Development and Implementation of the AIDA International Registry for Patients With Still's Disease

Antonio Vitale¹, Francesca Della Casa², Giuseppe Lopalco³, Rosa Maria Pereira⁴, Piero Ruscitti⁵, Roberto Giacomelli⁶, Gaafar Ragab^{7

8}, Francesco La Torre⁹, Elena Bartoloni¹⁰, Emanuela Del Giudice¹¹, Claudia Lomater¹², Giacomo Emmi¹³, Marcello Govoni¹⁴, Maria Cristina Maggio¹⁵, Armin Maier¹⁶, Joanna Makowska¹⁷, Benson Ogunjimi^{18

19

20

21}, Petros P Sfikakis²², Paolo Sfriso²³, Carla Gaggiano¹, Florenzo Iannone³, Marília A Dagostin⁴, Ilenia Di Cola⁵, Luca Navarini⁶, Ayman Abdelmonem Ahmed Mahmoud⁷, Fabio Cardinale⁹, Ilenia Riccucci¹⁰, Maria Pia Paroli²⁴, Elena Maria Marucco¹², Irene Mattioli¹³, Jurgen Sota¹, Anna Abbruzzese³, Isabele P B Antonelli⁴, Paola Cipriani⁵, Abdurrahman Tufan²⁵, Claudia Fabiani²⁶, Mustafa Mahmoud Ramadan⁷, Marco Cattalini²⁷, Riza Can Kardas²⁵, Gian Domenico Sebastiani²⁸, Henrique A Mayrink Giardini⁴, José Hernández-Rodríguez²⁹, Violetta Mastrorilli⁹, Ewa Więsik-Szewczyk³⁰, Micol Frassi³¹, Valeria Caggiano¹, Salvatore Telesca¹, Heitor F Giordano⁴, Emmanuele Guadalupi¹, Teresa Giani³², Alessandra Renieri^{33

34

35}, Sergio Colella³, Giulia Cataldi⁵, Martina Gentile⁵, Alessandra Fabbiani^{33

34

35}, Ibrahim A Al-Maghlouth³⁶, Bruno Frediani³⁷, Alberto Balistreri³⁸, Donato Rigante^{39

