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

• Status: Withdrawn
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3

Details

• Lead Sponsor: UCB Pharma
• Treatments: Certolizumab Pegol

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• Subject withdrawn prematurely from C87055 study.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.