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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 February 2024
• Main ID: NCT04131504
• Date of registration: 16/10/2019
• Prospective Registration: Yes
• Primary sponsor: Children's Hospital Medical Center, Cincinnati
• Public title: Precision Crohn's Disease Management Utilizing Predictive Protein Panels (ENvISION) ENvISION
• Scientific title: A Multi-Center, Prospective Study to Discover a Companion Diagnostic for Biologics Targeting TNF
• Date of first enrolment: October 16, 2019
• Target sample size: 239
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/ct2/show/NCT04131504
• Study type: Observational

Countries of recruitment

United States

Contacts

• Name: Phillip Minar, MD, MS
• Affiliation: Children's Hospital Medical Center, Cincinnati

Key inclusion & exclusion criteria

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

Inclusion Criteria:

1. Age criteria: > 1 year to < 22 years of age

2. Diagnosis of Crohn's disease, anti-TNF naïve, and colonoscopy scheduled OR

3. Clinical suspicion for IBD (treatment naïve) and colonoscopy scheduled

4. Permission of parent/guardian and assent or consent of research participant

Exclusion Criteria:

1. Any prior treatment with an anti-TNF, such as infliximab, adalimumab, certolizumab or
golimumab

2. Known diagnosis of ulcerative colitis (UC) or inflammatory bowel disease-unspecified
(IBD-U)

3. Active or prior evidence of internal (abdominal/pelvic) penetrating fistula(e)

4. Active intra-abdominal abscess or perianal abscess

5. Active Clostridium difficile infection or other known enteric infection in last 2
weeks

6. Current ileostomy or colostomy, extensive small bowel resection, ileoanal pouch or
short bowel syndrome

7. History of autoimmune disease (including autoimmune hepatitis, primary sclerosing
cholangitis, thyroiditis, psoriasis or juvenile idiopathic arthritis)

8. 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)

Inclusion Criteria:

1. Age criteria: > 1 year to < 22 years of age

2. Any CCHMC patient

3. Permission of parent/guardian and assent or consent of research participant

Exclusion Criteria:

1. 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

2. Received any antibiotic in the last 30 days or known viral or bacterial illness in the
last 30 days

3. Any NSAID use in the last 14 days

4. History of an autoimmune disease (including diabetes, autoimmune hepatitis, primary
sclerosing cholangitis, thyroiditis, psoriasis or juvenile idiopathic arthritis)

5. Any condition that in the opinion of the PI will prevent the research participant from
taking part in this study

Phase II - Longitudinal Study of Participants with CD

Inclusion Criteria:

1. Age criteria: > 1 year to < 22 years of age

2. Diagnosis of Crohn's disease with:

1. Luminal inflammation (ulcerations in ileum and/or colon visible by
ileocolonoscopy) and

2. Endoscopic evidence of active Crohn's disease (up to 90 days prior to starting
anti-TNF) OR if no colonoscopy within 90 days then fecal calprotectin =250 µg/g
or fecal lactoferrin >10 µg/g (<90 days from starting anti-TNF)

3. Anti-TNF naïve

4. Starting infliximab or adalimumab (or either biosimilar)

5. Permission of parent/guardian and assent or consent of research participant

Exclusion Criteria:

1. Crohn's disease limited to esophagus, stomach, duodenum or jejunum

2. Prior treatment with infliximab, adalimumab, certolizumab or golimumab

3. Known diagnosis of Ulcerative colitis (UC) or inflammatory bowel disease-unspecified
(IBD-U)

4. Active or prior evidence of internal (abdominal/pelvic) penetrating fistula(e)

5. Active intra-abdominal abscess or perianal abscess

6. Active Clostridium difficile infection or other known enteric infection in last 2
weeks

7. Current ileostomy or colostomy, extensive small bowel resection, ileoanal pouch or
short bowel syndrome

8. History of autoimmune disease (including autoimmune hepatitis, primary sclerosing
cholangitis, thyroiditis, psoriasis or juvenile idiopathic arthritis)

9. Contraindications to MRI scanning, such as metal implants/non-compatible medical
devices or medical conditions

10. Any condition that in the opinion of the PI will prevent the research participant from
taking part in this study



Age minimum: 1 Year
Age maximum: 22 Years
Gender: All

Health Condition(s) or Problem(s) studied

IBD

Crohn's Disease

Intervention(s)

Drug: Infliximab

Drug: Adalimumab

Primary Outcome(s)

Sustained Deep Remission [Time Frame: 1 year]

Secondary Outcome(s)

End of Induction Outcomes: Blood CRP Biochemical Remission [Time Frame: Week 16]

Week 52 Outcomes: Fecal Biochemical Remission [Time Frame: 1 year]

Week 52 Outcomes: Treatment Response [Time Frame: 1 year]

Week 52 Outcomes: Clinical Remission [Time Frame: 1 year]

Week 52 Outcomes: Endoscopic Response [Time Frame: 1 year]

End of Induction Outcomes: Clinical Remission [Time Frame: Week 16]

End of Induction Outcomes: Fecal Biochemical Remission [Time Frame: Week 16]

Week 52 Outcomes: CD64 Biochemical Remission [Time Frame: 1 year]

Week 52 Outcomes: Clinical Remission and Endoscopic Response [Time Frame: 1 year]

Week 52 Outcomes: Clinical Remission and Minimal Endoscopic Activity [Time Frame: 1 year]

Week 52 Outcomes: Transmural ileal healing [Time Frame: 1 year]

End of Induction Outcomes: Clinical Response [Time Frame: Week 16]

End of Induction Outcomes: Fecal Biochemical Response [Time Frame: Week 16]

Week 52 Outcomes: Minimal Endoscopic Activity [Time Frame: 1 year]

Week 52 Outcomes: Total Bowel Transmural healing [Time Frame: 1 year]

End of Induction Outcomes: Steroid Free Clinical Remission [Time Frame: Week 16]

Week 52 Outcomes: CRP Biochemical Remission [Time Frame: 1 year]

Week 52 Outcomes: Endoscopic Remission [Time Frame: 1 year]

End of Induction Outcomes: Blood CD64 Biochemical Remission [Time Frame: Week 16]

Week 52 Outcomes: Complete Intestinal Healing [Time Frame: 1 year]

Week 52 Outcomes: Transmural colonic healing [Time Frame: 1 year]

Week 52 Outcomes: Deep Fecal Biochemical Remission [Time Frame: 1 year]

Week 52 Outcomes: PGA Remission [Time Frame: 1 year]

Week 52 Outcomes: Sustained, Steroid-free Clinical Remission [Time Frame: 1 year]

Secondary ID(s)

2019-0730

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

The Leona M. and Harry B. Helmsley Charitable Trust