Certolizumab in Crohn's Disease Patients With Loss of Response or Intolerance to Infliximab
| Status: | Completed |
|---|---|
| Conditions: | Gastrointestinal, Crohns Disease |
| Therapuetic Areas: | Gastroenterology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 8/9/2018 |
| Start Date: | April 2006 |
| End Date: | April 2008 |
Phase IIIb Open-label Induction and Double-blind Comparison of 2 Maintenance Schedules Evaluating Clinical Benefit and Tolerability of Certolizumab Pegol in Crohn's Disease Patients With Prior Loss of Response or Intolerance to Infliximab
To assess the clinical efficacy of subcutaneous (sc) certolizumab pegol administration over
26 weeks in patients suffering from Crohn's Disease (CD) and previously treated with
infliximab
26 weeks in patients suffering from Crohn's Disease (CD) and previously treated with
infliximab
Inclusion Criteria:
- Subjects with Crohn's Disease
- Previous treatment failure to Infliximab (intolerance and/or no response)
Exclusion Criteria:
- Obstructive intestinal strictures
- Recent bowel resection
- Proctocolectomy or total colectomy
- Current total parenteral nutrition
- Short bowel syndrome
- All concomitant diseases or pathological conditions that could interfere with Crohn's
disease assessment or to be harmful for the well being of the patient
- Previous clinical trials and previous biological therapy that could interfere with the
results in the present clinical trial
We found this trial at
32
sites
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