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

NCT ID: NCT01349920

Last Updated: 2018-10-15

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 15 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2012-11-28
• Study Completion Date: 2015-09-28

Brief Summary

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.

Conditions

Crohn Disease

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Infliximab 5 mg/kg

Infliximab treatment and endoscopy.

Infliximab

Intervention Type: DRUG

Infliximab administered intravenously at a dose of 5 mg/kg at study Weeks 0, 2, 6, 14, and 22.

Interventions

Infliximab

Infliximab administered intravenously at a dose of 5 mg/kg at study Weeks 0, 2, 6, 14, and 22.

Intervention Type: DRUG

Other Intervention Names

Remicade; SCH 215596; MK-2155

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Director

Role: STUDY_DIRECTOR

Merck Sharp & Dohme LLC

Other Identifiers

2011-000517-40

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

MK-2155-195

Identifier Type: -

Identifier Source: secondary_id

P08143

Identifier Type: -

Identifier Source: org_study_id