Certolizumab Pegol for Treatment of Adult Greek Patients With Moderate to Severe Crohn's Disease Who Failed Infliximab

UCB

Status and phase: Terminated; Phase 3

Conditions: Crohn's Disease

Treatments: Biological: Certolizumab pegol

Study type: Interventional

Funder types: Industry

Identifiers

NCT00307931

C87055

Eudract n° - 2006-002027-16

Details and patient eligibility

About

An open-label multi-center single-cohort study to assess the safety and efficacy of certolizumab pegol for the treatment of signs and symptoms of active Crohn's disease in Greek patients who have previously responded to infliximab but who no longer have a sustained response or became intolerant to infliximab

Enrollment: 16 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adult men and women with Crohn's disease previously responsive to infliximab who became non-responsive or intolerant

Exclusion criteria

• Symptomatic obstructive intestinal strictures
• Bowel resection within 4 weeks
• Current total parenteral nutrition
• Short bowel syndrome
• Concomitant disease or pathological condition that could interfere with Crohn's disease or to be harmful for the well being of the patient.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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16 participants in 1 patient group

Certolizumab pegol

Experimental group

Description:

certolizumab pegol 400 mg

Treatment:

Biological: Certolizumab pegol