Clinical, Imaging, and Endoscopic Outcomes of Children Newly Diagnosed With Crohn's Disease
NCT ID: NCT05781152
Last Updated: 2025-09-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE4
900 participants
INTERVENTIONAL
2023-06-10
2029-07-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Anti-tumor necrosis factor (TNF)
Patients newly diagnosed with pediatric-onset Crohn's disease starting anti-TNF therapy within 6 months of diagnosis
Anti-TNF therapy
Use of anti-TNF therapy for children and adolescents with newly diagnosed Crohn's disease guided by a clinical decision support tool
Interventions
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Anti-TNF therapy
Use of anti-TNF therapy for children and adolescents with newly diagnosed Crohn's disease guided by a clinical decision support tool
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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
Exclusion Criteria
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
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)
6 Years
17 Years
ALL
No
Sponsors
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National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
NIH
Emory University
OTHER
Children's Hospital Medical Center, Cincinnati
OTHER
University of North Carolina, Chapel Hill
OTHER
Connecticut Children's Medical Center
OTHER
Responsible Party
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Principal Investigators
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Jeffrey S Hyams, MD
Role: PRINCIPAL_INVESTIGATOR
Connecticut Children's Medical Center
Subra Kugathasan, MD
Role: PRINCIPAL_INVESTIGATOR
Emory University
Lee Denson, MD
Role: PRINCIPAL_INVESTIGATOR
Children's Hospital Medical Center, Cincinnati
Locations
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Phoenix Children's Hospital
Phoenix, Arizona, United States
Cedars-Sinai
Los Angeles, California, United States
Rady Children's Hospital - San Diego and University of California, San Diego
San Diego, California, United States
UCSF Benioff Children's Hospitals
San Francisco, California, United States
Connecticut Children's Medical Center
Hartford, Connecticut, United States
Emory University
Atlanta, Georgia, United States
Riley Hospital for Children at Indiana University Health
Indianapolis, Indiana, United States
The Johns Hopkins Children's Medical Center
Baltimore, Maryland, United States
Boston Children's Hospital
Boston, Massachusetts, United States
University of Michigan
Ann Arbor, Michigan, United States
Goryeb Children's Hospital/Morristown Medical Center/Atlantic Children's Health
Morristown, New Jersey, United States
Cohen Children's Medical Center of NY
Lake Success, New York, United States
Columbia University Medical Center
New York, New York, United States
Levine Children's
Charlotte, North Carolina, United States
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States
UH/Rainbow Babies and Children's Hospital
Cleveland, Ohio, United States
Nationwide Children's Hospital
Columbus, Ohio, United States
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States
UPMC Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania, United States
Rhode Island Hospital
Providence, Rhode Island, United States
Seattle Children's Hospital
Seattle, Washington, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, United States
Stollery Children's Hospital
Edmonton, Alberta, Canada
Children's Hospital Western Ontario
London, Ontario, Canada
Children's Hospital of Eastern Ontario
Ottawa, Ontario, Canada
Toronto SickKids Hospital
Toronto, Ontario, Canada
Countries
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Central Contacts
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Facility Contacts
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Role: backup
Lindsey Albenberg, DO
Role: primary
Provided Documents
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Document Type: Informed Consent Form
Related Links
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CAMEO Study Website
Other Identifiers
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22-066
Identifier Type: -
Identifier Source: org_study_id
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