Optimizing Cimzia in Crohn's Patients

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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.

Condition or disease	Intervention/treatment	Phase
Crohn's Disease	Biological: certolizumab pegol	Phase 4

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 Design

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Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	50 participants
Allocation:	Non-Randomized
Intervention Model:	Parallel Assignment
Masking:	None (Open Label)
Primary Purpose:	Treatment
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
Study Start Date :	December 2009
Estimated Primary Completion Date :	May 2013
Estimated Study Completion Date :	May 2013

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm	Intervention/treatment
Active Comparator: Loss of Reponse Reinduction Responders; Loss of Response Reinduction Responders:certolizumab pegol (Cimzia) 200 mg every 2 weeks	Biological: certolizumab pegol; certolizumab pegol 200 mg every 2 weeks; Other Name: Cimzia
Active Comparator: Response loss Reinduction Non-Responders; Response Loss Reinduction Non-Responders:certolizumab pegol(Cimzia) 400 mg every 2 weeks	Biological: certolizumab pegol; certolizumab pegol 400 mg every 2 weeks; Other Name: Cimzia
Active Comparator: Responders; Responders: certolizumab pegol(Cimzia) 400 mg every 4 weeks	Biological: certolizumab pegol; certolizumab pegol 400 mg every 4 weeks; Other Name: Cimzia
Active Comparator: Non-Responders; Non-Responders: certolizumab pegol (Cimzia) 400 mg every 2 weeks	Biological: certolizumab pegol; certolizumab pegol 400 mg every 2 weeks; Other Name: Cimzia

Outcome Measures

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Primary Outcome Measures :

1. Crohn's Disease Activity Index [ Time Frame: 26 Weeks, if responder up to 52 weeks ]
   ≥ 100 point decrease in CDAI represents response

Eligibility Criteria

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Contacts

Contact: Lamia S Mereby, BSN	404-257-9000 ext 2142	lamia.mereby@atlantagastro.com
Contact: Ashleigh K Arnold, BS	404-257-9000 ext 2138	ashleigh.kapperman@atlantagastro.com

Locations

United States, Georgia
Atlanta Gastroenterology Associates	Recruiting
Atlanta, Georgia, United States, 30342
Contact: Lamia S Mereby, BSN 404-257-9000 ext 2142 lamia.mereby@atlantagastro.com

Sponsors and Collaborators

Atlanta Gastroenterology Associates

UCB Pharma

Investigators

Principal Investigator:	Douglas C Wolf, MD	Atlanta Gastroenterology Associates

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	Douglas C. Wolf, MD, Medical Director of Clinical Research, Atlanta Gastroenterology Associates
ClinicalTrials.gov Identifier:	NCT01024647 History of Changes
Other Study ID Numbers:	CMZ-2010
First Posted:	December 3, 2009
Last Update Posted:	November 5, 2012
Last Verified:	November 2012

Additional relevant MeSH terms:

Crohn Disease; Inflammatory Bowel Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases	Certolizumab Pegol; Immunosuppressive Agents; Immunologic Factors; Physiological Effects of Drugs; Antirheumatic Agents