Biomarkers of Intestinal Mucosal Healing in Crohn's Disease (P08143)

An Open Label Study to Discover Biomarkers of Intestinal Mucosal Healing in Crohn's Disease (CD)

This study will evaluate biomarkers that reflect changes in gut mucosal status during therapy with infliximab and determine whether changes in the levels of the selected biomarkers can be used to predict endoscopically assessed gut mucosal status changes.

Inclusion Criteria:

• Clinical diagnosis of Crohn's Disease (CD) of at least 6 weeks duration, or acute diagnosis of sufficiently severe CD warranting initiation of infliximab sooner than allowed by fecal calprotectin turnaround time
• History of colonic involvement verified by prior endoscopy or radiography
• Indicated for treatment with infliximab according to current best medical practice
• Body Mass Index (BMI) between 15 kg/m^2 and 35 kg/m^2
• Women of childbearing potential and non-vasectomized men agree to use medically-acceptable contraception
• Negative pregnancy test
• No signs or symptoms of active tuberculosis (TB) and has a negative TB test within 6 weeks of first study drug administration

Exclusion Criteria:

• Pregnancy, intention to become pregnant, or breastfeeding
• Evidence of a colon unaffected by CD
• Indication for surgery
• Perianal disease likely to interfere with study participation
• Presence of a stoma or history of colectomy
• Symptomatic diarrhea unrelated to CD
• Strictures or evidence of bowel obstruction
• Presence of abscess unless completed definitive treatment can be documented one week prior to screening
• Presence of fistulas
• Contraindication to infliximab
• Intolerance to sedatives or other medications required for endoscopy
• Any prior use of anti-inflammatory biologic therapy
• Moderate or severe congestive heart failure
• History of demyelinating disease or symptoms suggestive of multiple sclerosis or optic neuritis
• Major surgery or donation/loss of at least one unit of blood within 4 weeks of screening
• Positive for hepatitis B surface antigen, hepatitis C antibodies, or Human Immunodeficiency Virus (HIV)
• History of any tumor except adequately treated basal cell carcinoma or carcinoma in situ of the cervix
• History of systemic granulomatous infection
• History of nontuberculous mycobacterial disease, or any opportunistic infection within 12 months of study entry
• Transplanted organ including bone marrow or hematopoietic stem cell-derived marrow