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

M
Marian Pfefferkorn

Primary Investigator

Enrolling By Invitation
6 years - 17 years
All
Phase N/A
900 participants needed
2 Locations

Brief description of study

Crohn's disease (CD) is a condition that causes inflammation (swelling, redness) of theg and wall of the small intestine, large intestine, or both. CD may be associated withbdominal cramps/pain, diarrhea, blood in the stool, weight loss, or delayed growth inhildren. While the exact cause of CD is not certain it is thought that the immune systemd 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 thedoctors 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 isvolved in inflammation. When this type of treatment is given early after diagnosis it isve than when it is given later. The investigators have learned that it isgive 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 understandhe 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 healshe inflammation after anti-TNF therapy. The investigators will do that by measuring certainkers 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 howuch healing has taken place by comparing the results of the colonoscopy and a special typeRI 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 arehought to have CD and are about to undergo their diagnostic colonoscopy are eligible to bed. If they are found to indeed have CD and start an anti-TNF medicine within 6 monthshey 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.

Detailed description of study

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 Studybjective: Identify clinical, radiologic, genomic, immune, microbial and transcriptomicd with complete intestinal healing (CH) in the context of optimized anti-TNFherapy in children with newly diagnosed CD Secondary Study Objective: Identify clinical,diologic, genomic, immune, microbial and transcriptomic factors associated with endoscopic healing only, transmural healing by MRE only, endoscopic response only, transmural responsey, clinical remission, fecal calprotectin normalization, in the context of optimizedTNF therapy in children with newly diagnosed CD Study Design: Prospective multicenterbel single arm clinical trial with 2-phase enrollment Sample Size: Phase 1: 900; Phase 2: 550

Eligibility of study

You may be eligible for this study if you meet the following criteria:

  • Conditions: Crohn Disease, Riley
  • Age: 6 years - 17 years
  • Gender: All

Phase 1 Inclusion Criteria (all must be fulfilled)
  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,higella, Campylobacter, E. coli 0157:H7) and Clostridium difficile toxin in patientsg with diarrhea. If history of C. difficile then a minimum of 6 weeksduration 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 aum 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
  2. Investigator judgment that patient has high likelihood (>50%) of needing bowelwithin 3 months of diagnosis (i.e., presentation with perforation, bowelbstruction from stricture)
  3. Use of any oral corticosteroid (CS) for non-gastrointestinal indication within theur weeks prior to diagnostic assessment and biosampling (e.g., asthma)
  4. Use of any investigational drug within the past four weeks prior to diagnosticd sampling
  5. Pregnancy
  6. Patients with poorly controlled medical conditions (e.g. diabetes, congestive hearture)
  7. Previous treatment with immunomodulators or anti-TNF therapy for other medicalditions (e.g., juvenile idiopathic arthritis) at any time prior to enrollment
  8. Previous treatment with non-anti TNF biologics or small molecules for non-IBDdications in the past 6 months
Phase 2 Inclusion Criteria (all must be fulfilled)
  1. Met all eligibility criteria for Phase 1 and participated in Phase 1
  2. Diagnosed with active luminal CD involving the terminal ileum and/or colon bydoscopic and/or radiographic evidence
  3. Magnetic Resonance Enterography (MRE) imaging within 6 weeks of ileocolonoscopy and nohan 4 weeks after starting initial therapy. A limited 'research protocol' MRE isble in participants who have undergone a clinical CTE during their initialdiagnostic 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. Defined nutritional therapy
    4. 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 first therapy, with or without concomitantunomodulator
  6. Had ileal and rectal biopsies
  7. Parent/guardian re-consent and patient re-assent
  8. Ability to remain in follow-up for a minimum of 52 weeks after start of anti-TNFherapy
Phase 2 Exclusion Criteria
  1. Diagnosis of CD using video capsule endoscopy only with normal ileocolonoscopy andRE
  2. Orofacial CD only
  3. Esophageal, gastric, duodenal, and/or jejunal CD only
  4. Severe complex fistulizing perianal disease +/- abscess, or perianal disease requiringurgical intervention or likely to require on-going surgical intervention possiblyuding diversion
  5. Perianal CD only with no evidence of luminal disease
  6. Internal fistulizing disease at diagnosis
  7. Initial inflammatory bowel disease (IBD) treatment with non-anti-TNF biologic or smallule therapy
  8. Received any anti-TNF agent other than adalimumab or infliximab
  9. Investigator judgment that patient unlikely to return for clinical, endoscopic or MREw-up
  10. Inability to have MRE because of claustrophobia or other reasons
  11. Incomplete lower endoscopic diagnostic evaluation where the investigation isd prior to intubation of the ileum
  12. Video of baseline endoscopy not available for central reading
  13. Underwent bowel resection within 3 months of initial therapy

Updated on 13 Sep 2024. Study ID: 22-066, PGI-CCMC-CAMEO, 19252
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