Observational Study of Pediatric Rheumatic Diseases: The CARRA Registry

October 13, 2025 updated by: Duke University

Continuation of the CARRA Registry as described in the protocol will support data collection on patients with pediatric-onset rheumatic diseases. The CARRA Registry will form the basis for future CARRA studies. In particular, this observational registry will be used to answer pressing questions about therapeutics used to treat pediatric rheumatic diseases, including safety questions.

Study Overview

Status

Recruiting

Conditions

Rheumatic Joint Disease

Detailed Description

The original Childhood Arthritis & Rheumatology Research Alliance (CARRA) Registry (Protocol Number: CRNT_REGST01) was first established in 2010 to advance alliance infrastructure, facilitate expanded clinical and translational pediatric research, and transform the culture of pediatric rheumatology toward universal participation in research. This original CARRA Registry will be referred to throughout the protocol as the CARRA Legacy Registry. Through the creation of a sophisticated informatics infrastructure, provision of comprehensive site support and the engagement of families, patients, and communities, the CARRA Registry will provide the opportunity for affected children at every CARRA Registry site to participate in high-quality clinical and translational research.

Continuation of the CARRA Registry as described in this protocol will support data collection on patients with pediatric-onset rheumatic diseases. The CARRA Registry will form the basis for future CARRA studies. In particular, this observational registry will be used to answer pressing questions about therapeutics used to treat pediatric rheumatic diseases, including examining safety questions. The Duke Clinical Research Institute (DCRI) is serving as the CARRA Clinical and Data Coordinating Center (CDCC) for the protocol.

Traditional exposure-based post-marketing registries of individual therapeutic agents for juvenile idiopathic arthritis (JIA), systemic lupus erythematosus, and other rheumatic diseases are inadequate for answering important safety questions for many reasons:

Sample sizes are too small to detect uncommon but important events
No unexposed comparators exist to evaluate risk attributable to underlying disease
Duration of follow-up of individual patients is too short to evaluate many potential delayed adverse events (AEs)
Sample sizes are inadequate to assess myriad complex and dynamic concurrent medication regimens common to treatment of rheumatic diseases
Selective patient enrollment limits evaluation of co-morbid conditions and other patient factors

These limitations prevent patients, families, and providers from understanding the true risks and benefits of therapy in order to make appropriate and informed decisions. They also prevent drug manufacturers and regulatory agencies from conducting an informed review of marketed products for these diseases.

A registry based on disease diagnosis rather than specific therapeutic agents overcomes many of the limitations of exposure-based single-agent registries in the assessment of delayed or uncommon safety events. Indeed, data from a consolidated disease-based registry "...could provide the information necessary for individual companies to satisfy post-marketing requirements and commitments and obviate the need for an individual product registry" (letters from the United States (US) Food and Drug Administration (FDA) to CARRA, 21 December 2010 and 9 December 2011). This protocol details the foundation of a registry to meet these objectives.

The CARRA Registry aims to detect and understand the epidemiology of important AEs, including those that are delayed or uncommon. Subjects followed at active CARRA Registry sites are eligible for enrollment, regardless of past or current treatment. Each subject will be followed prospectively for a goal of 10 years duration; the study will continue indefinitely as resources allow and continued need exists. Data will be systematically collected, including important patient factors, therapies, serious adverse events (SAEs), and protocol-defined events of special interest. Selected safety events (e.g., malignancies) will be adjudicated by a panel of experts via a review of medical records. The CARRA Registry, a disease-based prospective observational registry, enables both detection of potential safety signals and hypothesis-driven, rigorous, and adequately-controlled pharmacoepidemiologic studies of important AEs and their associations with therapeutic agents.

In addition to answering questions about the safety of therapeutics, the data collected in the CARRA Registry are anticipated to serve many other valuable uses. Within the confines of observational study design, the effectiveness of therapeutic agents may be examined for short- and long-term clinical and patient-centered outcomes.

The Registry is the data collection platform for Consensus Treatment Plan (CTP) comparative effectiveness research in pediatric rheumatic disease. Patients enrolled in the Registry may also be eligible to be followed as part of a CTP subset. Examples of CTP projects include:

FiRst line Options for Systemic JIA Treatment (FROST). The purpose of FROST was to compare the effectiveness of CARRA systemic JIA (sJIA) treatment strategies (biologic vs. non-biologic) in achieving clinically inactive disease in patients with new-onset sJIA. Additionally, FROST aimed to compare patient/caregiver reported outcomes between treatment strategies. FROST enrolled new-onset, previously untreated sJIA patients who are starting treatment with one of the 4 sJIA CTPs (glucocorticoid (GC) only; Methotrexate + GC; IL-1 inhibitor + GC; IL-6 + GC). Enrollment will occur over 3 years at all CARRA Registry sites. In addition to routine Registry data collection, patients followed as part of the FROST CTP completed additional questionnaires about their disease status and quality of life.

Medication use for pediatric rheumatic diseases is dynamic and not well characterized. The CARRA Registry represents a powerful data source to follow drug use patterns and provides the opportunity to study predictors of medication use. Important outcomes are likely to be influenced by other factors in addition to therapy (e.g., disease severity) and the CARRA Registry is positioned to help answer these types of questions. Patient-reported outcomes (PROs) generated by patients outside the context of clinical encounters may be collected in the Registry to provide a rich, additional dimension of data to better understand rheumatic diseases. Practitioners may review clinical data from their sites as part of a quality improvement approach to better outcomes.

Analyses of CARRA Registry data aim to provide results to guide the therapeutic decisions made by affected children, families, and providers while improving regulatory efficiency and reducing cost. Ultimately, this approach might serve as a model for successful collaboration between research community networks, industry, and public agencies to promote the effective and efficient evaluation of drugs and devices across the regulatory continuum.

Study Type

Observational

Enrollment (Estimated)

20000

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

Name: Mara L Becker, MD, MSCE
Phone Number: (919) 419-5032
Email: mara.becker@duke.edu

Study Contact Backup

Name: Mary Beth Son, MD
Phone Number: (617) 919-6083
Email: marybeth.son@childrens.harvard.edu

Study Locations

Canada
- Alberta
  - Calgary, Alberta, Canada, AB T38 6A8
    - Recruiting
    - University of Calgary - Alberta Children's Hospital
    - Principal Investigator:
      
      Marinka Twilt, MD, PhD
    - Sub-Investigator:
      
      Nicole Johnson, MD
    - Sub-Investigator:
      
      Paivi Miettunen, MD
    - Sub-Investigator:
      
      Heinrike Schmeling, MD, PhD
    - Sub-Investigator:
      
      Rebeka Stevenson, MD
    - Sub-Investigator:
      
      Muhammad Dhalla, MD
    - Sub-Investigator:
      
      Jeanine McColl, MD, MPT
    - Contact:
      
      Daniel Lee
      
      Phone Number: 403-955-5537
      
      Email: daniel.lee4@ucalgary.ca
- Manitoba
  - Winnipeg, Manitoba, Canada, R3E 3P4
    - Recruiting
    - University of Manitoba - Children's Hospital of Manitoba
    - Principal Investigator:
      
      Lily Lim, PhD
    - Contact:
      
      Manzuma Khanam
      
      Phone Number: 204-789-3888
      
      Email: mkhanam@chrim.ca
- Nova Scotia
  - Halifax, Nova Scotia, Canada, NS B3K 6R8
    - Recruiting
    - IWK Health Center
    - Principal Investigator:
      
      Adam Huber, MD
    - Sub-Investigator:
      
      Bianca A Lang, MD
    - Sub-Investigator:
      
      Elizabeth Stringer, MD
    - Sub-Investigator:
      
      Chelsea DeCoste, MD
    - Contact:
      
      Abigail Butler
      
      Phone Number: 902-470-7414
      
      Email: Abbie.Butler@iwk.nshealth.ca
- Ontario
  - Toronto, Ontario, Canada
    - Recruiting
    - The Hospital for Sick Children
    - Contact:
      
      Ingrid Goh
      
      Phone Number: 416-813-6372
      
      Email: ingrid.goh@sickkids.ca
    - Principal Investigator:
      
      Brian Feldman, MD
    - Sub-Investigator:
      
      Linda Hiraki, MD
    - Sub-Investigator:
      
      Ronald Laxer, MDCM
    - Sub-Investigator:
      
      Deborah Levy, MD
    - Sub-Investigator:
      
      Elizaveta Limenis, MD
    - Sub-Investigator:
      
      Oscar Mwizerwa, MD
    - Sub-Investigator:
      
      Alaa Shehab, MD
    - Sub-Investigator:
      
      Lynn Spiegel, MD
    - Sub-Investigator:
      
      Shirley Tse, MD
    - Sub-Investigator:
      
      Ruud Verstegen, MD
    - Sub-Investigator:
      
      Rae Yeung, MD, PhD
    - Sub-Investigator:
      
      Dilan Dissanayake, MD
    - Sub-Investigator:
      
      Andrea Knight, MD
    - Sub-Investigator:
      
      Anwar Alkandari, MD
    - Sub-Investigator:
      
      Rana Alsulami, MD
    - Sub-Investigator:
      
      Edan Itzkovitz, MD
    - Sub-Investigator:
      
      Greta Mastrangelo, MD
    - Sub-Investigator:
      
      Hamada Natour, MD
    - Sub-Investigator:
      
      Rebecca Quilty, MD
    - Sub-Investigator:
      
      Srikarn Tangcheewinsirikul, MD
    - Sub-Investigator:
      
      Yulia Vyzhga, MD
Israel
- - Petah Tikva, Israel, 49202-35
    - Recruiting
    - Schneider Children's Medical Center of Israel
    - Sub-Investigator:
      
      Neta Aviran Dagan, MD
    - Sub-Investigator:
      
      Muhamad Hamda Natur, MD
    - Sub-Investigator:
      
      Kfir Kaidar, MD
    - Sub-Investigator:
      
      Yoel Levinsky, MD
    - Sub-Investigator:
      
      Ruth Livny, MD
    - Sub-Investigator:
      
      Rotem Tal, MD
    - Sub-Investigator:
      
      Adi PappoToledano, MD
    - Contact:
      
      Adi Paz
      
      Email: adipaz@clalit.org.il
    - Principal Investigator:
      
      Gil Amarilyo, MD, PhD
Italy
- - Rome, Italy
    - Not yet recruiting
    - IRCCS Ospedale Pediatrico Bambino Gesu (OPBG)
    - Principal Investigator:
      
      Fabrizio De Benedetti
    - Contact:
      
      Denise Pires Marafon
      
      Phone Number: 0039 06 6859 2801
      
      Email: demarafon@yahoo.com
    - Sub-Investigator:
      
      Claudia Bracaglia
    - Sub-Investigator:
      
      Silvia Federici
    - Sub-Investigator:
      
      Antonella Insalaco
    - Sub-Investigator:
      
      Silvia Magni Manzoni
    - Sub-Investigator:
      
      Rebecca Nicolai
    - Sub-Investigator:
      
      Manuela Pardeo
    - Sub-Investigator:
      
      Emanuela Sacco
Puerto Rico
- - San Juan, Puerto Rico, 00912
    - Withdrawn
    - San Jorge Children's Hospital
United States
- Alabama
  - Birmingham, Alabama, United States, 35233
    - Recruiting
    - University of Alabama at Birmingham
    - Principal Investigator:
      
      Melissa Mannion, MD
    - Sub-Investigator:
      
      John Bridges, MD
    - Sub-Investigator:
      
      Randy Cron, MD, PhD
    - Sub-Investigator:
      
      Linda McAllister, CRNP
    - Sub-Investigator:
      
      Annelle Reed, CRNP
    - Sub-Investigator:
      
      Emily Smitherman, MD
    - Sub-Investigator:
      
      Matthew Stoll, MD, PhD
    - Sub-Investigator:
      
      Peter Weiser, MD
    - Sub-Investigator:
      
      Bethany Walker, CRNP
    - Sub-Investigator:
      
      Carolyn Smith, RN
    - Sub-Investigator:
      
      Eileen Rife, MD
    - Contact:
      
      Livie Timmerman
      
      Phone Number: 205-625-9140
      
      Email: liviet09@uab.edu
- Arizona
  - Phoenix, Arizona, United States, 85254
    - Recruiting
    - Phoenix Children's Hospital
    - Contact:
      
      Sabrina Gorry
      
      Phone Number: 602-933-3822
      
      Email: sgorry@phoenixchildrens.com
    - Principal Investigator:
      
      Kaleo Ede, MD
    - Sub-Investigator:
      
      Michael Shishov, MD
    - Sub-Investigator:
      
      Elisa Wershba, MD
    - Sub-Investigator:
      
      Nikita Goswami, MD
- California
  - Los Angeles, California, United States, 90027
    - Not yet recruiting
    - Children's Hospital of Los Angeles
    - Principal Investigator:
      
      Katherine Marzan, MD
    - Sub-Investigator:
      
      Diane Brown, MD
    - Sub-Investigator:
      
      Michal Cidon, MD
    - Sub-Investigator:
      
      Sara Haro, MD
    - Sub-Investigator:
      
      Iris Reyhan, MD
    - Contact:
      
      Ana Cancino
      
      Phone Number: 323-361-5958
      
      Email: ancabrera@chla.usc.edu
  - Los Angeles, California, United States, 90095
    - Recruiting
    - Mattel Children's Hospital at University of California Los Angeles
    - Contact:
      
      Alexis Stephens
      
      Phone Number: 310-825-7257
      
      Email: AVStephens@mednet.ucla.edu
    - Principal Investigator:
      
      Deborah McCurdy, MD
    - Sub-Investigator:
      
      Alice Chang-Hoftman, MD
  - Palo Alto, California, United States, 94304
    - Recruiting
    - Stanford University Medical Center
    - Contact:
      
      Aihua Zhu
      
      Phone Number: 650-384-5917
      
      Email: azhu1@stanford.edu
    - Principal Investigator:
      
      Joyce Hsu, MD
    - Sub-Investigator:
      
      Imelda Balboni, MD
    - Sub-Investigator:
      
      Quoc Du, NP
    - Sub-Investigator:
      
      Tzielan Lee, MD
    - Sub-Investigator:
      
      Rajdeep Pooni, MD
    - Sub-Investigator:
      
      Vivian Saper, MD
    - Sub-Investigator:
      
      Cathy Tsin, MD
    - Sub-Investigator:
      
      Amanda Moyer, MD
    - Sub-Investigator:
      
      Siva Kasinathan, MD, PhD
    - Sub-Investigator:
      
      Afshan Najafi, MD
    - Sub-Investigator:
      
      Arianne Peters, MD
    - Sub-Investigator:
      
      Adrienne Ramirez, MSN, RN
    - Sub-Investigator:
      
      Amritha Yellamilli, MD, PhD
  - San Diego, California, United States, 92123
    - Recruiting
    - Rady Children's Hospital San Diego
    - Principal Investigator:
      
      Johanna Chang, MD
    - Sub-Investigator:
      
      Robert Sheets, MD
    - Contact:
      
      Shane Blanchard
      
      Phone Number: 858-966-1700
      
      Email: sblanchard1@rchsd.org
    - Sub-Investigator:
      
      Aviya Levy, MD
    - Sub-Investigator:
      
      Omkar Phadke
  - San Francisco, California, United States, 94143
    - Recruiting
    - University of California at San Francisco Medical Center
    - Principal Investigator:
      
      Susan Kim, MD
    - Sub-Investigator:
      
      William Bernal, MD
    - Sub-Investigator:
      
      Erica Lawson, MD
    - Sub-Investigator:
      
      Nicole Ling, MD
    - Sub-Investigator:
      
      Jessica Neely, MD
    - Sub-Investigator:
      
      Tara Valcarel, NP
    - Sub-Investigator:
      
      Emily von Scheven, MD
    - Sub-Investigator:
      
      Michael Waterfield, MD, PhD
    - Sub-Investigator:
      
      Taylor LaFlam, MD, PhD
    - Sub-Investigator:
      
      Geraldina Lionetti, MD
    - Sub-Investigator:
      
      Andy Nguyen, FNP
    - Sub-Investigator:
      
      Roberto Valdovinos, MD
    - Contact:
      
      Zilan Zheng
      
      Phone Number: 415-353-1301
      
      Email: Zilan.Zheng@ucsf.edu
    - Sub-Investigator:
      
      Carolina Tamashiro, MD
- Colorado
  - Aurora, Colorado, United States, 80045
    - Recruiting
    - The Children's Hospital of Colorado
    - Principal Investigator:
      
      Katharine Moore, MD
    - Sub-Investigator:
      
      Jennifer Cooper, MD, PharmD
    - Sub-Investigator:
      
      Rob Fuhlbrigge, MD, PhD
    - Sub-Investigator:
      
      Clara Lin, MD
    - Sub-Investigator:
      
      Holly Reid, RN, PNP
    - Sub-Investigator:
      
      Joel Shirley, DO
    - Sub-Investigator:
      
      Jennifer Soep, MD
    - Sub-Investigator:
      
      Michelle Sutter, RN, PNP
    - Contact:
      
      Ana Aristiguieta
      
      Email: Ana.Aristiguieta@childrenscolorado.org
- Connecticut
  - Hartford, Connecticut, United States, 06106
    - Recruiting
    - Connecticut Children's Medical Center
    - Contact:
      
      Jennifer Twachtman-Bassett
      
      Email: Jtwachtman@connecticutchildrens.org
    - Principal Investigator:
      
      Barbara Edelheit, MD
    - Sub-Investigator:
      
      Blaine Lapin, MD
    - Sub-Investigator:
      
      Heather Tory, MD
    - Sub-Investigator:
      
      Jessica Fennell, MD
  - New Haven, Connecticut, United States, 06519
    - Terminated
    - Yale University
- District of Columbia
  - Washington D.C., District of Columbia, United States, 20010
    - Recruiting
    - Childrens National Medical Center
    - Contact:
      
      Katie Dunnock
      
      Phone Number: 202-476-5746
      
      Email: kdunnock@childrensnational.org
    - Principal Investigator:
      
      Tova Ronis, MD
    - Sub-Investigator:
      
      Rachael Connor, NP
    - Sub-Investigator:
      
      Hemalatha Srinivasalu, MD
    - Sub-Investigator:
      
      Sangeeta Sule, MD, PhD
    - Sub-Investigator:
      
      Brian Dizon, MD, PhD
    - Sub-Investigator:
      
      Abigail Bosk, DO
- Florida
  - Gainesville, Florida, United States, 32608
    - Recruiting
    - University of Florida - Shand's Children's Hospital
    - Principal Investigator:
      
      Leandra Woolnough, MD
    - Sub-Investigator:
      
      Melissa Elder, MD, PhD
    - Sub-Investigator:
      
      Renee Frances Modica, MD
    - Contact:
      
      Logan Lentini
      
      Phone Number: 813-263-5899
      
      Email: Logan.Lentini@peds.ufl.edu
    - Sub-Investigator:
      
      Heather Bell-Brunson, APRN
    - Sub-Investigator:
      
      Leeandra Cleaver, MD
  - Miami, Florida, United States, 33155
    - Recruiting
    - Nicklaus Children's Hospital
    - Principal Investigator:
      
      Yonit Sterba Rakovchik, MD
    - Sub-Investigator:
      
      Arielle Hay, MD
    - Contact:
      
      Aldrich Carmona
      
      Phone Number: 786-685-8137
      
      Email: Aldrich.Carmona@Nicklaushealth.org
  - Orlando, Florida, United States, 32827
    - Recruiting
    - Nemours Children's Hospital
    - Principal Investigator:
      
      Mary Toth, MD
    - Sub-Investigator:
      
      Traci Futch-West, NP
    - Sub-Investigator:
      
      Samira Nazzar Romero, MD
    - Contact:
      
      Sherry Wooldridge
      
      Phone Number: 407-567-6206
      
      Email: sherry.wooldridge@nemours.org
    - Sub-Investigator:
      
      Shalini Bajaj
  - St. Petersburg, Florida, United States, 33701
    - Recruiting
    - Johns Hopkins All Children's Hospital
    - Contact:
      
      Naketra Thomas
      
      Phone Number: 727-767-6949
      
      Email: nthoma58@jhmi.edu
    - Principal Investigator:
      
      Diana Milojevic, MD
    - Sub-Investigator:
      
      Mary Brothers, APRN
    - Sub-Investigator:
      
      Laisa Santiago, MD
    - Sub-Investigator:
      
      Amanda Schlefman, DO
    - Sub-Investigator:
      
      Ann Marie Szymanski, MD
- Georgia
  - Atlanta, Georgia, United States, 30322
    - Recruiting
    - Emory Children's Center
    - Contact:
      
      Lori Ponder
      
      Phone Number: 404-727-3583
      
      Email: laponde@emory.edu
    - Sub-Investigator:
      
      Cynthia Manos, MD
    - Sub-Investigator:
      
      Elaine Flanagan, MD
    - Sub-Investigator:
      
      Kelly Rouster-Stevens, MD
    - Sub-Investigator:
      
      Angela Taneja, MD
    - Principal Investigator:
      
      Sampath Prahalad, MD
  - Augusta, Georgia, United States, 30912
    - Recruiting
    - Georgia Regents University Medical Center
    - Contact:
      
      Heidi Stapp
      
      Phone Number: 706-721-7699
      
      Email: hstapp@augusta.edu
    - Principal Investigator:
      
      Julisa Patel, MD
    - Sub-Investigator:
      
      Barbara Kienzle, RN
- Illinois
  - Chicago, Illinois, United States, 60637
    - Recruiting
    - University of Chicago Medical Center
    - Principal Investigator:
      
      Melissa Tesher, MD
    - Sub-Investigator:
      
      Cuoghi Edens, MD
    - Sub-Investigator:
      
      Linda Wagner-Weiner, MD
    - Sub-Investigator:
      
      Joseph McDonald, MD
    - Sub-Investigator:
      
      Carolyn Zic, NP
    - Contact:
      
      Sydni Hill
      
      Email: Sydni.Hill@bsd.uchicago.edu
  - Chicago, Illinois, United States, 60614
    - Recruiting
    - Ann & Robert H. Lurie Children's Hospital of Chicago
    - Principal Investigator:
      
      Marisa Klein-Gitelman, MD
    - Sub-Investigator:
      
      Deirdre De Ranieri, MD
    - Sub-Investigator:
      
      Megan Hiskey, APN
    - Sub-Investigator:
      
      Brian Nolan, MD
    - Sub-Investigator:
      
      Amy Paller, MD
    - Sub-Investigator:
      
      Pooja Patel, DO
    - Contact:
      
      Maria Amoruso
      
      Phone Number: 312-227-6276
      
      Email: MAmoruso@luriechildrens.org
    - Sub-Investigator:
      
      Angela Chun
  - Chicago, Illinois, United States, 60607
    - Withdrawn
    - University of Illinois at Chicago
- Indiana
  - Indianapolis, Indiana, United States, 46202
    - Recruiting
    - Indiana University School of Medicine
    - Principal Investigator:
      
      Stacey Tarvin, MD
    - Sub-Investigator:
      
      Susan Ballinger, MD
    - Sub-Investigator:
      
      Michael Blakley, MD
    - Sub-Investigator:
      
      Melissa Oliver, MD
    - Sub-Investigator:
      
      Martha Rodriguez, MD
    - Contact:
      
      Elly Duncan
      
      Email: emckinse@iu.edu
- Iowa
  - Iowa City, Iowa, United States, 52242
    - Recruiting
    - The University of Iowa Hospitals and Clinics (University of Iowa Children's Hospital)
    - Principal Investigator:
      
      Sandy Hong, MD
    - Sub-Investigator:
      
      Polly Ferguson, MD
    - Sub-Investigator:
      
      Courtney Kremer, ARNP
    - Sub-Investigator:
      
      Scott Lieberman, MD, PhD
    - Contact:
      
      Joehan Quach
      
      Phone Number: 402-237-9936
      
      Email: joehan-quach@uiowa.edu
    - Sub-Investigator:
      
      Inna Powers, MD
- Kansas
  - Kansas City, Kansas, United States, 66160
    - Terminated
    - University of Kansas Medical Center
- Kentucky
  - Louisville, Kentucky, United States, 40202
    - Recruiting
    - University of Louisville Schoole of Medicine
    - Contact:
      
      Kristin Klein
      
      Phone Number: 502-588-4911
      
      Email: kristin.klein@louisville.edu
    - Principal Investigator:
      
      Kenneth Schikler, MD
    - Sub-Investigator:
      
      Janice Sullivan, MD
    - Sub-Investigator:
      
      Alexis Begezda, MD
    - Sub-Investigator:
      
      Jacqueline Fabricius, MD
- Massachusetts
  - Boston, Massachusetts, United States, 02115
    - Recruiting
    - Boston Children's Hospital
    - Contact:
      
      Kyle McBrearty
      
      Email: Kyle.McBrearty@childrens.harvard.edu
    - Sub-Investigator:
      
      Olha Halyabar, MD
    - Sub-Investigator:
      
      Lauren Henderson, MD
    - Sub-Investigator:
      
      Pui Lee, MD, PhD
    - Sub-Investigator:
      
      Mindy Lo, MD, PhD
    - Sub-Investigator:
      
      Peter Nigrovic, MD
    - Sub-Investigator:
      
      Mary Beth Son, MD
    - Sub-Investigator:
      
      Margaret Chang, MD
    - Sub-Investigator:
      
      Ezra Cohen, MD
    - Principal Investigator:
      
      Joyce Chang, MD
    - Sub-Investigator:
      
      Fatma Dedeoglu, MD
    - Sub-Investigator:
      
      Liyoung Kim, MD
  - Boston, Massachusetts, United States, 02111
    - Recruiting
    - Tufts Medical Center
    - Principal Investigator:
      
      Trevor Davis, MD
    - Sub-Investigator:
      
      Yujuan (Julia) Zhang, MD
    - Contact:
      
      Kiran Singh
      
      Phone Number: 617-636-9197
      
      Email: Kiran.Singh@tuftsmedicine.org
  - Boston, Massachusetts, United States, 02114
    - Recruiting
    - Massachusetts General Hospital for Children
    - Principal Investigator:
      
      Marc Natter, MD
    - Sub-Investigator:
      
      Holly Rothermel, MD
    - Sub-Investigator:
      
      Deborah Rothman, MD
    - Contact:
      
      Marc Natter
      
      Phone Number: 617-726-2730
      
      Email: mnatter@mgh.harvard.edu
  - Springfield, Massachusetts, United States, 01105
    - Terminated
    - Bay State Medical Center
- Michigan
  - Ann Arbor, Michigan, United States, 48109
    - Recruiting
    - University of Michigan
    - Principal Investigator:
      
      Smriti Mohan, MD
    - Sub-Investigator:
      
      Cynthia Black, RN, BSN
    - Sub-Investigator:
      
      Anne Jackson, RN
    - Sub-Investigator:
      
      Jackie Madison, MD
    - Sub-Investigator:
      
      Anne Murphy, MD
    - Sub-Investigator:
      
      Meredith Riebschleger, MD
    - Sub-Investigator:
      
      Ajay Tambralli, MD
    - Sub-Investigator:
      
      Andrew Grim, MD
    - Contact:
      
      Sophia Matossian
      
      Email: somatoss@med.umich.edu
    - Sub-Investigator:
      
      Marianne Kerski, MD
    - Sub-Investigator:
      
      Atiye Dagci, MD
    - Sub-Investigator:
      
      Erin Janssen, MD
    - Sub-Investigator:
      
      Nicholas McClellan, MD
    - Sub-Investigator:
      
      Jeff Rafko, BSN, RN
    - Sub-Investigator:
      
      Jessica Turnier, MD
    - Sub-Investigator:
      
      Christine Wang, MD
  - Grand Rapids, Michigan, United States, 49503
    - Recruiting
    - Helen DeVos Children's Hospital
    - Sub-Investigator:
      
      Elizabeth Kessler, MD
    - Principal Investigator:
      
      Cory Stingl, MD
    - Sub-Investigator:
      
      Khalid Abulaban, MD
    - Contact:
      
      Amy Pribyl
      
      Phone Number: 616-391-1783
      
      Email: Amy.Pribyl@corewellhealth.org
  - Grand Rapids, Michigan, United States, 49546
    - Terminated
    - West Michigan Rheumatology
- Minnesota
  - Minneapolis, Minnesota, United States, 55454
    - Recruiting
    - University of Minnesota
    - Principal Investigator:
      
      Colleen Correll, MD
    - Sub-Investigator:
      
      Bryce Binstadt, MD
    - Sub-Investigator:
      
      Danielle Brueck, MD
    - Sub-Investigator:
      
      Patricia Hobday, MD
    - Sub-Investigator:
      
      Mona Riskalla, MD
    - Sub-Investigator:
      
      Shawn Mahmud
    - Contact:
      
      Samantha LaBelle
      
      Phone Number: 612-301-1554
      
      Email: brahm030@umn.edu
  - Rochester, Minnesota, United States, 55905
    - Recruiting
    - Mayo Clinic
    - Principal Investigator:
      
      Matthew Basiaga, DO
    - Sub-Investigator:
      
      Amir Orandi, MD
    - Contact:
      
      Katrina Olson
      
      Phone Number: 507-293-9555
      
      Email: Olson.Katrina@mayo.edu
- Mississippi
  - Jackson, Mississippi, United States, 39216
    - Recruiting
    - University of Mississippi Medical Center
    - Principal Investigator:
      
      Anita Dhanrajani, MBBS
    - Sub-Investigator:
      
      Linda Ray, MD
    - Sub-Investigator:
      
      Charles Spencer, MD
    - Sub-Investigator:
      
      Yasmin Elzaki, MD
    - Contact:
      
      Anita Dhanrajani
      
      Email: adhanrajani@umc.edu
- Missouri
  - Kansas City, Missouri, United States, 64108
    - Recruiting
    - Children's Mercy Hospital
    - Contact:
      
      Ashley Lytch
      
      Phone Number: 816-855-1957
      
      Email: amlytch@cmh.edu
    - Principal Investigator:
      
      Ashley Cooper, MD
    - Sub-Investigator:
      
      Leslie Favier, MD
    - Sub-Investigator:
      
      Emily Fox, MD
    - Sub-Investigator:
      
      Julia Harris, MD
    - Sub-Investigator:
      
      Cara Hoffart, DO
    - Sub-Investigator:
      
      Michael (Jamie) Holland, MD
    - Sub-Investigator:
      
      Maria Ibarra, MD
    - Sub-Investigator:
      
      Jordan Jones, DO
  - St Louis, Missouri, United States, 63104
    - Recruiting
    - Saint Louis University School of Medicine
    - Principal Investigator:
      
      Terry Moore, MD
    - Sub-Investigator:
      
      Austin Dalrymple, DO
    - Sub-Investigator:
      
      Alexandra Theisen, MD
    - Sub-Investigator:
      
      George Theiroff, MD
    - Contact:
      
      Elizabeth Bacar
      
      Phone Number: 314-977-8844
      
      Email: elizabeth.bacar@health.slu.edu
  - St Louis, Missouri, United States, 63110
    - Recruiting
    - Saint Louis Children's Hospital
    - Contact:
      
      Kristen McDaniels
      
      Phone Number: 314-273-9064
      
      Email: k.mcdaniels@wustl.edu
    - Sub-Investigator:
      
      Tarin Bigley, MD, PhD
    - Sub-Investigator:
      
      Leslie Fogel, MD, PhD
    - Sub-Investigator:
      
      Maleewan Kitcharoensakkul, MD
    - Sub-Investigator:
      
      Erica Schmitt, MD, PhD
    - Sub-Investigator:
      
      Claire Seper, NP
    - Principal Investigator:
      
      Kevin Baszis, MD
    - Sub-Investigator:
      
      Brad Ornstein, MD
    - Sub-Investigator:
      
      Lance Peterson, MD, PhD
- New Jersey
  - Hackensack, New Jersey, United States, 07601
    - Recruiting
    - Hackensack University Medical Center
    - Principal Investigator:
      
      Jennifer Weiss, MD
    - Sub-Investigator:
      
      Ginger Janow, MD
    - Sub-Investigator:
      
      Yukiko Kimura, MD
    - Sub-Investigator:
      
      Sivia Lapidus, MD
    - Sub-Investigator:
      
      Suzanne Li, MD
    - Sub-Investigator:
      
      Anna Carmela Gironella, MD
    - Contact:
      
      Amanda Nowakowski
      
      Phone Number: 551-996-3114
      
      Email: amanda.nowakowski@hmhn.org
  - Morristown, New Jersey, United States, 07960
    - Recruiting
    - Goryeb Children's Hospital
    - Contact:
      
      Marie Fox
      
      Phone Number: 973-971-6308
      
      Email: marie.fox@atlantichealth.org
    - Principal Investigator:
      
      Simona Nativ, MD
    - Sub-Investigator:
      
      Sarah Paul, DO
  - New Brunswick, New Jersey, United States, 08901
    - Recruiting
    - Robert Wood Johnson Medical School
    - Contact:
      
      Christina Varghese
      
      Phone Number: 732-235-7570
      
      Email: chrisvar@rwjms.rutgers.edu
    - Principal Investigator:
      
      Nandini Moorthy, MD
    - Sub-Investigator:
      
      Dan Horton, MD
  - West Orange, New Jersey, United States, 07052
    - Recruiting
    - The Pediatric Specialty Center at Saint Barnabas
    - Principal Investigator:
      
      Elizabeth Chalom, MD
    - Contact:
      
      Sharon Jared
      
      Phone Number: 973-322-6961
      
      Email: Sharon.jared@rwjbh.org
    - Sub-Investigator:
      
      Marla Guzman, MD
- New York
  - Albany, New York, United States, 122089
    - Recruiting
    - Albany Medical College
    - Sub-Investigator:
      
      Liza Bermudez-Santiago, MD
    - Contact:
      
      Chris Figueroa
      
      Phone Number: 518-262-6682
      
      Email: figuerc@amc.edu
    - Principal Investigator:
      
      Suhas Ganguli
    - Sub-Investigator:
      
      Cynthia Salvant
  - Lake Success, New York, United States, 11042
    - Recruiting
    - Cohen Children's Medical Center of New York
    - Sub-Investigator:
      
      Anne Eberhard, MSc
    - Sub-Investigator:
      
      Joyce Hui-Yuen, MD
    - Sub-Investigator:
      
      Patricia Lee, RN
    - Sub-Investigator:
      
      Heather Walters, MD
    - Sub-Investigator:
      
      Zanab Mian, DO
    - Sub-Investigator:
      
      Lydia Thomas, MD
    - Contact:
      
      Ashley Machado
      
      Phone Number: 516-472-3711
      
      Email: amachado3@northwell.edu
    - Principal Investigator:
      
      Beth Gottlieb, MD
  - New York, New York, United States, 10021
    - Recruiting
    - Hospital For Special Surgery
    - Principal Investigator:
      
      Karen Onel, MD
    - Sub-Investigator:
      
      Alexa Adams, MD
    - Sub-Investigator:
      
      Nancy Pan, MD
    - Sub-Investigator:
      
      Sarah Taber, MD
    - Sub-Investigator:
      
      Lauren Robinson, MD
    - Sub-Investigator:
      
      Jheel Pandya, MD
    - Contact:
      
      Julia Klauss
      
      Phone Number: 212-774-2703
      
      Email: klaussj@HSS.EDU
  - New York, New York, United States, 10032
    - Recruiting
    - Columbia University Medical Center
    - Principal Investigator:
      
