Evaluate Efficacy of Certolizumab in Crohn's Patients With Draining Fistulas

UCB Pharma

Overview

To investigate the clinical efficacy of certolizumab pegol for fistula closure in Crohn's disease subjects with active draining fistulas.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Conditions

Crohn Disease

Interventions

Certolizumab pegolDRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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 Outcomes

Investigation of Clinical efficacy of certolizumab pegol for maintenance of fistula closure.

Data from ClinicalTrials.gov

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