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Optimizing Cimzia in Crohn's Patients

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ClinicalTrials.gov Identifier: NCT01024647
Recruitment Status : Unknown
Verified November 2012 by Douglas C. Wolf, MD, Atlanta Gastroenterology Associates.
Recruitment status was:  Recruiting
First Posted : December 3, 2009
Last Update Posted : November 5, 2012
Sponsor:
Collaborator:
UCB Pharma
Information provided by (Responsible Party):
Douglas C. Wolf, MD, Atlanta Gastroenterology Associates

Study Description
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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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Crohn's Disease

Arms and Interventions
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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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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01024647


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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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    Key Record Dates
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