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

May 22, 2026 updated by: Connecticut Children's Medical Center
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Study Sites: Approximately 27 pediatric clinical centers in North America Study Period: Planned enrollment period - 3 years Planned duration of the study: 5 years Primary Study Objective: Identify clinical, radiologic, genomic, immune, microbial and transcriptomic factors associated with complete intestinal healing (CH) in the context of optimized anti-TNF therapy in children with newly diagnosed CD Secondary Study Objective: Identify clinical, radiologic, genomic, immune, microbial and transcriptomic factors associated with endoscopic healing only, transmural healing by MRE only, endoscopic response only, transmural response only, clinical remission, fecal calprotectin normalization, in the context of optimized anti-TNF therapy in children with newly diagnosed CD Study Design: Prospective multicenter open label single arm clinical trial with 2-phase enrollment Sample Size: Phase 1: 900; Phase 2: 550

Study Type

Interventional

Enrollment (Estimated)

900

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Canada
    • Alberta
      • Edmonton, Alberta, Canada, T6G 1C9
        • Recruiting
        • Stollery Children's Hospital
        • Sub-Investigator:
          • Matthew Carroll, MD
        • Principal Investigator:
          • Hien Q. Huynh, MD
        • Contact:
    • Ontario
      • London, Ontario, Canada, N6A 5W9
        • Recruiting
        • Children's Hospital Western Ontario
        • Principal Investigator:
          • Eileen Crowley, MB BCh BAO
        • Sub-Investigator:
          • Ian Ross, MD, FRCPC
        • Contact:
      • Ottawa, Ontario, Canada, K1H 8L1
        • Recruiting
        • Children's Hospital of Eastern Ontario
        • Principal Investigator:
          • David Mack, MD
        • Contact:
      • Toronto, Ontario, Canada, M5G1X8
        • Recruiting
        • Toronto SickKids Hospital
        • Contact:
        • Sub-Investigator:
          • Anne Griffiths, MD
        • Principal Investigator:
          • Thomas Walters, MBBS, MSc
  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85016
        • Recruiting
        • Phoenix Children's Hospital
        • Contact:
        • Principal Investigator:
          • Paula Tizzard, MD
        • Sub-Investigator:
          • Elizabeth Hilow, MD
    • California
      • Los Angeles, California, United States, 90048
        • Recruiting
        • Cedars-Sinai
        • Principal Investigator:
          • Shervin Rabizadeh, MD, MBA
        • Sub-Investigator:
          • David Ziring, MD
        • Contact:
      • San Diego, California, United States, 92123
        • Active, not recruiting
        • Rady Children's Hospital - San Diego and University of California, San Diego
      • San Francisco, California, United States, 94158
        • Recruiting
        • UCSF Benioff Children's Hospitals
        • Contact:
        • Principal Investigator:
          • Sofia Verstraete, MD, MAS
        • Sub-Investigator:
          • Melvin Heyman, MD, MPH
    • Connecticut
      • Hartford, Connecticut, United States, 06106
        • Recruiting
        • Connecticut Children's Medical Center
        • Principal Investigator:
          • Victoria Grossi, DO
        • Sub-Investigator:
          • Jeffrey S Hyams, MD
        • Contact:
    • Georgia
      • Atlanta, Georgia, United States, 30328
        • Recruiting
        • Emory University
        • Contact:
          • Phone Number: 404-727-4503
        • Principal Investigator:
          • Subra Kugathasan, MD
        • Contact:
        • Sub-Investigator:
          • B. Joanna Niklinska-Schirtz, MD
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Recruiting
        • Riley Hospital for Children at Indiana University Health
        • Principal Investigator:
          • Marian Pfefferkorn, MD
        • Sub-Investigator:
          • Steven Steiner, MD
        • Contact:
    • Maryland
      • Baltimore, Maryland, United States, 21287
        • Recruiting
        • The Johns Hopkins Children's Medical Center
        • Principal Investigator:
          • Maria Oliva-Hemker, MD
        • Sub-Investigator:
          • Anthony Guerrerio, MD, PhD
        • Contact:
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Recruiting
        • Boston Children's Hospital
        • Contact:
        • Principal Investigator:
          • Jodie Ouahed, MD, MMSc
        • Sub-Investigator:
          • Scott Snapper, MD, PhD
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • Recruiting
        • University of Michigan
        • Contact:
        • Sub-Investigator:
          • G. Jennifer Lee, MD
        • Principal Investigator:
          • Jeremy Adler, MD, MSc
    • New Jersey
      • Morristown, New Jersey, United States, 07960
        • Recruiting
        • Goryeb Children's Hospital/Morristown Medical Center/Atlantic Children's Health
        • Contact:
        • Principal Investigator:
          • Oren Koslowe, MD
        • Sub-Investigator:
          • Peter Wilmot, MD
    • New York
      • Lake Success, New York, United States, 11042
        • Recruiting
        • Cohen Children's Medical Center of NY
        • Contact:
        • Principal Investigator:
          • James Markowitz, MD
        • Sub-Investigator:
          • Benjamin Sahn, MD
      • New York, New York, United States, 10032
        • Recruiting
        • Columbia University Medical Center
        • Contact:
        • Principal Investigator:
          • Neal LeLeiko, MD, PhD
        • Sub-Investigator:
          • Joseph Picoraro, MD
    • North Carolina
      • Charlotte, North Carolina, United States, 28203
        • Recruiting
        • Levine Children's
        • Principal Investigator:
          • Tiffany Linville, MD
        • Sub-Investigator:
          • Nathan Fleishman, MD
        • Contact:
    • Ohio
      • Cincinnati, Ohio, United States, 45229
        • Recruiting
        • Cincinnati Children's Hospital Medical Center
        • Principal Investigator:
          • Jasbir Dhaliwal, MD
        • Sub-Investigator:
          • Lee Denson, MD
        • Contact:
      • Cleveland, Ohio, United States, 44106
        • Recruiting
        • UH/Rainbow Babies and Children's Hospital
        • Contact:
        • Principal Investigator:
          • Denise Young, MD
        • Sub-Investigator:
          • Thomas Sferra, MD
      • Columbus, Ohio, United States, 43205
        • Recruiting
        • Nationwide Children's Hospital
        • Contact:
        • Principal Investigator:
          • Brendan Boyle, MD, MPH
        • Sub-Investigator:
          • Hilary Michel, MD
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19146
        • Recruiting
        • Children's Hospital of Philadelphia
        • Principal Investigator:
          • Lindsey Albenberg, DO
        • Contact:
          • Lindsey Albenberg, DO
          • Phone Number: 267-426-7791
        • Sub-Investigator:
          • Robert Baldassano, MD
      • Pittsburgh, Pennsylvania, United States, 15224
        • Recruiting
        • UPMC Children's Hospital of Pittsburgh
        • Contact:
        • Principal Investigator:
          • Whitney Sunseri, MD
    • Rhode Island
      • Providence, Rhode Island, United States, 02903
        • Recruiting
        • Rhode Island Hospital
        • Principal Investigator:
          • Jason Shapiro, MD
        • Sub-Investigator:
          • Shova Subedi, MD
        • Contact:
    • Washington
      • Seattle, Washington, United States, 98105
        • Recruiting
        • Seattle Children's Hospital
        • Sub-Investigator:
          • David Suskind, MD
        • Contact:
        • Principal Investigator:
          • Hengqi (Betty) Zheng, MD
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53226
        • Recruiting
        • Medical College of Wisconsin
        • Sub-Investigator:
          • Jose Cabrera, MD
        • Sub-Investigator:
          • Abdul Elkadri, MD
        • Principal Investigator:
          • Joshua Noe, MD
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 years to 17 years (Child)

Accepts Healthy Volunteers

No

Study Population

Patients newly diagnosed with pediatric-onset CD (ages 6-17 years inclusive) starting anti-TNF therapy within 6 months of diagnosis

