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Outcomes of Children Newly Diagnosed With Crohn's Disease

Clinical, Imaging, and Endoscopic Outcomes of Children Newly Diagnosed With Crohn's Disease

Phase 4 Interventional Connecticut Children's Medical Center · NCT05781152

This study is testing how well a new treatment for Crohn's disease works in helping children feel better and heal their intestines after being newly diagnosed.

Quick facts

PhasePhase 4
Study typeInterventional
Enrollment900 (estimated)
Ages6 Years to 17 Years
SexAll
SponsorConnecticut Children's Medical Center Academic / other
Drugs / interventionsdupilumab, adalimumab, infliximab, ROADMAB
Locations26 sites (Phoenix, Arizona and 25 other locations)
Trial IDNCT05781152 on ClinicalTrials.gov

What this trial studies

This study investigates the clinical, imaging, and endoscopic outcomes in children who have recently been diagnosed with Crohn's disease. It focuses on the effectiveness of anti-TNF therapy, a biologic treatment aimed at reducing inflammation in the intestines. The study will enroll approximately 1,450 children across 27 pediatric centers in North America over a planned period of five years. Researchers will analyze various factors, including clinical and genomic data, to determine their association with intestinal healing and other treatment responses.

Who should consider this trial

Good fit: Ideal candidates for this study are children aged 6 to 17 years who have a suspected diagnosis of Crohn's disease.

Not a fit: Patients who have undergone abdominal surgery for Crohn's disease or are likely to require bowel resection shortly after diagnosis may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved treatment strategies for children with Crohn's disease, enhancing their chances of achieving complete intestinal healing.

How similar studies have performed: Other studies have shown promise with anti-TNF therapies in treating Crohn's disease, indicating that this approach is supported by prior research.

Eligibility criteria

Show full inclusion / exclusion criteria 
Phase 1 Inclusion Criteria

1. Age ≥ 6 years and \< 18 years at enrollment
2. Suspected diagnosis of CD
3. Stool culture if performed that is negative for routine enteric pathogens (Salmonella, Shigella, Campylobacter, E. coli 0157:H7) and Clostridium difficile toxin in patients presenting with diarrhea. If history of C. difficile then a minimum of 6 weeks duration from treatment start and negative repeat stool for C. difficile toxin.
4. Parent/guardian consent and patient assent
5. Ability to remain in follow-up for up to 6 months of initial observation followed by a minimum of 52 weeks after possible start of anti-TNF therapy

Phase 1 Exclusion Criteria

1. Diagnosis of CD following abdominal resectional surgery/appendectomy at initial presentation
2. Investigator judgment that patient has high likelihood (\>50%) of needing bowel resection within 3 months of diagnosis (i.e., presentation with perforation, bowel obstruction from stricture)
3. Use of any oral CS for non-gastrointestinal indication within the four weeks prior to diagnostic assessment and biosampling (e.g., asthma)
4. Use of any investigational drug within the past four weeks prior to diagnostic assessment and sampling
5. Pregnancy
6. Patients with poorly controlled medical conditions (e.g. diabetes, congestive heart failure)
7. Previous treatment with immunomodulators within one year of enrollment or anti-TNF therapy within two years of enrollment for other medical conditions (e.g., juvenile idiopathic arthritis)
8. Previous treatment with non-anti TNF biologics or small molecules for non-IBD indications in the past 6 months, with the exception of dupilumab (Dupixent) for asthma, eczema, or eosinophilic esophagitis
9. Inability to have MRE because of claustrophobia or other reasons

Phase 2 Inclusion Criteria

1. Met all eligibility criteria for Phase 1 and participated in Phase 1
2. Diagnosed with macroscopic CD involving the terminal ileum and/or colon by endoscopic evaluation and/or MRE
3. MRE imaging within 6 weeks of ileocolonoscopy and no more than 4 weeks after starting initial therapy (TT). A limited 'research protocol' MRE is acceptable in participants who have undergone a clinical CTE during their initial diagnostic evaluation; see Manual of Procedures for details.
4. Received at least one of the following as initial therapy upon diagnosis:

   1. Corticosteroids
   2. Immunomodulator
   3. Aminosalicylic acids (5-ASA)
   4. Defined nutritional therapy
   5. Anti-TNF (adalimumab or infliximab)
5. Commenced adalimumab or infliximab anti-TNF therapy guided by ROADMAB™ CDST as first therapy or within 180 days of diagnosis (TD), with or without concomitant immunomodulator

6 a. Had ileal and rectal biopsies, OR b. Ileal biopsies are not obtained secondary to inflammatory or structural changes at the ileocecal valve or distal ileum that prevent ileal intubation. To be acceptable for Phase 2, the following additional criteria must be met: b1. Gross inflammation or obvious narrowing at the IC valve or distal ileum as documented by the video colonoscopy, AND b2. MRE documentation of TI inflammation with or without narrowing, OR c. Ileal biopsies are not obtained secondary to inflammatory or structural changes due to colonic CD.

7\. Parent/guardian consent and patient assent 8. Ability to remain in follow-up for a minimum of 52 weeks after start of anti-TNF therapy

Phase 2 Exclusion Criteria

1. Diagnosis of CD using video capsule endoscopy only with normal ileocolonoscopy and normal MRE
2. Orofacial CD only
3. Esophageal, gastric, duodenal, and/or jejunal CD only
4. Severe complex fistulizing perianal disease +/- abscess, or perianal disease requiring surgical intervention or likely to require on-going surgical intervention possibly including diversion. The placement of a seton is not exclusionary. Incision and drainage of a perirectal abscess is also not exclusionary.
5. Perianal CD only with no evidence of luminal disease
6. Internal fistulizing disease at diagnosis
7. Initial IBD treatment with non-anti-TNF biologic or small molecule therapy
8. Received any anti-TNF agent other than adalimumab or infliximab
9. Investigator judgment that patient unlikely to return for clinical, endoscopic or MRE follow-up
10. Inability to have MRE because of claustrophobia or other reasons
11. Video of baseline endoscopy not available for central reading, unless otherwise approved by the Clinical Coordinating Center (Adequate photo documentation required)
12. Underwent bowel resection within 3 months of diagnosis (TD)

Where this trial is running

Phoenix, Arizona and 25 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Crohn Diseasecrohn diseasechildrenpediatricanti-TNF therapytherapeutic drug monitoringintestinal microbiomeinflammatory bowel disease
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.