Observational Study of Pediatric Rheumatic Diseases: The CARRA Registry

• ClinicalTrials.gov Identifier: NCT02418442
• Recruitment Status: Recruiting
• First Posted: April 16, 2015
• Last Update Posted: May 9, 2022
• Sponsor: Duke University
• Collaborator: Childhood Arthritis and Rheumatology Research Alliance
• Information provided by (Responsible Party): Duke University

Study Description

Brief Summary:

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.

Condition or disease
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 Design

• Study Type: Observational [Patient Registry]
• Estimated Enrollment: 20000 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Target Follow-Up Duration: 10 Years
• Official Title: Observational Study of Pediatric Rheumatic Diseases: The CARRA Registry
• Study Start Date: July 2015
• Estimated Primary Completion Date: June 2028
• Estimated Study Completion Date: December 2028

Groups and Cohorts

Outcome Measures

Primary Outcome Measures :

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

Secondary Outcome Measures :

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

Biospecimen Retention:   Samples With DNA

Biosample collection is active for a subset of subjects within the registry

Eligibility Criteria

• Ages Eligible for Study: up to 21 Years (Child, Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No
• Sampling Method: Non-Probability Sample

Study Population

Children with pediatric rheumatic diseases enrolled from participating CARRA sites.

Criteria

Inclusion Criteria:

1. 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).
2. Subject (and/or parent/legal guardian when required) is able to provide written informed consent and willing to comply with study procedures.
3. 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.

