Study to Evaluate Efficacy and Safety of Certolizumab Pegol for Induction of Remission in Patients With Crohn's Disease
| Status: | Completed |
|---|---|
| Conditions: | Gastrointestinal, Crohns Disease |
| Therapuetic Areas: | Gastroenterology |
| Healthy: | No |
| Age Range: | 18 - 75 |
| Updated: | 8/11/2018 |
| Start Date: | March 2008 |
| End Date: | November 2009 |
Phase IIIb, Multinational, Randomized, Double-blind, Placebo-controlled Trial to Assess the Efficacy and Safety of Certolizumab Pegol, a Pegylated Fab' Fragment of a Humanized Anti-Tumor Necrosis Factor(TNF)-Alpha Monoclonal Antibody, Administered in Subjects With Moderately to Severely Active Crohn's Disease.
The primary objective of the study is to evaluate efficacy of certolizumab pegol in inducing
clinical remission in patients with moderate to severe Crohn's disease as compared with
placebo based on Crohn's Disease Activity Index (CDAI) score at Week 6.
clinical remission in patients with moderate to severe Crohn's disease as compared with
placebo based on Crohn's Disease Activity Index (CDAI) score at Week 6.
Inclusion Criteria:
- male/female
- 18 - 75 years inclusive
- diagnosis of Crohn's disease confirmed
- moderate to severe disease activity (Crohn's Disease Activity Index (CDAI) 225 - 450)
- no previous treatment with anti-tumor necrosis factor (anti-TNF) medications
Exclusion Criteria:
- previous participation in a certolizumab pegol study
- general exclusion criteria as common for studies in this indication
We found this trial at
25
sites
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