Purpose: The purpose of this study is to identify the risk factors that are most important in developing severe UC (PUCAI >65 and/or colectomy), so that they can be mitigated and more intensive therapy can be initiated earlier in order to avoid surgery.

Specific Aims:

• Identify risk factors for colectomy and severe disease in UC. Search ICN database to identify patients with UC who required colectomy or had PUCAI>65. Identify top 10 risk factors patients had in common. Compare and contrast risk factors to a case control group of UC patients in the ICN database, marked by physician global assessment “quiescent” and in remission. Check for statistically significant differences among the risk factors between the two groups.
• Identify the medications patients used in each group. Assess statistically if certain medications were used or not by patients who had colectomy or PUCAI > 65.

Contact: Gitit Tomer

Purpose: The purpose of this study aims to investigate whether the initial diagnostic evaluation and treatment of pediatric inflammatory bowel disease has changed as a result of the current COVID-19 pandemic.

Study Period: March 2019-June 2020

Contact: Melissa Shapiro

Purpose: The purpose of this study is to evaluate the trends in biologic drug discontinuation, reasons for discontinuation, and evaluation performed prior to discontinuation in patients enrolled in the ImproveCareNow network.

Specific Aims:

1. Determine the frequency of biologic drug discontinuation, including associations with patient and practice characteristics, as well as drug dosing and monitoring.
2. Determine the associations between biologic drug discontinuation and adverse events, evaluation performed prior to drug discontinuation, and barriers to care.
3. Develop materials and quality improvement processes aimed at reducing biologic drug discontinuation.
4. BISCUIT - The Biologic dISContinUatIon sTudy - Disease Outcomes. Funded by The Gary and Rachel Glick Charitable Fund.

Study Period: January 2021-December 2022

Contact: Jeremy Adler

Purpose: The purpose of this study is to evaluate patient characteristics and treatment patterns that may be associated with diagnostic delay.

Specific Aims:

1. Determine the variation in height z-score at diagnosis
2. Determine the association between height z-score at diagnosis and socio-demographic information
3. Determine association between growth stunting at diagnosis and variation in treatment selection and disease outcomes

Contact: Joann Samalik

Principal Investigator: Ross Maltz, MD; Nationwide Children's Hospital

Overall Study Question: Evaluate variation in prescribing habits of IV anti-TNF therapies across the pediatric IBD community. Evaluate the safety and efficacy of non-medical switches from the originator to a biosimilar

Specific Aims:

1. To evaluate infliximab use over time for patients who are anti-TNF naïve, to determine if biosimilar use is increasing nationally, variation amongst practices, geographic regions, by commercial vs Medicaid insurance, and race.
2. To evaluate long-term clinical outcomes of pediatric patients initiated on an infliximab biosimilars vs the originator.
3. Evaluate how often switching from the originator to a biosimilar are occurring within the ICN Network.  Determine if non-medical switching adversely affects clinical outcomes in pediatric IBD patients including the impact upon clinical remission in addition to anti-TNF drug and antibody levels. Evaluate how often patients are switching back to the originator or to a different therapy class.

Study Period: Beginning in May 2022

Contact: Ross Maltz, MD

Purpose: Our primary aim is to examine the frequency of normal laboratory results (i.e. hemoglobin, c-reactive protein, erythrocyte sedimentation rate, albumin, and fecal calprotectin) in the at the time of IBD diagnosis, prior to initiating medical therapy. A secondary aim will be to determine the variation in frequency of normal labs between subgroups of patients (disease type, age at diagnosis, race, ethnicity, gender, etc.).

Primary Outcome: The proportion of patients with normal laboratory findings at diagnosis, prior to initiating medical therapy.

Study Period: March 2022 - August 2023

Contact: Nicholas Litchin, Jeremy Adler

Title: Real-world Evidence for the Effectiveness and Safety of Ustekinumab Treatment in Children with Crohn’s Disease: A Retrospective Cohort Study using the ImproveCareNow Registry Data

PIs:

Steve Steiner, MD, REALITI Co-Principal Investigator, Riley Children’s Hospital 

Shehzad Saeed, MD, REALITI Co-Principal Investigator, ImproveCareNow & Dayton Children’s Hospital 

Jeremy Adler, MD, REALITI Co- Principal Investigator, University of Michigan – C.S. Mott Children’s Hospital

Purpose: The primary objective of this study is to evaluate the clinical effectiveness of ustekinumab by determining the clinical remission rate in pediatric patients with moderately to  severely active Crohn’s Disease (CD) in the ICN registry who were treated with ustekinumab.

