AutoInflammatory Disease Alliance Registry (AIDA) (AIDA)

July 7, 2025 updated by: Luca Cantarini, University of Siena

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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).

Study Type

Observational

Enrollment (Estimated)

3500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Algeria
      • Algiers, Algeria
        • Recruiting
        • University Algiers 1
        • Contact:
          • Ghalia Khellaf
      • Boumerdas, Algeria
        • Recruiting
        • Université M'Hamed Bougara de Boumerdas
        • Contact:
          • Djouher Ait-Idir
  • Australia
      • Adelaide, Australia
        • Recruiting
        • Flinders University
        • Contact:
          • Syed Ali
      • Adelaide, Australia
        • Recruiting
        • University of Adelaide
        • Contact:
          • Pravin Hissaria
  • Belgium
      • Antwerp, Belgium
        • Recruiting
        • Antwerp University Hospital
        • Contact:
          • Benson Ogunjimi
  • Brazil
      • São Paulo, Brazil
        • Recruiting
        • Hospital das Clinicas da Faculdade de Medicina HCFMUSP
        • Contact:
          • Henrique A Mayrink Giardini
  • China
      • Beijing, China
        • Recruiting
        • Peking University People's Hospital
        • Contact:
          • Haihong Yao
      • Chongqing, China
        • Recruiting
        • The First Affiliated Hospital of Chongqing Medical University
        • Contact:
          • Peizeng Yang
  • Colombia
      • Bogotá, Colombia
        • Recruiting
        • Universidad del Rosario - Escuela de Medicina Y Ciencias de La Salud
        • Contact:
          • Alejandra De-la-Torre
  • Egypt
      • Cairo, Egypt
        • Recruiting
        • Cairo University
        • Contact:
          • Gaafar Ragab
      • Cairo, Egypt
        • Recruiting
        • Al-Azhar University
        • Contact:
          • Abdelhfeez Moshrif
      • Mansoura, Egypt
        • Recruiting
        • Mansoura University, Faculty of Medicine
        • Contact:
          • Samar Tharwat
  • Germany
      • Lübeck, Germany
        • Recruiting
        • Universitätsklinikum Schleswig-Holstein
        • Contact:
          • Andreas Recke
  • Greece
      • Athens, Greece
        • Recruiting
        • Evangelismos General Hospital
        • Contact:
          • Anastasios Karamanakos
      • Athens, Greece
        • Recruiting
        • National and Kapodistrian University of Athens
        • Contact:
          • Lampros Fotis
  • India
      • Bangalore, India
        • Recruiting
        • Prabha Eye Clinic & Research Centre
        • Contact:
          • Kalpana Babu
      • Chandigarh, India
        • Recruiting
        • Postgraduate Institute of Medical Education and Research
        • Contact:
          • Vishali Gupta
  • Iran, Islamic Republic of
      • Tehran, Iran, Islamic Republic of
        • Recruiting
        • Shariati Hospital - Tehran University of Medical Sciences
        • Contact:
          • Farhad Shahram
  • Italy
      • Bari, Italy
        • Recruiting
        • AOUC Policlinico di Bari
        • Contact:
          • Silvana Guerriero
      • Bari, Italy
        • Recruiting
        • University-Hospital of Bari - UOC Pediatria
        • Contact:
          • Francesco La Torre
      • Bari, Italy
        • Recruiting
        • University-Hospital of Bari - UOC Reumatologia
        • Contact:
          • Giuseppe Lopalco
      • Bari, Italy
        • Recruiting
        • University of Bari Medical School
        • Contact:
          • Marcella Prete
      • Bari, Italy
        • Recruiting
        • University-Hospital of Bari - UOC Medicina Interna
        • Contact:
          • Piero Portincasa
      • Bolzano, Italy
        • Recruiting
        • Central Hospital of Bolzano
        • Contact:
          • Armin Maier
      • Brescia, Italy
        • Recruiting
        • ASST degli Spedali Civili
        • Contact:
          • Micol Frassi
      • Brescia, Italy
        • Recruiting
        • ASST degli Spedali Civili - P.O. Ospedale dei Bambini
        • Contact:
          • Marco Cattalini
      • Cagliari, Italy
        • Recruiting
