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 Pharma
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

December 2, 2009
November 1, 2012
December 2009
May 2013   (final data collection date for primary outcome measure)
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
Crohn's Disease Activity Index [ Time Frame: 26 Weeks ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01024647 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Optimizing Cimzia in Crohn's Patients
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

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.

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.

Interventional
Phase 4
Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Crohn's Disease
  • Biological: certolizumab pegol
    certolizumab pegol 200 mg every 2 weeks
    Other Name: Cimzia
  • Biological: certolizumab pegol
    certolizumab pegol 400 mg every 2 weeks
    Other Name: Cimzia
  • Biological: certolizumab pegol
    certolizumab pegol 400 mg every 4 weeks
    Other Name: Cimzia
  • Biological: certolizumab pegol
    certolizumab pegol 400 mg every 2 weeks
    Other Name: Cimzia
  • Active Comparator: Loss of Reponse Reinduction Responders
    Loss of Response Reinduction Responders:certolizumab pegol (Cimzia) 200 mg every 2 weeks
    Intervention: Biological: certolizumab pegol
  • Active Comparator: Response loss Reinduction Non-Responders
    Response Loss Reinduction Non-Responders:certolizumab pegol(Cimzia) 400 mg every 2 weeks
    Intervention: Biological: certolizumab pegol
  • Active Comparator: Responders
    Responders: certolizumab pegol(Cimzia) 400 mg every 4 weeks
    Intervention: Biological: certolizumab pegol
  • Active Comparator: Non-Responders
    Non-Responders: certolizumab pegol (Cimzia) 400 mg every 2 weeks
    Intervention: Biological: certolizumab pegol
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
50
May 2013
May 2013   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
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
United States
 
NCT01024647
CMZ-2010
No
Douglas C. Wolf, MD, Atlanta Gastroenterology Associates
Atlanta Gastroenterology Associates
UCB Pharma
Principal Investigator: Douglas C Wolf, MD Atlanta Gastroenterology Associates
Atlanta Gastroenterology Associates
November 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP