
- Age ≥18 and ≤75 years
- Sustained remission (DAS<1.6 for at least 3 sequential evaluations 6months apart).
- Without evidence of ultrasound detected synovitis (Power Doppler negative in knee, wrist, II-V MCP, II-V PIP and II-V MTP bilaterally).
- Patients under treatment with stable dose of conventional, synthetic or biological DMARDs.
- Patients without steroid treatment in the last 6 months.
Who cannot join
- With other diagnosis of chronic joint diseases rather than RA.
- Unable to participate to the clinical outpatient follow-up.
- Exposed to steroid treatment within 6 months from study screening.
- With evidence of ultrasound detected synovitis (Power Doppler positivity) in other joints than the ones included in the screening visit.
Trial locations and contacts
3 sites in 1 country.
Italy3 sites
UOC Reumatologia - Policlinico di Bari
Bari, Apulia, 70100
Centro di Ricerca E. Menni - Fondazione Poliambulanza Brescia
Brescia, Lombardy, 25121
Division of Rheumatology
Rome, 00168
About this study
Official title: Synovial Tissue and Blood Signature to Personalize the Management of Rheumatoid Arthritis Patients With Disease Flare After Biological DMARDs Discontinuation for Sustained Remission.
Flares of immune-mediated inflammatory diseases, as Rheumatoid Arthritis (RA), are a major burden for patients in routine care. They occur unpredictably, adding to the physical and psychological burden of the condition. In this study we will deeply dissect the synovial tissue and peripheral blood signature of RA in sustained remission eligible to treatment discontinuation to better understand the individualized factors determining disease flare once biological treatment is discontinued. We expect that the combined study of synovial tissue, imaging and peripheral blood derived biomarkers, associated with disease flare after treatment discontinuation in RA in remission, will provide a tool for the routine assessment of RA eligible to treatment discontinuation reducing the relapse rate and increasing the optimization of the use of expensive pharmacological treatments only for patients still needing them.
- Conditions
- Rheumatoid Arthritis
- Being tested
- Evaluation of subclinical inflammation
- Keywords
- synovial tissue, disease flare, sustained remission, peripheral blood
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Evaluation of subclinical inflammationProcedure or surgery
Minimally invasive synovial tissue biopsy for the semiquantitative and qualitative assessment of synovial immune and stromal cells; Peripheral blood collection for MBDA assessment and phenotyping of immune cells;
| Study group | Role | What they receive |
|---|---|---|
| RA patients in sustained clinical and ultrasound remission not changing treatment | Not described Receives: Procedure: Evaluation of subclinical inflammation | |
| RA patients in sustained clinical and ultrasound remission changing treatment | Not described Receives: Procedure: Evaluation of subclinical inflammation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease flare rate
Measured: 24 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 start15 Nov 2019
- Primary completion14 Mar 2022
- Study completion14 Mar 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rheumatoid 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-control
- Time perspective
- Prospective
- Enrolment
- 200 participants (actual)
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
- NCT05767801
- Sponsor's protocol ID
- 2667
- 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
- Synovial Tissue and Blood Signature to Personalize the Management of Rheumatoid Arthritis Patients With Disease Flare After Biological DMARDs Discontinuation for Sustained Remission.
- ClinicalTrials.gov ID
- NCT05767801
- Acronym / sponsor ID
- 2667
- Conditions
- Rheumatoid Arthritis
- Keywords
- synovial tissue, disease flare, sustained remission, peripheral blood
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSUniversity, hospital or other
- Study start
- 15 Nov 2019 (actual)
- Primary completion
- 14 Mar 2022 (actual)
- Study completion
- 14 Mar 2023 (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.
Flares of immune-mediated inflammatory diseases, as Rheumatoid Arthritis (RA), are a major burden for patients in routine care. They occur unpredictably, adding to the physical and psychological burden of the condition. In this study we will deeply dissect the synovial tissue and peripheral blood signature of RA in sustained remission eligible to treatment discontinuation to better understand the individualized factors determining disease flare once biological treatment is discontinued. We expect that the combined study of synovial tissue, imaging and peripheral blood derived biomarkers, associated with disease flare after treatment discontinuation in RA in remission, will provide a tool for the routine assessment of RA eligible to treatment discontinuation reducing the relapse rate and increasing the optimization of the use of expensive pharmacological treatments only for patients still needing them.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| RA patients in sustained clinical and ultrasound remission not changing treatment | – | Procedure: Evaluation of subclinical inflammation |
| RA patients in sustained clinical and ultrasound remission changing treatment | – | Procedure: Evaluation of subclinical inflammation |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with Rheumatoid Arthritis in stable remission (DAS<1.6 for at least 6 months) and under treatment with stable dose of conventional, synthetic or biological DMARDs. All patients at the time of enrolment must fulfil the ultrasound criteria of Power Doppler negativity of knee, wrist, II-V MCP and II-V MTP bilaterally and any other reported painful joint not included in the screening ultrasound protocol.
Key inclusion criteria (6 listed)
- Diagnosis of RA following the 2010 ACR/EULAR classification criteria
- Age ≥18 and ≤75 years
- Sustained remission (DAS<1.6 for at least 3 sequential evaluations 6months apart).
- Without evidence of ultrasound detected synovitis (Power Doppler negative in knee, wrist, II-V MCP, II-V PIP and II-V MTP bilaterally).
- Patients under treatment with stable dose of conventional, synthetic or biological DMARDs.
Key exclusion criteria (4 listed)
- With other diagnosis of chronic joint diseases rather than RA.
- Unable to participate to the clinical outpatient follow-up.
- Exposed to steroid treatment within 6 months from study screening.
- With evidence of ultrasound detected synovitis (Power Doppler positivity) in other joints than the ones included in the screening visit.
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 |
|---|---|---|
| Evaluation of subclinical inflammationMinimally invasive synovial tissue biopsy for the semiquantitative and qualitative assessment of synovial immune and stromal cells; Peripheral blood collection for MBDA assessment and phenotyping of immune cells; | Procedure or surgery | RA patients in sustained clinical and ultrasound remission changing treatment, RA patients in sustained clinical and ultrasound remission not changing treatment |
Primary outcome
Disease flare rate
Time frame: 24 months
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.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Rheumatoid Arthritis, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 3 sites in Italy.
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 4 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 3 sites in Italy. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Disease flare rate (time frame: 24 months). 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; AzTrials last refreshed its copy on 8 Nov 2026.