Know Cancer

forgot password

Metabolic Response to Infliximab in Pediatric Ulcerative Colitis

6 Years
18 Years
Not Enrolling
Ulcerative Colitis, Protein Metabolism, Energy Expenditure

Thank you

Trial Information

Metabolic Response to Infliximab in Pediatric Ulcerative Colitis

Inclusion Criteria:

- 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
of enrollment):

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.

Exclusion Criteria:

- 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

Type of Study:


Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science

Outcome Measure:

Measure protein kinetics and balance in response to anti-TNF-alpha therapy in children with steroid-resistant ulcerative colitis, during both the fasting state and parenteral nutrition infusion.

Outcome Time Frame:

Week 0 and 2

Safety Issue:


Principal Investigator

Steven J Steiner, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Indiana University


United States: Institutional Review Board

Study ID:

GCRC 1274



Start Date:

June 2005

Completion Date:

September 2008

Related Keywords:

  • Ulcerative Colitis
  • Protein Metabolism
  • Energy Expenditure
  • Ulcerative colitis
  • pediatrics
  • UC
  • protein metabolism
  • energy expenditure
  • Colitis
  • Colitis, Ulcerative
  • Ulcer



Indiana University- Riley Hospital for Children Indianapolis, Indiana  46202