Crohn's DiseaseREALITINCT05242458
A Study of Ustekinumab Treatment in Children With Crohn's Disease
An observational study of Crohn's Disease, run by Janssen Research & Development, LLC at 1 site in United States.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 2 to 25 years
- Conditions the study is for
- Crohn's Disease
- What is being tested?
- Ustekinumab
- How many people
- 545 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Mar 2022to 22 May 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 25 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: The study population includes pediatric participants (age greater than or equal to [>=] 2 to less than [<] 18 years with body weight >=40 kilograms [kg]) and young adults (age >= 18 to < 26 years) with moderately to severely active Crohn's disease. The primary study population will be pediatric participants who have moderate to severe disease activity defined as short pediatric Crohn's disease activity index (sPCDAI) >= 30, are treated with ustekinumab, and are followed at an ImproveCareNow (ICN) center.
Who may be able to join
- 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
Who cannot join
- Documented exposure to ustekinumab before enrollment in ICN (by chart review)
Trial locations and contacts
1 site in 1 country.
About this study
Official 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
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).
- Conditions
- Crohn's Disease
- Being tested
- Ustekinumab
- Medical subject headings
- Crohn Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UstekinumabDrug
No interventions will be administered as a part of this study. Participants will receive ustekinumab as per their routine clinical practice.
| Study group | Role | What they receive |
|---|---|---|
| Participants with Crohn's Disease (CD) | 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. Receives: Drug: Ustekinumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cohort 1: Percentage of Pediatric Participants with Clinical Remission at Week 52
Percentage of Pediatric participants with clinical remission at Week 52 will be reported. Clinical remission is defined by short pediatric Crohn's disease activity index (sPCDAI) less than or equal to (<=) 10.
Measured: Week 52
Secondary outcomes (14)
Cohort 7: Percentage of Young Adult Participants with Clinical Remission at Week 52
Percentage of young adult participants with clinical remission at Week 52 will be reported.
Measured: Week 52
Cohorts 2, 3, 4, 5, 6, 8 and 9: Percentage of Participants with Clinical Remission at Week 52
Percentage of participants with clinical remission at Week 52 will be reported.
Measured: Week 52
Cohorts 1 and 7: Percentage of Participants with Clinical Remission at Week 52 Evaluated by Ustekinumab Dose Bands
Percentage of participants with clinical remission at Week 52 evaluated by ustekinumab dose bands will be reported.
Measured: Week 52
Cohorts 1 and 7: Percentage of Participants with Clinical Remission at Week 52 with No Corticosteroid Use
Percentage of participants with clinical remission at Week 52 with no corticosteroid use will be reported.
Measured: Week 52
Cohorts 1 and 7: Percentage of Participants with Clinical Remission at Week 52 by PGA Score
Percentage of participants with clinical remission at Week 52 by Physician Global Assessment (PGA) score will be reported.
Measured: Week 52
Cohorts 1 and 7: Change from Baseline in Height at Week 52
Change from baseline in height at Week 52 will be reported.
Measured: Baseline and Week 52
Cohorts 1 and 7: Change from Baseline in Weight at Week 52
Change from baseline in weight at Week 52 will be reported.
Measured: Baseline and Week 52
Cohorts 1 and 7: Change from Baseline in Body Mass Index (BMI) at Week 52
Change from baseline in BMI (measured with age and sex-specific z-scores) at Week 52 will be reported.
Measured: Baseline and Week 52
Cohorts 1 and 7: Percentage of Participants Who Achieve Endoscopic Remission with SEMA-CD Score of 0 or 1 at Week 52
Percentage of participants who achieve endoscopic remission with simplified endoscopic mucosal assessment for Crohn's disease (SEMA-CD) score of 0 or 1 at Week 52 will be reported. Endoscopic remission is defined as SEMA-CD score of 0 or 1. SEMA-CD mucosal disease activity score is defined as inactive = 0; minimal = 1; mild = 2-4; moderate = 5-9, or severe = greater than or equal to (>=) 10.