        • Azienda Ospedaliera Universitaria di Cagliari
        • Contact:
          • Alberto Cauli
      • Catania, Italy
        • Recruiting
        • AOU Policlinico Vittorio Emanuele - Dip. Materno-Infantile
        • Contact:
          • Patrizia Barone
      • Catania, Italy
        • Recruiting
        • ARNAS Garibaldi - Catania
        • Contact:
          • Alberto Lo Gullo
      • Catanzaro, Italy
        • Recruiting
        • Azienda Ospedaliera di Catanzaro Pugliese Ciaccio
        • Contact:
          • Romina Gallizzi
      • Chieti, Italy
        • Recruiting
        • Ospedale SS Annunziata
        • Contact:
          • Luciana Breda
      • Civitavecchia, Italy
        • Recruiting
        • Ospedale San Paolo
        • Contact:
          • Alessandro Conforti
      • Ferrara, Italy
        • Recruiting
        • Arcispedale Sant'Anna
        • Contact:
          • Marcello Govoni
      • Firenze, Italy
        • Recruiting
        • Azienda Ospedaliero-Universitaria Meyer
        • Contact:
          • Gabriele Simonini
      • Firenze, Italy
        • Recruiting
        • Azienda Ospedaliera Universitaria Careggi - SOD Medicina Interna Interdisciplinare
        • Contact:
          • To be Assigned
      • Firenze, Italy
        • Recruiting
        • Azienda Ospedaliero-Universitaria Careggi - SOD Immunologia e Terapie Cellulari
        • Contact:
          • Paola Parronchi
      • Firenze, Italy
        • Recruiting
        • Azienza Ospedaliero-Universitaria Careggi - SOD Reumatologia
        • Contact:
          • Serena Guiducci
      • Firenze, Italy
        • Recruiting
        • Ospedale San Giovanni di Dio
        • Contact:
          • Francesca Li Gobbi
      • L'Aquila, Italy
        • Recruiting
        • ASL1 Avezzano, Sulmona, L'Aquila
        • Contact:
          • Piero Ruscitti
      • L'Aquila, Italy
        • Recruiting
        • Università degli Studi di L'Aquila - UOC Medicina Interna e Nefrologia
        • Contact:
          • Francesco Carubbi
      • Latina, Italy
        • Recruiting
        • Sapienza University - Polo Pontino
        • Contact:
          • Emanuela Del Giudice
      • Lecce, Italy
        • Recruiting
        • Ospedale Vito Fazzi
        • Contact:
          • Adele Civino
      • Messina, Italy
        • Recruiting
        • AOU Policlinico G. Martino
        • Contact:
          • Giovanni Conti
      • Milan, Italy
        • Recruiting
        • ASST Gaetano Pini/ CTO
        • Contact:
          • Stefania Costi
      • Milan, Italy
        • Recruiting
        • Policlinico di Milano
        • Contact:
          • Francesca Minoia
      • Milano, Italy
        • Recruiting
        • ASST Fatebenefratelli Sacco - UO Medicina Generale
        • Contact:
          • Antonio Gidaro
      • Milano, Italy
        • Recruiting
        • IRCCS Ospedale San Raffaele
        • Contact:
          • Lorenzo Dagna
      • Milano, Italy
        • Recruiting
        • ASST Fatebenefratelli Sacco - UOC Reumatologia
        • Contact:
          • Piercarlo Sarzi Puttini
      • Milano, Italy
        • Recruiting
        • ASST Gaetano Pini/CTO
        • Contact:
          • Cecilia Chighizola
      • Milano, Italy
        • Recruiting
        • Ospedale Fatebenefratelli e Oftalmico
        • Contact:
          • Angela Mauro
      • Napoli, Italy
        • Recruiting
        • AOU Luigi Vanvitelli - UO Reumatologia
        • Contact:
          • Francesco Ciccia
      • Napoli, Italy
        • Recruiting
        • AORN Cardarelli
        • Contact:
          • Maria Bova
      • Napoli, Italy
        • Recruiting
        • AOU Federico II
        • Contact:
          • Mariolina Alessio
      • Napoli, Italy
        • Recruiting
        • AOU Luigi Vanvitelli - UOC Pediatria 2
        • Contact:
          • Alma Nunzia Olivieri
      • Padova, Italy
        • Recruiting
        • Azienda Ospedaliera Universitaria Di Padova
        • Contact:
          • Paolo Sfriso
      • Palermo, Italy
        • Recruiting
        • ARNAS Ospedale Civico di Cristina Benfratelli
        • Contact:
          • Maria Cristina Maggio
      • Palermo, Italy
        • Recruiting
        • Azienda Ospedaliera Ospedali Riuniti Villa Sofia-Cervello
        • Contact:
          • Emma Aragona
      • Palermo, Italy
        • Recruiting
        • ARNAS Civico Di Cristina Benfratelli
        • Contact:
          • Annarita Giardina
      • Palermo, Italy
        • Recruiting
        • Universita degli Studi di Palermo
        • Contact:
          • Giuliana Guggino
      • Pavia, Italy
        • Recruiting
        • Fondazione IRRCS San Matteo - SC Reumatologia
        • Contact:
          • Serena Bugatti
      • Perugia, Italy
        • Recruiting
        • Azienda Ospedaliera di Perugia
        • Contact:
          • Elena Bartoloni Bocci
      • Pisa, Italy
        • Recruiting
        • Azienda Ospedaliero Universitaria Pisana
        • Contact:
          • Rosaria Talarico
      • Pisa, Italy
        • Recruiting
        • University of Pisa
        • Contact:
          • Valentina Pucino
      • Roma, Italy
        • Recruiting
        • Azienda Ospedaliera San Camillo Forlanini
        • Contact:
          • Gian Domenico Sebastiani
      • Roma, Italy
        • Recruiting
        • IRCCS Fondazione PU Agostino Gemelli - UOC Medicina Interna Columbus
        • Contact:
          • Elena Verrecchia
      • Roma, Italy
        • Recruiting
        • IRCCS Fondazione PU Agostino Gemelli - UOC Pediatria
        • Contact:
          • Donato Rigante
      • Roma, Italy
        • Recruiting
        • Ospedale Pediatrico Bambino Gesu
        • Contact:
          • Antonella Insalaco
      • Roma, Italy
        • Recruiting
        • Ospedale Universitario Campus Bio-Medico
        • Contact:
          • Roberto Giacomelli
      • Roma, Italy
        • Recruiting
        • AOU Policlinico Umberto I
        • Contact:
          • Fabrizio Conti
      • Roma, Italy
        • Recruiting
        • Sapienza University - Polo Pontino
        • Contact:
          • Maria Pia Paroli
      • Roma, Italy
        • Recruiting
        • Universita Di Roma Tor Vergata
        • Contact:
          • Maria Sole Chimenti
      • Salerno, Italy
        • Recruiting
        • Azienda Ospedaliera Universitaria di Salerno
        • Contact:
          • Paolo Moscato
      • Tempio Pausania, Italy
        • Recruiting
        • ATS Sardegna
        • Contact:
          • Daniela Marotto
      • Torino, Italy
        • Recruiting
        • AO Ordine Mauriziano
        • Contact:
          • Annamaria Iagnocco
      • Vercelli, Italy
        • Recruiting
        • A.S.L. Vercelli - Ospedale S. Andrea
        • Contact:
          • Rosetta Vitetta
      • Verona, Italy
        • Recruiting
        • Azienda Ospedaliera Universitaria Integrata
        • Contact:
          • Ombretta Viapiana
    • Tuscany
      • Siena, Tuscany, Italy, 53100
        • Recruiting
        • Azienda Ospedaliero-Universitaria Senese
        • Contact:
          • Luca Cantarini, MD,PhD
        • Sub-Investigator:
          • Antonio Vitale, MD,PhD
        • Sub-Investigator:
          • Claudia Fabiani, MD,PhD
        • Sub-Investigator:
          • Stefano Gentileschi, MD
        • Sub-Investigator:
          • Maria Tarsia, MD
        • Sub-Investigator:
          • Valeria Caggiano, MD
        • Sub-Investigator:
          • Bruno Frediani, MD
        • Sub-Investigator:
          • Gian Marco Tosi, MD,PhD
        • Sub-Investigator:
          • Salvatore Grosso, MD,PhD
        • Principal Investigator:
          • Luca Cantarini, MD,PhD
        • Sub-Investigator:
          • Jurgen Sota, MD,PhD
        • Sub-Investigator:
          • Carla Gaggiano, MD,PhD
        • Sub-Investigator:
          • Jessica Sbalchiero, MD
        • Sub-Investigator:
          • Laura Calabrese, MD,PhD
  • Libyan Arab Jamahiriya
      • Tripoli, Libyan Arab Jamahiriya
        • Recruiting
        • Tripoli Children Hospital
        • Contact:
          • Awatif Abushhaiwia
  • Martinique
      • Fort-de-France, Martinique
        • Recruiting
        • University Hospital of Martinique
        • Contact:
          • Benoit Suzon
  • Mexico
      • Mexico City, Mexico
        • Recruiting
        • Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
        • Contact:
          • Andrea Hinojosa-Azaola
      • Mexico City, Mexico
        • Recruiting
        • Asociación Para Evitar la Ceguera en México
        • Contact:
          • Luz Elena Concha Del Rio
  • Poland
      • Warsaw, Poland
        • Recruiting
        • Central Clinical Hospital of the Ministry of National Defense - Military Institute of Medicine
        • Contact:
          • Ewa Wiesik-Szewczyk
      • Łódź, Poland
        • Recruiting
        • Medical University of Lodz
        • Contact:
          • Joanna Makowska
  • Romania
      • Bucharest, Romania
        • Recruiting
        • Sf. Maria Hospital - University of Medicine and Pharmacy "Carol Davila"
        • Contact:
          • Daniela Opris-Belinski
  • Saudi Arabia
      • Jazan, Saudi Arabia
        • Recruiting
        • Jazan University
        • Contact:
          • Zahraa Moafa
      • Riyadh, Saudi Arabia
        • Recruiting
        • King Faisal Specialist Hospital and Research Center
        • Contact:
          • Sulaiman M Al-Mayouf
      • Riyadh, Saudi Arabia
        • Recruiting
        • King Saud University
        • Contact:
          • Ibrahim AlMaghlouth
  • Spain
      • Barakaldo, Spain
        • Recruiting
        • Hospital Universitario Cruces
        • Contact:
          • Guillermo Ruiz-Irastorza
      • Barakaldo, Spain
        • Recruiting
        • Hospital Universitario Cruces - Instituto de investigación sanitaria Biocruces
        • Contact:
          • Alex Fonollosa-Calduch
      • Barcelona, Spain
        • Recruiting
        • Hospital Clinic of Barcelona
        • Contact:
          • José José Hernández-Rodríguez
      • Madrid, Spain
        • Recruiting
        • Hospital Fundación Jiménez Díaz
        • Contact:
          • Fernando Tornero Romero
      • Madrid, Spain
        • Recruiting
        • Hospital Ramon y Cajal
        • Contact:
          • Andrés González-García
      • Madrid, Spain
        • Recruiting
        • Hospital Universitario Fundación Jiménez Díaz/Hospital Universitario Rey Juan Carlos
        • Contact:
          • Inés Hernanz Rodriguez
      • Santander, Spain
        • Recruiting
        • Hospital Universitario Marques de Valdecilla
        • Contact:
          • Natalia Palmou-Fontana
      • Valencia, Spain
        • Recruiting
        • Hospital Universitari Doctor Peset
        • Contact:
          • Adrián Mayo-Juanatey
  • Tunisia
      • Sousse, Tunisia
        • Recruiting
        • Farhat Hached Hospital
        • Contact:
          • Maissa Thabet
  • Turkey
      • Adana, Turkey
        • Recruiting
        • Çukurova University
        • Contact:
          • Seher Şener
      • Ankara, Turkey
        • Recruiting
        • Gazi University
        • Contact:
          • Abdurrahman Tufan
      • Ankara, Turkey
        • Recruiting
        • Ankara Yıldırım Beyazıt University
        • Contact:
          • Şükran Erten
      • Ankara, Turkey
        • Recruiting
        • Hacettepe University Faculty of Medicine
        • Contact:
          • Ezgi D Batu
      • Istanbul, Turkey
        • Recruiting
        • Cerrahpasa Medical School Istanbul University
        • Contact:
          • Gulen Hatemi
      • Istanbul, Turkey
        • Recruiting
        • Başakşehir Çam and Sakura City Hospital
        • Contact:
          • Cemal Bes
      • Istanbul, Turkey
        • Recruiting
        • Marmara University, Research And Education Hospital
        • Contact:
          • Haner Direskeneli
      • Manisa, Turkey
        • Recruiting
        • Manisa Celal Bayar University
        • Contact:
          • Soysal Gündüz Özgül
      • Sakarya, Turkey
        • Recruiting
        • Sakarya University
        • Contact:
          • Emre Bilgin
      • Sivas, Turkey
        • Recruiting
        • Sivas Cumhuriyet University
        • Contact:
          • Ali Şahin
      • İzmir, Turkey
        • Recruiting
        • Dokuz Eylul University School of Medicine
        • Contact:
          • Fatos Onen
  • Ukraine
      • Ternopil, Ukraine
        • Recruiting
        • I. Horbachevsky Ternopil National Medical University - Ternopil Regional Children's Hospital
        • Contact:
          • Oksana Boyarchuk

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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/)

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Other

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patients affected by autoinflammatory diseases
Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change of the number of enrolled subjects
Time Frame: 0-36-60-120 months
This is an observational registry. The primary outcome is the increase of the number of subjects enrolled within each nosologic group.
0-36-60-120 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in the disease activity score
Time Frame: 0-36-60-120 months
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.
0-36-60-120 months
Change in the % of patients with new organ involvement
Time Frame: 0-36-60-120 months
0-36-60-120 months
Incidence of death or adverse events
Time Frame: 0-36-60-120 months
0-36-60-120 months
Change in the inflammatory markers values (ESR)
Time Frame: 0-36-60-120 months
ESR measured in mm/h
0-36-60-120 months
Change in the inflammatory markers values (CRP and SAA)
Time Frame: 0-36-60-120
CRP and SAA measured in mg/dl
0-36-60-120
Change in visual acuity expressed as Best Corrected Visual Acuity (BCVA)
Time Frame: 0-36-60-120 months
0-36-60-120 months
Change in the overall function score
Time Frame: 0-36-60-120 months
Change in the overall function score according to HAQ (adults) or CHAQ (children)
0-36-60-120 months
Change in the overall damage score
Time Frame: 0-36-60-120 months
Change in the overall damage score specific for the nosologic entity (ADDI score, BODI score, JADI score)
0-36-60-120 months
Change in articular pain measured as Visual Analogue Scale for articular Pain (VAS Pain)
Time Frame: 0-36-60-120 months
0-36-60-120 months
Changes in height and weight percentile values for age and sex
Time Frame: 0-36-60-120 months
0-36-60-120 months
Change in the % of patients experiencing fatigue
Time Frame: 0-36-60-120 months
0-36-60-120 months
Change in the % of patients with fertility reduction or pregnancy complications
Time Frame: 0-36-60-120
0-36-60-120
Change in the socioeconomic indicators
Time Frame: 0-36-60-120 months
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
0-36-60-120 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Siena

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 6, 2020

Primary Completion (Estimated)

August 6, 2026

Study Completion (Estimated)

August 6, 2030

Study Registration Dates

First Submitted

December 18, 2021

First Submitted That Met QC Criteria

January 6, 2022

First Posted (Actual)

January 21, 2022

Study Record Updates

Last Update Posted (Actual)

July 10, 2025

Last Update Submitted That Met QC Criteria

July 7, 2025

Last Verified

July 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AIDA V.04 19.05.2021

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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