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Monitoring Disease Activity Using Video Capsule Endoscopy (VCE) in Crohn's Disease (CD) Subjects Receiving an Immunomodulator (IMM) and\or a Biological Treatment

This study is currently recruiting participants.
Verified January 2014 by Given Imaging Ltd.
Sponsor:
Information provided by (Responsible Party):
Given Imaging Ltd.
ClinicalTrials.gov Identifier:
NCT01942720
First received: September 11, 2013
Last updated: January 16, 2014
Last verified: January 2014
  Purpose

This study is designed to evaluate the responsiveness of VCE in the assessment of mucosal inflammation after 6 months of treatment with either an Immunomodulator (IMM) and\or biological drug.


Condition Intervention Phase
Active Crohn Disease With Terminal Ileal Disease
Device: Capsule endoscopy and Ileocolonoscopy tests
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Monitoring Disease Activity Using Video Capsule Endoscopy (VCE) in Crohn's Disease (CD) Subjects Receiving an Immunomodulator (IMM) and\or a Biological Treatment

Resource links provided by NLM:


Further study details as provided by Given Imaging Ltd.:

Primary Outcome Measures:
  • mucosal change in VCE mucosal scores and PGA [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    To correlate the mucosal change in VCE mucosal score (Lewis score and CECDEIS) with change in Physician Global Assessment of CD activity 6 months after Immunomodulator (IMM) and\or biological treatment


Secondary Outcome Measures:
  • correlation between SES CD score and capsule scoring indexes [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Evaluate the correlation between SES CD score and capsule scoring indexes (Lewis and CECDEIS) in the TI at baseline.

  • correlation between the change in SES CD score and the change in capsule scoring indexes- in terminal ileum [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Evaluate the correlation between the change in SES CD score and the change in capsule scoring indexes (Lewis and CECDEIS) in the TI after 6 months (for the subset of subjects who have IC at 6 months)

  • Evaluate the entire SB CE Scores [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Evaluate the entire SB CE Scores (Lewis & CECDEIS) change as compared to the change at TI in CE Scores (Lewis & CECDEIS)

  • safety related to capsule [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
    To assess safety related to capsule retention and other adverse events


Estimated Enrollment: 75
Study Start Date: August 2013
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: July 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Capsule endoscopy Device: Capsule endoscopy and Ileocolonoscopy tests

Detailed Description:

This is a prospective, multi-center (up to 15 sites) study which aims to assess the ability of VCE (Video capsule endoscopy) to detect change in the severity of the small bowel mucosal disease activity in CD subjects after 6 months of treatment with either an Immunomodulator (IMM) and\ or biological drug.

Up to 75 subjects will participate in this study. An interim analysis will be done after study completion with 20 subjects. All subjects to be enrolled in this study will be pediatric and\or adult subjects with Crohn's disease who will be treated with an Immunomodulator and/or a biological treatment based on standard clinical evaluation

  Eligibility

Ages Eligible for Study:   2 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Subject ages 2-75 years, inclusive
  2. Subjects with a diagnosis of known Crohn disease
  3. Referred to standard-of-care ileocolonoscopy (up to 4 weeks before the CE procedure)
  4. Subjects with a plan to be treated with an immunomodulator and/or a biologic medication following the ileocolonoscopy exam including any of the following:

    1. modification of dose or frequency of current therapy
    2. addition of a new therapy
    3. change to a different therapy within-class or out-of-class
  5. Subject has active terminal ileal disease proven by capsule or ileocolonoscopy procedure (note that subjects with colonic disease or other disease locations can be enrolled as long as they also have terminal ileal disease)
  6. Proven patency by the Agile capsule or another approach deemed clinically acceptable by the investigator, e.g. CT enterography, MRE, performed within the 90 days prior to enrollment.
  7. Subject or parent agrees to sign consent form

Exclusion Criteria:

The presence of any of the following will exclude a subject from study enrollment:

