Atlanta, Georgia 30342

  • Crohn's Disease

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.


Study summary:

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.


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


NCT ID:

NCT01024647


Primary Contact:

Principal Investigator
Douglas C Wolf, MD
Atlanta Gastroenterology Associates

Lamia S Mereby, BSN
Phone: 404-257-9000 ext. 2142
Email: lamia.mereby@atlantagastro.com


Backup Contact:

Email: ashleigh.kapperman@atlantagastro.com
Ashleigh K Arnold, BS
Phone: 404-257-9000 ext. 2138


Location Contact:

Atlanta, Georgia 30342
United States

Lamia S Mereby, BSN
Phone: 404-257-9000
Email: lamia.mereby@atlantagastro.com

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: September 17, 2021

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