Rheumatic DiseaseGLORIANCT06932497
Gemelli Longitudinal Cohort on Long-term Outcomes in RheumatIc diseAses
An observational study of Rheumatic Disease, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rheumatic Disease
- How many people
- 5,000 participants
- Where
- 1 siteItaly
- Study dates
- 7 Apr 2025to 7 Apr 2035
- How long will I take part?
- 10 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- Adult, Older adult
Study population: Patients with chronic rheumatic diseases.
Who may be able to join
- 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).
Who cannot join
- Active follow-up and inability to express informed consent
Trial locations and contacts
1 site in 1 country.
Italy1 site
Fondazione Policlinico Universitario A. Gemelli IRCCS
Rome, Lazio, 00168
About this study
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.
Read more
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.
Read the detailed description
Rationale of GLORIA Chronic rheumatic diseases (CRDs) represent a heterogeneous group of conditions with varying epidemiological, pathophysiological, and clinical aspects. CRDs are characterized substantial impact on population morbidity and mortality and relevance in terms of public health decision making and social costs. A timely and accurate definition of the prognosis for CRDs patients is crucial for improving clinical outcomes, as well as for strategically allocating healthcare resources and minimizing indirect economic and non-economic costs.
The most significant CRDs in terms of prevalence or need for intensive care fall into three main categories: autoimmune and inflammatory immune-mediated diseases, metabolic and degenerative diseases, and extra articular pain syndromes of which fibromyalgia (FM) is the most diffuse.
The category of autoimmune or inflammatory immune-mediated diseases includes conditions attributed to aberrant activation of the immune system, with the highest prevalence conditions being primary arthritis and conditions that are individually less common but collectively epidemiologically relevant such as connective tissue diseases, vasculitis, and autoinflammatory syndromes. Similarly to organ-specific autoimmune conditions, these have shown an increasing incidence in the last decades. Most of them are associated with multi-organ involvement and potentially life-threatening complications.
Degenerative and metabolic pathologies include primary and secondary osteoarthritis, crystal arthropathies, and metabolic bone diseases, with osteoporosis and algodystrophy being the most prevalent forms. These conditions are extensively associated with aging processes and endocrine-metabolic diseases. Their prevalence has increased over the last decades considering the demographic trends of the Italian population and concurrently with the rising incidence of closely related conditions such as the so called "metabolic syndrome". They represent a relevant morbidity burden in the general population around the world and their complications have been associated with increased mortality.
Finally, FM is the most common cause of chronic widespread musculoskeletal pain particularly in women between 20 and 55 years of age. FM is often accompanied by fatigue, cognitive disorders, psychiatric symptoms, and multiple somatic symptoms. It is characterized by forms of central sensitization in the absence of documented inflammation affecting joints, muscles, ligaments, and tendons.
- Conditions
- Rheumatic Disease
- Being tested
- Standard of care
- Medical subject headings
- Rheumatic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard of careOther
Standard of care according to national and international guideline or recommendations
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Other: Standard of care |
What is being measured
The primary outcome is the main question the study is designed to answer.
HAQ-DI
Degree of disability in CRD patients, quantified according to the Health Assessment Questionnaire-Disability Index.
Measured: 10 years
Secondary outcomes (4)
Mortality
CRD-related mortality and mortality from any cause.
Measured: 10 years
Complications
Major disease- or treatment-related complications, such as severe infections, cancer, major cardiovascular events, bone fractures, and organ failure.
Measured: 10 years
Heathcare service access
Access to outpatient clinics, day hospitals, emergency services, and hospital wards, along with related healthcare costs.
Measured: 10 years
Drug and surgery access
Access to medications and surgical procedures, and their associated healthcare costs.
