MedDataX Logo

Certolizumab Pegol for Treatment of Adult Greek Patients With Moderate to Severe Crohn's Disease Who Failed Infliximab

NCT ID: NCT00307931

Last Updated: 2011-08-31

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-04-30

Study Completion Date

2008-08-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

An open-label multi-center single-cohort study to assess the safety and efficacy of certolizumab pegol for the treatment of signs and symptoms of active Crohn's disease in Greek patients who have previously responded to infliximab but who no longer have a sustained response or became intolerant to infliximab

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Crohn's Disease

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Certolizumab pegol Cimzia Crohn's disease Greek patients

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Certolizumab pegol

certolizumab pegol 400 mg

Group Type EXPERIMENTAL

Certolizumab pegol

Intervention Type BIOLOGICAL

certolizumab pegol 400 mg (lyophilized product) administered as 2 x 200 mg subcutaneous injections at Weeks 0, 2, 4, 8 and 12.

Treatment duration: 12 weeks.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Certolizumab pegol

certolizumab pegol 400 mg (lyophilized product) administered as 2 x 200 mg subcutaneous injections at Weeks 0, 2, 4, 8 and 12.

Treatment duration: 12 weeks.

Intervention Type BIOLOGICAL

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Cimzia

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

• Adult men and women with Crohn's disease previously responsive to infliximab who became non-responsive or intolerant

Exclusion Criteria

* Symptomatic obstructive intestinal strictures
* Bowel resection within 4 weeks
* Current total parenteral nutrition
* Short bowel syndrome
* Concomitant disease or pathological condition that could interfere with Crohn's disease or to be harmful for the well being of the patient.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

UCB Pharma

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

UCB Clinical Trial Call Center

Role: STUDY_DIRECTOR

+1 877 822 9493 (UCB)

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Heraklion, Crete, Greece

Site Status

Athens, , Greece

Site Status

Ioannina, , Greece

Site Status

Piraeus, , Greece

Site Status

Thessaloniki, , Greece

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Greece

Related Links

Access external resources that provide additional context or updates about the study.

http://www.fda.gov/Safety/MedWatch/SafetyInformation/default.htm

FDA Safety Alerts and Recalls

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

Eudract n° - 2006-002027-16

Identifier Type: -

Identifier Source: secondary_id

C87055

Identifier Type: -

Identifier Source: org_study_id