Examining the Long Term Safety, Efficacy, and Corticosteroid-sparing Effect of Certolizumab Pegol in Crohn's Disease (COSPAR II)

UCB

Status and phase: Completed; Phase 3

Conditions: Crohn's Disease

Treatments: Biological: Certolizumab pegol

Study type: Interventional

Funder types: Industry

Identifiers

NCT00356408

2006-003871-11 (EudraCT Number)

C87065

Details and patient eligibility

About

This is an open-label extension study designed to measure the safety, efficacy, and corticosteroid-sparing effect of certolizumab pegol (CDP870) in patients with moderate to severe Crohn's disease previously enrolled in C87059 (COSPAR I, NCT00349752).

Enrollment: 106 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients previously enrolled in C87059 (COSPAR I, NCT00349752)

Exclusion criteria

• Subject withdrawn or discontinued from C87059 (COSPAR I, NCT00349752) study under specific conditions
• Subject who received treatment other than study medication and other than medications permitted in C87059 (COSPAR I, NCT00349752)
• Subjects from countries where certolizumab pegol is authorized in Crohn's disease treatment

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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106 participants in 1 patient group

CDP870 400 mg

Experimental group

Description:

Certolizumab pegol (CDP870) 400 mg (2 injections of 1 mL) every 4 weeks from Week 2 until Week 34, or until CDP870 is available for a Crohn's disease indication in the patient's country. Subjects who were Non-completers of C87059 (COSPAR I, NCT00349752) receive an additional CDP870 400 mg dose at Week 2

Treatment:

Biological: Certolizumab pegol