40}, Luca Cantarini¹

Affiliations

¹ Department of Medical Sciences, Surgery and Neurosciences, Research Center of Systemic Autoinflammatory Diseases and Behçet's Disease Clinic, University of Siena, Siena, Italy.
² Department of Translational Medical Sciences, Section of Clinical Immunology, University of Naples Federico II, Naples, Italy.
³ Rheumatology Unit, Department of Emergency and Organ Transplantation, University of Bari, Bari, Italy.
⁴ Rheumatology Division, Faculdade de Medicina, Hospital das Clínicas, Universidade de São Paulo, São Paulo, Brazil.
⁵ Rheumatology Unit, Department of Biotechnological and Applied Clinical Sciences, University of L'Aquila, L'Aquila, Italy.
⁶ Rheumatology, Immunology and Clinical Medicine Unit, Department of Medicine, Università Campus Bio-Medico di Roma, Rome, Italy.
⁷ Internal Medicine Department, Rheumatology and Clinical Immunology Unit, Faculty of Medicine, Cairo University, Giza, Egypt.
⁸ Internal Medicine Department, Clinical Immunology and Rheumatology Unit, Newgiza University (NGU), Giza, Egypt.
⁹ Department of Pediatrics, Pediatric Rheumatology Center, Giovanni XXIII Pediatric Hospital, University of Bari, Bari, Italy.
¹⁰ Rheumatology Unit, Department of Medicine and Surgery, University of Perugia, Perugia, Italy.
¹¹ Department of Maternal Infantile and Urological Sciences, Sapienza University of Rome, Rome, Italy.
¹² Azienda Ospedaliera (AO) Mauriziano, Universita degli Studi di Torino, Academic Rheumatology Centre, Turin, Italy.
¹³ Department of Experimental and Clinical Medicine, University of Florence, Florence, Italy.
¹⁴ Rheumatology Unit, Azienda Ospedaliero-Universitaria S. Anna - Ferrara, Department of Medical Sciences, University of Ferrara, Ferrara, Italy.
¹⁵ University Department PROMISE "G. D'Alessandro", University of Palermo, Palermo, Italy.
¹⁶ Rheumatology Unit, Department of Medicine, Central Hospital of Bolzano, Bolzano, Italy.
¹⁷ Department of Rheumatology, Medical University of Lodz, Łódź, Poland.
¹⁸ Antwerp Unit for Data Analysis and Computation in Immunology and Sequencing, University of Antwerp, Antwerp, Belgium.
¹⁹ Antwerp Center for Translational Immunology and Virology, Vaccine and Infectious Disease Institute, University of Antwerp, Antwerp, Belgium.
²⁰ Department of Paediatrics, Antwerp University Hospital, Antwerp, Belgium.
²¹ Center for Health Economics Research and Modeling Infectious Diseases, Vaccine and Infectious Disease Institute, University of Antwerp, Antwerp, Belgium.
²² Joint Academic Rheumatology Program, First Department of Propedeutic Internal Medicine, School of Medicine, National and Kapodistrian University of Athens, Athens, Greece.
²³ Rheumatology Unit, Department of Medicine, University of Padua, Padua, Italy.
²⁴ Uveitis Unit, Department of Sense Organs, Eye Clinic, Sapienza University of Rome, Rome, Italy.
²⁵ Division of Rheumatology, Department of Internal Medicine, Gazi University Faculty of Medicine, Ankara, Turkey.
²⁶ Ophthalmology Unit, Department of Medicine, Surgery and Neurosciences, University of Siena, Siena, Italy.
²⁷ Pediatric Clinic, University of Brescia and Spedali Civili di Brescia, Brescia, Italy.
²⁸ U.O.C. Reumatologia, Ospedale San Camillo-Forlanini, Rome, Italy.
²⁹ Vasculitis Research Unit and Autoinflammatory Diseases Clinical Unit, Department of Autoimmune Diseases, Hospital Clinic of Barcelona, Institut d'Investigacions Biomédiques August Pi i Sunyer (IDIBAPS), University of Barcelona, Barcelona, Spain.
³⁰ Department of Internal Medicine, Pulmonology, Allergy and Clinical Immunology, Central Clinical Hospital of the Ministry of National Defence, Military Institute of Medicine, Warsaw, Poland.
³¹ Rheumatology and Clinical Immunology, Spedali Civili, Department of Clinical and Experimental Sciences, University of Brescia, Brescia, Italy.
³² Azienda Socio-Sanitaria Territoriale (ASST) Gaetano Pini-Centro Traumatologico Ortopedico (CTO), Department of Clinical Sciences and Community Health, Research Center for Adult and Pediatric Rheumatic Diseases, University of Milan, Milan, Italy.
³³ Medical Genetics, Department of Medical Biotechnologies, University of Siena, Siena, Italy.
³⁴ Department of Medical Biotechnologies, Med Biotech Hub and Competence Center, University of Siena, Siena, Italy.
³⁵ Genetica Medica, Azienda Ospedaliero-Universitaria Senese, Siena, Italy.
³⁶ Department of Family and Community Medicine, College of Medicine, King Saud University, Riyadh, Saudi Arabia.
³⁷ Unit of Rheumatology, Azienda Ospedaliero-Universitaria Senese, Siena, Italy.
³⁸ Bioengineering and Biomedical Data Science Lab, Department of Medical Biotechnologies, University of Siena, Siena, Italy.
³⁹ Department of Life Sciences and Public Health, Fondazione Policlinico Universitario A. Gemelli IRCCS, Rome, Italy.
⁴⁰ Rare Diseases and Periodic Fevers Research Centre, Università Cattolica Sacro Cuore, Rome, Italy.

PMID: 35463015
PMCID: PMC9021753
DOI: 10.3389/fmed.2022.878797

Development and Implementation of the AIDA International Registry for Patients With Still's Disease

Antonio Vitale et al. Front Med (Lausanne). 2022.

. 2022 Apr 7:9:878797.

doi: 10.3389/fmed.2022.878797. eCollection 2022.

Authors

Affiliations

¹ Department of Medical Sciences, Surgery and Neurosciences, Research Center of Systemic Autoinflammatory Diseases and Behçet's Disease Clinic, University of Siena, Siena, Italy.
² Department of Translational Medical Sciences, Section of Clinical Immunology, University of Naples Federico II, Naples, Italy.
³ Rheumatology Unit, Department of Emergency and Organ Transplantation, University of Bari, Bari, Italy.
⁴ Rheumatology Division, Faculdade de Medicina, Hospital das Clínicas, Universidade de São Paulo, São Paulo, Brazil.
⁵ Rheumatology Unit, Department of Biotechnological and Applied Clinical Sciences, University of L'Aquila, L'Aquila, Italy.
⁶ Rheumatology, Immunology and Clinical Medicine Unit, Department of Medicine, Università Campus Bio-Medico di Roma, Rome, Italy.
⁷ Internal Medicine Department, Rheumatology and Clinical Immunology Unit, Faculty of Medicine, Cairo University, Giza, Egypt.
⁸ Internal Medicine Department, Clinical Immunology and Rheumatology Unit, Newgiza University (NGU), Giza, Egypt.
⁹ Department of Pediatrics, Pediatric Rheumatology Center, Giovanni XXIII Pediatric Hospital, University of Bari, Bari, Italy.
¹⁰ Rheumatology Unit, Department of Medicine and Surgery, University of Perugia, Perugia, Italy.
¹¹ Department of Maternal Infantile and Urological Sciences, Sapienza University of Rome, Rome, Italy.
¹² Azienda Ospedaliera (AO) Mauriziano, Universita degli Studi di Torino, Academic Rheumatology Centre, Turin, Italy.
¹³ Department of Experimental and Clinical Medicine, University of Florence, Florence, Italy.
¹⁴ Rheumatology Unit, Azienda Ospedaliero-Universitaria S. Anna - Ferrara, Department of Medical Sciences, University of Ferrara, Ferrara, Italy.
¹⁵ University Department PROMISE "G. D'Alessandro", University of Palermo, Palermo, Italy.
¹⁶ Rheumatology Unit, Department of Medicine, Central Hospital of Bolzano, Bolzano, Italy.
¹⁷ Department of Rheumatology, Medical University of Lodz, Łódź, Poland.
¹⁸ Antwerp Unit for Data Analysis and Computation in Immunology and Sequencing, University of Antwerp, Antwerp, Belgium.
¹⁹ Antwerp Center for Translational Immunology and Virology, Vaccine and Infectious Disease Institute, University of Antwerp, Antwerp, Belgium.
²⁰ Department of Paediatrics, Antwerp University Hospital, Antwerp, Belgium.
²¹ Center for Health Economics Research and Modeling Infectious Diseases, Vaccine and Infectious Disease Institute, University of Antwerp, Antwerp, Belgium.
²² Joint Academic Rheumatology Program, First Department of Propedeutic Internal Medicine, School of Medicine, National and Kapodistrian University of Athens, Athens, Greece.
²³ Rheumatology Unit, Department of Medicine, University of Padua, Padua, Italy.
²⁴ Uveitis Unit, Department of Sense Organs, Eye Clinic, Sapienza University of Rome, Rome, Italy.
²⁵ Division of Rheumatology, Department of Internal Medicine, Gazi University Faculty of Medicine, Ankara, Turkey.
²⁶ Ophthalmology Unit, Department of Medicine, Surgery and Neurosciences, University of Siena, Siena, Italy.
²⁷ Pediatric Clinic, University of Brescia and Spedali Civili di Brescia, Brescia, Italy.
²⁸ U.O.C. Reumatologia, Ospedale San Camillo-Forlanini, Rome, Italy.
²⁹ Vasculitis Research Unit and Autoinflammatory Diseases Clinical Unit, Department of Autoimmune Diseases, Hospital Clinic of Barcelona, Institut d'Investigacions Biomédiques August Pi i Sunyer (IDIBAPS), University of Barcelona, Barcelona, Spain.
³⁰ Department of Internal Medicine, Pulmonology, Allergy and Clinical Immunology, Central Clinical Hospital of the Ministry of National Defence, Military Institute of Medicine, Warsaw, Poland.
³¹ Rheumatology and Clinical Immunology, Spedali Civili, Department of Clinical and Experimental Sciences, University of Brescia, Brescia, Italy.
³² Azienda Socio-Sanitaria Territoriale (ASST) Gaetano Pini-Centro Traumatologico Ortopedico (CTO), Department of Clinical Sciences and Community Health, Research Center for Adult and Pediatric Rheumatic Diseases, University of Milan, Milan, Italy.
³³ Medical Genetics, Department of Medical Biotechnologies, University of Siena, Siena, Italy.
³⁴ Department of Medical Biotechnologies, Med Biotech Hub and Competence Center, University of Siena, Siena, Italy.
³⁵ Genetica Medica, Azienda Ospedaliero-Universitaria Senese, Siena, Italy.
³⁶ Department of Family and Community Medicine, College of Medicine, King Saud University, Riyadh, Saudi Arabia.
³⁷ Unit of Rheumatology, Azienda Ospedaliero-Universitaria Senese, Siena, Italy.
³⁸ Bioengineering and Biomedical Data Science Lab, Department of Medical Biotechnologies, University of Siena, Siena, Italy.
³⁹ Department of Life Sciences and Public Health, Fondazione Policlinico Universitario A. Gemelli IRCCS, Rome, Italy.
⁴⁰ Rare Diseases and Periodic Fevers Research Centre, Università Cattolica Sacro Cuore, Rome, Italy.

PMID: 35463015
PMCID: PMC9021753
DOI: 10.3389/fmed.2022.878797

Abstract

Objective: Aim of this paper is to present the design, construction, and modalities of dissemination of the AutoInflammatory Disease Alliance (AIDA) International Registry for patients with systemic juvenile idiopathic arthritis (sJIA) and adult-onset Still's disease (AOSD), which are the pediatric and adult forms of the same autoinflammatory disorder.

Methods: This Registry is a clinical, physician-driven, population- and electronic-based instrument implemented for the retrospective and prospective collection of real-world data. The collection of data is based on the Research Electronic Data Capture (REDCap) tool and is intended to obtain evidence drawn from routine patients' management. The collection of standardized data is thought to bring knowledge about real-life clinical research and potentially communicate with other existing and future Registries dedicated to Still's disease. Moreover, it has been conceived to be flexible enough to easily change according to future scientific acquisitions.

Results: Starting from June 30th to February 7th, 2022, 110 Centers from 23 Countries in 4 continents have been involved. Fifty-four of these have already obtained the approval from their local Ethics Committees. Currently, the platform counts 290 users (111 Principal Investigators, 175 Site Investigators, 2 Lead Investigators, and 2 data managers). The Registry collects baseline and follow-up data using 4449 fields organized into 14 instruments, including patient's demographics, history, clinical manifestations and symptoms, trigger/risk factors, therapies and healthcare access.

Conclusions: This international Registry for patients with Still's disease will allow a robust clinical research through collection of standardized data, international consultation, dissemination of knowledge, and implementation of observational studies based on wide cohorts of patients followed-up for very long periods. Solid evidence drawn from "real-life" data represents the ultimate goal of this Registry, which has been implemented to significantly improve the overall management of patients with Still's disease. NCT05200715 available at https://clinicaltrials.gov/.

Keywords: autoinflammatory diseases; personalized medicine; precision medicine; rare diseases; research; treatment.

Copyright © 2022 Vitale, Della Casa, Lopalco, Pereira, Ruscitti, Giacomelli, Ragab, La Torre, Bartoloni, Del Giudice, Lomater, Emmi, Govoni, Maggio, Maier, Makowska, Ogunjimi, Sfikakis, Sfriso, Gaggiano, Iannone, Dagostin, Di Cola, Navarini, Ahmed Mahmoud, Cardinale, Riccucci, Paroli, Marucco, Mattioli, Sota, Abbruzzese, Antonelli, Cipriani, Tufan, Fabiani, Ramadan, Cattalini, Kardas, Sebastiani, Giardini, Hernández-Rodríguez, Mastrorilli, Więsik-Szewczyk, Frassi, Caggiano, Telesca, Giordano, Guadalupi, Giani, Renieri, Colella, Cataldi, Gentile, Fabbiani, Al-Maghlouth, Frediani, Balistreri, Rigante and Cantarini.

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Conflict of interest statement

The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest.

Figures

**Figure 1**
Worldwide distribution of the AIDA network in February 2022.

See this image and copyright information in PMC

References

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Development and Implementation of the AIDA International Registry for Patients With Still's Disease

Affiliations

Development and Implementation of the AIDA International Registry for Patients With Still's Disease

Authors

Affiliations

Abstract

Conflict of interest statement

Figures

References

Associated data

LinkOut - more resources

Full Text Sources

Medical