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

This study has been withdrawn prior to enrollment.

Sponsor:

Information provided by:

UCB Pharma

ClinicalTrials.gov Identifier:

NCT00358683

First received: July 28, 2006

Last updated: May 25, 2012

Last verified: May 2012

History of Changes

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 3


Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
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.

Resource links provided by NLM:

Genetics Home Reference related topics: Crohn disease

MedlinePlus related topics: Crohn's Disease

Drug Information available for: Certolizumab pegol

U.S. FDA Resources

Further study details as provided by UCB Pharma:

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.


Enrollment:	0
Study Start Date:	November 2007

Eligibility


Ages Eligible for Study:	18 Years and older (Adult, Senior)
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Subject withdrawn prematurely from C87055 study.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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Sponsors and Collaborators

UCB Pharma

Investigators


Study Director:	George Syrmalis, M.D. M.Sc. Ph.D.	UCB Pharma

More Information


ClinicalTrials.gov Identifier:	NCT00358683 History of Changes
Other Study ID Numbers:	C87069 RPCE06G0406
Study First Received:	July 28, 2006
Last Updated:	May 25, 2012
Health Authority:	Greece: National Organization of Medicines

Keywords provided by UCB Pharma:


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

Additional relevant MeSH terms:


Crohn Disease Inflammatory Bowel Diseases Gastroenteritis Gastrointestinal Diseases Digestive System Diseases Intestinal Diseases	Certolizumab Pegol Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Antirheumatic Agents

ClinicalTrials.gov processed this record on September 23, 2016

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