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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)
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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
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Secondary ID [1]
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AIDA V.04 19.05.2021
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Universal Trial Number (UTN)
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Trial acronym
AIDA
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Hereditary Autoinflammatory Diseases
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Schnitzler Syndrome
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Behcet Syndrome
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PFAPA Syndrome
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Still Disease
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Autoinflammatory Syndrome, Unspecified
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Uveitis
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Scleritis
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Vexas Syndrome
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Spondyloarthritis (SpA)
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Castleman Disease
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Condition category
Condition code
Human Genetics and Inherited Disorders
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0
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Other human genetics and inherited disorders
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Cardiovascular
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Other cardiovascular diseases
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Skin
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Other skin conditions
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Inflammatory and Immune System
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Other inflammatory or immune system disorders
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Eye
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Diseases / disorders of the eye
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Cardiovascular
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Diseases of the vasculature and circulation including the lymphatic system
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Neurological
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Neurodegenerative diseases
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Metabolic and Endocrine
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Other metabolic disorders
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Other
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Research that is not of generic health relevance and not applicable to specific health categories listed above
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Intervention/exposure
Study type
Observational [Patient Registry]
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Patient registry
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Target follow-up duration
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Target follow-up type
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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.
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Intervention code [1]
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Other interventions
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Change of the number of enrolled subjects
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Assessment method [1]
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This is an observational registry. The primary outcome is the increase of the number of subjects enrolled within each nosologic group.
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Timepoint [1]
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0-36-60-120 months
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Secondary outcome [1]
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Change in the disease activity score
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Assessment method [1]
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Change in the disease activity score specific for the nosologic entity (BDCAF score, Pouchot score, modified Pouchot score, JADAS27/JADAS27(CRP), DAS28) or according to composite indexes that will be defined in each study based on the registry.
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Timepoint [1]
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0-36-60-120 months
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Secondary outcome [2]
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Change in the % of patients with new organ involvement
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Assessment method [2]
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Timepoint [2]
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0-36-60-120 months
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Secondary outcome [3]
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Incidence of death or adverse events
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Assessment method [3]
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Timepoint [3]
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0-36-60-120 months
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Secondary outcome [4]
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Change in the inflammatory markers values (ESR)
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Assessment method [4]
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ESR measured in mm/h
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Timepoint [4]
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0-36-60-120 months
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Secondary outcome [5]
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Change in the inflammatory markers values (CRP and SAA)
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Assessment method [5]
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CRP and SAA measured in mg/dl
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Timepoint [5]
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0-36-60-120
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Secondary outcome [6]
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Change in visual acuity expressed as Best Corrected Visual Acuity (BCVA)
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Assessment method [6]
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0
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Timepoint [6]
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0-36-60-120 months
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Secondary outcome [7]
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Change in the overall function score
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Assessment method [7]
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Change in the overall function score according to HAQ (adults) or CHAQ (children)
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Timepoint [7]
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0-36-60-120 months
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Secondary outcome [8]
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Change in the overall damage score
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Assessment method [8]
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Change in the overall damage score specific for the nosologic entity (ADDI score, BODI score, JADI score)
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Timepoint [8]
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0-36-60-120 months
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Secondary outcome [9]
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Change in articular pain measured as Visual Analogue Scale for articular Pain (VAS Pain)
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Assessment method [9]
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0
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Timepoint [9]
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0-36-60-120 months
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Secondary outcome [10]
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Changes in height and weight percentile values for age and sex
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Assessment method [10]
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0
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Timepoint [10]
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0-36-60-120 months
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Secondary outcome [11]
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Change in the % of patients experiencing fatigue
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Assessment method [11]
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0
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Timepoint [11]
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0-36-60-120 months
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Secondary outcome [12]
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Change in the % of patients with fertility reduction or pregnancy complications
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Assessment method [12]
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0
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Timepoint [12]
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0-36-60-120
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Secondary outcome [13]
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Change in the socioeconomic indicators
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Assessment method [13]
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Number of days lost at work/school during the last 3 months, Number of visits/ phone calls to the general practitioner during the last 3 months, Number of accesses to the Emergency Room during the last 6 months, Days of hospitalization during the last 3 months, Overall number of days lost at work by relatives during the last 3 months
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Timepoint [13]
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0-36-60-120 months
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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;
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Minimum age
No limit
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
- informed consent/assent not provided by the patient and/or his/her legal representative.
