AutoInflammatory Disease Alliance Registry (AIDA)

Last updated: July 7, 2025
Sponsor: University of Siena
Overall Status: Active - Recruiting

Phase

N/A

Condition

Lupus

Eye Disorders/infections

Lymphoproliferative Disorders

Treatment

No intervention is foreseen by the protocol.

Clinical Study ID

NCT05200715
AIDA V.04 19.05.2021
  • All Genders

Study 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

Inclusion Criteria:

  • to be diagnosed with a monogenic AID according to the clinical phenotype and thedetection of a confirmative genotype;

  • to be diagnosed with clinical familial Mediterranean fever or Behçet's disease orStill disease or PFAPA syndrome or Schnitzler's disease or CRMO according to thecorresponding clinical diagnostic and/or classification criteria;

  • to be diagnosed with undifferentiated systemic AID;

  • to be diagnosed with non-infectious uveitis according to the standardization foruveitis 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

Exclusion Criteria:

  • informed consent/assent not provided by the patient and/or his/her legalrepresentative.

Study Design

Total Participants: 3500
Treatment Group(s): 1
Primary Treatment: No intervention is foreseen by the protocol.
Phase:
Study Start date:
August 06, 2020
Estimated Completion Date:
August 06, 2030

Study 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).

Connect with a study center

  • University Algiers 1

    Algiers,
    Algeria

    Active - Recruiting

  • Université M'Hamed Bougara de Boumerdas

    Boumerdas,
    Algeria

    Active - Recruiting

  • Flinders University

    Adelaide,
    Australia

    Active - Recruiting

  • University of Adelaide

    Adelaide,
    Australia

    Active - Recruiting

  • Antwerp University Hospital

    Antwerp,
    Belgium

    Active - Recruiting

  • UZ Leuven Gasthuisberg Campus

    Leuven,
    Belgium

    Site Not Available

  • Hospital das Clinicas da Faculdade de Medicina HCFMUSP

    São Paulo,
    Brazil

    Active - Recruiting

  • Peking University People's Hospital

    Beijing,
    China

    Active - Recruiting

  • The First Affiliated Hospital of Chongqing Medical University

    Chongqing,
    China

    Active - Recruiting

  • Universidad del Rosario - Escuela de Medicina Y Ciencias de La Salud

    Bogotá,
    Colombia

    Active - Recruiting

  • Al-Azhar University

    Cairo,
    Egypt

    Active - Recruiting

  • Cairo University

    Cairo,
    Egypt

    Active - Recruiting

  • Mansoura University, Faculty of Medicine

    Mansoura,
    Egypt

    Active - Recruiting

  • Charité - Universitätsmedizin Berlin

    Berlin,
    Germany

    Site Not Available

  • Universitätsklinikum Schleswig-Holstein

    Lübeck,
    Germany

    Active - Recruiting

  • Korle Bu Teaching Hospital

    Accra,
    Ghana

    Site Not Available

  • Evangelismos General Hospital

    Athens,
    Greece

    Active - Recruiting

  • National and Kapodistrian University of Athens

    Athens,
    Greece

    Active - Recruiting

  • Prabha Eye Clinic & Research Centre

    Bangalore,
    India

    Active - Recruiting

  • Postgraduate Institute of Medical Education and Research

    Chandigarh,
    India

    Active - Recruiting

  • Shariati Hospital - Tehran University of Medical Sciences

    Tehran,
    Iran, Islamic Republic of

    Active - Recruiting

  • Azienda Ospedaliero-Universitaria Senese

    Siena, Tuscany 53100
    Italy

    Active - Recruiting

  • Ospedale San Donato

    Arezzo,
    Italy

    Site Not Available

  • AOUC Policlinico di Bari

    Bari,
    Italy

    Active - Recruiting

  • University of Bari Medical School

    Bari,
    Italy

    Active - Recruiting

  • University-Hospital of Bari - UOC Medicina Interna

    Bari,
    Italy

    Active - Recruiting

  • University-Hospital of Bari - UOC Pediatria

    Bari,
    Italy

    Active - Recruiting

  • University-Hospital of Bari - UOC Reumatologia

    Bari,
    Italy

    Active - Recruiting

  • IRCCS Istituto Ortopedico Rizzoli

    Bologna,
    Italy

    Site Not Available

  • Central Hospital of Bolzano

    Bolzano,
    Italy

    Active - Recruiting

  • ASST degli Spedali Civili

    Brescia,
    Italy

    Active - Recruiting

  • ASST degli Spedali Civili - P.O. Ospedale dei Bambini

    Brescia,
    Italy

    Active - Recruiting

  • Azienda Ospedaliera Universitaria di Cagliari

    Cagliari,
    Italy

    Active - Recruiting

  • AOU Policlinico Vittorio Emanuele - Dip. Materno-Infantile

    Catania,
    Italy

    Active - Recruiting

  • ARNAS Garibaldi - Catania

    Catania,
    Italy

    Active - Recruiting

  • Azienda Ospedaliera per l'Emergenza Cannizzaro

    Catania,
    Italy

    Site Not Available

  • Azienda Ospedaliera di Catanzaro Pugliese Ciaccio

    Catanzaro,
    Italy

    Active - Recruiting

  • Ospedale SS Annunziata

    Chieti,
    Italy

    Active - Recruiting

  • Ospedale San Paolo

    Civitavecchia,
    Italy

    Active - Recruiting

  • Arcispedale Sant'Anna

    Ferrara,
    Italy

    Active - Recruiting

  • Azienda Ospedaliera Universitaria Careggi - SOD Medicina Interna Interdisciplinare

    Firenze,
    Italy

    Active - Recruiting

  • Azienda Ospedaliero-Universitaria Careggi - SOD Immunologia e Terapie Cellulari

