Lupus Arthritis: Muscoloskeletal Ultrasound as Clinical Outcome of Peripheral Blood and Synovial Deep Phenotyping

NCT07102238 | Active Not Recruiting

• 1 other identifier: 7740
• Study Type: interventional
• Target: 269
• Locations: 1 country
• Sites: 1

Brief Summary

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:

• To enhance the characterization of joint involvement by reducing the heterogeneity associated with clinical examination through a standardized US evaluation.
• 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.

Conditions

Systemic Lupus Erythematosus

Outcome Measures

Primary Outcomes (1)

• 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.

  18 months

Secondary Outcomes (1)

• Identification of candidate biomarkers associated with MSK disease activity and flares in SLE

  18 months

Study Arms (2)

SLE with muscoloskeletal involvement

EXPERIMENTAL

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

other connective tissue diseases with muscoloskeletal involvement

EXPERIMENTAL

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

Interventions

muscoloskeletal ultrasound and synovial biopsy PROCEDURE

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.

SLE with muscoloskeletal involvement; other connective tissue diseases with muscoloskeletal involvement

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Clinical diagnosis of SLE under ACR/EULAR 2019 criteria \[8\]
• Age between 18 and 75 years
• Must have inflammatory arthralgia, i.e. signs or symptoms deemed due to active SLE according to the investigator, in relation to distribution and typical inflammatory patterns as previously suggested, including joint symptoms lasting more than 6 weeks, morning stiffness lasting ≥60 minutes, and the most severe symptoms occurring at night and early morning.
• Must be capable of providing informed consent

You may not qualify if:

• \- Patients with contraindications to synovial biopsy or not accepting to perform the synovial biopsy

Sponsors & Collaborators

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS: lead

Study Sites (1)

Fondazione Policlinico Universitario A. Gemelli IRCCS

Rome, RM, 00168, Italy

Location

MeSH Terms

Conditions

Lupus Erythematosus, Systemic

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Maria Antonietta D'Agostino

  Fondazione Policlinico Universitario A. Gemelli, IRCCS

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: July 17, 2025
• First Posted: August 3, 2025
• Study Start: July 10, 2025
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): August 1, 2028
• Last Updated: August 3, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)