Contacts and Locations

Contacts

Contact: Laura Schanberg, MD; (919) 684-6601; Laura.Schanberg@duke.edu

Contact: Yuki Kimura, MD; (551) 996-5306; Yukiko.Kimura@hmhn.org

Locations

United States, Alabama

University of Alabama at Birmingham; Recruiting

Birmingham, Alabama, United States, 35233

Contact: Livie Huie 205-625-9140 liviet09@uab.edu

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: Victoria Gennaro, CRNP

Sub-Investigator: Dan Reiff, MD

Sub-Investigator: Carolyn Smith, RN

United States, Arizona

Phoenix Children's Hospital; Recruiting

Phoenix, Arizona, United States, 85254

Contact: Sabrina Gorry 602-933-3822 sgorry@phoenixchildrens.com

Principal Investigator: Kaleo Ede, MD

Sub-Investigator: Michael Shishov, MD

Sub-Investigator: Elisa Wershba, MD

Sub-Investigator: Nikita Goswami, MD

United States, California

Children's Hospital of Los Angeles; Not yet recruiting

Los Angeles, California, United States, 90027

Contact: Ana Cabrera 323-361-5958 ancabrera@chla.usc.edu

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

Sub-Investigator: Bracha Shaham, MD

Mattel Children's Hospital at University of California Los Angeles; Recruiting

Los Angeles, California, United States, 90095

Contact: Alexis Stephens 310-825-7257 AVStephens@mednet.ucla.edu

Principal Investigator: Deborah McCurdy, MD

Sub-Investigator: Alice Chang-Hoftman, MD

Stanford University Medical Center; Recruiting

Palo Alto, California, United States, 94304

Contact: Aihua Zhu 650-384-5917 azhu1@stanford.edu

Principal Investigator: Joyce Hsu, MD

Sub-Investigator: Imelda Balboni, MD

Sub-Investigator: Quoc Du, NP

Sub-Investigator: Dana Gerstbacher, MD

Sub-Investigator: Tzielan Lee, MD

Sub-Investigator: Elizabeth Mellins, MD

Sub-Investigator: Rajdeep Pooni, MD

Sub-Investigator: Meiqian Ma, MD

Sub-Investigator: Vivian Saper, MD

Sub-Investigator: Sara Patrizi, DO

Sub-Investigator: Cathy Tsin, MD

Sub-Investigator: Amanda Moyer, MD

Sub-Investigator: Jully Padam, MD

Rady Children's Hospital San Diego; Recruiting

San Diego, California, United States, 92123

Contact: Tatiana Garcia tgarcia3@rchsd.org

Principal Investigator: Johanna Chang, MD

Sub-Investigator: Peter Chiraseveenuprapund, MD

Sub-Investigator: Robert Sheets, MD

University of California at San Francisco Medical Center; Recruiting

San Francisco, California, United States, 94143

Contact: Katrina Gonzales katrina.gonzales@ucsf.edu

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: Rebecca Olveda, MD

United States, Colorado

The Children's Hospital of Colorado; Recruiting

Aurora, Colorado, United States, 80045

Contact: Ryan Oakes Ryan.Oakes@childrenscolorado.org

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

Sub-Investigator: Katherine Nowicki, MD

Sub-Investigator: Megan Perron, MD

United States, Connecticut

Connecticut Children's Medical Center; Recruiting

Hartford, Connecticut, United States, 06106

Contact: Jennifer Twachtman-Bassett Jtwachtman@connecticutchildrens.org

Principal Investigator: Barbara Edelheit, MD

Sub-Investigator: Blaine Lapin, MD

Sub-Investigator: Heather Tory, MD

Sub-Investigator: Janine Collinge, MD

Yale University; Recruiting

New Haven, Connecticut, United States, 06519

Contact: Catherine Tsao 203-785-5977 catherine.tsao@yale.edu

Principal Investigator: Ian Ferguson, MD

United States, District of Columbia

Childrens National Medical Center; Recruiting

Washington, District of Columbia, United States, 20010

Contact: Katie Dunnock 202-476-5746 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: Matthew Sherman, MD

Sub-Investigator: Sandra Ogbonnaya-Whittesley, MD

United States, Florida

University of Florida - Shand's Children's Hospital; Recruiting

Gainesville, Florida, United States, 32608

Contact: Heather Bell-Brunson, ARNP 352-294-5585 brunsdh@peds.ufl.edu

Principal Investigator: Leandra Woolnough, MD

Sub-Investigator: Melissa Elder, MD, PhD

Sub-Investigator: Renee Frances Modica, MD

Nicklaus Children's Hospital; Recruiting

Miami, Florida, United States, 33155

Contact: Stephanie Uriguen 786-624-4610 Stephanie.Uriguen@Nicklaushealth.org

Principal Investigator: Yonit Sterba Rakovchik, MD

Sub-Investigator: Arielle Hay, MD

Nemours Children's Hospital; Recruiting

Orlando, Florida, United States, 32827

Contact: Jeamy Hecker jh0056@NEMOURS.ORG

Principal Investigator: Mary Toth, MD

Sub-Investigator: Traci Futch-West, NP

Johns Hopkins All Children's Hospital; Recruiting

Saint Petersburg, Florida, United States, 33701

Contact: Naketra Thomas 727-767-6949 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