    Firenze,
    Italy

    Active - Recruiting

  • Azienda Ospedaliero-Universitaria Meyer

    Firenze,
    Italy

    Active - Recruiting

  • Azienza Ospedaliero-Universitaria Careggi - SOD Reumatologia

    Firenze,
    Italy

    Active - Recruiting

  • Ospedale San Giovanni di Dio

    Firenze,
    Italy

    Active - Recruiting

  • Fondazione IRCCS Ospedale Casa Sollievo della Sofferenza

    Foggia,
    Italy

    Site Not Available

  • IRCCS Ospedale Pediatrico Giannina Gaslini

    Genova,
    Italy

    Site Not Available

  • ASL1 Avezzano, Sulmona, L'Aquila

    L'Aquila,
    Italy

    Active - Recruiting

  • Università degli Studi di L'Aquila - UOC Medicina Interna e Nefrologia

    L'Aquila,
    Italy

    Active - Recruiting

  • Sapienza University - Polo Pontino

    Latina,
    Italy

    Active - Recruiting

  • Ospedale Galateo - San Cesario

    Lecce,
    Italy

    Site Not Available

  • Ospedale Vito Fazzi

    Lecce,
    Italy

    Active - Recruiting

  • AOU Policlinico G. Martino

    Messina,
    Italy

    Active - Recruiting

  • ASST Gaetano Pini/ CTO

    Milan,
    Italy

    Active - Recruiting

  • Policlinico di Milano

    Milan,
    Italy

    Active - Recruiting

  • ASST Fatebenefratelli Sacco - UO Medicina Generale

    Milano,
    Italy

    Active - Recruiting

  • ASST Fatebenefratelli Sacco - UOC Reumatologia

    Milano,
    Italy

    Active - Recruiting

  • ASST Gaetano Pini/CTO

    Milano,
    Italy

    Active - Recruiting

  • IRCCS Ospedale San Raffaele

    Milano,
    Italy

    Active - Recruiting

  • Ospedale Fatebenefratelli e Oftalmico

    Milano,
    Italy

    Active - Recruiting

  • AORN Cardarelli

    Napoli,
    Italy

    Active - Recruiting

  • AOU Federico II

    Napoli,
    Italy

    Active - Recruiting

  • AOU Luigi Vanvitelli - UO Reumatologia

    Napoli,
    Italy

    Active - Recruiting

  • AOU Luigi Vanvitelli - UOC Pediatria 2

    Napoli,
    Italy

    Active - Recruiting

  • Policlinico Federico II

    Napoli,
    Italy

    Site Not Available

  • Azienda Ospedaliera Universitaria di Padova

    Padova,
    Italy

    Active - Recruiting

  • ARNAS Civico Di Cristina Benfratelli

    Palermo,
    Italy

    Active - Recruiting

  • ARNAS Ospedale Civico di Cristina Benfratelli

    Palermo,
    Italy

    Active - Recruiting

  • Azienda Ospedaliera Ospedali Riuniti Villa Sofia-Cervello

    Palermo,
    Italy

    Active - Recruiting

  • Università degli Studi di Palermo

    Palermo,
    Italy

    Active - Recruiting

  • AOU di Parma - Ospedale dei Bambini P. Barilla

    Parma,
    Italy

    Site Not Available

  • Fondazione IRCCS Policlinico San Matteo - Dip. Medicina Diagnostica e Servizi: L.S.R. Area Biotecnologie

    Pavia,
    Italy

    Site Not Available

  • Fondazione IRRCS San Matteo - SC Reumatologia

    Pavia,
    Italy

    Active - Recruiting