  1. Subjects with change in IBD drug therapy between the baseline ileocolonoscopy and VCE
  2. Subjects with a history of prior ileocecectomy, Ileal Pouch-Anal Anastomosis (IPAA) and J pouch or an ostomy
  3. Stricture seen on radiological exam.
  4. Indeterminate Colitis
  5. Ulcerative Colitis
  6. Antibiotic Associated Colitis
  7. Known history of intestinal obstruction or current obstructive symptoms, such as severe abdominal pain with accompanying nausea or vomiting, based on investigator judgment.
  8. Non-steroidal anti-inflammatory drugs including aspirin (twice weekly or more), not including aspirin up to 81mg daily, during the 4 weeks preceding enrollment
  9. Suspected GI stricture, followed by PillCam® Patency study or other imaging study that could not prove patency of the GI tract.
  10. Subject is expected to undergo MRI examination within 7 days after ingestion of the capsule.
  11. Subjects with known or suspected delayed gastric emptying
  12. Subjects with known or suspected delayed Small bowel motility
  13. Subject has any allergy or other known contraindication to the medications used in the study.
  14. Women who are either pregnant or nursing at the time of screening, or are of child-bearing potential and do not agree to practice medically acceptable methods of contraception.
  15. Unwillingness to use a medically accepted method of contraception throughout duration of study
  16. Concurrent participation in another clinical trial using any investigational drug or device.
  17. Subject has cardiac pacemaker or other implanted electromedical devices
  18. Subject suffers from a life threatening condition.
  19. Subject with a history or clinical evidence of renal disease and/or previous clinically significant laboratory abnormalities of renal function parameters.
  20. Subject suffers from any condition, such as swallowing problems, which precludes compliance with study and/or device instructions.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01942720

Contacts
Contact: Moran Weisshof +972-4-9907759

Locations
United States, Arizona
Mayo Clinic Recruiting
Scottsdale, AZ, Arizona, United States
Contact: Grant Erickson         
Principal Investigator: Shabbana Pasha, MD         
United States, California
Cedars Sinai Medical Center Not yet recruiting
LA, California, United States
Contact: Cynthia Walsh         
Principal Investigator: Gil Melmed, MD         
United States, Florida
Borland-Groover Clinic Recruiting
Jacksonville, Florida, United States
Contact: Laura Walter         
Principal Investigator: Mark Fleisher, MD         
Shafran Gastroenterology Center Recruiting
Winter Park, Florida, United States
Contact: kara Fitch         
Principal Investigator: Irra Shafran, MD         
United States, Georgia
Children's Center for Digestive Healthcare Not yet recruiting
Atlanta, Georgia, United States
Contact: Angela Stallworth         
Principal Investigator: Stan Cohen         
United States, Illinois
The University of Chicago Not yet recruiting
Chicago, Illinois, United States
Contact: Rose Arrieta         
Principal Investigator: Sakuraba Atsushi, MD         
United States, Indiana
Indiana Unveresity Hospital Not yet recruiting
Indianapolis, Indiana, United States
Contact: Gewn Coock         
Principal Investigator: Debra Helper, MD         
United States, Iowa
Iowa Digestive Disease Center Recruiting
Clive, Iowa, United States
Contact: Jene Formaro         
Principal Investigator: Bernard Leman, MD         
United States, Maryland
University of Maryland Medical Center Not yet recruiting
Baltimore, Maryland, United States
Contact: Guruprasad Jambaulikar         
Principal Investigator: Gahazi, MD         
Metropolitan Gastroenterology Group Recruiting
Chevy Chase, Maryland, United States
Contact: Cindy coates         
Principal Investigator: Robert Hardi, MD         
United States, Michigan
Digestive Health Center of Michigan Recruiting
Michigan, Michigan, United States
Contact: Joe Palmer         
Principal Investigator: Robert Fogel, MD         
United States, New Jersey
Atlantic Health System Morristown Memorial Pediatric GE Not yet recruiting
Morristown, New Jersey, United States
Contact: Annette Langseder         
Principal Investigator: Joel Rosh, MD         
United States, North Carolina
UNC Chapel Hill Not yet recruiting
Chapel Hill, North Carolina, United States
Contact: Paris Laliberte         
Principal Investigator: Kim Isaacs, MD         
United States, Virginia
Gastroenterology Associates of Tidewater Not yet recruiting
Chesapeak, Virginia, United States
Contact: JoAnne Tiamzon         
Principal Investigator: Malik Pramod, MD         
Sponsors and Collaborators
Given Imaging Ltd.
Investigators
Principal Investigator: Jonathan Leighton, MD Mayo Clinic
Principal Investigator: Gil Melmed, MD Cyder Cinai LA
  More Information

No publications provided

Responsible Party: Given Imaging Ltd.
ClinicalTrials.gov Identifier: NCT01942720     History of Changes
Other Study ID Numbers: MA-209
Study First Received: September 11, 2013
Last Updated: January 16, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Ileal Diseases
Crohn Disease
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 17, 2014