About Us

The Pediatric Rheumatology Collaborative Study Group (PRCSG), founded in 1973, is a consortium of over 80 academic clinical pediatric rheumatology centers in the United States and Canada. The chief aim of the PRCSG is to conduct high quality clinical trials of therapeutic agents in children with rheumatic diseases.

The mission of the PRCSG is to conduct high quality clinical trials, of therapeutic agents, in children with rheumatic diseases.

 

The network is actively involved with regulatory authorities and industry sponsors to advance clinical trial design and develop clinical trial outcome measures for less common pediatric rheumatic diseases.

Hermine Brunner
Hermine Brunner, MD, MSc MBA Chairman and Scientific Director Cincinnati Children's Hospital Medical Center
Daniel Lovell
Daniel J. Lovell, MD, MPH Immediate Past Chairman Cincinnati Children's Hospital Medical Center
Michael Shishov
Michael Shishov, MD, MPH Scientific Director - elect Phoenix Children’s Hospital

The PRCSG is governed by a set of Bylaws  and is overseen by an Advisory Council (AC).  The chief functions of the Advisory Council are to provide leadership and guidance for the PRCSG in the following areas: identification and facilitation of research areas most likely to be successful and clinically useful; seeking of funded support for the groups research efforts; management and quality assurance of the PRCSG’s membership, its scientific studies, statistical analyses, databases generated, and publications. Membership of the AC consists of Chair and Scientific Director, Hermine Brunner, MD, MSc; Scientific Director-elect, Michael Shishov, MD, MPH; Immediate Past-Chairman, Dan Lovell, MD, MPH; Principal Investigators of the PRCSG; 3 established clinical investigators, 2 junior investigators.  In addition, representatives  from the Food and Drug Association (FDA), the National Institutes of Health (NIH), Rheumatology Nurses Society, Association of Rheumatology Professionals, and the Arthritis Foundation.

Hermine Brunner
Hermine Brunner, M.D., M.Sc., M.B.A. Dr. Brunner is a pediatric rheumatologist and clinical trialist in pediatric diseases. She serves several Steering Committees and Data Monitoring Committees for pediatric drug trials and has experience in interacting with regulatory agencies. She has experience in the development, selection and use of outcome or response measures for clinical trials in pediatric rheumatic disease studies. Among others, she was involved in the development of response criteria for juvenile myositis, autoinflammatory diseases, uveitis, scleroderma, and systemic lupus. Her individual research is focused on biomarker discovery and validation for lupus nephritis and neuropsychiatric lupus.
Daniel Lovell
Daniel J. Lovell, M.D., M.P.H. Dr. Lovell is the Joseph E. Levinson Professor of Pediatrics at the Cincinnati Children’s Hospital Medical Center. His research career has been focused on design and performance of clinical trials to evaluate more effective treatments for children with rheumatic diseases. He chaired the Pediatric Rheumatology Collaborative Study Group (PRCSG) for 30 years (1991-2021) and thus was a leader in the design and performance of all the national and international studies of biologics in JIA including those in SJIA. He is currently co-leading, with Dr. Hermine Brunner, all the North American sites in the international prospective study to redefine the classification criteria for chronic arthritis in children. He has been involved with PR-COIN since 2011 and has been the QI director or co-director in the Division of Rheumatology for 15 years. He has authored more than 150 peer-reviewed publications and has had NIH funding for over 25 continuous years.
Michael Shishov
Michael Shishov, M.D., M.P.H. Dr. Shishov has been division chief of pediatric rheumatology at Phoenix Children’s Hospital since 2006. He has served as PI of numerous clinical trials with PRCSG, including the SINCERE study (Celebrex), Dr. Lovell’s TNF withdrawal study in JIA, and the number one enroller in North America in the IV Benlysta GSK study. Dr. Shishov is also the PI in the PR-COIN learning network since 2015. He has particular clinical and research interests in systemic JIA and juvenile dermatomyositis. He has served as scientific director-elect.
Sheila T. Angeles-Han
Sheila T. Angeles-Han, M.D., M.Sc. Dr. Angeles-Han is a pediatric rheumatologist dedicated to improving the outcomes of patients with autoimmune ocular disease, juvenile idiopathic arthritis, and juvenile myositis. Her research focuses on investigating ocular biomarkers and genetic risk factors of uveitis, understanding predictors of medication response to prevent blindness, and establishing a comprehensive assessment of pediatric uveitis outcomes. She developed and validated the only tool for pediatric uveitis, the “Effects of Youngsters’ Eyesight on Quality of Life” questionnaire (EYE-Q©). She also established a local registry and biorepository to improve functional outcomes of patients with juvenile myositis.
Ekemini Akan Ogbu
Ekemini Akan Ogbu, M.D. M.Sc. Dr. Ogbu is a pediatric rheumatologist and Physician Scientist who aims to improve outcomes and availability of effective treatments for childhood-onset systemic lupus erythematosus (cSLE) and other rheumatic conditions. Her clinical and translational research focuses on neuro-hematologic manifestations of SLE and early diagnosis. She has specific interest in cerebrovascular disease and neurocognitive dysfunction in cSLE, and outcome measures for neurologic and hematologic disease in cSLE. She is involved in both pharmacologic and non-pharmacologic clinical trials in pediatric rheumatic diseases.
Joyce Chang
Joyce Chang, M.D., M.S.C.E. Dr. Chang is a pediatric rheumatologist and an Assistant Professor of Pediatrics in the Division of Immunology at Boston Children’s Hospital and Harvard Medical School. She serves as Director of Clinical Research in the Rheumatology Section of the Division of Immunology, principal investigator of the Boston Children’s Hospital Lupus Registry, and site principal investigator of the Childhood Arthritis and Rheumatology Research Alliance Registry. She has dedicated her career to evaluating and improving outcomes of childhood-onset systemic lupus erythematosus and other pediatric rheumatic conditions. Her research addresses some of the most challenging problems spanning pediatric and adult lupus care, including cardiovascular disease prevention, medication adherence, transition from pediatric to adult health care, and health equity.
Deborah Levy
Deborah Levy, M.D., M.S. Dr. Levy is a pediatric rheumatologist with diverse interests in childhood-onset systemic lupus erythematosus (cSLE), juvenile arthritis, uveitis and other rare diseases. Her research interests focus on the long-term medical and psychosocial outcomes of childhood-onset SLE, and the study of alternate models of care to improve access and outcomes for patients in underserved communities. She has experience as an investigator and site PI in multiple clinical trials, and has worked in an advocacy role interacting with government and regulators to ensure access to therapeutics for patients. Dr. Levy has lived, trained and worked in the US and Canada.
Kabita Nanda
Kabita Nanda, M.D. Dr. Nanda is a pediatric rheumatologist and pediatric rheumatology fellowship program director. Her research focus is clinical trials to improve medication options for children with juvenile idiopathic arthritis. She has served as the site PI on numerous clinical trials with PRCSG. As fellowship program director for the past 10 years, she recruits and trains the next generation of pediatric rheumatologists to help relieve workforce shortages in our specialty. She also has a clinical focus on treatment of uveitis, and started the first multidisciplinary uveitis clinic at Seattle Children’s Hospital.
Pamela Weiss
Pamela Weiss, M.D., M.S.C.E. Dr. Weiss is an academic pediatric rheumatologist with advanced training in clinical epidemiology and a focus on the pharmacoepidemiology and outcomes of children with spondyloarthritis (SpA). She has developed disease response and outcome measures for youth with SpA as well as classification criteria for axial disease in juvenile SpA. She has over fifteen years of experience leading clinical research endeavors, including multicenter research and research involving international collaborations. She has served on Steering Committees, Advisory Boards, and Data Monitoring Committees for pediatric trials.

The centralized Coordinating Center manages all administrative, financial, regulatory and scientific matters related to the PRCSG. Our system is registered by Eagle Registrations Inc. for International Organization for Standardization (ISO) 9001:2015. To see a Description of Services, click here.

The PRCSG has completed, or is currently in the process of conducting, a total of more than 45 trials in children with juvenile idiopathic arthritis (JIA), systemic lupus erythematosus, vasculitis and familial Mediterranean fever. In addition, the PRCSG has performed and published many studies on methodological issues and secondary analyses of trial databases. The PRCSG has performed the vast majority of trials of medications for JIA in North America since 1977.

Drugs previously tested include:
  • Abatacept
  • Adalimumab
  • Anakinra
  • Baricitinib
  • Belimumab (IV and SC)
  • Canakinumab
  • Certolizumab Pegol
  • D-penicillamine
  • Etanercept
  • Golimumab
  • Hydroxychloroquine
  • Infliximab
  • Intravenous immunoglobulin
  • Methotrexate
  • Naproxen/Esomeprazole
  • NSAIDs & selective Cox2 inhibitors
  • Rilonacept
  • Secukinumab
  • Tocilizumab
  • Tofacitinib
  • Upadacitinib
  • Ustekinumab
For the earliest studies of the PRCSG, Drs. Earl Brewer and Giannini lead the effort. Since 1991 including all of the trials of biologic agents, the efforts were led by Drs. Lovell and Giannini, and  more recently Dr. Brunner, who have served as the designers and coordinators of the studies as well as overseeing data analysis and publications. Numerous secondary analyses that used data generated in the initial studies have provided meaningful answers to important clinical questions. These investigators developed and validated the currently accepted measures of clinical response and flare used in clinical trials involving children with JIA. These definitions of clinical response and flare were approved by both the FDA and EMA and were successfully utilized in the trial of the TNF-a blocker, etanercept, in children with severe JIA and in all JIA clinical trials submitted for regulatory approval since then. These same investigators also designed and performed the validation study of the Childhood Myositis Assessment Scale and have been actively involved in the definition of core sets of outcome measures and definitions of improvement for children with Juvenile Idiopathic Inflammatory Myopathies and childhood onset SLE.  This work was done in collaboration with the Pediatric Rheumatology InterNational Trials Organization (PRINTO). Recently, the PRCSG, in collaboration with PRINTO and the Childhood Arthritis and Rheumatology Research Alliance (CARRA) developed a preliminary definitions of clinical inactive disease and clinical remission for children with JIA. The PRCSG and PRINTO are working together to advance research and treatments for children with rheumatic diseases. To foster this relationship, a collaborative agreement exists with PRINTO.

The PRCSG emerged as a pediatric rheumatology research network in 1973 Indeed, Dr. Brewer, along with colleagues, officially formed the Pediatric Rheumatology Collaborative Study Group (PRCSG) whose chief goal was to conduct scientifically valid studies of promising new anti-inflammatory and disease modifying agents in children in order that they may be labeled for use in pediatric patients. Dr. Brewer was named the first Chairman of the group and is considered its founding father. Just 4 years later the PRCSG published its first study (Levinson JE, Baum J, Brewer EJ, Fink C, Hanson V, Schaller J: Comparison of tolmetin and aspirin in the treatment of juvenile rheumatoid arthritis. J Pediatr 1977, 91:799-804).

 

A Coordinating Center was formed that would oversee the design and progress of the studies, retrieve, manage and report the data, and assure compliance with applicable regulatory affairs. In 1976 Dr. Edward Giannini, an epidemiologist and biostatistician, was named the Senior Scientist for the group and founded the PRCSG Coordinating Center at Texas Children’s Hospital. The Coordinating Center moved to Cincinnati Children's Hospital in 1990.

 

An Advisory Council was formed to oversee the direction and operation of the growing consortium, and Bylaws were adopted that served to govern membership requirements, overall operation and delineate authorship guidelines.

 

Between 1976 and 1982 the PRCSG conducted six more studies of NSAIDs while refining and sharpening its methodologies, communications, and standardization of reporting. Blinded, controlled trials of four DMARDs(oral gold, d-penicillamine, hydroxychloroquine and oral methotrexate) were successfully completed and published by 1992. The standout drug proved to be methotrexate. As a result, methotrexate became recognized as the second line agent of first choice for many years thereafter, while the other drugs showed no more efficacy than placebo and rapidly disappeared from usage in JIA. Since those studies were completed, an array of other agents with a variety of mechanisms of action have been tested in JIA by the PRCSG (see link to publications below).

Due to dramatic increases in technology and an in-depth understanding of the underlying mechanism of the inflammatory process central to JIA, a new class of agents had become available by the early 1990’s. Since these new molecules, many of which were monoclonal antibodies, were directed against specific inflammatory mediators, they became known as ‘immune response modifiers’ or, more simply, ‘biologics’. The first tested in a clinical trial was an anti-TNF agent named etanercept (Enbrel®) which underwent trial by the PRCSG using a newly developed randomized, withdrawal design. The efficacy and short-term safety of this agent proved to be remarkable and by March of 2000 the results were published in the New England Journal of Medicine. Soon afterwards the drug was approved for use in JIA by the FDA, the first biologic to be approved for children. In 1996 pediatric rheumatology leaders from 14 different European countries came together to form the Pediatric Rheumatology International Trials Organization (PRINTO). Since that time PRINTO has grown to include over 91 different countries around the world. Professor Alberto Martini at Gaslini Hospital in Genoa, Italy has served as the Chairman of PRINTO since its inception and Dr. Nicola Ruperto, who spent 1 ½ years training with Drs. Giannini and Lovell in Cincinnati, has been the Senior Scientist and remains in that position today. An alliance was quickly formed with the PRCSG and the two groups have now performed trials that have led to FDA, EMA and world-wide approval for children of numerous biologicals, and worked collaboratively on various methodological papers to improve further the ascertainment of a patient’s disease state and activity, advanced the efficiency and user-friendliness of new and innovative study designs, and streamlined the standardization of data collection, management and reporting (for details please see Publications).