  • Azienda Ospedaliera di Perugia

    Perugia,
    Italy

    Active - Recruiting

  • Azienda USL di Piacenza

    Piacenza,
    Italy

    Site Not Available

  • Azienda Ospedaliera Universitaria di Pisa

    Pisa,
    Italy

    Site Not Available

  • Azienda Ospedaliero Universitaria Pisana

    Pisa,
    Italy

    Active - Recruiting

  • University of Pisa

    Pisa,
    Italy

    Active - Recruiting

  • Azienda Ospedaliera San Carlo

    Potenza,
    Italy

    Site Not Available

  • Grande Ospedale Metropolitano - Azienda Ospedaliera Bianchi-Melacrino-Morelli

    Reggio Calabria,
    Italy

    Site Not Available

  • Arcispedale Santa Maria Nuova

    Reggio Emilia,
    Italy

    Site Not Available

  • AOU Policlinico Umberto I

    Roma,
    Italy

    Active - Recruiting

  • Azienda Ospedaliera San Camillo Forlanini

    Roma,
    Italy

    Active - Recruiting

  • IRCCS Fondazione PU Agostino Gemelli - UOC Medicina Interna Columbus

    Roma,
    Italy

    Active - Recruiting

  • IRCCS Fondazione PU Agostino Gemelli - UOC Pediatria

    Roma,
    Italy

    Active - Recruiting

  • Ospedale Pediatrico Bambino Gesù

    Roma,
    Italy

    Active - Recruiting

  • Ospedale Universitario Campus Bio-Medico

    Roma,
    Italy

    Active - Recruiting

  • Sapienza University - Polo Pontino

    Roma,
    Italy

    Active - Recruiting

  • Sapienza University - Polo Pontino - SCIAC

    Roma,
    Italy

    Active - Recruiting

  • Università di Roma Tor Vergata

    Roma,
    Italy

    Active - Recruiting

  • Azienda Ospedaliera Universitaria di Salerno

    Salerno,
    Italy

    Active - Recruiting

  • ATS Sardegna

    Tempio Pausania,
    Italy

    Active - Recruiting

  • AO Ordine Mauriziano

    Torino,
    Italy

    Active - Recruiting

  • Presidio Ospedaliero Molinette

    Torino,
    Italy

    Site Not Available

  • Presidio Ospedaliero Santa Chiara

    Trento,
    Italy

    Site Not Available

  • A.S.L. Vercelli - Ospedale S. Andrea

    Vercelli,
    Italy

    Active - Recruiting

  • Azienda Ospedaliera Universitaria Integrata

    Verona,
    Italy

    Active - Recruiting

  • American University of Beirut

    Beirut,
    Lebanon

    Site Not Available

  • Tripoli Children Hospital

    Tripoli,
    Libyan Arab Jamahiriya

    Active - Recruiting

  • University Hospital of Martinique

    Fort-de-France,
    Martinique

    Active - Recruiting

  • Asociacion para Evitar la Ceguera en México

    Mexico City,
    Mexico

    Active - Recruiting

  • Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán

    Mexico City,
    Mexico

    Active - Recruiting

  • Mohammed V University

    Rabat,
    Morocco

    Site Not Available

  • Pomeranian Medical University

    Szczecin,
    Poland

    Site Not Available

  • Central Clinical Hospital of the Ministry of National Defense - Military Institute of Medicine

