Optimizing Cimzia in Crohn's Patients

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2012 by Atlanta Gastroenterology Associates
Sponsor:
Collaborator:
UCB, Inc.
Information provided by (Responsible Party):
Douglas C. Wolf, MD, Atlanta Gastroenterology Associates
ClinicalTrials.gov Identifier:
NCT01024647
First received: December 2, 2009
Last updated: November 1, 2012
Last verified: November 2012
  Purpose

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 Intervention Phase
Crohn's Disease
Biological: certolizumab pegol
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Atlanta Gastroenterology Associates:

Primary Outcome Measures:
  • Crohn's Disease Activity Index [ Time Frame: 26 Weeks, if responder up to 52 weeks ] [ Designated as safety issue: No ]
    ≥ 100 point decrease in CDAI represents response


Estimated Enrollment: 50
Study Start Date: December 2009
Estimated Study Completion Date: May 2013
Estimated Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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, Inc.
Investigators
Principal Investigator: Douglas C Wolf, MD Atlanta Gastroenterology Associates
  More Information

No publications provided

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
Study First Received: December 2, 2009
Last Updated: November 1, 2012
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Crohn Disease
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases
Immunoglobulin Fab Fragments
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 22, 2014