Optimizing Cimzia in Crohn's Patients

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Crohn's Disease

Intervention / Treatment
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* Biological: certolizumab pegol
* Biological: certolizumab pegol
* Biological: certolizumab pegol
* Biological: certolizumab pegol


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Loss of Reponse Reinduction Responders<br>Loss of Response Reinduction Responders:certolizumab pegol (Cimzia) 200 mg every 2 weeks | Biological: certolizumab pegol<br>* certolizumab pegol 200 mg every 2 weeks<br>* Other names: Cimzia;|
| Active Comparator: Response loss Reinduction Non-Responders<br>Response Loss Reinduction Non-Responders:certolizumab pegol(Cimzia) 400 mg every 2 weeks | Biological: certolizumab pegol<br>* certolizumab pegol 400 mg every 2 weeks<br>* Other names: Cimzia;|
| Active Comparator: Responders<br>Responders: certolizumab pegol(Cimzia) 400 mg every 4 weeks | Biological: certolizumab pegol<br>* certolizumab pegol 400 mg every 4 weeks<br>* Other names: Cimzia;|
| Active Comparator: Non-Responders<br>Non-Responders: certolizumab pegol (Cimzia) 400 mg every 2 weeks | Biological: certolizumab pegol<br>* certolizumab pegol 400 mg every 2 weeks<br>* Other names: Cimzia;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Crohn's Disease Activity Index | ≥ 100 point decrease in CDAI represents response | 26 Weeks, if responder up to 52 weeks |