Study to Test the Effect of CDP870 in the Treatment of Crohn's Disease Over 26 Weeks, Comparing CDP870 to a Dummy Drug (Placebo), Following 3 Doses of Active Drug (CDP870).
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|ClinicalTrials.gov Identifier: NCT00152425|
Recruitment Status : Completed
First Posted : September 9, 2005
Last Update Posted : September 9, 2013
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|Condition or disease||Intervention/treatment||Phase|
|Crohn's Disease||Drug: Certolizumab Pegol (CDP870)||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Enrollment :||392 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||A Phase III Multi-national, Multi-centre, Double-blind Placebo-controlled Parallel Group, 26 Week Study to Assess the Maintenance of Clinical Response to Humanised Anti-TNF PEG Conjugate, CDP870 400 mg sc, (Dosed 4-weekly From Weeks 8 to 24), in the Treatment of Patients With Active Crohn's Disease Who Have Responded to Open Induction Therapy (Dosed at Weeks 0, 2 and 4) With CDP870|
|Study Start Date :||February 2004|
|Actual Primary Completion Date :||May 2005|
|Actual Study Completion Date :||May 2005|
- Clinical response at Week 26, in the strata defined by CRP ≥ 10 mg/L.
- In population with CRP ≥ 10 mg/L at baseline; Time to disease progression up to and including Week 26; Proportion of patients with clinical remission at Week 26; Proportion of patients with IBDQ response at Week 26; F-36 sub-scores and change from basel
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|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
- Definitive diagnosis of Crohn's disease confirmed (at least 3 months prior to study entry) either by radiological, endoscopic or histological evidence, affecting the terminal ileum (L1), colon (L2) or ileocolon (L3)*. * Vienna Classification (1998)
- Active Crohn's disease (≥ 220 and ≤ 450) scored over the 7 days prior to the first dose of study drug.
- Patients aged 18 years or above at screening.
- Crohn's Disease Related
- Fistula abscess present at screening.
- Stricturing type disease with symptoms or signs of non-inflammatory mechanical obstruction or bowel perforation in last 3 months.
- Short bowel syndrome.
- Functional colostomy or ileostomy (note: patients who have had a temporary stoma in the past, which has been reversed, are eligible to enter the study).
- Positive stool laboratory results for enteric pathogens.
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): NCT00152425
|Study Director:||UCB Clinical Trial Call Center||UCB Pharma|
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
|Other Study ID Numbers:||
|First Posted:||September 9, 2005 Key Record Dates|
|Last Update Posted:||September 9, 2013|
|Last Verified:||July 2010|
Crohn's disease, CDP870, CDAI, clinical response, remission, Certolizumab Pegol, Cimzia
Inflammatory Bowel Diseases
Digestive System Diseases
Tumor Necrosis Factor Inhibitors
Physiological Effects of Drugs