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.
18 Years
N/A
Both
Crohn's Disease
Trial Information
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.
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- Subject withdrawn prematurely from C87055 study.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.
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
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
Principal Investigator
George Syrmalis, M.D. M.Sc. Ph.D.
Investigator Role:
Study Director
Investigator Affiliation:
UCB, Inc.
Authority:
Greece: National Organization of Medicines
Study ID:
C87069
NCT ID:
NCT00358683
Start Date:
November 2007
Completion Date:
Related Keywords:
- Crohn's Disease
- certolizunab pegol
- long term safety follow-up
- Chrohn's disease
- infliximab failures patients
- Greek population
- Crohn Disease
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