Clinical trial NCT05200715: AutoInflammatory Disease Alliance Registry (AIDA)
Official title: Development of an International Multicenter Registry of Patients With Monogenic and Polygenic Autoinflammatory Diseases Aimed at Clinical and Therapeutical Data Collection and Analysis
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Hereditary Autoinflammatory Diseases
Schnitzler Syndrome
Behcet Syndrome
PFAPA Syndrome
Still Disease
Autoinflammatory Syndrome, Unspecified
Uveitis
Scleritis
Vexas Syndrome
Spondyloarthritis (SpA)
Castleman Disease
Lead sponsor: University of Siena
Sponsor class: OTHER
First posted: 2022-01-21
Enrollment: 3500
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: PROBABILITY_SAMPLE
Study population: Patients consecutively diagnosed and treated at the hospitals/ research centres affiliated to the AIDA Network (https://aidanetwork.org/en/)

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.

Detailed description: The AIDA registry service is based on REDCap (Research Electronic Data Capture, project-redcap.org), a secure web application for building and managing online surveys and databases, designed to support data capture for research studies. The platform is directly accessible through the AIDA website, after inserting a personal username and password. Currently, 11 registries are available, each one dedicated to the collection of data about:

* monogenic AID
* PFAPA syndrome
* undifferentiated systemic AID (USAID)
* Behçet's disease
* Schnitzler's disease
* VEXAS (vacuoles, E1 enzyme, X-linked, autoinflammatory, somatic) syndrome
* Still disease
* noninfectious uveitis
* noninfectious scleritis
* spondyloarthritis
* Castleman disease

The registry will pursue the following aims within the first 36 months from the start of the enrollment:

1. to identify any association between clinical manifestations and gender, disease duration, body mass index and tabagism;
2. to detect differences in the clinical phenotype between pediatric-onset and adult-onset patients;
3. to identify the impact of different treatment approaches on clinical and laboratory disease manifestations.

Additional aims of the AIDA project, to be reached over the next 10 years, are the following:

1. to overcome fragmentation in the clinical experience on these rare conditions by sharing the knowledge at the international level;
2. to improve knowledge about the clinical presentation, genotype-phenotype correlations, response to treatment, long-term complications and social impact when monogenic and polygenic AID manifest during either childhood or adulthood;
3. to identify the long-term clinical course of patients diagnosed with monogenic or polygenic AID;
4. to promote awareness among physicians and enhance early recognition of these diseases;
5. to describe the impact of AID on quality of life;
6. to identify any impact of monogenic and polygenic AID on fertility;
7. to study the course of AID during pregnancy;
8. to assess the socioeconomic impact of AID;
9. to promote future multicentric studies.

Data collection is both retrospective and prospective. It includes demographic, clinical, diagnostic, genetic, clinimetric, laboratory, radiologic, therapeutic and socio-economic data. Instruments are designed to be filled out during routine clinical visits, usually scheduled every 3-6 months. Separation of personally identifiable information and medical data by using only pseudonyms for storing medical data ensures compliance with data protection regulations. The description of symptoms, diseases, procedures and injuries is based on the International Statistical Classification of Diseases and Related Health Problems (ICD)-10 coding system. Data management is both central and decentral. Data are extracted and statistically analyzed on a regular basis according to individual study protocols. A policy for authorship and dissemination of research findings is in place among the AIDA partners contributing to the registry.

The AIDA registry will support data collection for the conduction of clinical trials, observational studies, comparative effectiveness research, and other research on patients with monogenic and polygenic AID.

Several healthcare providers contributing to the AIDA Network are members of the European Reference Network (ERN) for Rare Immunodeficiency, Autoinflammatory and Autoimmune Diseases (RITA).

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.

