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.
- 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
- Subject withdrawn prematurely from C87055 study.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:
Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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
George Syrmalis, M.D. M.Sc. Ph.D.
Greece: National Organization of Medicines
- Crohn's Disease
- certolizunab pegol
- long term safety follow-up
- Chrohn's disease
- infliximab failures patients
- Greek population
- Crohn Disease