Measured: Week 52
Cohorts 1 and 7: Change from Baseline to Week 52 in Mucosal Disease Activity Measured with SEMA-CD Score
Change from baseline to Week 52 in mucosal disease activity measured with SEMA-CD score will be reported. SEMA-CD mucosal disease activity score is defined as inactive = 0; minimal = 1; mild = 2-4; moderate = 5-9, or severe = greater than or equal to (>=) 10.
Measured: Baseline to Week 52
Cohorts 1 and 7: Percentage of Participants that Discontinued Ustekinumab Use Among Participants who Initiated Ustekinumab Therapy at Week 52
Percentage of participants that discontinued ustekinumab use among participants who initiated ustekinumab therapy at Week 52 will be reported.
Measured: Week 52
Cohorts 1 and 7: Percentage of Participants with Occurrence of Inflammatory Bowel Diseases (IBD)-related Hospitalizations Who had Initiated Ustekinumab Therapy
Percentage of participants with occurrence of IBD-related hospitalizations who had initiated ustekinumab therapy will be reported.
Measured: Up to Week 52
Cohorts 1 and 7: Percentage of Participants with Occurrence of IBD-related Surgeries Who had Initiated Ustekinumab Therapy
Percentage of participants with occurrence of IBD-related surgeries who had initiated ustekinumab therapy will be reported.
Measured: Up to Week 52
Cohorts 1 and 7: Percentage of Participants with Adverse Events of Special Interest (AESI) Who had Initiated Ustekinumab Therapy
Percentage of participants with AESIs (example: malignancies, serious and opportunistic infection, anaphylaxis requiring discontinuation of ustekinumab) who had initiated ustekinumab therapy will be reported.
Measured: Up to Week 52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2022
- Study start21 Mar 2022
- Primary completion22 May 2023
- Study completion22 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Crohn's DiseaseStudies of the same condition, open and under way.
- More trials run by Janssen Research & Development, LLCThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 545 participants (actual)
Sponsor and investigators
- Lead sponsor
- Janssen Research & Development, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- ImproveCareNow (ICN), Children's Hospital Medical Center, Cincinnati
- Responsible party
- Sponsor
- Investigators
- Janssen Research & Development, LLC Clinical Trial, Study director, Janssen Research & Development, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05242458
- Sponsor's protocol ID
- CR109167
- Other IDs
- CNTO1275CRD3010
- Acronym
- REALITI
- Status last verified
- May 2025
- First submitted
- 15 Feb 2022
- Last updated
- 13 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- Individual data sharing
- Yes: The data sharing policy of the Janssen Pharmaceutical Companies of Johnson \& Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu
Publications
Steiner SJ, Adler J, Saeed SA, Strauss RS, Howe KM, Sheahan A, Zhang R, Keihn KR, Harrow K, Olano KK, Evans DA, Lo KH, Zhang N, Kim L, Colletti RB, Volger S; ImproveCareNow Learning Health Network. Effectiveness and safety of ustekinumab in pediatric Crohn's disease: Results of the REALITI study. J Pediatr Gastroenterol Nutr. 2026 May;82(5):1242-1250. doi: 10.1002/jpn3.70372. Epub 2026 Mar 2.
PubMed 41766590
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT05242458
- Acronym / sponsor ID
- REALITI / CR109167
- Conditions
- Crohn's Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 545 participants (actual)
- Lead sponsor
- Janssen Research & Development, LLCIndustry (pharma, biotech, devices)
- Collaborators
- ImproveCareNow (ICN), Children's Hospital Medical Center, Cincinnati
- Study start
- 21 Mar 2022 (actual)
- Primary completion
- 22 May 2023 (actual)
- Study completion
- 22 May 2023 (actual)
- First posted
- 16 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Participants with Crohn's Disease (CD) | – | Drug: UstekinumabParticipants 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. |
Who may qualify
- Ages
- 2 to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- The study population includes pediatric participants (age greater than or equal to [>=] 2 to less than [<] 18 years with body weight >=40 kilograms [kg]) and young adults (age >= 18 to < 26 years) with moderately to severely active Crohn's disease. The primary study population will be pediatric participants who have moderate to severe disease activity defined as short pediatric Crohn's disease activity index (sPCDAI) >= 30, are treated with ustekinumab, and are followed at an ImproveCareNow (ICN) center.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (1 listed)
- Documented exposure to ustekinumab before enrollment in ICN (by chart review)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| UstekinumabNo interventions will be administered as a part of this study. Participants will receive ustekinumab as per their routine clinical practice. | Drug | Participants with Crohn's Disease (CD) |
Primary outcome
Cohort 1: Percentage of Pediatric Participants with Clinical Remission at Week 52
Time frame: Week 52
Percentage of Pediatric participants with clinical remission at Week 52 will be reported. Clinical remission is defined by short pediatric Crohn's disease activity index (sPCDAI) less than or equal to (<=) 10.
