NCT05200715 AutoInflammatory Disease Alliance Registry (AIDA)
| NCT ID | NCT05200715 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Siena |
| Condition | Hereditary Autoinflammatory Diseases |
| Study Type | OBSERVATIONAL |
| Enrollment | 3,500 participants |
| Start Date | 2020-08-06 |
| Primary Completion | 2026-08-06 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 3,500 participants in total. It began in 2020-08-06 with a primary completion date of 2026-08-06.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Autoinflammatory diseases (AID) are clinical entities characterized by recurrent inflammatory attacks in absence of infection, neoplasm or deregulation of the adaptive immune system. Among them, hereditary periodic syndromes, also known as monogenic AID, represent the prototype of this disease group, caused by mutations in genes involved in the regulation of innate immunity, inflammation and cell death. Based on recent experimental acquisitions in the field of monogenic AID, several immunologic disorders have been reclassified as polygenic/multifactorial AID, sharing pathogenetic and clinical features with hereditary periodic fevers. This has paved the way to new treatment targets for patients suffering from rare diseases of unknown origin, including Behçet's disease, Still disease, Schnitzler's disease, PFAPA (periodic fever, aphthous stomatitis, pharyngitis and cervical adenitis) syndrome, chronic recurrent multifocal osteomyelitis (CRMO), non-infectious uveitis and scleritis. Gathering information on such rare conditions is made difficult by the small number of patients, along with the difficulty of obtaining an accurate diagnosis in non-specialized clinical settings. In this context, the AIDA project promotes international collaboration among clinical centres to develop a permanent registry aimed at collecting demographic, genetic, clinical and therapeutic data of patients affected by monogenic and polygenic AID, in order to expand the current knowledge of these rare conditions.
Eligibility Criteria
Inclusion Criteria: * to be diagnosed with a monogenic AID according to the clinical phenotype and the detection of a confirmative genotype; * to be diagnosed with clinical familial Mediterranean fever or Behçet's disease or Still disease or PFAPA syndrome or Schnitzler's disease or CRMO according to the corresponding clinical diagnostic and/or classification criteria; * to be diagnosed with undifferentiated systemic AID; * to be diagnosed with non-infectious uveitis according to the standardization for uveitis nomenclature (SUN) criteria; * to be diagnosed with anterior or posterior non-infectious scleritis; * to be diagnosed with spondyloarthritis according to ASAS and/or New York criteria; * to be diagnosed with Castleman disease; Exclusion Criteria: \- informed consent/assent not provided by the patient and/or his/her legal representative.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05200715 clinical trial?
This trial is open to participants of all sexes, studying Hereditary Autoinflammatory Diseases. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05200715 currently recruiting?
Yes, NCT05200715 is actively recruiting participants. Contact the research team at cantarini@unisi.it for enrollment information.
Where is the NCT05200715 trial being conducted?
This trial is being conducted at Algiers, Algeria, Boumerdas, Algeria, Adelaide, Australia, Adelaide, Australia and 11 additional locations.
Who is sponsoring the NCT05200715 clinical trial?
NCT05200715 is sponsored by University of Siena. The trial plans to enroll 3,500 participants.