Research & Registry

FROST

CARRA Registry
FROST (FiRst-line Options for Systemic JIA Treatment) Study

Why This Is Important

Systemic juvenile idiopathic arthritis (sJIA) is a rare and aggressive form of childhood arthritis that can cause high fevers, rash, and other symptoms in addition to arthritis.

There are new and effective treatments for systemic JIA, but we don’t know if using these treatments first line makes an important difference in how quickly the patients get better, how they do in the long term, or is safer. That is why this study is being conducted.

This is the one of the first (and largest) studies that will look at the outcomes of current treatments for patients with newly diagnosed systemic JIA.

Project Description/Overview

FROST stands for “First-line Options for SJIA Treatment”.  The goal of FROST is to determine how newly diagnosed sJIA patients do on the currently available treatments. Patients and families worked together with CARRA researchers to design the FROST study. This study will assess the effectiveness of the CARRA systemic JIA Consensus Treatment Plans (CTPs) (link to CTP page). The CTPs all use medications that are commonly used to treat sJIA by pediatric rheumatologists. They include biologic medications (like anakinra, canakinumab and tocilizumab), and non-biologic medications (prednisone, methotrexate). The treatments are chosen through shared decision making with the physician, patient and family, and are standard of care. Information about how they are doing will be recorded in the CARRA Registry database. If one CTP doesn’t work, patients can change to a different one. Patients are followed for 2 years.

The CTPs are:

  1. Steroids alone (or prednisone)
  2. Methotrexate (methotrexate is a common anti-arthritis medication that is not a biologic medicine)
  3. IL-1 blocking Biologic (anakinra [Kineret] or canakinumab [Ilaris])
  4. IL-6 blocking Biologic (tocilizumab [Actemra])
FROST
Typical rash of systemic JIA

Enrollment

As of June 2019, 58 CARRA Registry sites are participating across the US and Canada and 61 patients have been enrolled (Goal: 100 patients).

Who is Involved?

Principal Investigator: Yukiko Kimura, MD (Joseph M. Sanzari Children’s Hospital, Hackensack University Medical Center)
Co-Principal Investigator: Timothy Beukelman, MD MSCE (University of Alabama, Birmingham)

Co-Investigators:

  • Peter Nigrovic, MD (Brigham and Women’s Hospital)
  • Laura Schanberg, MD (Duke Clinical Research Institute and Duke University)
  • Marc Natter, MD (Boston Children’s Hospital)
  • Brian Feldman, MD, M.Sc., FRCPC (Toronto Hospital for Sick Children)

Patient Partners:

  • Vincent del Gaizo (father of systemic JIA patient)
  • Marian Jelenik (young adult with systemic JIA)

Consultant: Brian Feldman, MD, M.Sc., FRCPC (Toronto Hospital for Sick Children)

Project Coordinator: Mary Ellen Riordan, BSN, CCRN (Joseph M. Sanzari Children’s Hospital, Hackensack University Medical Center)
Coordinating Center: Duke Clinical Research Institute (DCRI)

Lead Statistician: George Tomlinson, PhD, MSc (University of Toronto)

Additional Information

FROST is made possible through support from Genentech and CARRA Registry supporters including the Arthritis Foundation. Blood sample collection is made possible by the Systemic JIA Foundation.