United States, Georgia

Emory Children's Center; Recruiting

Atlanta, Georgia, United States, 30322

Contact: Lori Ponder 404-727-3583 laponde@emory.edu

Principal Investigator: Sampath Prahalad, MD

Sub-Investigator: Cynthia Manos, MD

Sub-Investigator: Elaine Flanagan, MD

Sub-Investigator: Kelly Rouster-Stevens, MD

Sub-Investigator: Angela Taneja, MD

Georgia Regents University Medical Center; Recruiting

Augusta, Georgia, United States, 30912

Contact: Heidi Stapp 706-721-7699 hstapp@augusta.edu

Principal Investigator: Julisa Patel, MD

Sub-Investigator: Barbara Kienzle, RN

Sub-Investigator: Lauren Newhall, DO

United States, Illinois

University of Illinois at Chicago; Withdrawn

Chicago, Illinois, United States, 60607

Ann & Robert H. Lurie Children's Hospital of Chicago; Recruiting

Chicago, Illinois, United States, 60614

Contact: Maria Amoruso MAmoruso@luriechildrens.org

Principal Investigator: Marisa Klein-Gitelman, MD

Sub-Investigator: Deirdre De Ranieri, MD

Sub-Investigator: Megan Hiskey, APN

Sub-Investigator: Michael Miller, MD

Sub-Investigator: Brian Nolan, MD

Sub-Investigator: Amy Paller, MD

Sub-Investigator: Pooja Patel, DO

University of Chicago Medical Center; Recruiting

Chicago, Illinois, United States, 60637

Contact: Charles Plasterer 773-702-1191 cplaster@peds.bsd.uchicago.edu

Principal Investigator: Melissa Tesher, MD

Sub-Investigator: Cuoghi Edens, MD

Sub-Investigator: Linda Wagner-Weiner, MD

Sub-Investigator: Joseph McDonald, MD

Sub-Investigator: Ryan Mitacek, MD

United States, Indiana

Indiana University School of Medicine; Recruiting

Indianapolis, Indiana, United States, 46202

Contact: Cari Gallagher 317-274-2143 carigall@iu.edu

Principal Investigator: Stacey Tarvin, MD

Sub-Investigator: Susan Ballinger, MD

Sub-Investigator: Michael Blakley, MD

Sub-Investigator: Thomas Klausmeier, MD

Sub-Investigator: Melissa Oliver, MD

Sub-Investigator: Martha Rodriguez, MD

Sub-Investigator: Brandi Stevens, MD

United States, Iowa

The University of Iowa Hospitals and Clinics (University of Iowa Children's Hospital); Recruiting