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Study design
Purpose
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Duration
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Selection
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Timing
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
6/08/2020
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
6/08/2030
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Actual
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Sample size
Target
3500
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
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Recruitment hospital [1]
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Flinders University - Adelaide
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Recruitment hospital [2]
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University of Adelaide - Adelaide
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Recruitment postcode(s) [1]
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- Adelaide
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Recruitment outside Australia
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Algeria
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Algiers
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Algeria
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Boumerdas
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Belgium
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Antwerp
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Brazil
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São Paulo
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China
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Beijing
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China
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Chongqing
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Colombia
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Bogotá
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Egypt
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Cairo
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Egypt
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Mansoura
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Germany
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Lübeck
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Greece
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Athens
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India
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Bangalore
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India
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Chandigarh
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Iran, Islamic Republic of
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Tehran
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Italy
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Tuscany
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Italy
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Bari
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Italy
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Bolzano
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Italy
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Brescia
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Italy
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Cagliari
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Catania
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Italy
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Catanzaro
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Chieti
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Civitavecchia
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Ferrara
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Italy
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Firenze
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L'Aquila
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Latina
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Lecce
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Italy
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Messina
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Milano
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Milan
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Napoli
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Padova
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Palermo
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Pavia
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Perugia
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Pisa
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Roma
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Tempio Pausania
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Torino
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Vercelli
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Italy
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Verona
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Libyan Arab Jamahiriya
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Tripoli
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Martinique
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Fort-de-France
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Mexico
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Mexico City
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Warsaw
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Poland
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Lódz
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Romania
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Bucharest
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Jazan
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Riyadh
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Barakaldo
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Spain
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Barcelona
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Spain
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Madrid
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Spain
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Santander
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Spain
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Valencia
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Tunisia
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Sousse
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Turkey
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Adana
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Turkey
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Ankara
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Turkey
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Istanbul
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Turkey
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Izmir
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Turkey
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Manisa
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Turkey
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Sakarya
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Turkey
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Sivas
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Ukraine
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Ternopil
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Funding & Sponsors
Primary sponsor type
Other
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Name
University of Siena
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Address
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Ethics approval
Ethics application status
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Summary
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.
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Trial website
https://clinicaltrials.gov/study/NCT05200715
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Trial related presentations / publications
Gaggiano C, Vitale A, Obici L, Merlini G, Soriano A, Viapiana O, Cattalini M, Maggio MC, Lopalco G, Montin D, Jaber MA, Dagna L, Manna R, Insalaco A, Piga M, La Torre F, Berlengiero V, Gelardi V, Ciarcia L, Emmi G, Ruscitti P, Caso F, Cimaz R, Hernandez-Rodriguez J, Parronchi P, Sicignano LL, Verrecchia E, Iannone F, Sota J, Grosso S, Salvarani C, Frediani B, Giacomelli R, Mencarelli MA, Renieri A, Rigante D, Cantarini L. Clinical Features at Onset and Genetic Characterization of Pediatric and Adult Patients with TNF-alpha Receptor-Associated Periodic Syndrome (TRAPS): A Series of 80 Cases from the AIDA Network. Mediators Inflamm. 