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

Open Label Investigator Initiated, Single Site Study of Mucosal Healing in Patients With Small Bowel Crohn's Disease Treated With Certolizumab Pegol (Cimzia) Assessed by Wireless Capsule Endoscopy

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01053559

Enrollment

Registered

2010-01-21

Start date

2010-01-31

Completion date

2013-09-30

Last updated

2014-04-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Crohn's Disease

Keywords

Crohn's, Inflammatory Bowel Disease

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.

Interventions

DRUGcertolizumab pegol

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

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Mucosal Healing	180 Days

Secondary

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026