Actively Recruiting

Phase 4
Age: 6Years - 17Years
All Genders
NCT05781152

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

Led by Connecticut Children's Medical Center · Updated on 2025-09-23

900

Participants Needed

26

Research Sites

316 weeks

Total Duration

On this page

Sponsors

C

Connecticut Children's Medical Center

Lead Sponsor

N

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 6Years - 17Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 6 years or older and younger than 18 years at enrollment
  • Suspected diagnosis of Crohn's disease
  • Negative stool culture for routine pathogens and Clostridium difficile toxin if diarrhea is present
  • Parent or guardian consent and patient assent
  • Ability to remain in follow-up for at least 6 months initial observation plus 52 weeks after starting anti-TNF therapy
  • Diagnosed with macroscopic Crohn's disease involving the terminal ileum and/or colon by endoscopic evaluation and/or MRI enterography
  • MRI enterography performed within 6 weeks of ileocolonoscopy and no more than 4 weeks after starting initial therapy
  • Received initial therapy including corticosteroids, immunomodulators, aminosalicylic acids, defined nutritional therapy, or anti-TNF (adalimumab or infliximab)
  • Commenced anti-TNF therapy guided by ROADMAB CDST as first therapy or within 180 days of diagnosis
  • Ileal and rectal biopsies obtained or documented inflammation preventing ileal biopsies
  • Ability to remain in follow-up for at least 52 weeks after starting anti-TNF therapy
Not Eligible

You will not qualify if you...

  • Diagnosis of Crohn's disease following abdominal surgery or appendectomy at initial presentation
  • High likelihood (>50%) of needing bowel resection within 3 months of diagnosis
  • Use of oral corticosteroids for non-gastrointestinal reasons within 4 weeks prior to assessment
  • Use of investigational drugs within 4 weeks prior to assessment
  • Pregnancy
  • Poorly controlled medical conditions such as diabetes or congestive heart failure
  • Previous treatment with immunomodulators within 1 year or anti-TNF therapy within 2 years for other conditions
  • Previous treatment with non-anti-TNF biologics or small molecules for non-IBD indications in past 6 months except dupilumab
  • Inability to undergo MRI enterography due to claustrophobia or other reasons
  • Diagnosis of Crohn's disease by video capsule endoscopy only with normal ileocolonoscopy and MRI
  • Orofacial Crohn's disease only
  • Esophageal, gastric, duodenal, or jejunal Crohn's disease only
  • Severe complex fistulizing perianal disease requiring or likely to require surgical intervention
  • Perianal Crohn's disease only with no luminal disease
  • Internal fistulizing disease at diagnosis
  • Initial treatment with non-anti-TNF biologic or small molecule therapy
  • Received any anti-TNF agent other than adalimumab or infliximab
  • Unlikely to return for follow-up visits
  • Video of baseline endoscopy not available for central reading unless approved
  • Underwent bowel resection within 3 months of diagnosis

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 26 locations

1

Phoenix Children's Hospital

Phoenix, Arizona, United States, 85016

Actively Recruiting

2

Cedars-Sinai

Los Angeles, California, United States, 90048

Actively Recruiting

3

Rady Children's Hospital - San Diego and University of California, San Diego

San Diego, California, United States, 92123

Actively Recruiting

4

UCSF Benioff Children's Hospitals

San Francisco, California, United States, 94158

Actively Recruiting

5

Connecticut Children's Medical Center

Hartford, Connecticut, United States, 06106

Actively Recruiting

6

Emory University

Atlanta, Georgia, United States, 30328

Actively Recruiting

7

Riley Hospital for Children at Indiana University Health

Indianapolis, Indiana, United States, 46202

Actively Recruiting

8

The Johns Hopkins Children's Medical Center

Baltimore, Maryland, United States, 21287

Actively Recruiting

9

Boston Children's Hospital

Boston, Massachusetts, United States, 02115

Actively Recruiting

10

University of Michigan

Ann Arbor, Michigan, United States, 48109

Actively Recruiting

11

Goryeb Children's Hospital/Morristown Medical Center/Atlantic Children's Health

Morristown, New Jersey, United States, 07960

Actively Recruiting

12

Cohen Children's Medical Center of NY

Lake Success, New York, United States, 11042

Actively Recruiting

13

Columbia University Medical Center

New York, New York, United States, 10032

Actively Recruiting

14

Levine Children's

Charlotte, North Carolina, United States, 28203

Actively Recruiting

15

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, United States, 45229

Actively Recruiting

16

UH/Rainbow Babies and Children's Hospital

Cleveland, Ohio, United States, 44106

Actively Recruiting

17

Nationwide Children's Hospital

Columbus, Ohio, United States, 43205

Actively Recruiting

18

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, United States, 19146

Actively Recruiting

19

UPMC Children's Hospital of Pittsburgh

Pittsburgh, Pennsylvania, United States, 15224

Actively Recruiting

20

Rhode Island Hospital

Providence, Rhode Island, United States, 02903

Actively Recruiting

21

Seattle Children's Hospital

Seattle, Washington, United States, 98105

Actively Recruiting

22

Medical College of Wisconsin

Milwaukee, Wisconsin, United States, 53226

Actively Recruiting

23

Stollery Children's Hospital

Edmonton, Alberta, Canada, T6G 1C9

Actively Recruiting

24

Children's Hospital Western Ontario

London, Ontario, Canada, N6A 5W9

Actively Recruiting

25

Children's Hospital of Eastern Ontario

Ottawa, Ontario, Canada, K1H 8L1

Actively Recruiting

26

Toronto SickKids Hospital

Toronto, Ontario, Canada, M5G1X8

Actively Recruiting

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Research Team

D

Dena E Hopkins, MPH, CCRP

CONTACT

J

Jeffrey S Hyams, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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