A follow-on Safety Study of CDP870 in Subjects With Crohn's Disease (CD) Who Have Completed a 26-week Double Blind Study CDP870-031 [NCT00152490] or CDP870-032 [NCT00152425] (PRECiSE 3)

UCB

Status and phase: Completed; Phase 3

Conditions: Crohn's Disease

Treatments: Biological: Certolizumab Pegol (CDP870)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00160524

C87033

2005-002622-60 (EudraCT Number)

Details and patient eligibility

About

An open-label follow-on safety study of CDP870 (400 mg every 4 weeks) in patients with Crohn's Disease who have completed a 26-week blinded study (CDP870-031 [NCT00152490] or CDP870-032 [NCT00152425]).

Enrollment: 596 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Participation in either of the CDP870-031 [NCT00152490] or CDP870-032 [NCT00152425] clinical studies in which the subject completed the trial at Week 26. Subjects may have received active or placebo or both treatments in the prior study
• Subjects must be able to understand the information provided to them and give written informed consent

Exclusion criteria

• Any exclusion criterion that would have prevented the subject's participation in the qualifying pivotal study CDP870-031 [NCT00152490] or CDP870-032 [NCT00152425], although the criterion that excludes previous participation in a clinical trial of Certolizumab Pegol does not apply. In addition there are no limits on the Clinical Disease Activity Index (CDAI) score at entry

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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596 participants in 1 patient group

Certolizumab Pegol

Experimental group

Description:

400 mg subcutaneous injection every 4 weeks from Week 2 to Week 362.

Treatment:

Biological: Certolizumab Pegol (CDP870)