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NCT00358683 Clinical Trial

A Trial Evaluating Safety of Chronic Therapy With Certolizumab Pegol in Crohn's Disease

Crohn's Disease Clinical Trial

Official title:
Open Label Long Term Clinical Trial Evaluating Safety of Chronic Therapy With Certolizumab Pegol, a PEGylated Fab Fragment of Humanized Antibody to Tumor Necrosis Factor Alpha (TNF) in Patients Suffering From Crohn's Disease and Having Completed C87055 Study.

Clinical Trial Details — Status: Withdrawn

Administrative data
NCT number NCT00358683
Other study ID # C87069
Secondary ID RPCE06G0406
Status Withdrawn
Phase Phase 3
First received July 28, 2006
Last updated May 25, 2012
Start date November 2007

Study information
Verified date May 2012
Source UCB Pharma
Contact n/a
Is FDA regulated No
Health authority Greece: National Organization of Medicines
Study type Interventional

Clinical Trial Summary

The primary aim of this study is allow the patients suffering from Crohn's disease , who both completed the therapeutic confirmatory study C87055 of certolizumab pegol and benefited from the treatment, to receive treatment with certolizumab pegol until the drug is available for the Crohn's disease indication in Greece.

Recruitment information / eligibility
Status Withdrawn
Enrollment 0
Est. completion date
Est. primary completion date
Accepts healthy volunteers
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Crohn's disease diagnosis

- Patients having completed the treatment period of study C87055 (previously treated with infliximab) and benefited from the study treatment, as per investigatior's discretion.

Exclusion Criteria:

- Subject withdrawn prematurely from C87055 study.

- Subject who received treatment other than certolizumab pegol and other than medications permitted in C87055 study.

- Female patients of childbearing age who are NOT practicing (in the Investigator's opinion) effective birth control. All female patients must test negative on a serum pregnancy test before study entry and negative on urine testing immediately before every certolizumab pegol administration.

Study Design

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Certolizumab pegol

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
UCB Pharma

Outcome
Type Measure Description Time frame Safety issue
Primary For ethical reasons, provide the opportunity for patients > 18 years suffering from Crohn's disease who both completed the therapeutic confirmatory study C87055 of certolizumab pegol and benefited from the treatment, to receive treatment with certolizum
Secondary Incidence of adverse events reported by the patients during the long-term treatment period of the study.
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