Iowa City, Iowa, United States, 52242

Contact: Emma Leisinger 402-237-9936 emma-leisinger@uiowa.edu

Principal Investigator: Sandy Hong, MD

Sub-Investigator: Polly Ferguson, MD

Sub-Investigator: Courtney Kremer, ARNP

Sub-Investigator: Scott Lieberman, MD, PhD

Sub-Investigator: Katherine Schultz, MD

Sub-Investigator: Shima Yasin, MD

United States, Kansas

University of Kansas Medical Center; Terminated

Kansas City, Kansas, United States, 66160

United States, Kentucky

University of Louisville Schoole of Medicine; Recruiting

Louisville, Kentucky, United States, 40202

Contact: Kristin Klein 502-588-4911 kristin.klein@louisville.edu

Principal Investigator: Kenneth Schikler, MD

Sub-Investigator: Janice Sullivan, MD

United States, Massachusetts

Tufts Medical Center; Recruiting

Boston, Massachusetts, United States, 02111

Contact: Bipin Malla 617-636-1044 BMalla@tuftsmedicalcenter.org

Principal Investigator: Trevor Davis, MD

Sub-Investigator: Yujuan (Julia) Zhang, MD

Massachusetts General Hospital for Children; Recruiting

Boston, Massachusetts, United States, 02114

Contact: Marc Natter, RN 617-726-2730 mnatter@mgh.harvard.edu

Principal Investigator: Marc Natter, MD

Sub-Investigator: Holly Rothermel, MD

Sub-Investigator: Deborah Rothman, MD

Boston Children's Hospital; Recruiting

Boston, Massachusetts, United States, 02115

Contact: Emily Zhang Emily.Zhang@childrens.harvard.edu

Principal Investigator: Fatma Dedeoglu, MD

Sub-Investigator: Olha Halyabar, MD

Sub-Investigator: Jonathan Hausmann, MD

Sub-Investigator: Lauren Henderson, MD

Sub-Investigator: Pui Lee, MD, PhD

Sub-Investigator: Mindy Lo, MD, PhD

Sub-Investigator: Esra Meidan, MD

Sub-Investigator: Peter Nigrovic, MD

Sub-Investigator: Mary Beth Son, MD

Sub-Investigator: Robert Sundel, MD

Sub-Investigator: Joyce Chang, MD

Sub-Investigator: Margaret Chang, MD

Sub-Investigator: Ezra Cohen, MD

Bay State Medical Center; Terminated

Springfield, Massachusetts, United States, 01105

United States, Michigan

University of Michigan; Recruiting

Ann Arbor, Michigan, United States, 48109

Contact: Sara Vandenbergen savanden@med.umich.edu

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: Jeff Rafko, RN, BSN

Sub-Investigator: Meredith Riebschleger, MD

Sub-Investigator: Ajay Tambralli, MD

Helen Devos Children's Hospital; Recruiting

Grand Rapids, Michigan, United States, 49503

Contact: Rachel Thome 616-267-2700 Rachel.Thome@helendevoschildrens.org

Principal Investigator: Khalid Abulaban, MD

Sub-Investigator: Elizabeth Kessler, MD

West Michigan Rheumatology; Terminated

Grand Rapids, Michigan, United States, 49546

United States, Minnesota

University of Minnesota; Recruiting

Minneapolis, Minnesota, United States, 55454

Contact: Sara Kramer 612-301-1554 krame455@umn.edu

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

Mayo Clinic; Recruiting

Rochester, Minnesota, United States, 55905

Contact: Noelle Drapeau 507-266-6397 drapeau.noelle2@mayo.edu

Principal Investigator: Matthew Basiaga, DO

Sub-Investigator: Thomas Mason, MD

Sub-Investigator: Amir Orandi, MD

United States, Mississippi

University of Mississippi Medical Center; Recruiting

Jackson, Mississippi, United States, 39216

Contact: Nicole Johnson lnjohnson@umc.edu

Principal Investigator: Anita Dhanrajani, MBBS

Sub-Investigator: Linda Ray, MD

Sub-Investigator: Charles Spencer, MD

Sub-Investigator: Yasmin Elzaki

United States, Missouri

Children's Mercy Hospital; Recruiting

Kansas City, Missouri, United States, 64108

Contact: Ashley Cooper 816-234-3686 amcooper@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

Saint Louis University School of Medicine; Recruiting

Saint Louis, Missouri, United States, 63104

Contact: Anne Imlay 314-977-8844 aimlay@slu.edu

Principal Investigator: Mara Horwitz, MD

Sub-Investigator: Austin Dalrymple, DO

Saint Louis Children's Hospital; Recruiting

Saint Louis, Missouri, United States, 63110

Contact: Kristen McDaniels 314-273-9064 k.mcdaniels@wustl.edu

Principal Investigator: Kevin Baszis, MD

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

Sub-Investigator: Reema Syed, MD

Principal Investigator: Andrew White, MD

Sub-Investigator: Kentaro Yomogida, MD

United States, New Jersey

Hackensack University Medical Center; Recruiting

Hackensack, New Jersey, United States, 07601

Contact: Mary Ellen Riordan 551-996-8126 Maryellen.Riordan@hackensackmeridian.org

