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

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.

Status

Withdrawn

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00358683

Enrollment

Registered

2006-08-01

Start date

2007-11-30

Completion date

Unknown

Last updated

2012-05-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Crohn's Disease

Keywords

certolizunab pegol, long term safety follow-up, Chrohn's disease, infliximab failures patients, Greek population

Brief 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.

Interventions

DRUGCertolizumab pegol

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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* Subject withdrawn prematurely from C87055 study.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.

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
Incidence of adverse events reported by the patients during the long-term treatment period of the study.	—

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026