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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).

This study has been completed.
Sponsor:
Information provided by:
UCB, Inc.
ClinicalTrials.gov Identifier:
NCT00152425
First received: September 7, 2005
Last updated: July 14, 2010
Last verified: July 2010
History of Changes

September 7, 2005
July 14, 2010
February 2004
May 2005   (final data collection date for primary outcome measure)
Clinical response at Week 26, in the strata defined by CRP ≥ 10 mg/L.
Same as current
Complete list of historical versions of study NCT00152425 on ClinicalTrials.gov Archive Site
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
  • In the population with CRP ≥ 10 mg/L at baseline
  • 1. Time to disease progression up to and including Week 26.
  • 2. The proportion of patients with clinical remission at Week 26.
  • 3. The proportion of patients with IBDQ response at Week 26.
  • 4. SF-36 sub-scores and change from baseline in SF-36 sub-scores for bodily pain and role physical at Week 26.
Not Provided
Not Provided
 
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).
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

A 26 week maintenance study of CDP870 in Crohn's disease
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double-Blind
Crohn's Disease
Drug: Certolizumab Pegol (CDP870)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
392
May 2005
May 2005   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
Not Provided
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00152425
C87032
Not Provided
Not Provided
UCB, Inc.
Not Provided
Study Director: UCB Clinical Trial Call Center UCB, Inc.
UCB, Inc.
July 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP