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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05242458
Recruitment Status : Recruiting
First Posted : February 16, 2022
Last Update Posted : September 14, 2022
Sponsor:
Collaborators:
ImproveCareNow (ICN)
Children's Hospital Medical Center, Cincinnati
Information provided by (Responsible Party):
Janssen Research & Development, LLC

Brief 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).

Condition or disease Intervention/treatment
Crohn's Disease Drug: Ustekinumab

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Study Type : Observational
Estimated Enrollment : 662 participants
Observational Model: Cohort
Time Perspective: Retrospective
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
Actual Study Start Date : March 21, 2022
Estimated Primary Completion Date : November 1, 2022
Estimated Study Completion Date : November 1, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Crohn's Disease
Drug Information available for: Ustekinumab

Group/Cohort Intervention/treatment
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.
Drug: Ustekinumab
No interventions will be administered as a part of this study. Participants will receive ustekinumab as per their routine clinical practice.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Cohort 7: Percentage of Young Adult Participants with Clinical Remission at Week 52 [ Time Frame: Week 52 ]
    Percentage of young adult participants with clinical remission at Week 52 will be reported.

  2. Cohorts 2, 3, 4, 5, 6, 8 and 9: Percentage of Participants with Clinical Remission at Week 52 [ Time Frame: Week 52 ]
    Percentage of participants with clinical remission at Week 52 will be reported.

  3. Cohorts 1 and 7: Percentage of Participants with Clinical Remission at Week 52 Evaluated by Ustekinumab Dose Bands [ Time Frame: Week 52 ]
    Percentage of participants with clinical remission at Week 52 evaluated by ustekinumab dose bands will be reported.

  4. Cohorts 1 and 7: Percentage of Participants with Clinical Remission at Week 52 with No Corticosteroid Use [ Time Frame: Week 52 ]
    Percentage of participants with clinical remission at Week 52 with no corticosteroid use will be reported.

  5. Cohorts 1 and 7: Percentage of Participants with Clinical Remission at Week 52 by PGA Score [ Time Frame: Week 52 ]
    Percentage of participants with clinical remission at Week 52 by Physician Global Assessment (PGA) score will be reported.

  6. Cohorts 1 and 7: Change from Baseline in Height at Week 52 [ Time Frame: Baseline and Week 52 ]
    Change from baseline in height at Week 52 will be reported.

  7. Cohorts 1 and 7: Change from Baseline in Weight at Week 52 [ Time Frame: Baseline and Week 52 ]
    Change from baseline in weight at Week 52 will be reported.

  8. Cohorts 1 and 7: Change from Baseline in Body Mass Index (BMI) at Week 52 [ Time Frame: Baseline and Week 52 ]
    Change from baseline in BMI (measured with age and sex-specific z-scores) at Week 52 will be reported.

  9. 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 ]
    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.

  10. 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 ]
    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.

  11. Cohorts 1 and 7: Percentage of Participants that Discontinued Ustekinumab Use Among Participants who Initiated Ustekinumab Therapy at Week 52 [ Time Frame: Week 52 ]
    Percentage of participants that discontinued ustekinumab use among participants who initiated ustekinumab therapy at Week 52 will be reported.

  12. 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 ]
    Percentage of participants with occurrence of IBD-related hospitalizations who had initiated ustekinumab therapy will be reported.

  13. Cohorts 1 and 7: Percentage of Participants with Occurrence of IBD-related Surgeries Who had Initiated Ustekinumab Therapy [ Time Frame: Up to Week 52 ]
    Percentage of participants with occurrence of IBD-related surgeries who had initiated ustekinumab therapy will be reported.

  14. 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 ]
    Percentage of participants with AESIs (example: malignancies, serious and opportunistic infection, anaphylaxis requiring discontinuation of ustekinumab) who had initiated ustekinumab therapy will be reported.



Information from the National Library of Medicine

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Ages Eligible for Study:   2 Years to 25 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
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.
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05242458


Contacts
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Contact: Study Contact 844-434-4210 Participate-In-This-Study@its.jnj.com

Locations
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United States, Vermont
ImproveCareNow, Inc. Recruiting
Burlington, Vermont, United States, 05408
Sponsors and Collaborators
Janssen Research & Development, LLC
ImproveCareNow (ICN)
Children's Hospital Medical Center, Cincinnati
Investigators
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Study Director: Janssen Research & Development, LLC Clinical Trial Janssen Research & Development, LLC
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Responsible Party: Janssen Research & Development, LLC
ClinicalTrials.gov Identifier: NCT05242458    
Other Study ID Numbers: CR109167
CNTO1275CRD3010 ( Other Identifier: Janssen Research & Development, LLC )
First Posted: February 16, 2022    Key Record Dates
Last Update Posted: September 14, 2022
Last Verified: September 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: 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
URL: https://www.janssen.com/clinical-trials/transparency

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Studies a U.S. FDA-regulated Drug Product: Yes
Additional relevant MeSH terms:
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Crohn Disease
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases
Ustekinumab
Dermatologic Agents