An interventional study of muscoloskeletal ultrasound and synovial biopsy in Systemic Lupus Erythematosus, sponsored by Fondazione Policlinico Universitario Agostino Gemelli IRCCS. Active, not recruiting at 1 site in Italy. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2025-08-03.
Sponsored by Fondazione Policlinico Universitario Agostino Gemelli IRCCS · Not applicable, Interventional, and Diagnostic
Musculoskeletal involvement, defined as arthritis/arthralgia, is the most common manifestation of patients with systemic lupus erythematosus (SLE). It accounts for decreased quality of life and can lead to unemployment and disability.
Lupus arthritis is divided into non-erosive, with up to 80% of the cases, erosive, also known as Rhupus, with up to 5% of cases, and deforming, or Jaccoud's arthropathy which can involve up to 15% of the patients. Initially, these 3 forms can present similarly, therefore identifying early on their specific characteristics, can guide better treatments and improve outcomes.
Muscoloskeletal ultrasound (MSK-US) is an established modality to diagnose and investigate joint involvement in inflammatory arthropathies. While for these conditions, well-defined MSK-US approaches exist, much less, if any, for SLE.
The research hypothesis is that a longitudinal standardized prospective MSK-US evaluation coupled with deep phenotyping in patients with SLE peripheral musculoskeletal involvement, will allow us to:
Aims and methods
The following two aims are proposed:
For this Aim, blood and synovial multi-omics analysis will be performed exclusively in a subgroup of 10 SLE recruited patients. A US-guided synovial tissue biopsy will be performed for all patients enrolled in the study, regardless of multi-omics inclusion.
Patients will be longitudinally evaluated to identify clinical articular and systemic flares. The baseline US evaluation and the multi-omics approach will be correlated with the longitudinal manifestations to identify possible biomarkers of flares, both at the joint and systemic levels.
Expected results:
The combined achievement of the above-mentioned aims will address the need to standardize the MSK-US approach and pathogenic mechanisms via biomarkers' discovery of lupus arthritis, a yet still poorly understood SLE manifestation.
expectations:
1,202 studies on the registry are indexed under Lupus Erythematosus, Systemic; 399 are open to participants now.
This study's planned enrollment of 269 is above the median of 50 across 867 interventional studies indexed under Lupus Erythematosus, Systemic.
Browse Lupus Erythematosus, Systemic studies →Fondazione Policlinico Universitario Agostino Gemelli IRCCS is the lead sponsor of 920 studies on the registry; 529 are open to participants now.
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Exclusion Criteria:
- Patients with contraindications to synovial biopsy or not accepting to perform the synovial biopsy
Consecutive patients with MSK symptoms will be recruited and observed over time. Each enrolled patient will be asked for past and current medical history and treatment. Visits will be scheduled at baseline, at months 3 and 6, then every 6 months up to 18 months, and subsequently according to routine clinical practice. Clinical, laboratory and ultrasound assessments will be conducted at each visit. Each patient will be followed for at least 6 months.Important confounding factors such as immune suppression and short/long-term use of NSAIDs at the time of MSK-US will be taken into account. At baseline, a synovial biopsy will be performed at the joint affected by the inflammatory process, and blood samples will be collected.
Procedure: muscoloskeletal ultrasound and synovial biopsy
Consecutive patients with MSK symptoms will be recruited and observed over time. Each enrolled patient will be asked for past and current medical history and treatment.Clinical, laboratory and ultrasound assessments will be conducted at baseline. Important confounding factors such as immune suppression and short/long-term use of NSAIDs at the time of MSK-US will be taken into account. At baseline, a synovial biopsy will be performed at the joint affected by the inflammatory process, and blood samples will be collected. DAS28, Physician Global Assessment (PGA), Spondylarthritis Research Consortium of Canada (SPARCC) Enthesitis index, Swollen Joint counts (44 or 66) tender joints count (44-66), Widespread Pain Index/Symptom Severity Scale (WPI/SSS) will be collected at each visit. Patients will be treated according to international recommendations and the treating rheumatologist's decision.
Procedure: muscoloskeletal ultrasound and synovial biopsy
Use of a standardized US evaluation according with OMERACT definition and scoring system; Synovial biopsy; To identify systemic and synovial disease biomarkers in SLE patients that can predict different joint patterns, systemic manifestations and response to therapy through multi-omics technologies.
definition of prevalence of MSK involvement
The percentage of SLE patients with at least one joint, tendon or enthesis showing signs of inflammation (synovitis, tenosynovitis, enthesitis) detected by musculoskeletal ultrasound (MSK-US) using OMERACT definitions and EULAR-OMERACT scoring systems.
Time frame: 18 months
Identification of candidate biomarkers associated with MSK disease activity and flares in SLE
Number of transcripts (from single-cell RNA sequencing of PBMCs and spatial transcriptomics of synovial tissue) and proteins (from Olink proteomic assay in plasma) significantly associated with MSK-US findings and systemic disease flares over the 18-month follow-up. Associations will be evaluated using differential expression analysis and Gene Association with Multiple Traits (GAMuT) statistical models.
Time frame: 18 months
Plan to share: No
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This study is active, not recruiting, as verified in Jul 2025. You cannot join it, but the record below documents what was studied.
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Fondazione Policlinico Universitario Agostino Gemelli IRCCS