Back to resultsA Trial Evaluating Safety of Chronic Therapy With Certolizumab Pegol in Crohn's Disease
Primary Purpose
Crohn's Disease
Status
Withdrawn
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Certolizumab pegol
Sponsored by
About this trial
This is an interventional treatment trial for Crohn's Disease focused on measuring certolizunab pegol, long term safety follow-up, Chrohn's disease, infliximab failures patients, Greek population
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 Exclusion Criteria: Subject withdrawn prematurely from C87055 study.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.
Sites / Locations
Outcomes
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00358683
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.
Study Type
Interventional
2. Study Status
Record Verification Date
May 2012
Overall Recruitment Status
Withdrawn
Study Start Date
November 2007 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
UCB Pharma
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Crohn's Disease
Keywords
certolizunab pegol, long term safety follow-up, Chrohn's disease, infliximab failures patients, Greek population
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Certolizumab pegol
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
Incidence of adverse events reported by the patients during the long-term treatment period of the study.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
George Syrmalis, M.D. M.Sc. Ph.D.
Organizational Affiliation
UCB Pharma
Official's Role
Study Director
12. IPD Sharing Statement
Learn more about this trial
A Trial Evaluating Safety of Chronic Therapy With Certolizumab Pegol in Crohn's Disease
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