Evaluate Efficacy of Certolizumab in Crohn's Patients With Draining Fistulas
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|ClinicalTrials.gov Identifier: NCT00354367|
Recruitment Status : Withdrawn
First Posted : July 20, 2006
Last Update Posted : May 28, 2012
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|Condition or disease||Intervention/treatment||Phase|
|Crohn Disease||Drug: Certolizumab pegol||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase IIIB Multicenter, Open Label, Randomized Clinical Trial Evaluating Efficacy of Certolizumab Pegol, a PEGylated Fab Fragment of Humanized Antibody to Tumor Necrosis Factor (TNF) in Crohn's Disease Patients With Draining Fistulas.|
|Study Start Date :||January 2007|
- Investigation of Clinical efficacy of certolizumab pegol for fistula closure, as measured by the proportion of patients with fistula improvement after 16 weeks of treatment.
- Investigation of Clinical efficacy of certolizumab pegol for maintenance of fistula closure.
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|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
- Patients with single or multiple fistulas, including perianal and enterocutaneous fistulas for at least 3 months as a complication of Crohn's disease
- Symptomatic obstructive intestinal strictures, bowel resection, proctocolectomy or total colectomy, abscesses present at screening, current total parenteral nutrition, short bowel syndrome.
- All the concomitant diseases or pathological conditions that could interfere with Crohn's disease assessment or to be harmful for the well being of the patient.
- Previous clinical trials and previous biological therapy that could interfere with the results in the present clinical trial
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00354367
|Study Director:||Krassimir Mitchev, MD||UCB / Global Medical Affairs|
|Other Study ID Numbers:||
|First Posted:||July 20, 2006 Key Record Dates|
|Last Update Posted:||May 28, 2012|
|Last Verified:||May 2012|
Inflammatory Bowel Diseases
Digestive System Diseases
Pathological Conditions, Anatomical
Tumor Necrosis Factor Inhibitors
Physiological Effects of Drugs