Assessment of Small Bowel Healing in Crohn's Disease Pati... | NCT01053559

Studies
Assessment of Small Bowel Healing in Crohn's Disease Patients Treated With Cimzia Using Wireless Capsule Endoscopy

NCT01053559

Sponsor

Shafran Gastroenterology Center

Status

Completed

Last Update Posted

Apr 24, 2014Estimated

Enrollment

15Actual

Phase

Not Applicable

Conditions

Crohn's Disease

Interventions

certolizumab pegol

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

Annotation Module

Unposted Annotation

Unposted Responsible Party

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2014

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2010

Primary Completion Date

Sep 2013Actual

Completion Date

Sep 2013Actual

First Submitted Date

Jan 19, 2010

First Submission Date that Met QC Criteria

Jan 20, 2010

First Posted Date

Jan 21, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 23, 2014

Last Update Posted Date

Apr 24, 2014Estimated

Name	Class
UCB Pharma	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Wireless Capsule Endoscopy has been the most reliable diagnostic standard for small bowel Crohn's disease. Endoscopic healing is an important endpoint to measure response to treatment.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

15Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
certolizumab pegol	Other	Subjects will receive FDA approved Cimzia injections as indicated on the product label. Subjects will undergo 3 wireless capsule endoscopies, one at screening,Day 84 and Day 168 as well as monthly bloodwork.	Drug: certolizumab pegol

Interventions

Name	Type	Description	Arm Group Labels	Other Names
certolizumab pegol	Drug	400mg subcutaneous injections at week 0, week 2, week 4, then every 4 weeks thereafter	certolizumab pegol

Measure	Description	Time Frame
Mucosal Healing		180 Days

Measure	Description	Time Frame
C-Reactive Protein (CRP) Level		180 Days

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Adults aged 18-70 with confirmed Crohn's disease that includes small bowel disease
Moderately to severely active disease (CDAI score >220 and < 450)
Stable doses of steroids, 5-ASA, antibiotics, Immunosuppressants

Exclusion Criteria:

Any and all contraindications to the use of certolizumab pegol (including but not limited to hepatitis, infection, abscess, malignancy, congestive heart failure [CHF], cytopenia)
Small bowel obstruction, stricture, or any contraindication for capsule endoscopy
Previous treatment with certolizumab pegol
Are pregnant or lactating

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Ira Shafran, M.D.	Shafran Gastroenterology Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Shafran Gastroenterology Center		Winter Park	Florida	32789	United States

Label	URL
Practice Website	View source

Type	Date	Date Unknown
Release	Apr 20, 2016
Reset	May 26, 2016

Submission Tracking

Estimated Results First Submitted Date

Apr 20, 2016

First MCP Posted Date

Not provided

Submission Infos

Release Date	Unrelease Date	Unrelease Date Unknown	Reset Date	MCP Release Number
Apr 20, 2016			May 26, 2016

Condition Browse Module

MeSH Terms

ID	Term
D003424	Crohn Disease
D015212	Inflammatory Bowel Diseases

Ancestor Terms

ID	Term
D005759	Gastroenteritis
D005767	Gastrointestinal Diseases
D004066	Digestive System Diseases
D007410	Intestinal Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000068582	Certolizumab Pegol

Ancestor Terms

ID	Term
D011092	Polyethylene Glycols
D011108	Polymers
D046911	Macromolecular Substances
D007140	Immunoglobulin Fab Fragments

Browse Leaves

Not provided

Browse Branches

Not provided