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

UCB

Status and phase

Withdrawn

Phase 3

Conditions

Crohn's Disease

Treatments

Drug: Certolizumab pegol

Study type

Interventional

Funder types

Industry

Identifiers

NCT00358683

RPCE06G0406

C87069

Details and patient eligibility

About

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.

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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Subject withdrawn prematurely from C87055 study.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.