Certolizumab in Crohn's Disease Patients With Loss of Response or Intolerance to Infliximab

UCB

Status and phase: Completed; Phase 3

Conditions: Crohn's Disease

Treatments: Other: Placebo; Biological: Certolizumab pegol

Study type: Interventional

Funder types: Industry

Identifiers

NCT00308581

C87042

Eudract number: 2005-004104-37

Details and patient eligibility

About

To assess the clinical efficacy of subcutaneous (sc) certolizumab pegol administration over 26 weeks in patients suffering from Crohn's Disease (CD) and previously treated with infliximab

Enrollment: 539 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Subjects with Crohn's Disease
• Previous treatment failure to Infliximab (intolerance and/or no response)

Exclusion criteria

• Obstructive intestinal strictures
• Recent bowel resection
• Proctocolectomy or total colectomy
• Current total parenteral nutrition
• Short bowel syndrome
• All 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: Double Blind

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539 participants in 2 patient groups

Active 1

Experimental group

Description:

Q4W regimen - every 4 weeks: alternatively placebo and 400mg Certolizumab Pegol

Treatment:

Biological: Certolizumab pegol

Other: Placebo

Biological: Certolizumab pegol

Active 2

Experimental group

Description:

Q2W regimen - every 2 weeks: 400 mg Certolizumab Pegol

Treatment:

Biological: Certolizumab pegol

Biological: Certolizumab pegol