RecruitingNCT05200715

AutoInflammatory Disease Alliance Registry (AIDA)

Development of an International Multicenter Registry of Patients With Monogenic and Polygenic Autoinflammatory Diseases Aimed at Clinical and Therapeutical Data Collection and Analysis


Sponsor

University of Siena

Enrollment

3,500 participants

Start Date

Aug 6, 2020

Study Type

OBSERVATIONAL

Conditions

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

Inclusion Criteria7

  • 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 Criteria1

  • \- informed consent/assent not provided by the patient and/or his/her legal representative.

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Interventions

OTHERNo 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.


Locations(112)

University Algiers 1

Algiers, Algeria

Université M'Hamed Bougara de Boumerdas

Boumerdas, Algeria

Flinders University

Adelaide, Australia

University of Adelaide

Adelaide, Australia

Antwerp University Hospital

Antwerp, Belgium

Hospital das Clinicas da Faculdade de Medicina HCFMUSP

São Paulo, Brazil

Peking University People's Hospital

Beijing, China

The First Affiliated Hospital of Chongqing Medical University

Chongqing, China

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

Bogotá, Colombia

Mansoura University, Faculty of Medicine

Al Mansurah, Egypt

Al-Azhar University

Cairo, Egypt

Cairo University

Cairo, Egypt

Universitätsklinikum Schleswig-Holstein

Lübeck, Germany

Evangelismos General Hospital

Athens, Greece

National and Kapodistrian University of Athens

Athens, Greece

National and Kapodistrian University of Athens

Athens, Greece

Prabha Eye Clinic & Research Centre

Bangalore, India

Postgraduate Institute of Medical Education and Research

Chandigarh, India

Shariati Hospital - Tehran University of Medical Sciences

Tehran, Iran

Azienda Ospedaliero-Universitaria Senese

Siena, Tuscany, Italy

AOUC Policlinico di Bari

Bari, Italy

University of Bari Medical School

Bari, Italy

University-Hospital of Bari - UOC Medicina Interna

Bari, Italy

University-Hospital of Bari - UOC Pediatria

Bari, Italy

University-Hospital of Bari - UOC Reumatologia

Bari, Italy

Central Hospital of Bolzano

Bolzano, Italy

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

Brescia, Italy

ASST degli Spedali Civili

Brescia, Italy

Azienda Ospedaliera Universitaria di Cagliari

Cagliari, Italy

AOU Policlinico Vittorio Emanuele - Dip. Materno-Infantile

Catania, Italy

ARNAS Garibaldi - Catania

Catania, Italy

Azienda Ospedaliera di Catanzaro Pugliese Ciaccio

Catanzaro, Italy

Ospedale SS Annunziata

Chieti, Italy

Ospedale San Paolo

Civitavecchia, Italy

Arcispedale Sant'Anna

Ferrara, Italy

Azienda Ospedaliera Universitaria Careggi - SOD Medicina Interna Interdisciplinare