2020 Aug 7;2020:8562485. doi: 10.1155/2020/8562485. eCollection 2020. Vitale A, Sota J, Obici L, Ricco N, Maggio MC, Cattalini M, Ruscitti P, Caso F, Manna R, Viapiana O, Caggiano V, Emmi G, Insalaco A, Montin D, Licciardi F, Soriano A, Dagna L, Salvarani C, Lamacchia V, Hernandez-Rodriguez J, Giacomelli R, Frediani B, Renieri A, Cantarini L. Role of Colchicine Treatment in Tumor Necrosis Factor Receptor Associated Periodic Syndrome (TRAPS): Real-Life Data from the AIDA Network. Mediators Inflamm. 2020 May 27;2020:1936960. doi: 10.1155/2020/1936960. eCollection 2020. Gaggiano C, Rigante D, Hernandez-Rodriguez J, Vitale A, Tarsia M, Soriano A, Lopalco G, Iannone F, Abdel Jaber M, Giacomelli R, Wiesik-Szewczyk E, Cattalini M, Frassi M, Piga M, Ragab G, Sota J, Zunica F, Floris A, Sabato V, Hegazy MT, Araujo O, Pelegrin L, Fabbiani A, Renieri A, Grosso S, Fabiani C, Frediani B, Cantarini L. Anakinra and canakinumab for patients with R92Q-associated autoinflammatory syndrome: a multicenter observational study from the AIDA Network. Ther Adv Musculoskelet Dis. 2021 Sep 9;13:1759720X211037178. doi: 10.1177/1759720X211037178. eCollection 2021. Sota J, Rigante D, Cimaz R, Cattalini M, Frassi M, Manna R, Sicignano LL, Verrecchia E, Aragona E, Maggio MC, Lopalco G, Emmi G, Parronchi P, Cauli A, Wiesik-Szewczyk E, Hernandez-Rodriguez J, Gaggiano C, Tarsia M, Mourabi M, Ragab G, Vitale A, Fabiani C, Frediani B, Lamacchia V, Renieri A, Cantarini L; Autoinflammatory Diseases Alliance (AIDA) and the Autoinflammatory Diseases Working Group of the Italian Society of Rheumatology (SIR). Drug survival of anakinra and canakinumab in monogenic autoinflammatory diseases: observational study from the International AIDA Registry. Rheumatology (Oxford). 2021 Dec 1;60(12):5705-5712. doi: 10.1093/rheumatology/keab419. Sota J, Rigante D, Lopalco G, Emmi G, Gentileschi S, Gaggiano C, Ciarcia L, Berlengiero V, Mourabi M, Ricco N, Barneschi S, Mattioli I, Tosi GM, Frediani B, Tarsia M, di Scala G, Vitale A, Iannone F, Fabiani C, Cantarini L. Clinical profile and evolution of patients with juvenile-onset Behcet's syndrome over a 25-year period: insights from the AIDA network. Intern Emerg Med. 2021 Nov;16(8):2163-2171. doi: 10.1007/s11739-021-02725-9. Epub 2021 Apr 9. Vitale A, Obici L, Cattalini M, Lopalco G, Merlini G, Ricco N, Soriano A, La Torre F, Verrecchia E, Insalaco A, Dagna L, Jaber MA, Montin D, Emmi G, Ciarcia L, Barneschi S, Parronchi P, Ruscitti P, Maggio MC, Viapiana O, Sota J, Gaggiano C, Giacomelli R, Sicignano LL, Manna R, Renieri A, Lo Rizzo C, Frediani B, Rigante D, Cantarini L. Biotechnological Agents for Patients With Tumor Necrosis Factor Receptor Associated Periodic Syndrome-Therapeutic Outcome and Predictors of Response: Real-Life Data From the AIDA Network. Front Med (Lausanne). 2021 Jul 8;8:668173. doi: 10.3389/fmed.2021.668173. eCollection 2021. Gaggiano C, Vitale A, Tufan A, Ragab G, Aragona E, Wiesik-Szewczyk E, Ait-Idir D, Conti G, Iezzi L, Maggio MC, Cattalini M, Torre F, Lopalco G, Verrecchia E, de Paulis A, Sahin A, Insalaco A, Sfikakis PP, Marino A, Frassi M, Ogunjimi B, Opris-Belinski D, Parronchi P, Emmi G, Shahram F, Ciccia F, Piga M, Hernandez-Rodriguez J, Pereira RMR, Alessio M, Naddei R, Olivieri AN, Giudice ED, Sfriso P, Ruscitti P, Gobbi FL, Kucuk H, Sota J, Hussein MA, Malizia G, Jahnz-Rozyk K, Sari-Hamidou R, Romeo M, Ricci F, Cardinale F, Iannone F, Casa FD, Natale MF, Laskari K, Giani T, Franceschini F, Sabato V, Yildirim D, Caggiano V, Hegazy MT, Marzo RD, Kucharczyk A, Khellaf G, Tarsia M, Almaghlouth IA, Laymouna AH, Mastrorilli V, Dotta L, Benacquista L, Grosso S, Crisafulli F, Parretti V, Giordano HF, Mahmoud AAA, Nuzzolese R, Musso M, Chighizola CB, Gentileschi S, Morrone M, Cola ID, Spedicato V, Giardini HAM, Vasi I, Renieri A, Fabbiani A, Mencarelli MA, Frediani B, Balistreri A, Tosi GM, Fabiani C, Lidar M, Rigante D, Cantarini L. The Autoinflammatory Diseases Alliance Registry of monogenic autoinflammatory diseases. Front Med (Lausanne). 2022 Sep 9;9:980679. doi: 10.3389/fmed.2022.980679. eCollection 2022. Della Casa F, Vitale A, Cattalini M, La Torre F, Capozio G, Del Giudice E, Maggio MC, Conti G, Alessio M, Ogunjimi B, Ragab G, Emmi G, Aragona E, Giani T, Lopalco G, Parronchi P, Shahram F, Verrecchia E, Ricci F, Cardinale F, Di Noi S, Nuzzolese R, Lubrano R, Patroniti S, Naddei R, Sabato V, Hussein MA, Dotta L, Mastrorilli V, Gentileschi S, Tufan A, Caggiano V, Hegazy MT, Sota J, Almaghlouth IA, Ibrahim A, Wiesik-Szewczyk E, Ozkiziltas B, Grosso S, Frassi M, Tarsia M, Pereira RMR, Taymour M, Gaggiano C, Colella S, Fabiani C, Morrone M, Ruscitti P, Frediani B, Spedicato V, Giardini HAM, Balistreri A, Rigante D, Cantarini L. Development and implementation of the AIDA International Registry for patients with Periodic Fever, Aphthous stomatitis, Pharyngitis, and cervical Adenitis syndrome. Front Pediatr. 