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)

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

Detailed Description
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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).

Official Title
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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

Conditions
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Crohn's Disease

Intervention / Treatment
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* Drug: Certolizumab Pegol (CDP870)


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Certolizumab Pegol (CDP870)|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| In the population with CRP ≥ 10 mg/L at baseline |  |  | 
| Clinical response at week 6 |  |  | 
| Clinical response at week 6 and week 26 |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Crohn's disease, CDP870, CDAI, clinical response, remission,, Certolizumab Pegol, Cimzia