Corticosteroid Sparing Effect of Certolizumab in Crohn's Disease
| Status: | Terminated |
|---|---|
| Conditions: | Gastrointestinal, Crohns Disease |
| Therapuetic Areas: | Gastroenterology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 8/11/2018 |
| Start Date: | November 2006 |
| End Date: | July 2009 |
A Phase IIIb Multicenter, Double-blind, Placebo-controlled,Randomized Trial to Examine the Corticosteroid-sparing Effect of Certolizumab Pegol in Patients With Moderate to Severe Crohn's Disease.
The current study is designed to measure the corticosteroid-sparing effect of certolizumab
pegol using a defined schedule of corticosteroid tapering in subjects with moderate to severe
Crohn's disease. Subjects had to be in remission (CDAI<=150) and receiving corticosteroids at
a dose no higher than 30 mg/day prednisone or equivalent during the week prior to
randomization.
pegol using a defined schedule of corticosteroid tapering in subjects with moderate to severe
Crohn's disease. Subjects had to be in remission (CDAI<=150) and receiving corticosteroids at
a dose no higher than 30 mg/day prednisone or equivalent during the week prior to
randomization.
Inclusion Criteria:
- Men and women
- Age 18 years or older with moderate to severe Crohn's disease (Crohn's Disease
Activity Index (CDAI) score of ≥ 220 ≤450)
Exclusion Criteria:
- Active or draining fistula present at screening
- Lactating and/or pregnant female subjects
- A history of any health condition that could potentially interfere with the disease
and/or the treatment
- A history of an adverse reaction to polyethylene glycol (PEG) or a protein medicinal
product
- Any other condition which in the Investigator's judgment would make the patient
unsuitable for inclusion in the study
- History of drug or alcohol abuse in the prior year
- Receipt of any experimental therapy within or outside a clinical trial in the 3 months
prior to Visit 0
We found this trial at
55
sites
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