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

This study is currently recruiting participants.
Verified April 2014 by Merck Sharp & Dohme Corp.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT01349920
First received: May 5, 2011
Last updated: April 1, 2014
Last verified: April 2014
  Purpose

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.


Condition Intervention
Crohn Disease
Drug: Infliximab

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: An Open Label Study to Discover Biomarkers of Intestinal Mucosal Healing in Crohn's Disease (CD)

Resource links provided by NLM:


Further study details as provided by Merck Sharp & Dohme Corp.:

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 ]

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 ]

Biospecimen Retention:   Samples With DNA

stool, serum, peripheral blood mononuclear cells (PBMC)


Estimated Enrollment: 20
Study Start Date: November 2012
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Infliximab 5 mg/kg
Infliximab treatment and endoscopy.
Drug: Infliximab
Infliximab administered intravenously at a dose of 5 mg/kg at study Weeks 0, 2, 6, 14, and 22.
Other Names:
  • Remicade
  • SCH 215596
  • MK-2155

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Approximately 20 participants aged 18 to 55 years with Crohn's Disease will be enrolled from gastrointestinal specialist clinics.

Criteria

Inclusion Criteria:

  • Clinical diagnosis of Crohn's Disease (CD) of at least 6 week's 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 16 kg/m^2 and 32 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01349920

Contacts
Contact: Toll Free Number 1-888-577-8839

Locations
United Kingdom
Merck Sharp & Dohme Ltd. Recruiting
Hoddesdon, United Kingdom
Contact: Paul Robinson    44 1992452396      
Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
Study Director: Medical Director Merck Sharp & Dohme Corp.
  More Information

No publications provided

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT01349920     History of Changes
Other Study ID Numbers: P08143, 2011-000517-40, MK-2155-195-02
Study First Received: May 5, 2011
Last Updated: April 1, 2014
Health Authority: United Kingdom: Research Ethics Committee

Keywords provided by Merck Sharp & Dohme Corp.:
biological markers
endoscopy
gastrointestinal

Additional relevant MeSH terms:
Crohn Disease
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases
Infliximab
Dermatologic Agents
Therapeutic Uses
Pharmacologic Actions
Gastrointestinal Agents
Antirheumatic Agents
Anti-Inflammatory Agents

ClinicalTrials.gov processed this record on April 15, 2014