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

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ClinicalTrials.gov Identifier: NCT00358683
Recruitment Status : Withdrawn
First Posted : August 1, 2006
Last Update Posted : May 28, 2012
Sponsor:
Information provided by:
UCB Pharma

Study Description
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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.

Condition or disease Intervention/treatment Phase
Crohn's Disease Drug: Certolizumab pegol Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (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.
Study Start Date : November 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Crohn's Disease
U.S. FDA Resources

Arms and Interventions
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Outcome Measures
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Primary Outcome Measures :
  1. 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 :
  1. Incidence of adverse events reported by the patients during the long-term treatment period of the study.

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00358683


Sponsors and Collaborators
UCB Pharma
Investigators
Study Director: George Syrmalis, M.D. M.Sc. Ph.D. UCB Pharma
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

ClinicalTrials.gov Identifier: NCT00358683     History of Changes
Other Study ID Numbers: C87069
RPCE06G0406
First Posted: August 1, 2006    Key Record Dates
Last Update Posted: May 28, 2012
Last Verified: May 2012

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