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OpenTrials
Completed

NCT Number: NCT01053559

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

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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Key information

Conditions

Crohn's Disease Crohn Disease Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Inflammatory Bowel Diseases Intestinal Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Shafran Gastroenterology Center

Winter Park, Florida, 32789, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Certolizumab pegol

Drug

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

Other names: Cimzia

Primary outcomes

  1. Mucosal Healing

    Time frame: 180 Days

Secondary outcomes

  1. C-Reactive Protein (CRP) Level

    Time frame: 180 Days

Sponsors and collaborators

Lead sponsor

Shafran Gastroenterology Center

Other

Collaborators

  • UCB Pharma

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2013
Study completion
2013
First posted
Jan 21, 2010
Registry last updated
Apr 24, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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