A Study of Ustekinumab Treatment in Children With Crohn's Disease (REALITI)

Janssen (J&J Innovative Medicine)

Status: Completed

Conditions: Crohn's Disease

Treatments: Drug: Ustekinumab

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT05242458

CNTO1275CRD3010 (Other Identifier)

CR109167

Details and patient eligibility

About

The purpose of this study is to evaluate the effectiveness of ustekinumab in achieving clinical remission in pediatric participants (greater than or equal to [>=] 2 to less than [<] 18 years and weight >= 40 kilograms [kg] at baseline).

Enrollment: 545 patients

Sex: All

Ages: 2 to 25 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Having at least one ICN visit with documented new use of ustekinumab
• Participants with a documented Crohn's disease (CD) diagnosis at the time ustekinumab was initiated (that is, Baseline); If diagnosis at baseline is missing, then the diagnosis from previous visit within study window will be utilized
• Having at least one ICN visit prior to the ICN visit when ustekinumab is first documented
• Having received first dose of ustekinumab on or before June 22, 2019
• Having provided informed consent for use of ICN data for research purposes

Exclusion criteria

• Documented exposure to ustekinumab before enrollment in ICN (by chart review)

Trial design

545 participants in 1 patient group

Participants with Crohn's Disease (CD)

Description:

Participants with moderate-to-severe active CD enrolled in ImproveCareNow (ICN) pediatric Inflammatory bowel disease (IBD) registry will be observed who are being treated with ustekinumab under real world setting and will be divided into 9 cohorts. Cohorts 1-6 for age group \>=2 to \<18 years (pediatric), cohorts 7-9 for young adults within age group \>=18 to \<26 years. Cohort 1: participants with moderate-severe CD and body weight \>=40 kg, cohort 2: participants with moderate-severe CD and body weight \<40 kg, cohort 3: all participants with moderate-severe CD, cohort 4: participants with active disease and body weight \>=40 kg, cohort 5: participants with active disease and body weight \<40 kg, cohort 6: all participants treated with ustekinumab, cohort 7: young adults with moderate-severe CD, cohort 8: young adults with active-disease; and cohort 9: all young adults treated with ustekinumab. Only data available per routine clinical practice will be collected within this study.

Treatment:

Drug: Ustekinumab