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

UCB Pharma

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Conditions

Crohn's Disease

Interventions

Certolizumab pegolDRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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 Exclusion Criteria: * Subject withdrawn prematurely from C87055 study.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.

Outcomes

Primary Outcomes

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 Outcomes

Incidence of adverse events reported by the patients during the long-term treatment period of the study.

Data from ClinicalTrials.gov

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