Precision Crohn's Disease Management Utilizing Predictive Protein Panels (ENvISION)

NCT04131504 | Completed

• 1 other identifier: 2019-0730
• Study Type: observational
• Target: 239
• Locations: 1 country
• Sites: 4

Brief Summary

Crohn's disease and ulcerative colitis affect about 1.6 to 3 million people in the United States with many of those being young children and adolescents. Physicians need better ways to inform decisions on therapy selection and recognize ongoing intestinal injury while on treatment. The main reason for this research study is to see if a blood test or stool test, which measures specific proteins, taken just before starting a new treatment for Crohn's disease can predict a patient's ability to achieve complete intestinal healing. The investigators also want to see if the intensity of gut inflammation can be detected by measuring a separate set of proteins in the blood.

Conditions

Crohn's Disease; IBD

Outcome Measures

Primary Outcomes (1)

• Sustained Deep Remission

  Sustained Deep Remission, defined as meeting all of the following at 1 year (check all that apply): * no wPCDAI score of ≥12.5 on two consecutive visits between week 30-52 * wPCDAI at week 52 is \<12.5 * off prednisone between weeks 30-52 * endoscopic remission (SES-CD\<3)

  1 year

Secondary Outcomes (24)

• End of Induction Outcomes: Clinical Response

  Week 16

• End of Induction Outcomes: Clinical Remission

  Week 16

• End of Induction Outcomes: Steroid Free Clinical Remission

  Week 16

• End of Induction Outcomes: Fecal Biochemical Response

  Week 16

• End of Induction Outcomes: Fecal Biochemical Remission

  Week 16

Study Arms (3)

Phase I - Cross-sectional Study (CD and Suspected IBD)

150 children and young adults who have been previously diagnosed with CD (anti-TNF naïve) or suspected of having IBD (based on clinical symptoms and laboratory testing) who are scheduled for a clinically-indicated colonoscopy are eligible to be enrolled in this cohort.

Phase I - Cross-sectional Study (healthy volunteers)

20 healthy controls will be enrolled at Cincinnati Children's Hospital only. Once demographics, past medical/surgical history and biospecimens (blood/stool) are collected, controls will complete participation.

Phase II - Longitudinal Study of Participants with CD

70 children and young adults who have been diagnosed with CD (anti-TNF naïve) and are scheduled to receive infliximab (or adalimumab) are eligible to be enrolled in this cohort.

Drug: Infliximab; Drug: Adalimumab

Interventions

Infliximab DRUG

No standard dosing regimen will be used and the dose will be determined by the treating physician

Also known as: Remicade

Phase II - Longitudinal Study of Participants with CD

Adalimumab DRUG

No standard dosing regimen will be used and the dose will be determined by the treating physician

Also known as: Humira

Phase II - Longitudinal Study of Participants with CD

Eligibility Criteria

• Age: 1 Year - 22 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Potential IBD participants will be recruited through the Division of Gastroenterology at each participating site. Healthy volunteers will be recruited from through direct advertising methods approved by the IRB and formal local databases intended for recruitment.

You may qualify if:

• Age criteria: \> 1 year to \< 22 years of age
• Diagnosis of Crohn's disease, anti-TNF naïve, and colonoscopy scheduled OR
• Clinical suspicion for IBD (treatment naïve) and colonoscopy scheduled
• Permission of parent/guardian and assent or consent of research participant

You may not qualify if:

• Any prior treatment with an anti-TNF, such as infliximab, adalimumab, certolizumab or golimumab
• Known diagnosis of ulcerative colitis (UC) or inflammatory bowel disease-unspecified (IBD-U)
• Active or prior evidence of internal (abdominal/pelvic) penetrating fistula(e)
• Active intra-abdominal abscess or perianal abscess
• Active Clostridium difficile infection or other known enteric infection in last 2 weeks
• Current ileostomy or colostomy, extensive small bowel resection, ileoanal pouch or short bowel syndrome
• History of autoimmune disease (including autoimmune hepatitis, primary sclerosing cholangitis, thyroiditis, psoriasis or juvenile idiopathic arthritis)
• Any condition that in the opinion of the PI will prevent the research participant from taking part in this study
• Phase I - Cross-sectional Study (healthy volunteers)
• Age criteria: \> 1 year to \< 22 years of age
• Any CCHMC patient
• Permission of parent/guardian and assent or consent of research participant
• Known diagnosis of one or more of the following: irritable bowel syndrome, gastroesophageal reflux, constipation, BMI\>95% for age, small intestinal bacterial overgrowth (SIBO) or history of intestinal polyps
• Received any antibiotic in the last 30 days or known viral or bacterial illness in the last 30 days
• Any NSAID use in the last 14 days

Sponsors & Collaborators

• Children's Hospital Medical Center, Cincinnati: lead
• The Leona M. and Harry B. Helmsley Charitable Trust: collaborator

Study Sites (4)

Connecticut Children's Medical Center

Hartford, Connecticut, 06016, United States

Location

Cincinnati Children's Hospital

Cincinnati, Ohio, 45229, United States

Location

Nationwide Children's Hospital

Columbus, Ohio, 43205, United States

Location

Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

Location

Related Publications (1)

• Velez Lopez A, Waddell A, Antonacci S, Castillo D, Santucci N, Ollberding NJ, Eshleman EM, Denson LA, Alenghat T. Microbiota-derived butyrate dampens linaclotide stimulation of the guanylate cyclase C pathway in patient-derived colonoids. Neurogastroenterol Motil. 2023 Dec;35(12):e14681. doi: 10.1111/nmo.14681. Epub 2023 Sep 22.

  PMID: 37736865 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

* Blood specimens will be collected for biomarker discovery and validation * Stool specimens will be collected for microbial analysis and additional IBD-related stool biomarkers * OPTIONAL: Four additional research-only intestinal pinch biopsies at the time of a clinically indicated or research-only colonoscopy

MeSH Terms

Conditions

Crohn Disease

Interventions

Infliximab; Adalimumab

Condition Hierarchy (Ancestors)

Inflammatory Bowel Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Antibodies, Monoclonal, Humanized

Study Officials

• Phillip Minar, MD, MS

  Children's Hospital Medical Center, Cincinnati

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 16, 2019
• First Posted: October 18, 2019
• Study Start: October 16, 2019
• Primary Completion: October 31, 2023
• Study Completion: October 31, 2023
• Last Updated: January 30, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)