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

UCB

Status and phase: Withdrawn; Phase 3

Conditions: Crohn Disease

Treatments: Drug: Certolizumab pegol

Study type: Interventional

Funder types: Industry

Identifiers

NCT00354367

C87058

Details and patient eligibility

About

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

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)