Crohn Disease
Conditions
Keywords
Crohn Disease, Certolizumab pegol, Fistula
Brief summary
To investigate the clinical efficacy of certolizumab pegol for fistula closure in Crohn's disease subjects with active draining fistulas.
Interventions
DRUGCertolizumab pegol
Sponsors
UCB Pharma
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. | — |
Secondary
| Measure | Time frame |
|---|---|
| Investigation of Clinical efficacy of certolizumab pegol for maintenance of fistula closure. | — |
Outcome results
None listed