14 secondary outcomes
Cohort 7: Percentage of Young Adult Participants with Clinical Remission at Week 52
Time frame: Week 52
Cohorts 2, 3, 4, 5, 6, 8 and 9: Percentage of Participants with Clinical Remission at Week 52
Time frame: Week 52
Cohorts 1 and 7: Percentage of Participants with Clinical Remission at Week 52 Evaluated by Ustekinumab Dose Bands
Time frame: Week 52
Cohorts 1 and 7: Percentage of Participants with Clinical Remission at Week 52 with No Corticosteroid Use
Time frame: Week 52
Cohorts 1 and 7: Percentage of Participants with Clinical Remission at Week 52 by PGA Score
Time frame: Week 52
Cohorts 1 and 7: Change from Baseline in Height at Week 52
Time frame: Baseline and Week 52
Cohorts 1 and 7: Change from Baseline in Weight at Week 52
Time frame: Baseline and Week 52
Cohorts 1 and 7: Change from Baseline in Body Mass Index (BMI) at Week 52
Time frame: Baseline and Week 52
Cohorts 1 and 7: Percentage of Participants Who Achieve Endoscopic Remission with SEMA-CD Score of 0 or 1 at Week 52
Time frame: Week 52
Cohorts 1 and 7: Change from Baseline to Week 52 in Mucosal Disease Activity Measured with SEMA-CD Score
Time frame: Baseline to Week 52
Cohorts 1 and 7: Percentage of Participants that Discontinued Ustekinumab Use Among Participants who Initiated Ustekinumab Therapy at Week 52
Time frame: Week 52
Cohorts 1 and 7: Percentage of Participants with Occurrence of Inflammatory Bowel Diseases (IBD)-related Hospitalizations Who had Initiated Ustekinumab Therapy
Time frame: Up to Week 52
Cohorts 1 and 7: Percentage of Participants with Occurrence of IBD-related Surgeries Who had Initiated Ustekinumab Therapy
Time frame: Up to Week 52
Cohorts 1 and 7: Percentage of Participants with Adverse Events of Special Interest (AESI) Who had Initiated Ustekinumab Therapy
Time frame: Up to Week 52
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2025.
- Derived from this study: PubMed 41766590Steiner SJ, Adler J, Saeed SA, Strauss RS, Howe KM, Sheahan A, Zhang R, Keihn KR, Harrow K, Olano KK, Evans DA, Lo KH, Zhang N, Kim L, Colletti RB, Volger S; ImproveCareNow Learning Health Network. Effectiveness and safety of ustekinumab in pediatric Crohn's disease: Results of the REALITI study. J Pediatr Gastroenterol Nutr. 2026 May;82(5):1242-1250. doi: 10.1002/jpn3.70372. Epub 2026 Mar 2.
- Individual participant dataSharing planned: Yes. The data sharing policy of the Janssen Pharmaceutical Companies of Johnson \& Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Janssen Research & Development, LLC Clinical Trial study director
Janssen Research & Development, LLC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Crohn's Disease, run by Janssen Research & Development, LLC at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cohort 1: Percentage of Pediatric Participants with Clinical Remission at Week 52 (time frame: Week 52). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05242458, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 May 2025.