      Lisa Imundo, MD
    - Sub-Investigator:
      
      Alexis Boneparth, MD
    - Contact:
      
      Paloma Malta
      
      Phone Number: 212-342-2751
      
      Email: pm3281@cumc.columbia.edu
    - Sub-Investigator:
      
      Estee Ephron, CNP, CPNP-PC
  - New York, New York, United States, 10016
    - Terminated
    - New York University Langone Medical Center
  - New York, New York, United States, 10467
    - Recruiting
    - Children's Hospital at Montefiore
    - Principal Investigator:
      
      Dawn Wahezi, MD
    - Sub-Investigator:
      
      Tamar Rubinstein, MD
    - Sub-Investigator:
      
      Tamara Tanner, MD
    - Sub-Investigator:
      
      Natalia Vasquez, MD
    - Sub-Investigator:
      
      Jessica Perfetto, MD
    - Contact:
      
      Lisbel Guzman
      
      Email: lisbel.guzman@einsteinmed.edu
    - Sub-Investigator:
      
      Faith Ikalina
    - Sub-Investigator:
      
      Syeda Sohail
  - Rochester, New York, United States, 14642
    - Recruiting
    - University of Rochester
    - Contact:
      
      Kaili Widrick
      
      Phone Number: 585-275-8991
      
      Email: Kaili_Widrick@URMC.Rochester.edu
    - Principal Investigator:
      
      Christina Schutt, DO
    - Sub-Investigator:
      
      Bethany Marston, MD
    - Sub-Investigator:
      
      Barbra Murante, NP
    - Sub-Investigator:
      
      Homaira Rahimi, MD
    - Sub-Investigator:
      
      Amy Vallee, NP
    - Sub-Investigator:
      
      Sarah Baluta, MD
    - Sub-Investigator:
      
      Michael Tomani, MD
- North Carolina
  - Chapel Hill, North Carolina, United States, 27599
    - Recruiting
    - University of North Carolina At Chapel Hill
    - Principal Investigator:
      
      Eveline Wu, MD
    - Sub-Investigator:
      
      Laura Cannon, MD
    - Sub-Investigator:
      
      Leonard Kovalick, PNP
    - Sub-Investigator:
      
      Aliese Sarkissian, MD
    - Contact:
      
      Carolina Pastrana-Medina
      
      Phone Number: 919-564-5220
      
      Email: carol825@med.unc.edu
    - Sub-Investigator:
      
      Caitlan Pinotti, MD
  - Charlotte, North Carolina, United States, 28203
    - Recruiting
    - Levine Children's Hospital / Carolinas Medical Center
    - Principal Investigator:
      
      Thomas Griffin, MD
    - Sub-Investigator:
      
      Sheetal Vora, MD
    - Contact:
      
      Danielle Bodziony
      
      Phone Number: 704-770-6258
      
      Email: Danielle.Bodziony@atriumhealth.org
  - Durham, North Carolina, United States, 27710
    - Recruiting
    - Duke Children's Hospital & Health Center
    - Principal Investigator:
      
      Heather Van Mater, MD
    - Sub-Investigator:
      
      Stephen Balevic, MD
    - Sub-Investigator:
      
      Mara Becker, MD
    - Sub-Investigator:
      
      Mary Buckley, MD
    - Sub-Investigator:
      
      Jeffrey Dvergsten, MD
    - Sub-Investigator:
      
      Rachel Randell, MD
    - Sub-Investigator:
      
      Ann Reed, MD
    - Sub-Investigator:
      
      Rebecca Sadun, MD, PhD
    - Sub-Investigator:
      
      Yike Jiang, MD,PhD
    - Contact:
      
      Lynn Rodgers
      
      Phone Number: 919-668-2953
      
      Email: lynn.rodgers@duke.edu
  - Winston-Salem, North Carolina, United States, 27012
    - Recruiting
    - Wake Forest Baptist Brenner Children's Hospital
    - Principal Investigator:
      
      Onengiya Harry, MD
    - Contact:
      
      Rachel Shaylor
      
      Phone Number: 336-716-5650
      
      Email: rloggins@wakehealth.edu
    - Sub-Investigator:
      
      Brittany Richard, MMS
- North Dakota
  - Fargo, North Dakota, United States, 58122
    - Recruiting
    - Sanford Health
    - Contact:
      
      Josie Schahn
      
      Phone Number: 701-234-3722
      
      Email: Josephine.Schahn@SanfordHealth.org
    - Principal Investigator:
      
      Grant Syverson, MD
    - Sub-Investigator:
      
      Chris Failing, MD
- Ohio
  - Akron, Ohio, United States, 44308
    - Recruiting
    - Akron Children's Hospital
    - Contact:
      
      Danielle Rogers
      
      Email: drogers@akronchildrens.org
    - Sub-Investigator:
      
      Nancy Delnay, CNP
    - Principal Investigator:
      
      Kate Cook, DO
  - Cincinnati, Ohio, United States, 45229
    - Recruiting
    - Cincinnati Children's Hospital Medical Center
    - Sub-Investigator:
      
      Alexi Grom, MD
    - Sub-Investigator:
      
      Michael Henrickson, MD
    - Sub-Investigator:
      
      Jennifer Huggins, MD
    - Sub-Investigator:
      
      Daniel Lovell, MD
    - Sub-Investigator:
      
      Patricia Vega-Fernandez, MD
    - Sub-Investigator:
      
      Grant Schulert, MD, PhD
    - Sub-Investigator:
      
      Tracy Ting, MD
    - Sub-Investigator:
      
      Ekemini Ogbu, MD
    - Principal Investigator:
      
      Sheila Angeles-Han, MD
    - Sub-Investigator:
      
      Kara Schmidt, MD
    - Contact:
      
      Megan Quinlan-Waters
      
      Phone Number: 513-636-3644
      
      Email: Megan.Quinlan-Waters@cchmc.org
    - Sub-Investigator:
      
      Hermine Brunner, MD, MBA
  - Cleveland, Ohio, United States, 44195
    - Recruiting
    - Cleveland Clinic Foundation
    - Principal Investigator:
      
      Angela Robinson, MD
    - Sub-Investigator:
      
      Elizabeth Brooks, MD
    - Sub-Investigator:
      
      Sirada Panupattanapong, MD
    - Sub-Investigator:
      
      Andrew Zeft, MD
    - Contact:
      
      Brittany Randall
      
      Phone Number: 216-445-6405
      
      Email: RANDALB6@ccf.org
    - Sub-Investigator:
      
      Laura Nedorezov, MD
  - Cleveland, Ohio, United States, 44109
    - Recruiting
    - MetroHealth Medical Center
    - Principal Investigator:
      
      Hulya Bukulmez, MD
    - Sub-Investigator:
      
      Nora Singer, MD
    - Contact:
      
      Rozina Aamir
      
      Phone Number: 216-778-2628
      
      Email: raamir@metrohealth.org
  - Cleveland, Ohio, United States, 44106
    - Terminated
    - UH Rainbox Babies and Children's Hospital
  - Columbus, Ohio, United States, 43205
    - Recruiting
    - Nationwide Children's Hospital
    - Contact:
      
