Clinical Study of CDP870/Certolizumab Pegol in Patients With Active Crohn's Disease

UCB

Status and phase: Completed; Phase 2

Conditions: Crohn's Disease

Treatments: Biological: Certolizumab Pegol; Other: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00291668

C87037

2014-004399-42 (EudraCT Number)

Details and patient eligibility

About

This is a multi-centre, randomized, double-blind, dose response clinical study of CDP870 in patients with Crohn's disease.

Enrollment: 94 patients

Sex: All

Ages: 16 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

Inclusion Criteria:

• Patients who are diagnosed with Crohn's disease (according to the Crohn's disease diagnostic criteria developed by the research group on intractable inflammatory bowel disorders [Shimoyama group, January 25, 2002]) at least 24 weeks before the starting date of the observation period
• Patients with Crohn's Disease Activity Index (CDAI) score ranging from 220 to 450 inclusive during the observation period
• C-reactive protein (CRP) of 1 mg/dL or higher in the laboratory test performed at the start of the observation period

Exclusion criteria

• Stoma patient
• Patients with a history of severe hypersensitivity or anphylactic reaction to anti-TNF alpha antibody
• Patients who participated in a clinical study with CDP870
• Pregnant or lactating patients, patients of childbearing potential, or patients who will attempt pregnancy during the study period
• Patients who are judged inappropriate for enrollment by the principal investigator or subinvestigators

Exclusion Criteria:

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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94 participants in 3 patient groups, including a placebo group

Certolizumab pegol 200 mg

Experimental group

Description:

Subjects received one subcutaneous (sc) injection of 200 mg CZP and one injection of Placebo to maintain the study blind on Weeks 0 (first dose), 2 and 4.

Treatment:

Biological: Certolizumab Pegol

Other: Placebo

Certolizumab pegol 400 mg

Experimental group

Description:

Subjects received two subcutaneous (sc) injections of 200 mg CZP on Weeks 0 (first dose), 2 and 4.

Treatment:

Biological: Certolizumab Pegol

Placebo

Placebo Comparator group

Description:

Subjects received two subcutaneous (sc) injections of Placebo on Weeks 0 (first dose), 2 and 4.

Treatment:

Other: Placebo