Biomarkers of Intestinal Mucosal Healing in Crohn's Disease (P08143)
Verified September 2014 by Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
First received: May 5, 2011
Last updated: September 3, 2014
Last verified: September 2014
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.
||Observational Model: Cohort
Time Perspective: Prospective
||An Open Label Study to Discover Biomarkers of Intestinal Mucosal Healing in Crohn's Disease (CD)
Primary Outcome Measures:
- Change from Baseline in the Crohn's Disease Endoscopic Index of Severity (CDEIS) Score at Week 6 [ Time Frame: Baseline, Week 6 ] [ Designated as safety issue: No ]
- Change From Baseline in CDEIS Score at Week 22 [ Time Frame: Baseline, Week 22 ] [ Designated as safety issue: No ]
- Change From Baseline in Serum High Sensitivity C-reactive Protein (hsCRP) at Week 6 [ Time Frame: Baseline, Week 6 ] [ Designated as safety issue: No ]
- Change From Baseline in Serum hsCRP at Week 22 [ Time Frame: Baseline, Week 22 ] [ Designated as safety issue: No ]
- Change From Baseline in Stool Calprotectin at Week 6 [ Time Frame: Baseline, Week 6 ] [ Designated as safety issue: No ]
- Change From Baseline in Stool Calprotectin at Week 22 [ Time Frame: Baseline, Week 22 ] [ Designated as safety issue: No ]
- Change From Baseline in Serum Lipocalin-2 at Week 6 [ Time Frame: Baseline, Week 6 ] [ Designated as safety issue: No ]
- Change From Baseline in Serum Lipocalin-2 at Week 22 [ Time Frame: Baseline, Week 22 ] [ Designated as safety issue: No ]
- Change From Baseline in Regenerating Islet-Derived 3-Alpha (REG3-A) at Week 6 [ Time Frame: Baseline, Week 6 ] [ Designated as safety issue: No ]
- Change From Baseline in REG3-A at Week 22 [ Time Frame: Baseline, Week 22 ] [ Designated as safety issue: No ]
Biospecimen Retention: Samples With DNA
Secondary Outcome Measures:
- 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) ] [ Designated as safety issue: No ]
- Concordance Correlation Coefficient for Comparison Between Central Endoscopic Evaluation and Site Endoscopic Evaluation [ Time Frame: Baseline, Week 6, Week 22 ] [ Designated as safety issue: No ]
stool, serum, peripheral blood mononuclear cells (PBMC)
| Estimated Enrollment:
| Study Start Date:
| Estimated Study Completion Date:
| Estimated Primary Completion Date:
||June 2015 (Final data collection date for primary outcome measure)
Infliximab 5 mg/kg
Infliximab treatment and endoscopy.
Infliximab administered intravenously at a dose of 5 mg/kg at study Weeks 0, 2, 6, 14, and 22.
- SCH 215596
|Ages Eligible for Study:
||18 Years to 60 Years
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
Approximately 20 participants aged 18 to 60 years with Crohn's Disease will be enrolled from gastrointestinal specialist clinics.
- 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
- 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01349920
|Contact: Toll Free Number
|Merck Sharp & Dohme IDEA, Inc.
|Chisinau, Moldova, Republic of |
|Contact: Tatyana Gots 38 044 393-7480 |
|Merck Sharp & Dohme Ltd.
|Hoddesdon, United Kingdom |
|Contact: Paul Robinson 44 1992452396 |
Merck Sharp & Dohme Corp.
||Merck Sharp & Dohme Corp.
No publications provided
||Merck Sharp & Dohme Corp.
History of Changes
|Other Study ID Numbers:
||P08143, 2011-000517-40, MK-2155-195-02
|Study First Received:
||May 5, 2011
||September 3, 2014
||United Kingdom: Research Ethics Committee
Keywords provided by Merck Sharp & Dohme Corp.:
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on September 14, 2014
Inflammatory Bowel Diseases
Digestive System Diseases
Anti-Inflammatory Agents, Non-Steroidal
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Central Nervous System Agents