2022 Jul 22;10:930305. doi: 10.3389/fped.2022.930305. eCollection 2022. Vitale A, Caggiano V, Della Casa F, Hernandez-Rodriguez J, Frassi M, Monti S, Tufan A, Telesca S, Conticini E, Ragab G, Lopalco G, Almaghlouth I, Pereira RMR, Yildirim D, Cattalini M, Marino A, Giani T, La Torre F, Ruscitti P, Aragona E, Wiesik-Szewczyk E, Del Giudice E, Sfikakis PP, Govoni M, Emmi G, Maggio MC, Giacomelli R, Ciccia F, Conti G, Ait-Idir D, Lomater C, Sabato V, Piga M, Sahin A, Opris-Belinski D, Ionescu R, Bartoloni E, Franceschini F, Parronchi P, de Paulis A, Espinosa G, Maier A, Sebastiani GD, Insalaco A, Shahram F, Sfriso P, Minoia F, Alessio M, Makowska J, Hatemi G, Akkoc N, Li Gobbi F, Gidaro A, Olivieri AN, Al-Mayouf SM, Erten S, Gentileschi S, Vasi I, Tarsia M, Mahmoud AAA, Frediani B, Fares Alzahrani M, Laymouna AH, Ricci F, Cardinale F, Jahnz-Rozyk K, Tosi GM, Crisafulli F, Balistreri A, Dagostin MA, Ghanema M, Gaggiano C, Sota J, Di Cola I, Fabiani C, Giardini HAM, Renieri A, Fabbiani A, Carrer A, Bocchia M, Caroni F, Rigante D, Cantarini L. Development and Implementation of the AIDA International Registry for Patients With VEXAS Syndrome. Front Med (Lausanne). 2022 Jul 11;9:926500. doi: 10.3389/fmed.2022.926500. eCollection 2022. Vitale A, Della Casa F, Ragab G, Almaghlouth IA, Lopalco G, Pereira RM, Guerriero S, Govoni M, Sfikakis PP, Giacomelli R, Ciccia F, Monti S, Ruscitti P, Piga M, Lomater C, Tufan A, Opris-Belinski D, Emmi G, Hernandez-Rodriguez J, Sahin A, Sebastiani GD, Bartoloni E, Akkoc N, Gunduz OS, Cattalini M, Conti G, Hatemi G, Maier A, Parronchi P, Del Giudice E, Erten S, Insalaco A, Li Gobbi F, Maggio MC, Shahram F, Caggiano V, Hegazy MT, Asfina KN, Morrone M, Prado LL, Dammacco R, Ruffilli F, Arida A, Navarini L, Pantano I, Cavagna L, Conforti A, Cauli A, Marucco EM, Kucuk H, Ionescu R, Mattioli I, Espinosa G, Araujo O, Karkas B, Canofari C, Sota J, Laymouna AH, Bedaiwi AA, Colella S, Giardini HAM, Albano V, Lo Monaco A, Fragoulis GE, Kardas RC, Berlengiero V, Hussein MA, Ricci F, La Torre F, Rigante D, Wiesik-Szewczyk E, Frassi M, Gentileschi S, Tosi GM, Dagostin MA, Mahmoud AAA, Tarsia M, Alessio G, Cimaz R, Giani T, Gaggiano C, Iannone F, Cipriani P, Mourabi M, Spedicato V, Barneschi S, Aragona E, Balistreri A, Frediani B, Fabiani C, Cantarini L; Autoinflammatory Diseases Alliance (AIDA) Network. Development and implementation of the AIDA International Registry for patients with Behcet's disease. Intern Emerg Med. 2022 Oct;17(7):1977-1986. doi: 10.1007/s11739-022-03038-1. Epub 2022 Jul 14. Della Casa F, Vitale A, Lopalco G, Ruscitti P, Ciccia F, Emmi G, Cattalini M, Wiesik-Szewczyk E, Maggio MC, Ogunjimi B, Sfikakis PP, Tufan A, Al-Mayouf SM, Del Giudice E, Aragona E, La Torre F, Sota J, Colella S, Di Cola I, Iacono D, Mattioli I, Jahnz-Rozyk K, Joos R, Laskari K, Gaggiano C, Abbruzzese A, Cipriani P, Rozza G, AlSaleem A, Yildirim D, Tarsia M, Ragab G, Ricci F, Cardinale F, Korzeniowska M, Frassi M, Caggiano V, Saad MA, Pereira RM, Berlengiero V, Gentileschi S, Guerriero S, Giani T, Gelardi V, Iannone F, Giardini HAM, Almaghlouth IA, Kardas RC, Ait-Idir D, Frediani B, Balistreri A, Fabiani C, Rigante D, Cantarini L. Development and Implementation of the AIDA International Registry for Patients With Undifferentiated Systemic AutoInflammatory Diseases. Front Med (Lausanne). 2022 Jun 10;9:908501. doi: 10.3389/fmed.2022.908501. eCollection 2022. Vitale A, Della Casa F, Lopalco G, Pereira RM, Ruscitti P, Giacomelli R, Ragab G, La Torre F, Bartoloni E, Del Giudice E, Lomater C, Emmi G, Govoni M, Maggio MC, Maier A, Makowska J, Ogunjimi B, Sfikakis PP, Sfriso P, Gaggiano C, Iannone F, Dagostin MA, Di Cola I, Navarini L, Ahmed Mahmoud AA, Cardinale F, Riccucci I, Paroli MP, Marucco EM, Mattioli I, Sota J, Abbruzzese A, Antonelli IPB, Cipriani P, Tufan A, Fabiani C, Ramadan MM, Cattalini M, Kardas RC, Sebastiani GD, Giardini HAM, Hernandez-Rodriguez J, Mastrorilli V, Wiesik-Szewczyk E, Frassi M, Caggiano V, Telesca S, Giordano HF, Guadalupi E, Giani T, Renieri A, Colella S, Cataldi G, Gentile M, Fabbiani A, Al-Maghlouth IA, Frediani B, Balistreri A, Rigante D, Cantarini L. Development and Implementation of the AIDA International Registry for Patients With Still's Disease. Front Med (Lausanne). 2022 Apr 7;9:878797. doi: 10.3389/fmed.2022.878797. eCollection 2022.
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