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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05200715




Registration number
NCT05200715
Ethics application status
Date submitted
18/12/2021
Date registered
21/01/2022
Date last updated
10/07/2025

Titles & IDs
Public title
AutoInflammatory Disease Alliance Registry (AIDA)
Scientific title
Development of an International Multicenter Registry of Patients With Monogenic and Polygenic Autoinflammatory Diseases Aimed at Clinical and Therapeutical Data Collection and Analysis
Secondary ID [1] 0 0
AIDA V.04 19.05.2021
Universal Trial Number (UTN)
Trial acronym
AIDA
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hereditary Autoinflammatory Diseases 0 0
Schnitzler Syndrome 0 0
Behcet Syndrome 0 0
PFAPA Syndrome 0 0
Still Disease 0 0
Autoinflammatory Syndrome, Unspecified 0 0
Uveitis 0 0
Scleritis 0 0
Vexas Syndrome 0 0
Spondyloarthritis (SpA) 0 0
Castleman Disease 0 0
Condition category
Condition code
Human Genetics and Inherited Disorders 0 0 0 0
Other human genetics and inherited disorders
Cardiovascular 0 0 0 0
Other cardiovascular diseases
Skin 0 0 0 0
Other skin conditions
Inflammatory and Immune System 0 0 0 0
Other inflammatory or immune system disorders
Eye 0 0 0 0
Diseases / disorders of the eye
Cardiovascular 0 0 0 0
Diseases of the vasculature and circulation including the lymphatic system
Neurological 0 0 0 0
Neurodegenerative diseases
Metabolic and Endocrine 0 0 0 0
Other metabolic disorders
Other 0 0 0 0
Research that is not of generic health relevance and not applicable to specific health categories listed above

Intervention/exposure
Study type
Observational [Patient Registry]
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Other interventions - No intervention is foreseen by the protocol.

Patients affected by autoinflammatory diseases -


Other interventions: No intervention is foreseen by the protocol.
Patients will be observed for 10 years at least. Demographic, genetic, clinical, clinimetric, laboratory, radiologic and therapeutic data will be collected both retrospectively and prospectively during routine follow-up visits.

Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change of the number of enrolled subjects
Timepoint [1] 0 0
0-36-60-120 months
Secondary outcome [1] 0 0
Change in the disease activity score
Timepoint [1] 0 0
0-36-60-120 months
Secondary outcome [2] 0 0
Change in the % of patients with new organ involvement
Timepoint [2] 0 0
0-36-60-120 months
Secondary outcome [3] 0 0
Incidence of death or adverse events
Timepoint [3] 0 0
0-36-60-120 months
Secondary outcome [4] 0 0
Change in the inflammatory markers values (ESR)
Timepoint [4] 0 0
0-36-60-120 months
Secondary outcome [5] 0 0
Change in the inflammatory markers values (CRP and SAA)
Timepoint [5] 0 0
0-36-60-120
Secondary outcome [6] 0 0
Change in visual acuity expressed as Best Corrected Visual Acuity (BCVA)
Timepoint [6] 0 0
0-36-60-120 months
Secondary outcome [7] 0 0
Change in the overall function score
Timepoint [7] 0 0
0-36-60-120 months
Secondary outcome [8] 0 0
Change in the overall damage score
Timepoint [8] 0 0
0-36-60-120 months
Secondary outcome [9] 0 0
Change in articular pain measured as Visual Analogue Scale for articular Pain (VAS Pain)
Timepoint [9] 0 0
0-36-60-120 months
Secondary outcome [10] 0 0
Changes in height and weight percentile values for age and sex
Timepoint [10] 0 0
0-36-60-120 months
Secondary outcome [11] 0 0
Change in the % of patients experiencing fatigue
Timepoint [11] 0 0
0-36-60-120 months
Secondary outcome [12] 0 0
Change in the % of patients with fertility reduction or pregnancy complications
Timepoint [12] 0 0
0-36-60-120
Secondary outcome [13] 0 0
Change in the socioeconomic indicators
Timepoint [13] 0 0
0-36-60-120 months

Eligibility
Key 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;
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- informed consent/assent not provided by the patient and/or his/her legal representative.

