Gemelli Longitudinal Cohort on Long-term Outcomes in RheumatIc diseAses

NCT06932497 | Active Not Recruiting

• 1 other identifier: 7235
• Study Type: observational
• Target: 5,000
• Locations: 1 country
• Sites: 1

Brief Summary

Chronic rheumatic diseases (CRDs) are major determinant of disability in the general population. Particularly, immune-mediated CRDs also represent a significant cause of morbidity and mortality among younger individuals. CRDs lead to substantial direct costs related to healthcare service use and pharmacological expenses, as well as indirect social costs. Proper prognostic stratification of CRD patients could tailor diagnostic and therapeutic interventions to improve clinical outcomes and strategically allocate healthcare resources while minimizing both direct and indirect costs. Reported prognostic predictors in CRDs are largely derived from randomized therapeutic trials and therefore mostly reflect short-term outcomes under controlled experimental conditions. A real-life research could provide crucial information about long-term outcomes including survival, impact of comorbidities and polypharmacotherapy, and inform on healthcare costs. The Gemelli longitudinal cohort on Long-term Outcomes in Rheumatic Diseases (GLORIA) aims to define shared and disease-specific predictors of long-term disability, organ damage, mortality, and healthcare costs for patients under the care of the Division of Rheumatology at the Fondazione Policlinico Universitario A. Gemelli IRCCS - Catholic University of the Sacred Heart in Rome. This study will adopt an electronic database identified for collecting and analyze data (REDcap Research Electronic Data Capture platform), compliant with general data protection regulation (GDPR) law. Predictors will be selected from routinely collected demographic, clinical, laboratory, histological, and instrumental data. Additional blood samples may be collected from newly diagnosed patients or when diagnostic or therapeutic interventions are required according to clinical practice. Excepted for additional collection of peripheral blood, no additional procedure will be therefore performed.

Conditions

Rheumatic Disease

Outcome Measures

Primary Outcomes (1)

• HAQ-DI

  Degree of disability in CRD patients, quantified according to the Health Assessment Questionnaire-Disability Index.

  10 years

Secondary Outcomes (4)

• Mortality

  10 years

• Complications

  10 years

• Heathcare service access

  10 years

• Drug and surgery access

  10 years

Study Arms (1)

Rheumatic diseases

Enrolled patients must be older than 18 years and present at least one of the following: * A clinically defined diagnosis of immune-mediated CRD (primary arthritis, vasculitis, connective tissue disease, or auto-inflammatory syndromes). * A clinically defined diagnosis of degenerative or metabolic CRD (osteoarthritis, crystal-induced arthritis, osteoporosis, articular disease associated with endocrine or metabolic diseases) * A clinically defined diagnosis of FM. * Undifferentiated CRD-related conditions at high risk of clinical evolution (Inflammatory joint pain with auto-antibody positivity or personal/family history of psoriasis, Raynaud's phenomenon, sicca syndrome or photo-sensibility with auto-antibody positivity, interstitial lung disease with auto-antibody positivity, uncomplicated osteopenia).

Other: Standard of care

Interventions

Standard of care OTHER

Standard of care according to national and international guideline or recommendations

Rheumatic diseases

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with chronic rheumatic diseases.

You may qualify if:

• sign an informed consent
• A clinically defined diagnosis of immune-mediated CRD (primary arthritis, vasculitis, connective tissue disease, or auto-inflammatory syndromes).
• A clinically defined diagnosis of degenerative or metabolic CRD (osteoarthritis, crystal-induced arthritis, osteoporosis, articular disease associated with endocrine or metabolic diseases)
• A clinically defined diagnosis of FM.
• Undifferentiated CRD-related conditions at high risk of clinical evolution (Inflammatory joint pain with auto-antibody positivity or personal/family history of psoriasis, Raynaud's phenomenon, sicca syndrome or photo-sensibility with auto-antibody positivity, interstitial lung disease with auto-antibody positivity, uncomplicated osteopenia).

You may not qualify if:

• \- Active follow-up and inability to express informed consent

Sponsors & Collaborators

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS: lead

Study Sites (1)

Fondazione Policlinico Universitario A. Gemelli IRCCS

Rome, Lazio, 00168, Italy

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Outcome predictors for GLORIA will be selected from variables routinely collected according to clinical care. The main predictors will include. * Laboratory Variables: derived as per clinical practice from blood, synovial fluid, bronchoalveolar lavage, urine, and feces * Histological Data: derived from biopsies performed as per clinical practice, involving joints, enthesis, skin, muscle, salivary glands, lungs, and gastrointestinal tract.

MeSH Terms

Conditions

Rheumatic Diseases

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Musculoskeletal Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Maria Antonietta D'Agostino

  Fondazione Policlinico Universitario A. Gemelli, IRCCS

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 10 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 10, 2025
• First Posted: April 17, 2025
• Study Start: April 7, 2025
• Primary Completion (Estimated): April 7, 2030
• Study Completion (Estimated): April 7, 2035
• Last Updated: April 17, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)