NCT00358683

Brief 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.

Trial Health

10
At Risk

Trial Health Score

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Status
withdrawn

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Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 28, 2006

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 1, 2006

Completed
1.3 years until next milestone

Study Start

First participant enrolled

November 1, 2007

Completed
Last Updated

May 28, 2012

Status Verified

May 1, 2012

First QC Date

July 28, 2006

Last Update Submit

May 25, 2012

Conditions

Crohn's Disease

Keywords

certolizunab pegollong term safety follow-upChrohn's diseaseinfliximab failures patientsGreek population

Outcome Measures

Primary Outcomes (1)

  • 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 (1)

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

Interventions

Certolizumab pegolDRUG

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Subject withdrawn prematurely from C87055 study.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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Crohn Disease

Interventions

Certolizumab Pegol

Condition Hierarchy (Ancestors)

Inflammatory Bowel DiseasesGastroenteritisGastrointestinal DiseasesDigestive System DiseasesIntestinal Diseases

Intervention Hierarchy (Ancestors)

Polyethylene GlycolsPolymersMacromolecular SubstancesImmunoglobulin Fab FragmentsImmunoglobulin FragmentsPeptide FragmentsPeptidesAmino Acids, Peptides, and ProteinsAntibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsSerum GlobulinsGlobulins

Study Officials

  • George Syrmalis, M.D. M.Sc. Ph.D.

    UCB Pharma

    STUDY DIRECTOR
0

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

July 28, 2006

First Posted

August 1, 2006

Study Start

November 1, 2007

Last Updated

May 28, 2012

Record last verified: 2012-05