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Anti-tumor necrosis factor (TNF)
Patients newly diagnosed with pediatric-onset Crohn's disease starting anti-TNF therapy within 6 months of diagnosis
Drug: 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 Names:
  • Remicade, Inflectra, Renflexis, Avsola, Humira, Amgevita, Hulio, Hadlima, Hyrimoz, Idacio

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Complete healing (CH)
Time Frame: 52 weeks from anti-TNF start

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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Endoscopic mucosal healing only
Time Frame: 52 weeks
Following approximately 52 weeks of anti-TNF therapy guided by the ROADMAB™ Clinical Decision Support Tool (CDST), with a minimum of 4 weeks of being corticosteroid free, and in the absence of either intestinal resection or the addition of a biological or small molecule therapeutic agent other than anti-TNF± concomitant IM: Endoscopic mucosal healing only (total Simple Endoscopic Score - Crohn's Disease (SES-CD) <3)
52 weeks
Transmural healing only
Time Frame: 52 weeks
Following approximately 52 weeks of anti-TNF therapy guided by the ROADMAB™ Clinical Decision Support Tool (CDST), with a minimum of 4 weeks of being corticosteroid free, and in the absence of either intestinal resection or the addition of a biological or small molecule therapeutic agent other than anti-TNF± concomitant IM: Transmural healing only (no segmental simplified magnetic resonance index of activity (MaRIAs) score ≥1)
52 weeks
Clinical remission
Time Frame: 52 weeks
Following approximately 52 weeks of anti-TNF therapy guided by the ROADMAB™ Clinical Decision Support Tool (CDST), with a minimum of 4 weeks of being corticosteroid free, and in the absence of either intestinal resection or the addition of a biological or small molecule therapeutic agent other than anti-TNF± concomitant IM: Clinical remission (weighted Pediatric Crohn's Disease Activity Index (wPCDAI) < 12.5)
52 weeks
Fecal calprotectin
Time Frame: 52 weeks
Following approximately 52 weeks of anti-TNF therapy guided by the ROADMAB™ Clinical Decision Support Tool (CDST), with a minimum of 4 weeks of being corticosteroid free, and in the absence of either intestinal resection or the addition of a biological or small molecule therapeutic agent other than anti-TNF± concomitant IM: Fecal calprotectin <250 ug/g
52 weeks
Endoscopic response
Time Frame: 52 weeks
Following approximately 52 weeks of anti-TNF therapy guided by the ROADMAB™ Clinical Decision Support Tool (CDST), with a minimum of 4 weeks of being corticosteroid free, and in the absence of either intestinal resection or the addition of a biological or small molecule therapeutic agent other than anti-TNF± concomitant IM: Endoscopic response: 50% reduction in SES-CD
52 weeks
Transmural response
Time Frame: 52 weeks
Following approximately 52 weeks of anti-TNF therapy guided by the ROADMAB™ Clinical Decision Support Tool (CDST), with a minimum of 4 weeks of being corticosteroid free, and in the absence of either intestinal resection or the addition of a biological or small molecule therapeutic agent other than anti-TNF± concomitant IM: Transmural response: 50% reduction in MaRIAs
52 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Connecticut Children's Medical Center

Collaborators

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Emory University
University of North Carolina, Chapel Hill
Children's Hospital Medical Center, Cincinnati

Investigators

  • 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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 10, 2023

Primary Completion (Estimated)

July 1, 2028

Study Completion (Estimated)

July 1, 2029

Study Registration Dates

First Submitted

January 9, 2023

First Submitted That Met QC Criteria

March 10, 2023

First Posted (Actual)

March 23, 2023

Study Record Updates

Last Update Posted (Actual)

May 27, 2026

Last Update Submitted That Met QC Criteria

May 22, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 22-066
  • 1U01DK134356-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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.

IPD Sharing Time Frame

3 years after final outcome data collection

IPD Sharing 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.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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