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.|
|ClinicalTrials.gov Identifier: NCT00152490|
Recruitment Status : Completed
First Posted : September 9, 2005
Last Update Posted : September 9, 2013
|Condition or disease||Intervention/treatment||Phase|
|Crohn's Disease||Drug: Certolizumab Pegol (CDP870)||Phase 3|
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).
|Study Type :||Interventional (Clinical Trial)|
|Enrollment :||604 participants|
|Intervention Model:||Parallel Assignment|
|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|
- In the population with CRP ≥ 10 mg/L at baseline
- Clinical response at week 6
- Clinical response at week 6 and week 26
- 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
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 ClinicalTrials.gov identifier (NCT number): NCT00152490
|Study Director:||UCB Clinical Trial Call Center||UCB Pharma|