      Joanne Drew
      
      Phone Number: 614-722-0741
      
      Email: joanne.drew@nationwidechildrens.org
    - Principal Investigator:
      
      Stacy Ardoin, MD
    - Sub-Investigator:
      
      Shoghik Akoghlanian, MD
    - Sub-Investigator:
      
      Kyla Driest, MD
    - Sub-Investigator:
      
      Edward Oberle, MD
    - Sub-Investigator:
      
      Vidya Sivaraman, MD
    - Sub-Investigator:
      
      Bethanne Thomas, CPNP-PC
    - Sub-Investigator:
      
      Alysa Taxter, MD
    - Sub-Investigator:
      
      Melissa Argraves, MD
    - Sub-Investigator:
      
      Samantha Coss, MD, PhD
    - Sub-Investigator:
      
      Ysabella Esteban, MD
    - Sub-Investigator:
      
      Kendra Lauer, DO
    - Sub-Investigator:
      
      Ivana Stojkic, MD
    - Sub-Investigator:
      
      Alison Brittain, DO
    - Sub-Investigator:
      
      Elizabeth Murray, MD
- Oregon
  - Portland, Oregon, United States, 97227
    - Recruiting
    - Randall Children's Hospital at Legacy Emanuel
    - Sub-Investigator:
      
      Victoria Cartwright, MD
    - Sub-Investigator:
      
      Andrew Lasky, MD
    - Principal Investigator:
      
      Daniel Kingsbury, MD
    - Contact:
      
      Lisa Paine
      
      Phone Number: 503-413-3930
      
      Email: lpaine@lhs.org
- Pennsylvania
  - Hershey, Pennsylvania, United States, 17033
    - Recruiting
    - Penn State Children's Hospital
    - Contact:
      
      Meredith Buckley
      
      Phone Number: 286546 717-531-0003
      
      Email: mbuckley@pennstatehealth.psu.edu
    - Principal Investigator:
      
      Timothy Hahn, MD
    - Sub-Investigator:
      
      Catherine Bingham, MD
    - Sub-Investigator:
      
      Kim Hays, MD
    - Sub-Investigator:
      
      Lisa Scalzi, MD
    - Sub-Investigator:
      
      Acela Rosado, MD
    - Sub-Investigator:
      
      Andrew Kung, MD
  - Philadelphia, Pennsylvania, United States, 19104
    - Recruiting
    - Children's Hospital of Philadelphia
    - Principal Investigator:
      
      Pamela Weiss, MD
    - Sub-Investigator:
      
      Melissa Lerman, MD, PhD
    - Sub-Investigator:
      
      Scott Canna, MD
    - Contact:
      
      Chante Smith
      
      Phone Number: 267-426-8726
      
      Email: smithc56@chop.edu
  - Philadelphia, Pennsylvania, United States, 19134
    - Recruiting
    - Saint Christopher's Hospital for Children
    - Sub-Investigator:
      
      Svetlana Lvovich, DO
    - Principal Investigator:
      
      Dana Toib, MD
    - Contact:
      
      Kimberly Nocella
      
      Phone Number: 215-427-8460
      
      Email: Kimberly.Nocella@towerhealth.org
  - Pittsburgh, Pennsylvania, United States, 15224
    - Recruiting
    - Children's Hospital of Pittsburgh UPMC
    - Principal Investigator:
      
      Margalit Rosenkranz, MD
    - Sub-Investigator:
      
      Kathryn Torok, MD
    - Contact:
      
      Reagan Devine
      
      Phone Number: 412-692-7567
      
      Email: deviner3@upmc.edu
    - Sub-Investigator:
      
      Abigail Printz
- Rhode Island
  - Providence, Rhode Island, United States, 02903
    - Recruiting
    - Hasbro Children's Hospital
    - Contact:
      
      Ali Yalcindag
      
      Phone Number: 401-444-5543
      
      Email: ayalcindag@lifespan.org
    - Principal Investigator:
      
      Ali Yalcindag, MD
- South Carolina
  - Charleston, South Carolina, United States, 29425
    - Recruiting
    - Medical University of South Carolina Children's Hospital
    - Principal Investigator:
      
      Natasha Ruth, MD
    - Sub-Investigator:
      
      Mileka Gilbert, MD
    - Sub-Investigator:
      
      Emily Vara, MD
    - Contact:
      
      Susannah Wakefield
      
      Phone Number: 843-792-8317
      
      Email: wakefies@musc.edu
- Tennessee
  - Nashville, Tennessee, United States, 37232
    - Recruiting
    - Monroe Carrell Jr. Children's Hospital at Vanderbilt
    - Principal Investigator:
      
      Thomas Graham, MD
    - Contact:
      
      Betsy Blackmon
      
      Phone Number: 615-875-9700
      
      Email: betsy.haire@vumc.org
    - Sub-Investigator:
      
      Lisa Buckley, MD
    - Sub-Investigator:
      
      Anna Patrick, MD, PhD
    - Sub-Investigator:
      
      Emily Datyner, MD
    - Sub-Investigator:
      
      Catherine Deffendall
    - Sub-Investigator:
      
      Tyler Reese, MD
- Texas
  - Dallas, Texas, United States, 75219
    - Recruiting
    - University of Texas Southwestern Medical Center Dallas
    - Contact:
      
      Lenice Franklin
      
      Phone Number: 214-559-8531
      
      Email: lenice.franklin@tsrh.org
    - Sub-Investigator:
      
      Stephanie Armendariz, ARNP
    - Sub-Investigator:
      
      Julie Fuller, MD
    - Sub-Investigator:
      
      Lorioen Nassi, MD
    - Sub-Investigator:
      
      Tracey Wright, MD
    - Sub-Investigator:
      
      Kristina Ciaglia, MD
    - Principal Investigator:
      
      Elizabeth Sloan, MD
    - Sub-Investigator:
      
      Simrat Morris, MD
    - Sub-Investigator:
      
      Heather Benham, RN, PNP
    - Sub-Investigator:
      
      Esraa Eloseily, MD
  - Houston, Texas, United States, 77030
    - Recruiting
    - Baylor College of Medicine Pediatric Immunology Allergy Rheumatology
    - Sub-Investigator:
      
      Hannah Bradfield, MD
    - Contact:
      
      Monica Guevara
      
      Phone Number: 832-824-1206
      
      Email: Monica.Guevara@bcm.edu
    - Principal Investigator:
      
      Marietta DeGuzman, MD
    - Sub-Investigator:
      
      Martha Curry, PNP
    - Sub-Investigator:
      
      Eyal Muscal, MD
    - Sub-Investigator:
      
      Cagri Toruner, MD
- Utah
  - Salt Lake City, Utah, United States, 84113
    - Recruiting
    - University of Utah Hospitals and Clinics (Primary Children's Hospital)
    - Sub-Investigator:
      
      Peter Chiraseveenuprapund, MD
    - Principal Investigator:
      
      Christi Inman, MD
    - Sub-Investigator:
      
      John Bohnsack, MD
    - Sub-Investigator:
      
      Deborah Durkee, APRN
    - Sub-Investigator:
      
      Aimec Hersh, MD
    - Sub-Investigator:
      
      Karen James, MD
    - Sub-Investigator:
      
      Sara Stern, MD
    - Sub-Investigator:
      
      Katherine Thompson
    - Contact:
      
      Sarah Wallgren
      
      Email: sarah.wallgren@hsc.utah.edu
    - Sub-Investigator:
      
      Amanda Robinson, MD
    - Sub-Investigator:
      
      Kimberly Smith, MSN
    - Sub-Investigator:
      
      Erin Treemarcki, MD
- Vermont
  - Burlington, Vermont, United States, 05401
    - Recruiting
    - University of Vermont Medical Center
    - Principal Investigator:
      
      Matthew Hollander, MD
    - Contact:
      
      Sage Hannon
      
      Email: barbara.hannon@med.uvm.edu
- Virginia
  - Norfolk, Virginia, United States, 23507
    - Recruiting
    - Children's Hospital of The King's Daughters
    - Principal Investigator:
      
      Cassyanne Aguiar, MD
    - Contact:
      
      Cassy Todd
      
      Phone Number: 757-668-7176
      
      Email: Cassandra.Todd@CHKD.ORG
- Washington
  - Seattle, Washington, United States, 98105
    - Recruiting
    - Seattle Children's Hospital
    - Sub-Investigator:
      
      Eric Allenspach, MD, PhD
    - Sub-Investigator:
      
      Susan Canny, MD, PhD
    - Sub-Investigator:
      
      Sri Grevich, MD
    - Sub-Investigator:
      
      Kristen Hayward, MD
    - Sub-Investigator:
      
      Esi Morgan, MD
    - Sub-Investigator:
      
      Natalie Rosenwasser, MD
    - Sub-Investigator:
      
      Susan Shenoi, MBBS, MS
    - Sub-Investigator:
      
      Yongdong (Dan) Zhao, MD, PhD
    - Sub-Investigator:
      
      Stephen Wong, MD
    - Principal Investigator:
      
      Kabita Nanda, MD
    - Sub-Investigator:
      
      Jordan Roberts, MD
    - Sub-Investigator:
      
      Erin Balay-Dustrude, MD
    - Contact:
      
      Kabita Nanda
      
      Phone Number: 206-987-2057
      
      Email: Kabita.nanda@seattlechildrens.org
- Wisconsin
  - Madison, Wisconsin, United States, 53792
    - Recruiting
    - University of Wisconsin, American Family Children's Hospital
    - Principal Investigator:
      
      Dominic Co, MD, PhD
    - Sub-Investigator:
      
      Judith Smith, MD, PhD
    - Sub-Investigator:
      
      Joni Dean, NP
    - Contact:
      
      Susy Cranley
      
      Phone Number: 608-264-2200
      
      Email: cranley2@wisc.edu
  - Wauwatosa, Wisconsin, United States, 53226
    - Recruiting
    - Children's Hospital of Wisconsin
    - Contact:
      
      Erin Hammelev
      
      Phone Number: 412-266-6352
      
      Email: ehammele@mcw.edu
    - Principal Investigator:
      
      Sara Sabbagh, DO
    - Sub-Investigator:
      
      Danielle Fair, MD
    - Sub-Investigator:
      
      James Nocton, MD
    - Sub-Investigator:
      
      James Verbsky, MD, PhD
    - Sub-Investigator:
      
      Calvin Williams, MD, PhD
    - Sub-Investigator:
      
      Emma Austenfeld, MD
    - Sub-Investigator:
      
      James Bistolarides, MD
    - Sub-Investigator:
      
      Kaitlin Kirkpatrick, MD
    - Sub-Investigator:
      
      Amanda Jimenez, MD

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

No older than 21 years (Child, Adult)

Accepts Healthy Volunteers

Sampling Method

Non-Probability Sample

Study Population

Children with pediatric rheumatic diseases enrolled from participating CARRA sites.

Description

Inclusion Criteria:

Onset of rheumatic disease prior to age 16 years for JIA and onset prior to age 19 years for all other rheumatic diseases (see appendix A).
Subject (and/or parent/legal guardian when required) is able to provide written informed consent and willing to comply with study procedures.
Subject and/or parent/legal guardian is willing to be contacted in the future by study staff.

Exclusion Criteria:

1. Greater than 21 years of age at the time of enrollment.

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: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Prospectively collect essential data elements from children, adolescents and young adults with pediatric rheumatic diseases Time Frame: Approximately 10 years	Approximately 10 years
Evaluate the safety of therapeutic agents in persons with pediatric onset rheumatic diseases Time Frame: Approximately 10 years	Approximately 10 years

Secondary Outcome Measures

Outcome Measure	Time Frame
Evaluate clinical outcomes associated with the use of therapeutic agents in persons with pediatric onset rheumatic diseases Time Frame: Approximately 10 years	Approximately 10 years
Document drug treatment patterns and clinical course of persons with pediatric onset rheumatic diseases over time. Time Frame: Approximately 10 years	Approximately 10 years
Evaluate factors other than drug treatments that are associated with clinical outcomes in pediatric onset rheumatic diseases Time Frame: Approximately 10 years	Approximately 10 years

Collaborators and Investigators

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

Sponsor

Duke University

Collaborators

Childhood Arthritis and Rheumatology Research Alliance

Investigators

Principal Investigator: Mara L Becker, MD, MSCE, Duke Clinical Research Insitute
Principal Investigator: Mary Beth Son, MD, Boston Children's Hospital
Principal Investigator: Timothy Beukelman, MD, MSCE, University of Alabama at Birmingham

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

Nigrovic PA, Beukelman T, Tomlinson G, Feldman BM, Schanberg LE, Kimura Y; Childhood Arthritis and Rheumatology Research Alliance Systemic Juvenile Idiopathic Arthritis Consensus Treatment Plan Workgroup. Bayesian comparative effectiveness study of four consensus treatment plans for initial management of systemic juvenile idiopathic arthritis: FiRst-Line Options for Systemic juvenile idiopathic arthritis Treatment (FROST). Clin Trials. 2018 Jun;15(3):268-277. doi: 10.1177/1740774518761367. Epub 2018 Mar 15.

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

July 1, 2015

Primary Completion (Estimated)

June 1, 2028

Study Completion (Estimated)

December 1, 2028

Study Registration Dates

First Submitted

April 13, 2015

First Submitted That Met QC Criteria

April 13, 2015

First Posted (Estimated)

April 16, 2015

Study Record Updates

Last Update Posted (Estimated)

October 14, 2025

Last Update Submitted That Met QC Criteria

October 13, 2025

Last Verified

October 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Pro00054616

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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Study Overview

Status

Conditions

Detailed Description

Study Type

Enrollment (Estimated)

Contacts and Locations

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Eligibility Criteria

Ages Eligible for Study

Accepts Healthy Volunteers

Sampling Method

Study Population

Description

Study Plan

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure

Time Frame

Secondary Outcome Measures

Outcome Measure

Time Frame

Collaborators and Investigators

Sponsor

Collaborators

Investigators

Publications and helpful links

General Publications

Study record dates

Study Major Dates

Study Start

Primary Completion (Estimated)

Study Completion (Estimated)

Study Registration Dates

First Submitted

First Submitted That Met QC Criteria

First Posted (Estimated)

Study Record Updates

Last Update Posted (Estimated)

Last Update Submitted That Met QC Criteria

Last Verified

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Clinical Trials on Rheumatic Joint Disease

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