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


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: Jen Savas

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