Florence, Italy

Azienda Ospedaliero-Universitaria Careggi - SOD Immunologia e Terapie Cellulari

Florence, Italy

Azienda Ospedaliero-Universitaria Meyer

Florence, Italy

Azienza Ospedaliero-Universitaria Careggi - SOD Reumatologia

Florence, Italy

Ospedale San Giovanni di Dio

Florence, Italy

Sapienza University - Polo Pontino

Latina, Italy

Ospedale Vito Fazzi

Lecce, Italy

ASL1 Avezzano, Sulmona, L'Aquila

L’Aquila, Italy

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

L’Aquila, Italy

AOU Policlinico G. Martino

Messina, Italy

ASST Gaetano Pini/ CTO

Milan, Italy

Policlinico di Milano

Milan, Italy

ASST Fatebenefratelli Sacco - UO Medicina Generale

Milan, Italy

ASST Fatebenefratelli Sacco - UOC Reumatologia

Milan, Italy

ASST Gaetano Pini/CTO

Milan, Italy

IRCCS Ospedale San Raffaele

Milan, Italy

Ospedale Fatebenefratelli e Oftalmico

Milan, Italy

Ospedale Fatebenefratelli e Oftalmico

Milan, Italy

AORN Cardarelli

Naples, Italy

AOU Federico II

Naples, Italy

AOU Federico II

Naples, Italy

AOU Luigi Vanvitelli - UO Reumatologia

Naples, Italy

AOU Luigi Vanvitelli - UOC Pediatria 2

Naples, Italy

Azienda Ospedaliera Universitaria di Padova

Padova, Italy

ARNAS Civico Di Cristina Benfratelli

Palermo, Italy

ARNAS Ospedale Civico di Cristina Benfratelli

Palermo, Italy

Azienda Ospedaliera Ospedali Riuniti Villa Sofia-Cervello

Palermo, Italy

Università degli Studi di Palermo

Palermo, Italy

Fondazione IRRCS San Matteo - SC Reumatologia

Pavia, Italy

Azienda Ospedaliera di Perugia

Perugia, Italy

Azienda Ospedaliero Universitaria Pisana

Pisa, Italy

University of Pisa

Pisa, Italy

AOU Policlinico Umberto I

Roma, Italy

Azienda Ospedaliera San Camillo Forlanini

Roma, Italy

IRCCS Fondazione PU Agostino Gemelli - UOC Medicina Interna Columbus

Roma, Italy

IRCCS Fondazione PU Agostino Gemelli - UOC Pediatria

Roma, Italy

Ospedale Pediatrico Bambino Gesù

Roma, Italy

Ospedale Universitario Campus Bio-Medico

Roma, Italy

Sapienza University - Polo Pontino

Roma, Italy

Università di Roma Tor Vergata

Roma, Italy

Azienda Ospedaliera Universitaria di Salerno

Salerno, Italy

ATS Sardegna

Tempio Pausania, Italy

AO Ordine Mauriziano

Torino, Italy

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

Vercelli, Italy

Azienda Ospedaliera Universitaria Integrata

Verona, Italy

Tripoli Children Hospital

Tripoli, Libya

Tripoli Children Hospital

Tripoli, Libya

University Hospital of Martinique

Fort-de-France, Martinique

Asociacion para Evitar la Ceguera en México

Mexico City, Mexico

Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán

Mexico City, Mexico

Medical University of Lodz

Lodz, Poland

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

Warsaw, Poland

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

Bucharest, Romania

Jazan University

Jizan, Saudi Arabia

King Faisal Specialist Hospital and Research Center

Riyadh, Saudi Arabia

King Saud University

Riyadh, Saudi Arabia

Hospital Universitario Cruces - Instituto de investigación sanitaria Biocruces

Barakaldo, Spain

Hospital Universitario Cruces

Barakaldo, Spain

Hospital Clinic of Barcelona

Barcelona, Spain

Hospital Fundación Jiménez Díaz

Madrid, Spain

Hospital Ramón y Cajal

Madrid, Spain

Hospital Universitario Fundación Jiménez Díaz/Hospital Universitario Rey Juan Carlos

Madrid, Spain

Hospital Universitario Marqués de Valdecilla

Santander, Spain

Hospital Universitari Doctor Peset

Valencia, Spain

Farhat Hached Hospital

Sousse, Tunisia

Çukurova University

Adana, Turkey (Türkiye)

Ankara Yıldırım Beyazıt University

Ankara, Turkey (Türkiye)

Gazi University

Ankara, Turkey (Türkiye)

Hacettepe University Faculty of Medicine

Ankara, Turkey (Türkiye)

Başakşehir Çam and Sakura City Hospital

Istanbul, Turkey (Türkiye)

Cerrahpasa Medical School Istanbul University

Istanbul, Turkey (Türkiye)

Marmara University, Research And Education Hospital

Istanbul, Turkey (Türkiye)

Dokuz Eylul University School of Medicine

Izmir, Turkey (Türkiye)

Manisa Celal Bayar University

Manisa, Turkey (Türkiye)

Sakarya University

Sakarya, Turkey (Türkiye)

Sivas Cumhuriyet University

Sivas, Turkey (Türkiye)

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

Ternopil, Ukraine

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NCT05200715


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