Trials / Completed
CompletedNCT00308581
Certolizumab in Crohn's Disease Patients With Loss of Response or Intolerance to Infliximab
Phase IIIb Open-label Induction and Double-blind Comparison of 2 Maintenance Schedules Evaluating Clinical Benefit and Tolerability of Certolizumab Pegol in Crohn's Disease Patients With Prior Loss of Response or Intolerance to Infliximab
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 539 (actual)
- Sponsor
- UCB Pharma · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
To assess the clinical efficacy of subcutaneous (sc) certolizumab pegol administration over 26 weeks in patients suffering from Crohn's Disease (CD) and previously treated with infliximab
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Certolizumab pegol | 400mg Certolizumab Pegol, Q4W, administered 4-weekly |
| BIOLOGICAL | Certolizumab pegol | 400mg Certolizumab Pegol, Q2W, administered 2-weekly |
| OTHER | Placebo | placebo administered 4-weekly in Active 1 |
Timeline
- Start date
- 2006-04-01
- Primary completion
- 2008-04-01
- Completion
- 2008-04-01
- First posted
- 2006-03-29
- Last updated
- 2018-08-07
- Results posted
- 2009-11-17
Locations
107 sites across 14 countries: United States, Austria, Belgium, Canada, Denmark, France, Germany, Italy, Netherlands, Norway, Spain, Sweden, Switzerland, United Kingdom
Source: ClinicalTrials.gov record NCT00308581. Inclusion in this directory is not an endorsement.