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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
50
certolizumab pegol 200 mg every 2 weeks
certolizumab pegol 400 mg every 2 weeks
certolizumab pegol 400 mg every 4 weeks
Atlanta Gastroenterology Associates
Atlanta, Georgia, United States
RECRUITINGCrohn's Disease Activity Index
≥ 100 point decrease in CDAI represents response
Time frame: 26 Weeks, if responder up to 52 weeks
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
certolizumab pegol 400 mg every 2 weeks