Table 1.

REMODEL-CD eligibility criteria

Inclusion criteria

Written informed consent from the patient (≥18 years old) or from parent/legal guardian if patient is <18 years old Written informed assent from patient when age appropriate Diagnosis of Crohn’s disease within the last 90 days (luminal-only or luminal with a perianal fistula or abscess treated with antibiotics for at least 7 days) ≥6 years to ≤22 years of age, anti-TNF naïve and starting infliximab Clinical activity and luminal inflammation, defined by both (1) and (2) (1) PCDAI>10 (<18 years old) or CDAI>150 (≥18 years old) in last 60 days before the decision to start infliximab (2) SES-CD>6 or SES-CD>3 for isolated ileal disease (or a report of large intestinal ulcerations) within the last 60 days or a faecal calprotectin>250 µg/g within last 75 days prior to screening C-reactive protein>1.0 mg/dL in last 30 days and/or faecal calprotectin>250 µg/g within last 75 days prior to screening Negative TB (tuberculosis) interferon-gamma release test and a negative urine pregnancy test for female patients (if menstruation has started)

Exclusion criteria

Diagnosis of ulcerative colitis or inflammatory bowel disease-unspecified Prior use of anti-TNF therapy (infliximab, adalimumab, certolizumab pegol or golimumab) Internal (abdominal/pelvic) penetrating fistula(e) in last 180 days Intra-abdominal abscess/phlegmon/inflammatory mass in the last 180 days Active perianal abscess (receiving oral antibiotics for <7 days) Intestinal stricture (luminal narrowing with prestenotic dilation>3 cm) and surgery planned in next 90 days Have tested positive for Clostridium difficile toxin (stool assay) or other intestinal pathogens within 14 days of screening unless a repeat examination is negative and there are no signs of ongoing infection with that pathogen Current hospitalisation for complications of severe Crohn’s disease Planned use of methotrexate or 6-mercaptopurine (azathioprine) during the induction (first 3 doses of infliximab) phase Current ileostomy, colostomy, ileoanal pouch and/or previous extensive small bowel resection (>35 cm) or any Crohn’s disease surgery planned within the next 90 days History of autoimmune hepatitis, primary sclerosing cholangitis, thyroiditis or juvenile idiopathic arthritis Treatment with another investigational drug in last 4 weeks History of malignancy (including lymphoma or leukaemia) Currently receiving treatment for histoplasmosis History of TB, HIV, an immunodeficiency syndrome, a central nervous system demyelinating disease, history of heart failure or receiving intravenous antibiotics in last 14 days for any infection Currently pregnant, breast feeding or plans to become pregnant in the next 1 year Inability or failure to provide informed assent/consent Any developmental disabilities that would impede providing assent/consent

CD, Crohn’s disease ; CDAI, CD activity index; PCDAI, paediatric CD activity index; SES, simplified endoscopic score; TNF, tumour necrosis factor.