Optimizing Cimzia in Crohn's Patients

Phase 4

• Conditions: Crohn's Disease
• Interventions: Biological: certolizumab pegol

• Registration Number: NCT01024647
• Lead Sponsor: Atlanta Gastroenterology Associates

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2009-12
• Study First Submitted: 2009-12-02
• Study First Submitted QC: 2009-12-02
• Study First Posted: 2009-12-03
• Status Verified: 2012-11
• Last Update Submitted: 2012-11-01
• Last Update Posted: 2012-11-04
• Primary Completion: 2013-05
• Study Completion: 2013-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Loss of Reponse Reinduction Responders	certolizumab pegol	Loss of Response Reinduction Responders:certolizumab pegol (Cimzia) 200 mg every 2 weeks
Response loss Reinduction Non-Responders	certolizumab pegol	Response Loss Reinduction Non-Responders:certolizumab pegol(Cimzia) 400 mg every 2 weeks
Responders	certolizumab pegol	Responders: certolizumab pegol(Cimzia) 400 mg every 4 weeks
Non-Responders	certolizumab pegol	Non-Responders: certolizumab pegol (Cimzia) 400 mg every 2 weeks

Primary Outcome Measures

Name	Time	Method
Crohn's Disease Activity Index	26 Weeks, if responder up to 52 weeks	≥ 100 point decrease in CDAI represents response

Trial Locations

Locations (1)

Atlanta Gastroenterology Associates; 🇺🇸 Atlanta, Georgia, United States