Principal Investigator: Jennifer Weiss

Sub-Investigator: Ginger Janow

Sub-Investigator: Yukiko Kimura

Sub-Investigator: Sivia Lapidus

Sub-Investigator: Suzanne Li

Goryeb Children's Hospital; Recruiting

Morristown, New Jersey, United States, 07960

Contact: Marie Fox 973-971-6308 marie.fox@atlantichealth.org

Principal Investigator: Simona Nativ, MD

Sub-Investigator: Sarah Paul, DO

Sub-Investigator: Elizabeth DeSantis, APN

Robert Wood Johnson Medical School; Recruiting

New Brunswick, New Jersey, United States, 08901

Contact: Lisa Cerracchio 732-235-5976 cerracli@rwjms.rutgers.edu

Principal Investigator: Nandini Moorthy, MD

The Pediatric Specialty Center at Saint Barnabas; Recruiting

West Orange, New Jersey, United States, 07052

Contact: Marta Alpizar 973-322-6960 Marta.Alpizar@rwjbh.org

Principal Investigator: Elizabeth Chalom, MD

United States, New York

Albany Medical College; Recruiting

Albany, New York, United States, 122089

Contact: Wendy Stewart stewarw@amc.edu

Principal Investigator: Lilliana Barillas-Arias, MD

Sub-Investigator: Liza Bermudez-Santiago, MD

Sub-Investigator: Maricarmen Lopez-Pena, MD

Cohen Children's Medical Center of New York; Recruiting

Lake Success, New York, United States, 11042

Contact: Nanda Karan 516-659-5070 NKaran@northwell.edu

Principal Investigator: Beth Gottlieb, MD

Sub-Investigator: Anne Eberhard, MSc

Sub-Investigator: Joyce Hui-Yuen, MD

Sub-Investigator: Patricia Lee, RN

Sub-Investigator: Marilynn Orlando, RN

Sub-Investigator: Katherine Steigerwald, MD

Sub-Investigator: Heather Walters, MD

Sub-Investigator: Zanab Mian, DO

Sub-Investigator: Lydia Thomas, MD

New York University Langone Medical Center; Recruiting

New York, New York, United States, 10016

Contact: Philip Kahn 212-263-9969 philip.kahn@nyumc.org

Principal Investigator: Philip Kahn, MD

Sub-Investigator: Risa Alpersin, MD

Hospital for Special Surgery; Recruiting

New York, New York, United States, 10021

Contact: Lwam Asfaw 212-606-1302 asfawL@hss.edu

Principal Investigator: Karen Onel, MD

Sub-Investigator: Alexa Adams, MD

Sub-Investigator: Wiliam Ambler, MD

Sub-Investigator: Jessica Fennell, MD

Sub-Investigator: Nancy Pan, MD

Sub-Investigator: Sarah Taber, MD

Sub-Investigator: Lauren Robinson, MD

Sub-Investigator: Leanne Mansfield, MD

Sub-Investigator: Jheel Pandya, MD

Columbia University Medical Center; Recruiting

New York, New York, United States, 10032

Contact: Nisha Philip 212-342-2753 np2173@cumc.columbia.edu

Principal Investigator: Lisa Imundo, MD

Sub-Investigator: Alexis Boneparth, MD

Sub-Investigator: Hana Conlon, CPNP, RN

Children's Hospital at Montefiore; Recruiting

New York, New York, United States, 10467

Contact: Evin Rothschild evin.rothschild@einsteinmed.org

Principal Investigator: Dawn Wahezi, MD

Sub-Investigator: Tamar Rubinstein, MD

Sub-Investigator: Tamara Tanner, MD

Sub-Investigator: Natalia Vasquez, MD

Sub-Investigator: Jennifer Velez, NP

Sub-Investigator: Alisha Akinsete, MD

Sub-Investigator: Malki Peskin, MD

University of Rochester; Recruiting

Rochester, New York, United States, 14642

Contact: Kaili Widrick 585-275-8991 Kaili_Widrick@URMC.Rochester.edu

Principal Investigator: Christina Schutt, DO

Sub-Investigator: Andrew Long, MD

Sub-Investigator: Bethany Marston, MD

Sub-Investigator: Barbra Murante, NP

Sub-Investigator: Homaira Rahimi, MD

Sub-Investigator: David Siegel, MD

Sub-Investigator: Amy Vallee, NP

United States, North Carolina

University of North Carolina at Chapel Hill; Recruiting

Chapel Hill, North Carolina, United States, 27599

Contact: Corinne Lawler 919-962-9841 corinne.lawler@unc.edu

Principal Investigator: Eveline Wu, MD

Sub-Investigator: Laura Cannon, MD

Sub-Investigator: Leonard Kovalick, PNP

Sub-Investigator: Aliese Sarkissian, MD

Levine Children's Hospital / Carolinas Medical Center; Recruiting

Charlotte, North Carolina, United States, 28203

Contact: Elizabeth Rivas Elizabeth.Rivas@atriumhealth.org

Principal Investigator: Thomas Griffin, MD

Sub-Investigator: Sheetal Vora, MD

Duke Children's Hospital & Health Center; Recruiting

Durham, North Carolina, United States, 27710

Contact: Cara Mariani 919-684-2575 cara.mariani@duke.edu

Principal Investigator: Consuela Rabinovich, 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: Heather Van Mater, MD

