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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT01349920 |
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Date of registration:
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05/05/2011 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Biomarkers of Intestinal Mucosal Healing in Crohn's Disease (P08143)
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Scientific title:
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An Open Label Study to Discover Biomarkers of Intestinal Mucosal Healing in Crohn's Disease (CD) |
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Date of first enrolment:
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November 28, 2012 |
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Target sample size:
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15 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT01349920 |
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Study type:
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Observational |
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Study design:
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Phase:
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Countries of recruitment
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Moldova, Republic of
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United Kingdom
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Contacts
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Name:
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Medical Director |
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Address:
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Telephone:
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Email:
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Affiliation:
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Merck Sharp & Dohme Corp. |
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Key inclusion & exclusion criteria
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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
Age minimum:
18 Years
Age maximum:
60 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Crohn Disease
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Intervention(s)
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Drug: Infliximab
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Primary Outcome(s)
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Change From Baseline in REG3-A at Week 22
[Time Frame: Baseline and Week 22]
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Change From Baseline in Stool Calprotectin at Week 6
[Time Frame: Baseline and Week 6]
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Change From Baseline in Regenerating Islet-Derived 3-Alpha (REG3-A) at Week 6
[Time Frame: Baseline and Week 6]
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Change From Baseline in Stool Calprotectin at Week 22
[Time Frame: Baseline and Week 22]
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Change From Baseline in CDEIS Blinded Score at Week 22
[Time Frame: Baseline and Week 22]
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Change From Baseline in Serum hsCRP at Week 22
[Time Frame: Baseline and Week 22]
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Change From Baseline in Serum Lipocalin-2 at Week 22
[Time Frame: Baseline and Week 22]
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Change From Baseline in the Crohn's Disease Endoscopic Index of Severity (CDEIS) Blinded Score at Week 6
[Time Frame: Baseline and Week 6]
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Change From Baseline in Serum High Sensitivity C-reactive Protein (hsCRP) at Week 6
[Time Frame: Baseline and Week 6]
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Change From Baseline in Serum Lipocalin-2 at Week 6
[Time Frame: Baseline and Week 6]
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Coefficient of Determination (R^2) For Predicting The Change From Baseline In Blinded CDEIS Score From The Changes From Baseline In Four Biomarkers At Weeks 6 and 22
[Time Frame: Baseline and Week 6 or 22]
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Secondary Outcome(s)
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Concordance Correlation Coefficient for Comparison Between Central Endoscopic Evaluation and Site Endoscopic Evaluation
[Time Frame: Baseline, Week 6, Week 22]
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Concordance Correlation Coefficient for Comparison of Repeat Baseline Measurements of Biochemical Biomarkers
[Time Frame: Baseline Visit 1 (one week prior to dosing), Baseline Visit 2 (1-2 days prior to dosing)]
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Secondary ID(s)
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MK-2155-195
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2011-000517-40
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P08143
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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