A Phase IIIB Multicenter, Open Label, Randomized Clinical Trial Evaluating Efficacy of Certolizumab Pegol, a PEGylated Fab Fragment of Humanized Antibody to Tumor Necrosis Factor (TNF) in Crohn's Disease Patients With Draining Fistulas.
Phase 3
18 Years
N/A
18 Years
N/A
Not Enrolling
Both
Crohn Disease
Both
Crohn Disease
Trial Information
A Phase IIIB Multicenter, Open Label, Randomized Clinical Trial Evaluating Efficacy of Certolizumab Pegol, a PEGylated Fab Fragment of Humanized Antibody to Tumor Necrosis Factor (TNF) in Crohn's Disease Patients With Draining Fistulas.
Inclusion Criteria:
- Patients with single or multiple fistulas, including perianal and enterocutaneous
fistulas for at least 3 months as a complication of Crohn's disease
Exclusion Criteria:
- Symptomatic obstructive intestinal strictures, bowel resection, proctocolectomy or
total colectomy, abscesses present at screening, current total parenteral nutrition,
short bowel syndrome.
- All the 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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Investigation of Clinical efficacy of certolizumab pegol for fistula closure, as measured by the proportion of patients with fistula improvement after 16 weeks of treatment.
Principal Investigator
Krassimir Mitchev, MD
Investigator Role:
Study Director
Investigator Affiliation:
UCB / Global Medical Affairs
Authority:
United States: Food and Drug Administration
Study ID:
C87058
NCT ID:
NCT00354367
Start Date:
January 2007
Completion Date:
Related Keywords:
- Crohn Disease
- Crohn Disease
- Certolizumab pegol
- Fistula
- Crohn Disease
- Fistula
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