Primary Outcome: This study will generate knowledge about the use of ustekinumab in the management of pediatric Crohn’s Disease. The results of this study will be included as part of a Janssen submission to the FDA for the approval of the use of ustekinumab in pediatric patients, as they plan a phase 3 clinical trial of ustekinumab. In addition, the inclusion of RWE from ICN could help facilitate the approval of ustekinumab and other  new  drugs  for  IBD,  making  new  IBD treatments accessible  to  pediatric  patients sooner, enabling better outcomes for our patients. If the ICN-Janssen REALITI Study is successful, other new IBD drugs could be studied in a similar way, having a major impact on the health of our patients as well as on the sustainability of ICN.

Funding Source: Janssen has provided funding to ICN to perform this study; however, it is important to note that this  is  an  observational study with  a  retrospective  chart  review  and not an interventional study.

Study Period: The study will take approximately 9 to 18 months to complete from implementation to publication.

Recruitment Status: All eligible patients have been identified via the ICN  Registry, the 72 ICN centers with eligible patients have been invited to participate.

Contact: [email protected]

Purpose: Very early-onset inflammatory bowel disease (VEO-IBD) presents in children less than 6 years of age. These patients have more extensive, progressive and medically refractory disease making it phenotypically distinct from older-onset pediatric and adult IBD.

The incidence of pediatric IBD is increasing rapidly but there is no specific data for the US population. Given the paucity of information, our objective was to determine the prevalence of VEO-IBD within the ImproveCareNow (ICN) Network registry, which accounts for more than 50% of all pediatric IBD patients in the US.

Primary Outcome: Our primary outcomes are frequency of clinical remission in the VEO-IBD population and time to clinical remission. Clinical remission will be defined by normal physician global assessment (PGA), PCDAI, PUCAI, ESR or CRP.

Secondary Outcome: Our secondary outcomes will be frequency of and time to surgery (specifically, colectomy or creation of ileostomy or colostomy) and frequency of sustained corticosteroid free remission, one of the major outcomes tracked by the ImproveCareNow Network.

Study Period: June 2020-July 2021

Recruitment Status: This study makes use of existing data in the ICN registry. No patient recruitment at this time.

Contact: ImproveCareNow Research 

Purpose: Describe the phenotype of IBD in pediatric patients of Asian American ethnicity

Primary Outcome: Our hypothesis is that the phenotype of pediatric IBD in Asian American children is unique compared to the general population.

Funding Source: N/A

Study Period: Jan 2019-June 2020

Recruitment Status: This study makes use of existing data in the ICN registry. No patient recruitment at this time.

Contact: Ashish Patel 

Purpose: Crohn’s disease causes fistulas, which are abnormal openings from the bowel to adjacent structures such as the skin, bladder, genitals, or to other loops of bowel.  Fistulas frequently lead to serious and sometimes debilitating complications. 

Fistulas have a major negative impact on quality of life of children and their caregivers and are highly distressing.  Fistulas can cause many complications including fecal incontinence, infertility, chronic draining wounds, abscesses, and severe infections of the bladder, kidneys, uterus, or other internal structures. Fistulas are difficult to treat, requiring expensive medications and surgery, and treatments are often not effective. Strategies are needed to prevent fistulas from developing in the first place.

This study is designed to answer several important questions:

• What are the characteristics of children who at the greatest risk for developing fistulas? 
• Does early selection of therapy alter the risk for fistulas among children? 
• Does the risk of fistula among children change with the duration of disease?

Primary Outcomes: 

• Developing perianal fistula
• Time to perianal fistula development

Secondary Outcomes:

• Medication use
• Surgery

Funding Source: Shaevsky Family Research Fund for Crohn’s Disease

Study Period: 2013-2022

Recruitment Status: This study makes use of existing data in the ICN registry. No patient recruitment at this time.

Contact: ImproveCareNow Research