Clinical, Imaging, and Endoscopic Outcomes of Children Newly Diagnosed With Crohn's Disease
CAMEO
2 other identifiers
interventional
900
2 countries
26
Brief Summary
Crohn's disease (CD) is a condition that causes inflammation (swelling, redness) of the lining and wall of the small intestine, large intestine, or both. CD may be associated with abdominal cramps/pain, diarrhea, blood in the stool, weight loss, or delayed growth in children. While the exact cause of CD is not certain it is thought that the immune system located in the intestine reacts abnormally to the large number of bacteria contained there. The investigators think that diet, exposure to antibiotics early in life, and having a family history of CD puts people at increased risk for developing CD. In order to decrease the inflammation doctors use what is called biologic therapy with anti-TNF molecules that can be given through an intravenous or shots. TNF is a chemical made by white blood cells that is involved in inflammation. When this type of treatment is given early after diagnosis it is more effective than when it is given later. The investigators have learned that it is important to give the optimum (ideal) amount of this medicine guided by certain blood tests. The investigators also know that not everyone responds to this therapy but do not understand the reasons for this variability between people. The CAMEO study has been started to help understand what factors are important in determining whether a child with CD completely heals the inflammation after anti-TNF therapy. The investigators will do that by measuring certain markers of inflammation in the blood and stool and by looking at a person's genes (DNA) and how inflammation is controlled in the intestine. These inflammation tests will be done before, during, and after one year of anti-TNF therapy. The investigators will determine how much healing has taken place by comparing the results of the colonoscopy and a special type of MRI that are both done before anti-TNF and then again one year later. The goal in treating CD is to heal both the lining and the wall of the intestine. Children ages 6-17 years who are thought to have CD and are about to undergo their diagnostic colonoscopy are eligible to be enrolled. If they are found to indeed have CD and start an anti-TNF medicine within 6 months they can continue in the study. There are no increased risks of participating in this study beyond those normally associated with having CD and its treatment. By better understanding why the bowel does or does not heal, doctors will be better able to provide personalized care.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Jun 2023
Longer than P75 for phase_4
26 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 9, 2023
CompletedFirst Posted
Study publicly available on registry
March 23, 2023
CompletedStudy Start
First participant enrolled
June 10, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
July 1, 2029
September 23, 2025
September 1, 2025
5.1 years
January 9, 2023
September 18, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Complete healing (CH)
The achievement of complete healing (CH) 52 weeks after initiation of anti-TNF therapy guided by ROADMAB™ (therapeutic drug monitoring) as evidenced by a composite of all of the following four features below: 1. Endoscopic healing (EH) determined by centrally read ileocolonoscopy (total SES-CD score \<3) 2. Transmural healing (TH) determined by centrally read MRE (no segmental MaRIAs score of ≥1) 3. Corticosteroid free for a minimum of 4 weeks 4. The absence of either intestinal resection or the addition of a nutritional, biological or small molecule therapeutic agent other than anti-TNF± concomitant IM
52 weeks from anti-TNF start
Secondary Outcomes (6)
Endoscopic mucosal healing only
52 weeks
Transmural healing only
52 weeks
Clinical remission
52 weeks
Fecal calprotectin
52 weeks
Endoscopic response
52 weeks
- +1 more secondary outcomes
Study Arms (1)
Anti-tumor necrosis factor (TNF)
OTHERPatients newly diagnosed with pediatric-onset Crohn's disease starting anti-TNF therapy within 6 months of diagnosis
Interventions
Use of anti-TNF therapy for children and adolescents with newly diagnosed Crohn's disease guided by a clinical decision support tool
Eligibility Criteria
You may qualify if:
- Age ≥ 6 years and \< 18 years at enrollment
- Suspected diagnosis of CD
- 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.
