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This study has been withdrawn prior to enrollment.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, Inc.
ClinicalTrials.gov Identifier:
NCT00358683
First received: July 28, 2006
Last updated: May 25, 2012
Last verified: May 2012
  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:


Further study details as provided by UCB, Inc.:

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
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  • Subject withdrawn prematurely from C87055 study.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, Inc.
Investigators
Study Director: George Syrmalis, M.D. M.Sc. Ph.D. UCB, Inc.
  More Information

No publications provided

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, Inc.:
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
Immunoglobulin Fab Fragments
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 20, 2014