Optimizing Cimzia in Crohn's Patients

Crohn's Disease Clinical Trial

Official title:

Optimizing Response in Crohn's Disease Patients Who Have Insufficient Initial Response or Who Have Loss of Successful Response to Certolizumab Pegol (Cimzia) Induction Therapy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01024647
• Other study ID #: CMZ-2010
• Status: Recruiting
• Phase: Phase 4
• First received: December 2, 2009
• Last updated: November 1, 2012
• Start date: December 2009
• Est. completion date: May 2013

Study information

• Verified date: November 2012
• Source: Atlanta Gastroenterology Associates
• Contact: Lamia S Mereby, BSN
• Phone: 404-257-9000
• Email: lamia.mereby[@]atlantagastro.com
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine if increasing the dose and/or dosing frequency of certolizumab pegol (Cimzia) is effective in regaining and optimizing response in patients with moderate to severe Crohn's disease.

Description:

This open label study for patients with moderate to severe Crohn's disease will evaluate treatment options to improve capture of initial response and to regain loss of response to certolizumab pegol (Cimzia). It is a 26 week open label clinical trial that may be extended to 52 weeks in patients who respond to treatment during the initial 26 week study. The following dosing options will be tested: 1) Re-induction (one supplemental dose of 400mg) 2) Dose splitting (200mgQ2W) and 3) Dose Escalation (400mg Q2W. The highest dose in the study, 400mg Q2W, has been used in a large phase III trial (WELCOME) without any new safety signals. Efficacy and safety measures will be monitored.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: May 2013
• Est. primary completion date: May 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• ileal and/or colonic Crohn's disease

• moderate to severe Crohn's disease

Exclusion Criteria:

• short bowel syndrome

• ostomy

• anti-TNF therapy within 4 weeks

• prior certolizumab therapy

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Crohn Disease
• Crohn's Disease

Intervention

Biological:
• certolizumab pegol
certolizumab pegol 200 mg every 2 weeks
• certolizumab pegol
certolizumab pegol 400 mg every 2 weeks
• certolizumab pegol
certolizumab pegol 400 mg every 4 weeks
• certolizumab pegol
certolizumab pegol 400 mg every 2 weeks

Locations

Country	Name	City	State
United States	Atlanta Gastroenterology Associates	Atlanta	Georgia

Sponsors (2)

Lead Sponsor	Collaborator
Atlanta Gastroenterology Associates	UCB Pharma

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Crohn's Disease Activity Index	= 100 point decrease in CDAI represents response	26 Weeks, if responder up to 52 weeks	No