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).
|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: NCT00152425|
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|
|Study Type :||Interventional (Clinical Trial)|
|Enrollment :||392 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 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|
|Study Start Date :||February 2004|
|Actual Primary Completion Date :||May 2005|
|Actual Study Completion Date :||May 2005|
- Clinical response at Week 26, in the strata defined by CRP ≥ 10 mg/L.
- 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
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): NCT00152425
|Study Director:||UCB Clinical Trial Call Center||UCB Pharma|