    Warsaw,
    Poland

    Active - Recruiting

  • Medical University of Lodz

    Łódź,
    Poland

    Active - Recruiting

  • Centro Hospitalar e Universitário do Porto

    Porto,
    Portugal

    Site Not Available

  • Sf. Maria Hospital - University of Medicine and Pharmacy "Carol Davila"

    Bucharest,
    Romania

    Active - Recruiting

  • Jazan University

    Jazan,
    Saudi Arabia

    Active - Recruiting

  • King Faisal Specialist Hospital and Research Center

    Riyadh,
    Saudi Arabia

    Active - Recruiting

  • King Saud University

    Riyadh,
    Saudi Arabia

    Active - Recruiting

  • Hospital Universitario Cruces

    Barakaldo,
    Spain

    Active - Recruiting

  • Hospital Universitario Cruces - Instituto de investigación sanitaria Biocruces

    Barakaldo,
    Spain

    Active - Recruiting

  • Hospital Clinic of Barcelona

    Barcelona,
    Spain

    Active - Recruiting

  • Vall d'Hbron University Hospital

    Barcelona,
    Spain

    Site Not Available

  • Hospital Fundación Jiménez Díaz

    Madrid,
    Spain

    Active - Recruiting

  • Hospital Ramón y Cajal

    Madrid,
    Spain

    Active - Recruiting

  • Hospital Universitario Fundación Jiménez Díaz/Hospital Universitario Rey Juan Carlos

    Madrid,
    Spain

    Active - Recruiting

  • Hospital Universitario Marqués de Valdecilla

    Santander,
    Spain

    Active - Recruiting

  • Hospital Universitari Doctor Peset

    Valencia,
    Spain

    Active - Recruiting

  • Hospital Álvaro Cunquiero-Complejo Hospitalario Universitario de Vigo

    Vigo,
    Spain

    Site Not Available

  • China Medical University

    Taichung,
    Taiwan

    Site Not Available

  • Farhat Hached Hospital

    Sousse,
    Tunisia

    Active - Recruiting

  • Çukurova University

    Adana,
    Turkey

    Active - Recruiting

  • Ankara University

    Ankara,
    Turkey

    Site Not Available

  • Ankara Yıldırım Beyazıt University

    Ankara,
    Turkey

    Active - Recruiting

  • Gazi University

    Ankara,
    Turkey

    Active - Recruiting

  • Hacettepe University Faculty of Medicine

    Ankara,
    Turkey

    Active - Recruiting

  • Antalya Education and Research Hospital

    Antalya,
    Turkey

    Site Not Available

  • Erzurum Education and Research Hospital

    Erzurum,
    Turkey

    Site Not Available

  • Eskişehir Osmangazi University

    Eskişehir,
    Turkey

    Site Not Available

  • Başakşehir Çam and Sakura City Hospital

    Istanbul,
    Turkey

    Active - Recruiting

  • Cerrahpasa Medical School Istanbul University

    Istanbul,
    Turkey

    Active - Recruiting

  • Marmara University, Research And Education Hospital

    Istanbul,
    Turkey

    Active - Recruiting

  • Manisa Celal Bayar University

    Manisa,
    Turkey

    Active - Recruiting

  • Sakarya University

    Sakarya,
    Turkey

    Active - Recruiting

  • Sivas Cumhuriyet University

    Sivas,
    Turkey

    Active - Recruiting

  • Dokuz Eylul University School of Medicine

    İzmir,
    Turkey

    Active - Recruiting

  • I. Horbachevsky Ternopil National Medical University - Ternopil Regional Children's Hospital

    Ternopil,
    Ukraine

    Active - Recruiting

  • National Human Genome Research Institute

    Bethesda, Maryland 20892-2152
    United States

    Site Not Available

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