drugset / Trial / NCT00899678
The Use of Certolizumab Pegol for Treatment of Active Crohn's Disease in Children and Adolescents
RandomizedParallel-groupOpen-labelTreatment
Summary
The purpose of this study is to evaluate the safety, efficacy, pharmacokinetics, and immunogenicity of certolizumab pegol treatment in pediatric subjects, aged 6 to 17, with moderately to severely active Crohn's disease. The target enrollment is 160 subjects.
Timeline
- Start
- 2009-04
- Primary completion
- 2012-07
- Completion
- 2012-07
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Certolizumab Pegol | Protein / enzyme biologic | 200 mg | Subcutaneous |
| Comparator | Certolizumab Pegol | Protein / enzyme biologic | 400 mg | Subcutaneous |