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2025
- Study start7 Apr 2025
- Primary completion7 Apr 2030 (estimated)
- Study completion7 Apr 2035 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rheumatic DiseaseStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 5,000 participants (estimated)
- Target duration
- 10 Years
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Maria Antonietta D'Agostino, Principal investigator, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06932497
- Sponsor's protocol ID
- 7235
- Acronym
- GLORIA
- Status last verified
- Apr 2025
- First submitted
- 10 Apr 2025
- Last updated
- 17 Apr 2025
- 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 17 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gemelli Longitudinal Cohort on Long-term Outcomes in RheumatIc diseAses
- ClinicalTrials.gov ID
- NCT06932497
- Acronym / sponsor ID
- GLORIA / 7235
- Conditions
- Rheumatic Disease
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 5,000 participants (estimated)
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSUniversity, hospital or other
- Study start
- 7 Apr 2025 (actual)
- Primary completion
- 7 Apr 2030 (estimated)
- Study completion
- 7 Apr 2035 (estimated)
- First posted
- 17 Apr 2025 (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.
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.
Detailed description
Rationale of GLORIA Chronic rheumatic diseases (CRDs) represent a heterogeneous group of conditions with varying epidemiological, pathophysiological, and clinical aspects. CRDs are characterized substantial impact on population morbidity and mortality and relevance in terms of public health decision making and social costs. A timely and accurate definition of the prognosis for CRDs patients is crucial for improving clinical outcomes, as well as for strategically allocating healthcare resources and minimizing indirect economic and non-economic costs.
The most significant CRDs in terms of prevalence or need for intensive care fall into three main categories: autoimmune and inflammatory immune-mediated diseases, metabolic and degenerative diseases, and extra articular pain syndromes of which fibromyalgia (FM) is the most diffuse.
The category of autoimmune or inflammatory immune-mediated diseases includes conditions attributed to aberrant activation of the immune system, with the highest prevalence conditions being primary arthritis and conditions that are individually less common but collectively epidemiologically relevant such as connective tissue diseases, vasculitis, and autoinflammatory syndromes. Similarly to organ-specific autoimmune conditions, these have shown an increasing incidence in the last decades. Most of them are associated with multi-organ involvement and potentially life-threatening complications.
Degenerative and metabolic pathologies include primary and secondary osteoarthritis, crystal arthropathies, and metabolic bone diseases, with osteoporosis and algodystrophy being the most prevalent forms. These conditions are extensively associated with aging processes and endocrine-metabolic diseases. Their prevalence has increased over the last decades considering the demographic trends of the Italian population and concurrently with the rising incidence of closely related conditions such as the so called "metabolic syndrome". They represent a relevant morbidity burden in the general population around the world and their complications have been associated with increased mortality.
Finally, FM is the most common cause of chronic widespread musculoskeletal pain particularly in women between 20 and 55 years of age. FM is often accompanied by fatigue, cognitive disorders, psychiatric symptoms, and multiple somatic symptoms. It is characterized by forms of central sensitization in the absence of documented inflammation affecting joints, muscles, ligaments, and tendons.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 10 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Rheumatic diseases | – | Other: Standard of careEnrolled 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients with chronic rheumatic diseases.
Key inclusion criteria (5 listed)
- 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).
Key exclusion criteria (1 listed)
- Active follow-up and inability to express informed consent
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 |
|---|---|---|
| Standard of careStandard of care according to national and international guideline or recommendations | Other | Rheumatic diseases |
Primary outcome
HAQ-DI
Time frame: 10 years
Degree of disability in CRD patients, quantified according to the Health Assessment Questionnaire-Disability Index.
4 secondary outcomes
Mortality
Time frame: 10 years
Complications
Time frame: 10 years
Heathcare service access
Time frame: 10 years
Drug and surgery access
Time frame: 10 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2025.
- 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.
Maria Antonietta D'Agostino principal investigator
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Rheumatic Disease, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site 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 5 inclusion and 1 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: under way, not looking for participants, as of the sponsor's last update on 17 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
This study is still under way. Results are not available in the source record yet.
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?
HAQ-DI (time frame: 10 years). 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 17 Apr 2025; AzTrials last refreshed its copy on 6 Nov 2026.