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).
This study has been completed.
Information provided by:
First received: September 7, 2005
Last updated: July 14, 2010
Last verified: July 2010
A 26 week maintenance study of CDP870 in Crohn's disease
|Study Design:||Allocation: Randomized
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|
Resource links provided by NLM:
U.S. FDA Resources
Further study details as provided by UCB, Inc.:
Primary Outcome Measures:
- Clinical response at Week 26, in the strata defined by CRP ≥ 10 mg/L.
Secondary Outcome Measures:
- 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
|Study Start Date:||February 2004|
|Study Completion Date:||May 2005|
|Primary Completion Date:||May 2005 (Final data collection date for primary outcome measure)|
Contacts and Locations