Sub-Investigator: Caitlin Swaffar, MD

Wake Forest Baptist Brenner Children's Hospital; Recruiting

Winston-Salem, North Carolina, United States, 27012

Contact: Lauren Vannoy 336-716-7541 lvannoy@wakehealth.edu

Principal Investigator: Onengiya Harry, MD

United States, North Dakota

Sanford Health; Recruiting

Fargo, North Dakota, United States, 58122

Contact: Kathy McEvoy Kathryn.Mcevoy@SanfordHealth.org

Principal Investigator: Grant Syverson, MD

United States, Ohio

Akron Children's Hospital; Recruiting

Akron, Ohio, United States, 44308

Contact: Danielle Rogers drogers@akronchildrens.org

Principal Investigator: Kate Phillippi, DO

Sub-Investigator: Nancy Delnay, CNP

Sub-Investigator: Steven Spalding, MD

Cincinnati Children's Hospital Medical Center; Recruiting

Cincinnati, Ohio, United States, 45229

Contact: Megan Quinlan-Waters 513-803-2891 Megan.Quinlan-Waters@cchmc.org

Principal Investigator: Hermine Brunner, MD

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: Janalee Taylor, APRN

Sub-Investigator: Tracy Ting, MD

Sub-Investigator: Sheila Angeles-Han, MD

Sub-Investigator: Ekemini Ogbu, MD

UH Rainbox Babies and Children's Hospital; Terminated

Cleveland, Ohio, United States, 44106

Metrohealth Medical Center; Recruiting

Cleveland, Ohio, United States, 44109

Contact: Bonnie Rosolowski 216-778-5423 brosolowski@metrohealth.org

Principal Investigator: Hulya Bukulmez, MD

Sub-Investigator: Nora Singer, MD

Cleveland Clinic Foundation; Recruiting

Cleveland, Ohio, United States, 44195

Contact: Patrick O'Rourke OROURKP@ccf.org

Principal Investigator: Angela Robinson, MD

Sub-Investigator: Elizabeth Brooks, MD

Sub-Investigator: Sirada Panupattanapong, MD

Sub-Investigator: Andrew Zeft, MD

Nationwide Children's Hospital; Recruiting

Columbus, Ohio, United States, 43205

Contact: Joanne Drew 614-722-0741 joanne.drew@nationwidechildrens.org

Principal Investigator: Stacy Ardoin, MD

Sub-Investigator: Shoghik Akoghlanian, MD

Sub-Investigator: Christine Bacha, MD

Sub-Investigator: Kyla Driest, MD

Sub-Investigator: Samuel Gagne, MD

Sub-Investigator: Edward Oberle, MD

Sub-Investigator: Vidya Sivaraman, MD

Sub-Investigator: Bethanne Thomas, CPNP-PC

Sub-Investigator: Alysha Taxter, MD

United States, Oregon

Randall Children's Hospital at Legacy Emanuel; Recruiting

Portland, Oregon, United States, 97227

Contact: Jessica Marquis jmarquis@lhs.org

Principal Investigator: Daniel Kingsbury, MD

Sub-Investigator: Victoria Cartwright, MD

Sub-Investigator: Andrew Lasky, MD

United States, Pennsylvania

Penn State Children's Hospital; Recruiting

Hershey, Pennsylvania, United States, 17033

Contact: Meredith Buckley 717-531-0003 ext 286546 mbuckley@pennstatehealth.psu.edu