Study design
Purpose
Duration
Selection
Timing
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Flinders University - Adelaide
Recruitment hospital [2] 0 0
University of Adelaide - Adelaide
Recruitment postcode(s) [1] 0 0
- Adelaide
Recruitment outside Australia
Country [1] 0 0
Algeria
State/province [1] 0 0
Algiers
Country [2] 0 0
Algeria
State/province [2] 0 0
Boumerdas
Country [3] 0 0
Belgium
State/province [3] 0 0
Antwerp
Country [4] 0 0
Brazil
State/province [4] 0 0
São Paulo
Country [5] 0 0
China
State/province [5] 0 0
Beijing
Country [6] 0 0
China
State/province [6] 0 0
Chongqing
Country [7] 0 0
Colombia
State/province [7] 0 0
Bogotá
Country [8] 0 0
Egypt
State/province [8] 0 0
Cairo
Country [9] 0 0
Egypt
State/province [9] 0 0
Mansoura
Country [10] 0 0
Germany
State/province [10] 0 0
Lübeck
Country [11] 0 0
Greece
State/province [11] 0 0
Athens
Country [12] 0 0
India
State/province [12] 0 0
Bangalore
Country [13] 0 0
India
State/province [13] 0 0
Chandigarh
Country [14] 0 0
Iran, Islamic Republic of
State/province [14] 0 0
Tehran
Country [15] 0 0
Italy
State/province [15] 0 0
Tuscany
Country [16] 0 0
Italy
State/province [16] 0 0
Bari
Country [17] 0 0
Italy
State/province [17] 0 0
Bolzano
Country [18] 0 0
Italy
State/province [18] 0 0
Brescia
Country [19] 0 0
Italy
State/province [19] 0 0
Cagliari
Country [20] 0 0
Italy
State/province [20] 0 0
Catania
Country [21] 0 0
Italy
State/province [21] 0 0
Catanzaro
Country [22] 0 0
Italy
State/province [22] 0 0
Chieti
Country [23] 0 0
Italy
State/province [23] 0 0
Civitavecchia
Country [24] 0 0
Italy
State/province [24] 0 0
Ferrara
Country [25] 0 0
Italy
State/province [25] 0 0
Firenze
Country [26] 0 0
Italy
State/province [26] 0 0
L'Aquila
Country [27] 0 0
Italy
State/province [27] 0 0
Latina
Country [28] 0 0
Italy
State/province [28] 0 0
Lecce
Country [29] 0 0
Italy
State/province [29] 0 0
Messina
Country [30] 0 0
Italy
State/province [30] 0 0
Milano
Country [31] 0 0
Italy
State/province [31] 0 0
Milan
Country [32] 0 0
Italy
State/province [32] 0 0
Napoli
Country [33] 0 0
Italy
State/province [33] 0 0
Padova
Country [34] 0 0
Italy
State/province [34] 0 0
Palermo
Country [35] 0 0
Italy
State/province [35] 0 0
Pavia
Country [36] 0 0
Italy
State/province [36] 0 0
Perugia
Country [37] 0 0
Italy
State/province [37] 0 0
Pisa
Country [38] 0 0
Italy
State/province [38] 0 0
Roma
Country [39] 0 0
Italy
State/province [39] 0 0
Salerno
Country [40] 0 0
Italy
State/province [40] 0 0
Tempio Pausania
Country [41] 0 0
Italy
State/province [41] 0 0
Torino
Country [42] 0 0
Italy
State/province [42] 0 0
Vercelli
Country [43] 0 0
Italy
State/province [43] 0 0
Verona
Country [44] 0 0
Libyan Arab Jamahiriya
State/province [44] 0 0
Tripoli
Country [45] 0 0
Martinique
State/province [45] 0 0
Fort-de-France
Country [46] 0 0
Mexico
State/province [46] 0 0
Mexico City
Country [47] 0 0
Poland
State/province [47] 0 0
Warsaw
Country [48] 0 0
Poland
State/province [48] 0 0
Lódz
Country [49] 0 0
Romania
State/province [49] 0 0
Bucharest
Country [50] 0 0
Saudi Arabia
State/province [50] 0 0
Jazan
Country [51] 0 0
Saudi Arabia
State/province [51] 0 0
Riyadh
Country [52] 0 0
Spain
State/province [52] 0 0
Barakaldo
Country [53] 0 0
Spain
State/province [53] 0 0
Barcelona
Country [54] 0 0
Spain
State/province [54] 0 0
Madrid
Country [55] 0 0
Spain
State/province [55] 0 0
Santander
Country [56] 0 0
Spain
State/province [56] 0 0
Valencia
Country [57] 0 0
Tunisia
State/province [57] 0 0
Sousse
Country [58] 0 0
Turkey
State/province [58] 0 0
Adana
Country [59] 0 0
Turkey
State/province [59] 0 0
Ankara
Country [60] 0 0
Turkey
State/province [60] 0 0
Istanbul
Country [61] 0 0
Turkey
State/province [61] 0 0
Izmir
Country [62] 0 0
Turkey
State/province [62] 0 0
Manisa
Country [63] 0 0
Turkey
State/province [63] 0 0
Sakarya
Country [64] 0 0
Turkey
State/province [64] 0 0
Sivas
Country [65] 0 0
Ukraine
State/province [65] 0 0
Ternopil

Funding & Sponsors
Primary sponsor type
Other
Name
University of Siena
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Luca Cantarini, MD,PhD
Address 0 0
Country 0 0
Phone 0 0
+393479385457
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided


Results publications and other study-related documents

No documents have been uploaded by study researchers.