- Male and female children between the ages of six and eighteen years of age with
recurrence of active Crohn's disease, determined by their primary pediatric
gastroenterologist to require either:
1. Corticosteroid therapy ((1-2 mg/kg/d up to maximum of 60 mg/day) with taper, or
2. Infliximab therapy (5 mg/kg at 0, 2, and 6 weeks, followed by q 8 week therapy)
- Crohn's disease of at least 3 months since diagnosis, with gastritis, duodenitis,
ileitis, ileocolitis, or colitis, confirmed by endoscopy and biopsy
- PCDAI score >20
- If receiving concomitant medications, must have been on a stable regimen as follows:
1. Subjects on aminosalicylates and/or immunomodulators should be on a stable dose
for at least 2 weeks prior to enrollment.
2. Subjects must be off oral, rectal, and parenteral corticosteroids at least 2
weeks prior to enrollment.
- Screening laboratory tests that meet the following criteria (obtained within 4 weeks
1. Hemoglobin >8.0 g/dL
2. White blood cell count >3.5 x 109/L
3. Neutrophils >1.5 x 109/L
4. Platelets >100 x 109/L
5. Aspartate aminotransferase, alanine aminotransferase, and alkaline phosphatase
levels within 3 times the upper limit of normal.
- For those patients to receive infliximab, PPD skin tests with skin induration <5 mm.
- Signed written consent from the parent/legal guardian and assent from the child to be
obtained prior to enrollment.
- Local manifestations of Crohn's disease, including fistula(s), strictures, abscesses,
or other complications for which surgery may be indicated.
- Surgery for bowel diversion with placement of stoma within 3 months prior to
- Positive stool examination of enteric pathogens including Salmonella and Shigella
species, Clostridium difficile, and Giardia lamblia.
- Female subjects who are pregnant, nursing, or planning pregnancy.
- Concomitant diagnosis or history of congestive heart failure.
- Treatment with parenteral nutrition within 4 weeks of enrollment.
- Serious infection in the 3 months prior to enrollment.
- History of prior or current active or latent tuberculosis.
- Immune deficiency syndrome, including documented human immunodeficiency virus (HIV)
or acquired immunodeficiency syndrome (AIDS).
- History of systemic lupus erythematosus.
- A transplanted organ.
- Known malignancy or history of malignancy within 5 years of enrollment.
- History of demyelinating disease.
- History of substance abuse.
- Poor tolerability of venipuncture or lack of venous access during the study period.
- A live virus vaccination within 3 months of enrollment.
- Prior history of infliximab infusion, or any other therapeutic agent targeted at
reducing tumor necrosis factor-a (TNF-a).
- Hypersensitivity to any murine proteins or other component of infliximab for those
patients to receive infliximab.
- Inability to comply with study procedures