Principal Investigator: Timothy Hahn, MD

Sub-Investigator: Alexis Begezda, MD

Sub-Investigator: Catherine Bingham, MD

Sub-Investigator: Brandt Groh, MD

Sub-Investigator: Kim Hays, MD

Sub-Investigator: Lisa Scalzi, MD

Children's Hospital of Philadelphia; Recruiting

Philadelphia, Pennsylvania, United States, 19104

Contact: Colin Burns 267-426-8726 BURNSC3@EMAIL.CHOP.EDU

Principal Investigator: Pamela Weiss, MD

Sub-Investigator: Melissa Lerman, MD, PhD

Sub-Investigator: Edward Behrens, MD

Saint Christopher's Hospital for Children; Recruiting

Philadelphia, Pennsylvania, United States, 19134

Contact: Donald Goldsmith 251-427-4379 Donald.goldsmith@drexelmed.edu

Principal Investigator: Donald Goldsmith, MD

Sub-Investigator: Svetlana Lvovich, DO

Sub-Investigator: Dana Toib, MD

Children's Hospital of Pittsburgh UPMC; Recruiting

Pittsburgh, Pennsylvania, United States, 15224

Contact: Margalit Rosenkranz 412-692-5652 margalit.rosenkranz@chp.edu

Principal Investigator: Margalit Rosenkranz, MD

Sub-Investigator: Scott Canna, MD

Sub-Investigator: Elaine Cassidy, MD

Sub-Investigator: Kathryn Torok, MD

United States, Rhode Island

Hasbro Children's Hospital; Recruiting

Providence, Rhode Island, United States, 02903

Contact: Nadia Nasah 401-444-8722 NNasah@Lifespan.org

Principal Investigator: Ali Yalcindag, MD

United States, South Carolina

Medical University of South Carolina Children's Hospital; Recruiting

Charleston, South Carolina, United States, 29425

Contact: Allison Guill guill@musc.edu

Principal Investigator: Natasha Ruth, MD

Sub-Investigator: Mileka Gilbert, MD

United States, Tennessee

Monroe Carrell Jr. Children's Hospital at Vanderbilt; Recruiting

Nashville, Tennessee, United States, 37232

Contact: Lori Michalowski 615-343-8010 lori.michalowski@vumc.org

Principal Investigator: Thomas Graham, MD

United States, Texas

University of Texas Southwestern Medical Center Dallas; Recruiting

Dallas, Texas, United States, 75219

Contact: Lenice Franklin 214-559-8531 lenice.franklin@tsrh.org

Principal Investigator: Katie Stewart, MD

Sub-Investigator: Stephanie Armendariz, ARNP

Sub-Investigator: Julie Fuller, MD

Sub-Investigator: Lorioen Nassi, MD

Sub-Investigator: Tracey Wright, MD

Sub-Investigator: Maryem Al Manaa, MD

Sub-Investigator: Hannah Bradfield, MD

Sub-Investigator: Michelle Lloyd, RN

Sub-Investigator: Elizabeth Sloan, MD

Sub-Investigator: Kristina Ciaglia, MD

Baylor College of Medicine Pediatric Immunology Allergy Rheumatology; Recruiting

Houston, Texas, United States, 77030

Contact: Monica Guevara 832-824-1206 Monica.Guevara@bcm.edu

Principal Investigator: Marietta DeGuzman, MD

Sub-Investigator: Amanda Brown, MD

Sub-Investigator: Martha Curry, PNP

Sub-Investigator: Eyal Muscal, MD

Sub-Investigator: Scott Wenderfer, MD, PhD

United States, Utah

University of Utah Hospitals and Clinics (Primary Children's Hospital); Recruiting

Salt Lake City, Utah, United States, 84113

Contact: Suzy Richins 801-585-5067 suzy.richins@hsc.utah.edu

Principal Investigator: Christi Inman, MD

Sub-Investigator: John Bohnsack, MD

Sub-Investigator: Deborah Durkee, APRN

Sub-Investigator: Sylvie Fadrhonc, PA-C

Sub-Investigator: Aimec Hersh, MD

Sub-Investigator: Karen James, MD

Sub-Investigator: Sara Stern, MD

United States, Vermont

University of Vermont Medical Center; Recruiting

Burlington, Vermont, United States, 05401

Contact: Katherine Rampone 802-656-9041 katherine.rampone@med.uvm.edu

Principal Investigator: Matthew Hollander, MD

United States, Virginia

Children's Hospital of the King's Daughters; Recruiting

Norfolk, Virginia, United States, 23507

Contact: Cassyanne Aguiar Cassyanne.Aguiar@chkd.org

Principal Investigator: Cassyanne Aguiar, MD

United States, Washington

Seattle Children's Hospital; Recruiting

Seattle, Washington, United States, 98105

Contact: Avery Huberts Avery.Huberts@seattlechildrens.org

Principal Investigator: Yongdong (Dan) Zhao, MD, PhD

Sub-Investigator: Eric Allenspach, MD, PhD

Sub-Investigator: Sarah Baxter, 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: Kabita Nanda, MD

