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Trial record 1 of 3 for:    NCT00152425
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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).

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00152425
Recruitment Status : Completed
First Posted : September 9, 2005
Last Update Posted : September 9, 2013
Sponsor:
Information provided by:
UCB Pharma

Study Description
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Brief Summary:
A 26 week maintenance study of CDP870 in Crohn's disease

Condition or disease Intervention/treatment Phase
Crohn's Disease Drug: Certolizumab Pegol (CDP870) Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Enrollment : 392 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Crohn's Disease

Arms and Interventions
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Outcome Measures
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Primary Outcome Measures :
  1. Clinical response at Week 26, in the strata defined by CRP ≥ 10 mg/L.

Secondary Outcome Measures :
  1. 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

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

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


Sponsors and Collaborators
UCB Pharma
Investigators
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Study Director: UCB Clinical Trial Call Center UCB Pharma
More Information
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Publications of Results:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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ClinicalTrials.gov Identifier: NCT00152425    
Other Study ID Numbers: C87032
First Posted: September 9, 2005    Key Record Dates
Last Update Posted: September 9, 2013
Last Verified: July 2010
Keywords provided by UCB Pharma:
Crohn's disease, CDP870, CDAI, clinical response, remission, Certolizumab Pegol, Cimzia
Additional relevant MeSH terms:
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Crohn Disease
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases
Certolizumab Pegol
 Tumor Necrosis Factor Inhibitors
Anti-Inflammatory Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents