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

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• Recruitment Status: Withdrawn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

Tracking Information

• First Submitted Date: July 28, 2006
• First Posted Date: August 1, 2006
• Last Update Posted Date: May 28, 2012
• Study Start Date: November 2007
• Primary Completion Date: Not Provided
• Current Primary Outcome Measures (submitted: July 28, 2006): 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
• Original Primary Outcome Measures: Same as current
• Current Secondary Outcome Measures (submitted: July 28, 2006): Incidence of adverse events reported by the patients during the long-term treatment period of the study.
• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: A Trial Evaluating Safety of Chronic Therapy With Certolizumab Pegol in Crohn's Disease
• 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.
• 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.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 3
• Study Design: Allocation: Non-Randomized; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Crohn's Disease
• Intervention: Drug: Certolizumab pegol
• Study Arms: Not Provided
• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Withdrawn
• Actual Enrollment (submitted: May 25, 2012): 0
• Original Enrollment (submitted: July 28, 2006): 35
• Study Completion Date: Not Provided
• Primary Completion Date: Not Provided

Eligibility 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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Not Provided
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Not Provided

Administrative Information

• NCT Number: NCT00358683
• Other Study ID Numbers: C87069; RPCE06G0406
• Has Data Monitoring Committee: Not Provided
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Not Provided
• Study Sponsor: UCB Pharma
• Collaborators: Not Provided

Investigators

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

• PRS Account: UCB Pharma
• Verification Date: May 2012