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Research

Research in pediatric rheumatology is a fast-changing field, and pediatric rheumatology offers 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 pediatric rheumatology at IU School of Medicine.

Pediatric rheumatologists 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 to identify benefits and rare safety issues that are only seen years after a medication is begun. This information provides insight to optimal care of each individual patient. This pediatrics specialty area also studies various biomarkers (such as 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 such as children in a certain age group, those with an unusual variant of juvenile arthritis, or with a particular type of kidney involvement in lupus.

Ethical Recruitment

The pediatric rheumatology team works to ensure that no patient or family feels pressure to participate in research and follows the highest ethical standards throughout the consent process and throughout the research experience. Research participation is strictly voluntary, and every individual has the right to participate and to decline.

Current Studies

Studies in progress through the Division of Pediatric Rheumatology at IU School of Medicine include a range of topic areas.

Get Research Updates

Research faculty throughout IU School of Medicine’s academic departments post updates about their work to the research updates blog. Stay up-to-date about medical research in pediatrics.

Pharmaceutical Trial

Funding: Roche

Aim: to assess the efficacy, safety, and pharmacokinetics of obinutuzumab in adolescent participants with International Society of Nephrology and the Renal Pathology Society Class III or IV active lupus nephritis receiving standard of care therapy with mycophenolate mofetil and corticosteroids. Recruiting for ages 5 to <12.

PI: Dr. Stacey Tarvin

CRC: Amy Rakestraw

Pharmaceutical Trial

Funding: AbbVie

Aim: Assess efficacy, safety, tolerability, and pharmacokinetics of Risankizumab with an Adalimumab reference arm in children and adolescent subjects ages 5 to < 18 years with active jPsA who have had an inadequate response to, or are intolerant of, Methotrexate (MTX) or other conventional synthetic disease-modifying antirheumatic drugs.

PI: Dr. Stacey Tarvin

CRC: Christina Sparks, MSW

Pharmaceutical Trials

Funding: Amgen

Aim: This phase 3, open-label, uncontrolled single arm study is designed to explore the efficacy, pharmacokinetics, and safety of Avacopan in combination with a rituximab or cyclophosphamide containing regimen, in children from 6 years to < 18 years with active AAV.

PI: Dr. Stacey Tarvin

CRC: Elly Duncan

Intervention Trial

Funding: PCORI, NIH, SAA

Back Off Logo

Aim: to determine whether fixed standard dosing, fixed longer dosing, or stopping TNFi will have the lowest risk of flare during a 12-month surveillance period and continued follow-up for an additional 24 months in children and young adults ages 8 to <22 years with spondyloarthritis who have inactive disease.

Enrollment to close in June 2025

PI: Dr. Stacey Tarvin

CRC: Elly Duncan

Intervention Trial

Funding: Childhood Arthritis Rheumatology Research Alliance

Aim: To determine the association between adalimumab or biosimilar trough levels and uveitis activity in induction therapy of children with chronic anterior uveitis

PI: Dr. Stacey Tarvin

CRC: Christina Sparks, MSW


Registry Study

Funding: Riley Childrens’ Foundation

Aim: To establish a prospective disease registry for TMJ related disorders including TMJ disease related to juvenile idiopathic arthritis, to investigate the natural history of the disease and to better characterize patient responses to clinical management.

PI: Dr. Stacey Tarvin, Dr. Susan B

PRCSG Logo

Registry Study

Funding: Bristol Myers Squibb, Inc. Sponsored by PRCSG

Aim: To Identify long term outcomes, efficacy, and safety of abatacept treatment for JIA

Closed to enrollment

PI: Dr. Stacey Tarvin

CRC: Yaira Rodriguez

Associated publication: https://pmc.ncbi.nlm.nih.gov/articles/PMC11381685/

Registry StudyCARRA LogoCIHR Logo

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.

PI Dr. Stacey Tarvin

CRC: Yaira Rodriguez

Associated publication: https://pubmed.ncbi.nlm.nih.gov/39467015/

Registry Study

Funding: None

Aim 1: To determine the clinical characteristics that are related to prognosis

Aim 2: To compare the effectiveness of various clinical managements in practice setting.

