Crohn's Disease
Conditions
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.
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.
Interventions
BIOLOGICALcertolizumab pegol
certolizumab pegol 200 mg every 2 weeks
Sponsors
UCB Pharma
Atlanta Gastroenterology Associates
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Crohn's Disease Activity Index | 26 Weeks, if responder up to 52 weeks | ≥ 100 point decrease in CDAI represents response |
Countries
United States
Contacts
Primary ContactLamia S Mereby, BSN
Backup ContactAshleigh K Arnold, BS
Outcome results
None listed