A Trial Evaluating Safety of Chronic Therapy With Certolizumab Pegol in Crohn's Disease - Full Text View

Sponsored by:	UCB
Information provided by:	UCB
ClinicalTrials.gov Identifier:	NCT00358683

Purpose

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.

Condition	Intervention	Phase
Crohn's Disease	Drug: Certolizumab pegol	Phase III

Genetics Home Reference related topics: Crohn disease

MedlinePlus related topics: Crohn's Disease

Drug Information available for: Immunoglobulins Globulin, Immune Infliximab Certolizumab pegol Tumor Necrosis Factors

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment
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.

Further study details as provided by UCB:

Primary Outcome Measures:

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 Outcome Measures:

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

Estimated Enrollment:	35
Study Start Date:	November 2007

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both

Criteria

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Subject withdrawn prematurely from C87055 study.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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00358683

Sponsors and Collaborators

UCB

Investigators

Study Director:

George Syrmalis, M.D. M.Sc. Ph.D.

UCB

More Information

Study ID Numbers:	C87069, RPCE06G0406
Study First Received:	July 28, 2006
Last Updated:	December 18, 2007
ClinicalTrials.gov Identifier:	NCT00358683
Health Authority:	Greece: National Organization of Medicines

Keywords provided by UCB:

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

Study placed in the following topic categories:

Immunoglobulin Fab Fragments
Antibodies
Necrosis
Digestive System Diseases
Infliximab
Gastrointestinal Diseases

Crohn Disease
Inflammatory Bowel Diseases
Gastroenteritis
Intestinal Diseases
Immunoglobulins

Additional relevant MeSH terms:

Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009