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A Study to Test the Effect of CDP870 in the Treatment of Crohn's Disease Over 26 Weeks, Comparing CDP870 to a Dummy Drug (Placebo)

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. Identifier: NCT00152490
Recruitment Status : Completed
First Posted : September 9, 2005
Last Update Posted : September 9, 2013
Information provided by:
UCB Pharma

Brief Summary:
A 26 week study to examine the efficacy, safety and pharmacokinetics of CDP870 in Crohn's disease

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

Detailed Description:

Receiving immunosuppressants (azathioprine/6-MP/methotrexate) at Week 0 or not.

604 patients will be enrolled with 1006 patients screened (to allow for 25% screen failures between screening and Week 0 and expected presentation at Screening of 60% of patients with CRP < 10 mg/L and 40% of patients with CRP ≥ 10 mg/L).

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Study Type : Interventional  (Clinical Trial)
Enrollment : 604 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 Safety and Efficacy of the Humanised Anti-TNF PEG Conjugate, CDP870 400 mg sc, (Dosed at Weeks 0, 2, 4 Then 4-weekly to Week 24), in the Treatment of Patients With Active Crohn's Disease
Study Start Date : December 2003
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

Primary Outcome Measures :
  1. In the population with CRP ≥ 10 mg/L at baseline
  2. Clinical response at week 6
  3. Clinical response at week 6 and week 26

Secondary Outcome Measures :
  1. In the population with CRP ≥ 10 mg/L at baseline - % patients in clinical remission at Week 6; % patients in clinical remission at both Week 6 and Week 26; % patients with IBDQ response at Week 6; % patients with IBDQ response at both Week 6 and Week 2

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All

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.
  • Male and female aged 18 years or above at screening.
  • Patients who meet all concomitant medication criteria in the protocol specified table. For all drugs being taken at screening, the patient should be able to remain on a stable dose throughout the duration of the study, although steroids may be tapered starting at Weeks 8 to 12.

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.

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 identifier (NCT number): NCT00152490

Sponsors and Collaborators
UCB Pharma
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Study Director: UCB Clinical Trial Call Center UCB Pharma
Additional Information:
Publications of Results:
Publications automatically indexed to this study by Identifier (NCT Number):
Layout table for additonal information Identifier: NCT00152490    
Other Study ID Numbers: C87031
First Posted: September 9, 2005    Key Record Dates
Last Update Posted: September 9, 2013
Last Verified: February 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
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases
Certolizumab Pegol
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents