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.
Information provided by:
UCB, Inc. Identifier:
First received: September 7, 2005
Last updated: September 6, 2013
Last verified: July 2010

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:

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)

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both

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
Please refer to this study by its identifier: NCT00152425

Sponsors and Collaborators
UCB, Inc.
Study Director: UCB Clinical Trial Call Center UCB, Inc.
  More Information

Additional Information:

Additional publications automatically indexed to this study by Identifier (NCT Number): Identifier: NCT00152425     History of Changes
Other Study ID Numbers: C87032
Study First Received: September 7, 2005
Last Updated: September 6, 2013
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
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases
Immunoglobulin Fab Fragments
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions processed this record on April 16, 2014