Sub-Investigator: Natalie Rosenwasser, MD

Sub-Investigator: Susan Shenoi, MBBS, MS

Sub-Investigator: Jacob Spitznagle, MD

Sub-Investigator: Stephen Wong, MD

United States, Wisconsin

University of Wisconsin, American Family Children's Hospital; Recruiting

Madison, Wisconsin, United States, 53792

Contact: Joni Dean 608-890-8280 jdean@uwhealth.org

Principal Investigator: Dominic Co, MD, PhD

Sub-Investigator: Judith Smith, MD, PhD

Children's Hospital Of Wisconsin; Recruiting

Wauwatosa, Wisconsin, United States, 53226

Contact: Erin Hammelev 412-266-6352 ehammele@mcw.edu

Principal Investigator: Sara Sabbagh, DO

Sub-Investigator: Danielle Fair, MD

Sub-Investigator: James Nocton, MD

Sub-Investigator: Elizabeth Roth-Wojcicki, CPNP

Sub-Investigator: James Verbsky, MD, PhD

Sub-Investigator: Calvin Williams, MD, PhD

Canada, Alberta

University of Calgary - Alberta Children's Hospital; Recruiting

Calgary, Alberta, Canada, AB T38 6A8

Contact: Sarah Ahira 403-955-5537 sarah.ahira@albertahealthservices.ca

Principal Investigator: Marinka Twilt, MD, PhD

Sub-Investigator: Nicole Johnson, MD

Sub-Investigator: Nadia Luca, MD

Sub-Investigator: Paivi Miettunen, MD

Sub-Investigator: Heinrike Schmeling, MD, PhD

Sub-Investigator: Rebeka Stevenson, MD

Sub-Investigator: Susanne Benseler, MD, PhD

Canada, Manitoba

University of Manitoba - Children's Hospital of Manitoba; Recruiting

Winnipeg, Manitoba, Canada, R3E 3P4

Contact: Ramandeep Kaur Ramandeep.Kaur@umanitoba.ca

Principal Investigator: Lily Lim, PhD

Canada, Nova Scotia

IWK Health Center; Recruiting

Halifax, Nova Scotia, Canada, NS B3K 6R8

Contact: Victoria Westheuser 902-470-7414 Victoria.Dempsey@iwk.nshealth.ca

Principal Investigator: Adam Huber, MD

Sub-Investigator: Bianca A Lang, MD

Sub-Investigator: Suzanne Ramsey, MD

Sub-Investigator: Elizabeth Stringer, MD

Sub-Investigator: Chelsea DeCoste, MD

Canada, Ontario

The Hospital for Sick Children; Recruiting

Toronto, Ontario, Canada

Contact: Ingrid Goh 416-813-6372 ingrid.goh@sickkids.ca

Principal Investigator: Brian Feldman, MD

Sub-Investigator: Amani AlBijadi, MD

Sub-Investigator: Audrea Chen, MD

Sub-Investigator: Tala El Tal, MD

Sub-Investigator: Linda Hiraki, MD

Sub-Investigator: Ronald Laxer, MDCM

Sub-Investigator: Deborah Levy, MD

Sub-Investigator: Elizaveta Limenis, MD

Sub-Investigator: Jayne MacMahon, MD

Sub-Investigator: Jeanine McColl, MD

Sub-Investigator: Oscar Mwizerwa, MD

Sub-Investigator: Rayfel Schneider, 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: Abdulaziz Almutairi, MD

Sub-Investigator: Dilan Dissanayake, MD

Sub-Investigator: Andrea Knight, MD

Israel

Schneider Children's Medical Center of Israel; Recruiting

Petach Tikva, Israel, 49202-35

Contact: Talya Stein talyaste@clalit.org.il

Principal Investigator: Liora Harel, MD, PhD

Sub-Investigator: Gil Amarilyo, MD, PhD

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: Adi Paoop Toledano, MD

Sub-Investigator: Rotem Tal, MD

Italy

IRCCS Ospedale Pediatrico Bambino Gesu (OPBG); Not yet recruiting

Rome, Italy

Contact: Denise Pires Marafon 0039 06 6859 2801 demarafon@yahoo.com

Principal Investigator: Fabrizio De Benedetti

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 Jorge Children's Hospital; Withdrawn

San Juan, Puerto Rico, 00912

Sponsors and Collaborators

Duke University

Childhood Arthritis and Rheumatology Research Alliance

Investigators

• Principal Investigator: Laura Schanberg, MD; Duke Clinical Research Insitute
• Principal Investigator: Yuki Kimura, MD; Hackensack Meridian Health
• Principal Investigator: Timothy Beukelman, MD, MSCE; University of Alabama at Birmingham

More Information

Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: Duke University
• ClinicalTrials.gov Identifier: NCT02418442
• Other Study ID Numbers: Pro00054616
• First Posted: April 16, 2015
• Last Update Posted: May 9, 2022
• Last Verified: November 2021

Keywords provided by Duke University:

Systemic Arthritis; Oligoarthritis; Polyarthritis (Rheumatoid Factor Negative); Polyarthritis (Rheumatoid Factor Positive); Psoriatic Arthritis; Enthesitis Related Arthritis (ERA); Undifferianted Arthritis; CARRA Consensus Treatment Plans

Additional relevant MeSH terms:

Rheumatic Diseases; Joint Diseases; Collagen Diseases; Musculoskeletal Diseases; Connective Tissue Diseases