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).
This study has been completed.
Sponsor:
UCB, Inc.
Information provided by:
UCB, Inc.
ClinicalTrials.gov Identifier:
NCT00152425
First received: September 7, 2005
Last updated: July 14, 2010
Last verified: July 2010
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Purpose
A 26 week maintenance study of CDP870 in Crohn's disease
| Condition | Intervention | Phase |
|---|---|---|
|
Crohn's Disease |
Drug: Certolizumab Pegol (CDP870) |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double-Blind |
| 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 |
Resource links provided by NLM:
Genetics Home Reference related topics:
Crohn disease
MedlinePlus related topics:
Crohn's Disease
Drug Information available for:
Certolizumab pegol
U.S. FDA Resources
Further study details as provided by UCB, Inc.:
Primary Outcome Measures:
- Clinical response at Week 26, in the strata defined by CRP ≥ 10 mg/L.
Secondary Outcome Measures:
- 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
| Estimated Enrollment: | 392 |
| Study Start Date: | February 2004 |
| Study Completion Date: | May 2005 |
| Primary Completion Date: | May 2005 (Final data collection date for primary outcome measure) |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Contacts and Locations More Information
Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| ClinicalTrials.gov Identifier: | NCT00152425 History of Changes |
| Other Study ID Numbers: | C87032 |
| Study First Received: | September 7, 2005 |
| Last Updated: | July 14, 2010 |
| Health Authority: | Australia: Department of Health and Ageing Therapeutic Goods Administration Canada: Health Canada Denmark: Danish Medicines Agency Germany: Paul-Ehrlich-Institut Hungary: National Institute of Pharmacy Ireland: Irish Medicines Board Israel: Israeli Health Ministry Pharmaceutical Administration Lithuania: State Medicine Control Agency - Ministry of Health New Zealand: Food Safety Authority Norway: Norwegian Medicines Agency Poland: Ministry of Health Serbia and Montenegro: Agency for Drugs and Medicinal Devices Singapore: Health Sciences Authority South Africa: Medicines Control Council Spain: Spanish Agency of Medicines Ukraine: State Pharmacological Center - Ministry of Health United States: Food and Drug Administration |
Keywords provided by UCB, Inc.:
|
Crohn's disease, CDP870, CDAI, clinical response, remission, Certolizumab Pegol, Cimzia |
Additional relevant MeSH terms:
|
Crohn Disease Inflammatory Bowel Diseases Gastroenteritis Gastrointestinal Diseases Digestive System Diseases |
Intestinal Diseases Immunoglobulin Fab Fragments Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 16, 2013