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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-01-31

Study Completion Date

2013-09-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Crohn's Disease

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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certolizumab pegol

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.

Group Type OTHER

certolizumab pegol

Intervention Type DRUG

400mg subcutaneous injections at week 0, week 2, week 4, then every 4 weeks thereafter

Interventions

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certolizumab pegol

400mg subcutaneous injections at week 0, week 2, week 4, then every 4 weeks thereafter

Intervention Type DRUG

Other Intervention Names

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Cimzia

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No