- Parent/guardian consent and patient assent
- 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
You may not qualify if:
- Diagnosis of CD following abdominal resectional surgery/appendectomy at initial presentation
- 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)
- Use of any oral CS for non-gastrointestinal indication within the four weeks prior to diagnostic assessment and biosampling (e.g., asthma)
- Use of any investigational drug within the past four weeks prior to diagnostic assessment and sampling
- Pregnancy
- Patients with poorly controlled medical conditions (e.g. diabetes, congestive heart failure)
- 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)
- 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
- Inability to have MRE because of claustrophobia or other reasons
- Met all eligibility criteria for Phase 1 and participated in Phase 1
- Diagnosed with macroscopic CD involving the terminal ileum and/or colon by endoscopic evaluation and/or MRE
- 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.
- Received at least one of the following as initial therapy upon diagnosis:
- Corticosteroids
- Immunomodulator
- +17 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (26)
Phoenix Children's Hospital
Phoenix, Arizona, 85016, United States
Cedars-Sinai
Los Angeles, California, 90048, United States
Rady Children's Hospital - San Diego and University of California, San Diego
San Diego, California, 92123, United States
UCSF Benioff Children's Hospitals
San Francisco, California, 94158, United States
Connecticut Children's Medical Center
Hartford, Connecticut, 06106, United States
Emory University
Atlanta, Georgia, 30328, United States
Riley Hospital for Children at Indiana University Health
Indianapolis, Indiana, 46202, United States
The Johns Hopkins Children's Medical Center
Baltimore, Maryland, 21287, United States
Boston Children's Hospital
Boston, Massachusetts, 02115, United States
University of Michigan
Ann Arbor, Michigan, 48109, United States
Goryeb Children's Hospital/Morristown Medical Center/Atlantic Children's Health
Morristown, New Jersey, 07960, United States
Cohen Children's Medical Center of NY
Lake Success, New York, 11042, United States
Columbia University Medical Center
New York, New York, 10032, United States
Levine Children's
Charlotte, North Carolina, 28203, United States
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229, United States
UH/Rainbow Babies and Children's Hospital
Cleveland, Ohio, 44106, United States
Nationwide Children's Hospital
Columbus, Ohio, 43205, United States
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19146, United States
UPMC Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania, 15224, United States
Rhode Island Hospital
Providence, Rhode Island, 02903, United States
Seattle Children's Hospital
Seattle, Washington, 98105, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226, United States
Stollery Children's Hospital
Edmonton, Alberta, T6G 1C9, Canada
Children's Hospital Western Ontario
London, Ontario, N6A 5W9, Canada
Children's Hospital of Eastern Ontario
Ottawa, Ontario, K1H 8L1, Canada
Toronto SickKids Hospital
Toronto, Ontario, M5G1X8, Canada
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jeffrey S Hyams, MD
Connecticut Children's Medical Center
- PRINCIPAL INVESTIGATOR
Subra Kugathasan, MD
Emory University
- PRINCIPAL INVESTIGATOR
Lee Denson, MD
Children's Hospital Medical Center, Cincinnati
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 9, 2023
First Posted
March 23, 2023
Study Start
June 10, 2023
Primary Completion (Estimated)
July 1, 2028
Study Completion (Estimated)
July 1, 2029
Last Updated
September 23, 2025
Record last verified: 2025-09
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
- Time Frame
- 3 years after final outcome data collection
- Access Criteria
- The institutions and PIs will adhere to the NIH Grants Policy on Sharing of Unique Research Resources including the Sharing of Biomedical Research Resources: Guidelines for Recipients of NIH Grants and Contracts on Obtaining and Disseminating Biomedical Research Resources.
The final dataset will include de-identified demographic, clinical, genetic, serological, immune, microbiome, and gene expression data along with patient outcomes. The project will generate a bank of biological samples including serum, plasma, genomic DNA, ileal and colonic biopsy DNA \& RNA, and stool. The investigators will use a data sharing agreement that provides for a commitment to using the data only for research purposes, a commitment to securing the data using appropriate computer technology, and a commitment to destroying or returning the data after analyses are completed. The data and access to the biospecimens for ancillary studies will be made available in a timely fashion following completion and publication of the primary outcome papers. The investigators will follow the prevailing standards and NIDDK Data Sharing Policy guidelines in documenting and depositing data sets. Quality-controlled raw data and processed data used in publications will be made available.