- Male and female children between the ages of six and eighteen years of age
- Endoscopic or histologic evidence of ulcerative colitis
- Active ulcerative colitis determined by primary pediatric gastroenterologist to
require anti-tumor necrosis factor-alpha antibody (infliximab) therapy
- Colitis symptom score ≥2
- 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.
6. PPD skin test with skin induration <5 mm.
7. Signed written consent from the parent/legal guardian and assent from the child
to be obtained prior to enrollment.
- Female subjects who are pregnant, nursing, or planning pregnancy.
- Concomitant diagnosis or history of congestive heart failure.
- 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.
- History of diabetes mellitus.
- 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-alpha (TNF-alpha).
- Hypersensitivity to any murine proteins or other component of the product.
- Inability to comply with study procedures