Primary outcomes:
measure: Change of the number of enrolled subjects
timeFrame: 0-36-60-120 months
Secondary outcomes:
measure: Change in the disease activity score
timeFrame: 0-36-60-120 months
measure: Change in the % of patients with new organ involvement
timeFrame: 0-36-60-120 months
measure: Incidence of death or adverse events
timeFrame: 0-36-60-120 months
measure: Change in the inflammatory markers values (ESR)
timeFrame: 0-36-60-120 months
measure: Change in the inflammatory markers values (CRP and SAA)
timeFrame: 0-36-60-120
measure: Change in visual acuity expressed as Best Corrected Visual Acuity (BCVA)
timeFrame: 0-36-60-120 months
measure: Change in the overall function score
timeFrame: 0-36-60-120 months
measure: Change in the overall damage score
timeFrame: 0-36-60-120 months
measure: Change in articular pain measured as Visual Analogue Scale for articular Pain (VAS Pain)
timeFrame: 0-36-60-120 months
measure: Changes in height and weight percentile values for age and sex
timeFrame: 0-36-60-120 months
measure: Change in the % of patients experiencing fatigue
timeFrame: 0-36-60-120 months
measure: Change in the % of patients with fertility reduction or pregnancy complications
timeFrame: 0-36-60-120
measure: Change in the socioeconomic indicators
timeFrame: 0-36-60-120 months
Other outcomes:
Locations:
city: Bethesda
country: United States
facility: National Human Genome Research Institute
state: Maryland
city: Boumerdas
country: Algeria
facility: Université M'Hamed Bougara de Boumerdas
city: Antwerp
country: Belgium
facility: Antwerp University Hospital
city: Leuven
country: Belgium
facility: UZ Leuven Gasthuisberg Campus
city: São Paulo
country: Brazil
facility: Hospital das Clinicas da Faculdade de Medicina HCFMUSP
city: Cairo
country: Egypt
facility: Cairo University
city: Berlin
country: Germany
facility: Charité - Universitätsmedizin Berlin
city: Lübeck
country: Germany
facility: Universitätsklinikum Schleswig-Holstein
city: Accra
country: Ghana
facility: Korle Bu Teaching Hospital
city: Athens
country: Greece
facility: National and Kapodistrian University of Athens
city: Tehran
country: Iran, Islamic Republic of
facility: Shariati Hospital - Tehran University of Medical Sciences
city: Siena
country: Italy
facility: Azienda Ospedaliero-Universitaria Senese
state: Tuscany
city: Arezzo
country: Italy
facility: Ospedale San Donato
city: Bari
country: Italy
facility: AOUC Policlinico di Bari
city: Bari
country: Italy
facility: University-Hospital of Bari - UOC Medicina Interna
city: Bari
country: Italy
facility: University-Hospital of Bari - UOC Pediatria
city: Bari
country: Italy
facility: University-Hospital of Bari - UOC Reumatologia
city: Bologna
country: Italy
facility: IRCCS Istituto Ortopedico Rizzoli
city: Bolzano
country: Italy
facility: Central Hospital of Bolzano
city: Brescia
country: Italy
facility: ASST degli Spedali Civili - P.O. Ospedale dei Bambini
city: Brescia
country: Italy
facility: ASST degli Spedali Civili
city: Cagliari
country: Italy
facility: Azienda Ospedaliera Universitaria di Cagliari
city: Catania
country: Italy
facility: AOU Policlinico Vittorio Emanuele - Dip. Materno-Infantile
city: Catania
country: Italy
facility: Azienda Ospedaliera per l'Emergenza Cannizzaro
city: Catanzaro
country: Italy
facility: Azienda Ospedaliera di Catanzaro Pugliese Ciaccio
city: Chieti
country: Italy
facility: Ospedale SS Annunziata
city: Ferrara
country: Italy
facility: Arcispedale Sant'Anna
city: Firenze
country: Italy
facility: Azienda Ospedaliera Universitaria Careggi - SOD Medicina Interna Interdisciplinare
city: Firenze
country: Italy
facility: Azienda Ospedaliero-Universitaria Careggi - SOD Immunologia e Terapie Cellulari
city: Firenze
country: Italy
facility: Azienda Ospedaliero-Universitaria Meyer
city: Firenze
country: Italy
facility: Azienza Ospedaliero-Universitaria Careggi - SOD Reumatologia
city: Firenze
country: Italy
facility: Ospedale San Giovanni di Dio
city: Foggia
country: Italy
facility: Fondazione IRCCS Ospedale Casa Sollievo della Sofferenza
city: Genova
country: Italy
facility: IRCCS Ospedale Pediatrico Giannina Gaslini
city: L'Aquila
country: Italy
facility: ASL1 Avezzano, Sulmona, L'Aquila
city: L'Aquila
country: Italy
facility: Università degli Studi di L'Aquila - UOC Medicina Interna e Nefrologia
city: Latina
country: Italy
facility: Sapienza University - Polo Pontino
city: Lecce
country: Italy
facility: Ospedale Galateo - San Cesario
city: Messina
country: Italy
facility: AOU Policlinico G. Martino
city: Milano
country: Italy
facility: ASST Fatebenefratelli Sacco - UO Medicina Generale
city: Milano
country: Italy
facility: ASST Fatebenefratelli Sacco - UOC Reumatologia
city: Milano
country: Italy
facility: IRCCS Ospedale San Raffaele
city: Milano
country: Italy
facility: Ospedale Fatebenefratelli e Oftalmico
city: Milan
country: Italy
facility: ASST Gaetano Pini/ CTO
city: Milan
country: Italy
facility: Policlinico di Milano
city: Napoli
country: Italy
facility: AOU Luigi Vanvitelli - UO Reumatologia
city: Napoli
country: Italy
facility: AOU Luigi Vanvitelli - UOC Pediatria 2
city: Napoli
country: Italy
facility: Policlinico Federico II
city: Padova
country: Italy
facility: Azienda Ospedaliera Universitaria di Padova
city: Palermo
country: Italy
facility: ARNAS Ospedale Civico di Cristina Benfratelli
city: Palermo
country: Italy
facility: Azienda Ospedaliera Ospedali Riuniti Villa Sofia-Cervello
city: Palermo
country: Italy
facility: Università degli Studi di Palermo
city: Parma
country: Italy
facility: AOU di Parma - Ospedale dei Bambini P. Barilla
city: Pavia
country: Italy
facility: Fondazione IRCCS Policlinico San Matteo - Dip. Medicina Diagnostica e Servizi: L.S.R. Area Biotecnologie
city: Pavia
country: Italy
facility: Fondazione IRRCS San Matteo - SC Reumatologia
city: Perugia
country: Italy
facility: Azienda Ospedaliera di Perugia
city: Piacenza
country: Italy
facility: Azienda USL di Piacenza
city: Pisa
country: Italy
facility: Azienda Ospedaliera Universitaria di Pisa
city: Potenza
country: Italy
facility: Azienda Ospedaliera San Carlo
city: Reggio Calabria
country: Italy
facility: Grande Ospedale Metropolitano - Azienda Ospedaliera Bianchi-Melacrino-Morelli
city: Reggio Emilia
country: Italy
facility: Arcispedale Santa Maria Nuova
city: Roma
country: Italy
facility: AOU Policlinico Umberto I
city: Roma
country: Italy
facility: Azienda Ospedaliera San Camillo Forlanini
city: Roma
country: Italy
facility: IRCCS Fondazione PU Agostino Gemelli - UOC Medicina Interna Columbus
city: Roma
country: Italy
facility: IRCCS Fondazione PU Agostino Gemelli - UOC Pediatria
city: Roma
country: Italy
facility: Ospedale Pediatrico Bambino Gesù
city: Roma
country: Italy
facility: Ospedale Universitario Campus Bio-Medico
city: Roma
country: Italy
facility: Sapienza University - Polo Pontino - SCIAC
city: Salerno
country: Italy
facility: Azienda Ospedaliera Universitaria di Salerno
city: Tempio Pausania
country: Italy
facility: ATS Sardegna
city: Torino
country: Italy
facility: AO Ordine Mauriziano
city: Torino
country: Italy
facility: Presidio Ospedaliero Molinette
city: Trento
country: Italy
facility: Presidio Ospedaliero Santa Chiara
city: Verona
country: Italy
facility: Azienda Ospedaliera Universitaria Integrata
city: Beirut
country: Lebanon
facility: American University of Beirut
city: Rabat
country: Morocco
facility: Mohammed V University
city: Szczecin
country: Poland
facility: Pomeranian Medical University
city: Warsaw
country: Poland
facility: Central Clinical Hospital of the Ministry of National Defense - Military Institute of Medicine
city: Łódź
country: Poland
facility: Medical University of Lodz
city: Porto
country: Portugal
facility: Centro Hospitalar e Universitário do Porto
city: Bucharest
country: Romania
facility: Sf. Maria Hospital - University of Medicine and Pharmacy "Carol Davila"
city: Riyadh
country: Saudi Arabia
facility: King Faisal Specialist Hospital and Research Center
city: Riyadh
country: Saudi Arabia
facility: King Saud University
city: Barcelona
country: Spain
facility: Hospital Clinic of Barcelona
city: Barcelona
country: Spain
facility: Vall d'Hbron University Hospital
city: Madrid
country: Spain
facility: Hospital Ramón y Cajal
city: Santander
country: Spain
facility: Hospital Universitario Marqués de Valdecilla
city: Vigo
country: Spain
facility: Hospital Álvaro Cunquiero-Complejo Hospitalario Universitario de Vigo
city: Taichung
country: Taiwan
facility: China Medical University
city: Adana
country: Turkey
facility: Çukurova University
city: Ankara
country: Turkey
facility: Ankara University
city: Ankara
country: Turkey
facility: Ankara Yıldırım Beyazıt University
city: Ankara
country: Turkey
facility: Gazi University
city: Antalya
country: Turkey
facility: Antalya Education and Research Hospital
city: Erzurum
country: Turkey
facility: Erzurum Education and Research Hospital
city: Eskişehir
country: Turkey
facility: Eskişehir Osmangazi University
city: Istanbul
country: Turkey
facility: Cerrahpasa Medical School Istanbul University
city: İzmir
country: Turkey
facility: Dokuz Eylul University School of Medicine
city: Manisa
country: Turkey
facility: Manisa Celal Bayar University
city: Sivas
country: Turkey
facility: Sivas Cumhuriyet University
Study officials:
References:
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