A Study to Evaluate Safety of Long Term Therapy of Certolizumab Pegol Patients With Crohn's Disease

UCB

Status and phase: Completed; Phase 3

Conditions: Crohn Disease

Treatments: Biological: Cimzia

Study type: Interventional

Funder types: Industry

Identifiers

NCT00552344

C87088

2007-002716-26 (EudraCT Number)

Details and patient eligibility

About

The primary objective of the study is to assess the safety of long term therapy with Certolizumab Pegol in those subjects participating in study C87085 [NCT00552058].

Full description

This study consisted of:

• Induction Period (dosing at Weeks 0, 2, and 4)
• Maintenance Dosing (dosing every 4 weeks up to Week 260)
• End of Treatment Visit that occurred at Week 262/Withdrawal Visit and a Safety Follow-up Visit (SFU; 12 weeks after final dose)

Enrollment: 403 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Subject participated in study C87085 [NCT00552058] in which the subject completed the study at Week 6
• Subject is capable of providing informed consent, which must be obtained prior to any study related procedures
• Have a chest X-ray taken at Visit 1 that is read by a qualified radiologist or pulmonary physician, with no evidence of current active Tuberculosis (TB) or old inactive TB
• Subject has taken a TB survey and is committed to comply with TB prophylaxis if applicable

Exclusion criteria

• Subject is experiencing an ongoing serious adverse event assessed as being related to study medication or is experiencing a serious adverse event that is still not assessable
• Subject has an intercurrent illness that requires termination of treatment, such as a serious infection (e.g. TB, pneumonia, sepsis, pyelonephritis, fistula abscess)
• Subject is non-compliant with TB prophylactic treatment (if applicable)
• Subject has had a chest X-ray at Visit 1 that shows an abnormality suggestive of a malignancy or active infection, including TB
• Female who is pregnant or breast feeding
• Female of child bearing age or post puberty males not practicing effective birth control
• Subject is expecting to receive any live virus or bacterial vaccination within 3 months of first Study Medication administration, during the trial or 3 months after last dose of study drug

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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403 participants in 1 patient group

Certolizumab Pegol

Experimental group

Description:

Certolizumab Pegol 200 mg/vial; 400 mg subcutaneously at Week 0, 2 and 4, thereafter 400 mg subcutaneously at every 4 weeks.

Treatment:

Biological: Cimzia