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)

This study has been completed.
Sponsor:
Information provided by:
UCB, Inc.
ClinicalTrials.gov Identifier:
NCT00152490
First received: September 8, 2005
Last updated: September 6, 2013
Last verified: February 2010

September 8, 2005
September 6, 2013
December 2003
May 2005   (final data collection date for primary outcome measure)
  • In the population with CRP ≥ 10 mg/L at baseline
  • Clinical response at week 6
  • Clinical response at week 6 and week 26
Same as current
Complete list of historical versions of study NCT00152490 on ClinicalTrials.gov Archive Site
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
  • In the population with CRP ≥ 10 mg/L at baseline
  • 1. (i) % patients in clinical remission at Week 6
  • (ii) % patients in clinical remission at both Week 6 and Week 26
  • 2. (i) % patients with IBDQ response at Week 6
  • (ii) % patients with IBDQ response at both Week 6 and Week 26.
  • 3. (i) SF-36 sub-scores and changes from baseline in SF-36 sub-scores for bodily pain and role physical at Week 6.
  • (ii) SF-36 sub-scores and changes from baseline in SF-36 sub-scores for bodily pain and role physical at both Week 6 and Week 26.
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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)
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

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

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).

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
604
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.
  • 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.
Both
18 Years and older
Not Provided
Contact information is only displayed when the study is recruiting subjects
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NCT00152490
C87031
Not Provided
Not Provided
UCB, Inc.
Not Provided
Study Director: UCB Clinical Trial Call Center UCB, Inc.
UCB, Inc.
February 2010

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