Clinical trial NCT05767801: Synovial Tissue and Blood Signature of Rheumatoid Arthritis Patients With Disease Flare After Treatment Discontinuation for Sustained Remission.
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.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Rheumatoid Arthritis
Keywords: synovial tissue
disease flare
sustained remission
peripheral blood
Lead sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Sponsor class: OTHER
First posted: 2023-03-14
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
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.

Brief 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. 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.


Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Disease flare rate
timeFrame: 24 months
Secondary outcomes:
Other outcomes:
Locations:
city: Brescia
country: Italy
facility: Centro di Ricerca E. Menni - Fondazione Poliambulanza Brescia
state: Lombardia
city: Bari
country: Italy
facility: UOC Reumatologia - Policlinico di Bari
state: Puglia
city: Rome
country: Italy
facility: Division of Rheumatology
Study officials:
References: