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

Shafran Gastroenterology Center

Status: Completed

Conditions: Crohn's Disease

Treatments: Drug: certolizumab pegol

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01053559

Exempt IND

Details and patient eligibility

About

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.

Enrollment: 15 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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15 participants in 1 patient group

certolizumab pegol

Other group

Description:

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.

Treatment:

Drug: certolizumab pegol