Clinical trial Recruiting at 112 sites Observational

Registry for hereditary autoinflammatory diseases

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

Run by University of Siena · NCT05200715 · Data updated 2026-11-12

This study is collecting information about hereditary autoinflammatory diseases to see how they affect patients of different ages and genders, with the goal of improving treatment and care for everyone affected.

Quick facts

Study typeObservational
SexAll
Enrollment3500 (estimated)
SponsorUniversity of Siena
Academic / other
Locations112 sites (Algiers and 111 other locations)
StatusRecruiting
StartedAugust 6, 2020
Main results expectedAugust 6, 2026
Study endsAugust 6, 2030
Registry record updatedJuly 10, 2025
Trial IDNCT05200715 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates include individuals diagnosed with hereditary autoinflammatory diseases or related conditions such as Behçet's disease, Still disease, or PFAPA syndrome.

Probably not a fit

Patients who do not have a confirmed diagnosis of the specified autoinflammatory diseases or who cannot provide informed consent may not benefit from this registry.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

The AIDA registry collects data on hereditary autoinflammatory diseases and related conditions to better understand their clinical manifestations and treatment outcomes. Utilizing a secure online platform, the registry aims to identify associations between various factors such as gender and disease duration, and to compare clinical phenotypes between pediatric and adult patients. Over the next decade, the project seeks to enhance international collaboration and knowledge sharing regarding these rare diseases, ultimately improving patient care and treatment strategies.

Why it matters

Potential benefit: If successful, this registry could lead to improved diagnosis and treatment options for patients with rare autoinflammatory diseases.

How similar studies have gone: Other studies focusing on registries for rare diseases have shown success in improving understanding and treatment, indicating that this approach is promising.

Who can join: the full rules

Show full inclusion / exclusion 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.

Where it's running

  • University Algiers 1
    Algiers, Algeria
    Recruiting
  • Université M'Hamed Bougara de Boumerdas
    Boumerdas, Algeria
    Recruiting
  • Flinders University
    Adelaide, Australia
    Recruiting
  • University of Adelaide
    Adelaide, Australia
    Recruiting
  • Antwerp University Hospital
    Antwerp, Belgium
    Recruiting
  • Hospital das Clinicas da Faculdade de Medicina HCFMUSP
    São Paulo, Brazil
    Recruiting
Show 44 more locations
  • Peking University People's Hospital
    Beijing, China
    Recruiting
  • The First Affiliated Hospital of Chongqing Medical University
    Chongqing, China
    Recruiting
  • Universidad del Rosario - Escuela de Medicina Y Ciencias de La Salud
    Bogotá, Colombia
    Recruiting
  • Mansoura University, Faculty of Medicine
    Al Mansurah, Egypt
    Recruiting
  • Al-Azhar University
    Cairo, Egypt
    Recruiting
  • Cairo University
    Cairo, Egypt
    Recruiting
  • Universitätsklinikum Schleswig-Holstein
    Lübeck, Germany
    Recruiting
  • Evangelismos General Hospital
    Athens, Greece
    Recruiting
  • National and Kapodistrian University of Athens
    Athens, Greece
    Recruiting
  • National and Kapodistrian University of Athens
    Athens, Greece
    Recruiting
  • Prabha Eye Clinic & Research Centre
    Bangalore, India
    Recruiting
  • Postgraduate Institute of Medical Education and Research
    Chandigarh, India
    Recruiting
  • Shariati Hospital - Tehran University of Medical Sciences
    Tehran, Iran
    Recruiting
  • Azienda Ospedaliero-Universitaria Senese
    Siena, Tuscany, Italy
    Recruiting
  • AOUC Policlinico di Bari
    Bari, Italy
    Recruiting
  • University of Bari Medical School
    Bari, Italy
    Recruiting
  • University-Hospital of Bari - UOC Medicina Interna
    Bari, Italy
    Recruiting
  • University-Hospital of Bari - UOC Pediatria
    Bari, Italy
    Recruiting
  • University-Hospital of Bari - UOC Reumatologia
    Bari, Italy
    Recruiting
  • Central Hospital of Bolzano
    Bolzano, Italy
    Recruiting
  • ASST degli Spedali Civili - P.O. Ospedale dei Bambini
    Brescia, Italy
    Recruiting
  • ASST degli Spedali Civili
    Brescia, Italy
    Recruiting
  • Azienda Ospedaliera Universitaria di Cagliari
    Cagliari, Italy
    Recruiting
  • AOU Policlinico Vittorio Emanuele - Dip. Materno-Infantile
    Catania, Italy
    Recruiting
  • ARNAS Garibaldi - Catania
    Catania, Italy
    Recruiting
  • Azienda Ospedaliera di Catanzaro Pugliese Ciaccio
    Catanzaro, Italy
    Recruiting
  • Ospedale SS Annunziata
    Chieti, Italy
    Recruiting
  • Ospedale San Paolo
    Civitavecchia, Italy
    Recruiting
  • Arcispedale Sant'Anna
    Ferrara, Italy
    Recruiting
  • Azienda Ospedaliera Universitaria Careggi - SOD Medicina Interna Interdisciplinare
    Florence, Italy
    Recruiting
  • Azienda Ospedaliero-Universitaria Careggi - SOD Immunologia e Terapie Cellulari
    Florence, Italy
    Recruiting
  • Azienda Ospedaliero-Universitaria Meyer
    Florence, Italy
    Recruiting
  • Azienza Ospedaliero-Universitaria Careggi - SOD Reumatologia
    Florence, Italy
    Recruiting
  • Ospedale San Giovanni di Dio
    Florence, Italy
    Recruiting
  • Sapienza University - Polo Pontino
    Latina, Italy
    Recruiting
  • Ospedale Vito Fazzi
    Lecce, Italy
    Recruiting
  • ASL1 Avezzano, Sulmona, L'Aquila
    L’Aquila, Italy
    Recruiting
  • Università degli Studi di L'Aquila - UOC Medicina Interna e Nefrologia
    L’Aquila, Italy
    Recruiting
  • AOU Policlinico G. Martino
    Messina, Italy
    Recruiting
  • ASST Gaetano Pini/ CTO
    Milan, Italy
    Recruiting
  • Policlinico di Milano
    Milan, Italy
    Recruiting
  • ASST Fatebenefratelli Sacco - UO Medicina Generale
    Milan, Italy
    Recruiting
  • ASST Fatebenefratelli Sacco - UOC Reumatologia
    Milan, Italy
    Recruiting
  • ASST Gaetano Pini/CTO
    Milan, Italy
    Recruiting

+62 more sites. See ClinicalTrials.gov for the full list.

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.