Corticosteroid Sparing Effect of Certolizumab in Crohn's Disease (COSPAR1)

UCB

Status and phase: Terminated; Phase 3

Conditions: Crohn's Disease

Treatments: Other: Placebo; Biological: certolizumab pegol 400 mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT00349752

2006-003870-88 (EudraCT Number)

C87059

Details and patient eligibility

About

The current study is designed to measure the corticosteroid-sparing effect of certolizumab pegol using a defined schedule of corticosteroid tapering in subjects with moderate to severe Crohn's disease. Subjects had to be in remission (CDAI<=150) and receiving corticosteroids at a dose no higher than 30 mg/day prednisone or equivalent during the week prior to randomization.

Enrollment: 174 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Men and women
• Age 18 years or older with moderate to severe Crohn's disease (Crohn's Disease Activity Index (CDAI) score of ≥ 220 ≤450)

Exclusion criteria

• Active or draining fistula present at screening
• Lactating and/or pregnant female subjects
• A history of any health condition that could potentially interfere with the disease and/or the treatment
• A history of an adverse reaction to polyethylene glycol (PEG) or a protein medicinal product
• Any other condition which in the Investigator's judgment would make the patient unsuitable for inclusion in the study
• History of drug or alcohol abuse in the prior year
• Receipt of any experimental therapy within or outside a clinical trial in the 3 months prior to Visit 0

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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174 participants in 2 patient groups, including a placebo group

Certolizumab pegol 400 mg

Experimental group

Description:

Certolizumab pegol 400 mg

Treatment:

Biological: certolizumab pegol 400 mg

Placebo

Placebo Comparator group

Description:

Placebo

Treatment:

Other: Placebo