PI: Dr. Melissa Oliver

CRC: Elly Duncan

https://acrabstracts.org/abstract/validation-of-patient-reported-outcomes-measurementinformation-system-promis-pediatric-measures-for-children-with-chronic-nonbacterialosteomyelitis-using-the-choir-data/

https://pubmed.ncbi.nlm.nih.gov/37399459/

Registry Study

Funding: Childhood Arthritis and Rheumatology Research Alliance

Aim 1: Prospectively collect essential data from children, adolescents and young adults with pediatric onset rheumatic diseases.

Aim 2: Evaluate the safety of therapeutic agents in persons with pediatric rheumatic disease.

PI: Dr. Stacey Tarvin

CRCs: Elly Duncan, Stephanie Birdsong

https://carragroup.org/

CARRA Sub-Study

Funding: CARRA

Aim: To evaluate the effectiveness of a 24-dose course of weekly treatment with Orencia plus usual care versus usual care subjects from the CARRA Registry to prevent polyarthritis, uveitis, or treatment with other systemic medication(s) for JIA within 12 months of enrollment in children with recent-onset limited JIA.

Closed to Enrollment

PI: Dr. Stacey Tarvin

CARRA Sub-Study

Funding: CARRA

Aim: To track the disease course and treatment outcomes for children with scleroderma, as a subset of the CARRA Registry.

Closed to Enrollment

PI: Dr. Stacey Tarvin, Dr. Brandi Stevens

CARRA Sub-Study

Funding: CARRA

Aim: To clarify the most optimal timelines for initiating treatment of polyarticular JIA with biologic medications, guiding the formulation of consensus treatment plans for this.

Closed to Enrollment

PI: Dr. Stacey Tarvin

Associated publication: https://pubmed.ncbi.nlm.nih.gov/34105312/

CARRA Sub-Study

Funding: CARRA

Aim: To determine trajectories and predictors of cognitive function in a representative subsample of participants with pSLE (add ages)

Site PI: Dr. Martha Rodriguez

CRCs: Stephanie Birdsong

CARRA Sub-Study

Development of a Phenotype Algorithm to Identify Children with Juvenile Idiopathic Arthritis Across Institutions

Aim: To test the accuracy of an electronic algorithm's ability to pull uniform information from different electronic medical record systems in order to create cohesive patient subpopulations

Site PI: Dr. Stacey Tarvin

CRC: Amy Rakestraw

Completed Studies

Completed studies through the Division of Pediatric Rheumatology at IU School of Medicine include a range of topic areas.

Funding: NIAID

Determine the effect of tcVNS on disease activity in participants with active JIA as assessed by the JIA ACR 50 response

Randomized, double-blind, placebo-controlled trial of the efficacy and safety of rilonacept in the treatment of systemic juvenile idiopathic arthritis

Funding: Regeneron Pharmaceuticals

Associated publication: https://pmc.ncbi.nlm.nih.gov/articles/PMC4314719/

A multicenter, open-label study to assess the pharmacokinetics, safety, and efficacy of certolizumab pegol in children and adolescents with moderately to severely active polyarticularcourse juvenile idiopathic arthritis

Funding: UCB pharmaceuticals

Funding: Pfizer, Inc.

A3921104: Efficacy, safety, and tolerability of tofacitinib for treatment of polyarticular course juvenile idiopathic arthritis in children and adolescent subjects.

A3921145: A long-term, open-label follow-up study of tofacitinib for treatment of juvenile idiopathic arthritis.

Associated publication: https://pubmed.ncbi.nlm.nih.gov/39135452/

A Long-term, Multi-center, Longitudinal Post-marketing, Observational Registry to Assess Long Term Safety and Effectiveness of HUMIRA® (Adalimumab) in Children With Moderately to Severely Active Polyarticular or Polyarticular-course Juvenile Idiopathic Arthritis (JIA)

Associated Publication: https://pubmed.ncbi.nlm.nih.gov/31421019/