Research in Pediatric Rheumatology is a fast-changing field, and we offer opportunities to participate in research studies of several types. As new medications are developed and tested in adults, they require further research before they can be given to children with similar diseases. Such pharmacologic trials or drug trials are one category of research done through Riley Rheumatology. We also conduct post-market, observational research studies, known as registries that monitor long-term outcomes of children taking approved medications over the course of several years. Data from these registries help us identify benefits and rare safety issues that are only seen years after a medication is begun. This information is for optimal care of our individual patients. Additionally, we have studies that look at various biomarkers (like blood test results or other characteristics of a disease) that may help predict an individual child’s response to a medication.
Regardless of the study design, the protocols are often very specific, and enroll only a narrow range of research volunteers: perhaps children in a certain age group, perhaps those with an unusual variant of juvenile arthritis, or with a particular type of kidney involvement in lupus. If we find that your child fits the spectrum of disease studied in a clinical trial, your physician may ask your consent to discuss the trial with our research coordinators. Our team works to ensure that no patient or family feels pressure to participate in research, and we follow the highest ethical standards throughout the consent process and throughout the research experience. Research participation is strictly voluntary, and we support every individual’s right to participate, and to decline.
Current studies in progress through Riley Rheumatology include:
- Effects of Pubertal Hormone Changes on Early Onset Systemic Lupus Erythematosus. Funding – NIH, Lupus Foundation of America, Department of Pediatrics at Indiana University School of Medicine. Aim: To identify major hormonal triggers to flare in lupus disease activity and the molecular pathways by which they occur after hormone changes during natural puberty in childhood SLE. Principal Investigator: K. M. O’Neil, MD. Closed.
- Infections as Triggers to Flare in Systemic Lupus Erythematosus. Funding – Department of Pediatrics, IU School of Medicine. Aim: To identify if and through what immunologic mechanisms flares of lupus are triggered by common viral infections. Principal Investigator: K. M. O’Neil, MD. Enrolling.
- HER-2 Transcription Factor as a Urinary Biomarker in Juvenile Systemic Lupus Erythematosus. Funding – CARRA. Aim: to test the utility of a potential urine biomarker of renal inflammation (glomerulonephritis) in children and adolescents with systemic lupus erythematosus. Principal Investigator: K. M. O’Neil, MD. Enrolling.
- Abatacept Registry in Juvenile Idiopathic Arthritis. Funding – Bristol Meyers Squibb, Inc. Sponsored by PRCSG (Pediatric Rheumatology Collaborative Study Group). Aim: To identify long term outcomes, efficacy and safety of abatacept treatment for JIA. Principal Investigator: K. M. O’Neil, MD. Enrolling.
- PedVas: A pediatric vasculitis registry. Funding – Canadian Institutes for Health Research. Sponsored by CARRA. Aim: To better understand the clinical manifestations of systemic vasculitis in childhood and to find best treatment practices. Principal Investigator: K. M. O’Neil, MD. Enrolling.
- The Childhood Arthritis and Rheumatology Research Alliance (CARRA) Registry. Riley at IU Health participates in this multicenter research study, which is housed at Duke University. This registry represents an ongoing effort that will be used to answer pressing questions about the current medicines used to treat pediatric rheumatic conditions. For more information on The CARRA Registry, please contact department research coordinator Mariah Boncek at 317.274.2172.
- FiRst Line Options for Systemic JIA Treatment (FROST). This is an extension of the CARRA Registry. FROST is specifically for patients who are newly diagnosed with systemic JIA. The goal of the study is compare and determine the effectiveness of treatment strategies in the early stages of treatment intervention.
- Start Time Optimization in Polyarticular Juvenile Idiopathic Arthritis (STOP-JIA) Project. This is an extension of the CARRA Registry. STOP-JIA is specifically for patients who are newly diagnosed with polyarticular JIA. The goal of the study is compare and determine the effectiveness of treatment strategies in the early stages of treatment intervention.
- Gene Expression In Polyarticular Juvenile Idiopathic Arthritis. Funding – NIH. Aim: The purpose of this multicenter national study is to understand responses to different medications for juvenile idiopathic arthritis (JIA). Site Principal Investigator: K. M. O’Neil, MD. Closed to enrollment.
- Safety and Efficacy of tofacitinib in polyarticular juvenile idiopathic arthritis. Funding – Pfizer Inc. Aim: To determine the safety and efficacy of a liquid suspension of tofacitinib in treating polyarticular juvenile idiopathic arthritis. Principal Investigator: S. E. Tarvin, MD, MSc.
- Safety and Efficacy of subcutaneous certolizumab pegol in polyarticular juvenile idiopathic arthritis. Funding – UCB Inc. Aim: To establish safety and efficacy of certolizumab pegol in the treatment of polyarticular juvenile idiopathic arthritis. Principal Investigator: S. E. Tarvin, MD, MSc. Closed to enrollment.