Study to Evaluate Efficacy and Safety of Certolizumab Pegol for Induction of Remission in Patients With Crohn's Disease

UCB

Status and phase: Completed; Phase 3

Conditions: Crohn Disease

Treatments: Other: Placebo; Biological: certolizumab pegol (CDP870, CZP)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00552058

2007-001913-41 (EudraCT Number)

C87085

Details and patient eligibility

About

The primary objective of the study is to evaluate efficacy of certolizumab pegol in inducing clinical remission in patients with moderate to severe Crohn's disease as compared with placebo based on Crohn's Disease Activity Index (CDAI) score at Week 6.

Enrollment: 439 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• male/female
• 18 - 75 years inclusive
• diagnosis of Crohn's disease confirmed
• moderate to severe disease activity (Crohn's Disease Activity Index (CDAI) 225 - 450)
• no previous treatment with anti-tumor necrosis factor (anti-TNF) medications

Exclusion criteria

• previous participation in a certolizumab pegol study
• general exclusion criteria as common for studies in this indication

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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439 participants in 2 patient groups, including a placebo group

Certolizumab pegol

Experimental group

Description:

Certolizumab pegol 400 mg for subcutaneous (sc) injection

Treatment:

Biological: certolizumab pegol (CDP870, CZP)

Placebo

Placebo Comparator group

Description:

Placebo, saline solution for sc injection

Treatment:

Other: Placebo