drugset / Trial / NCT01190410
Extension Study to Assess Long Term Safety in Children and Adolescents With Crohn's Disease Receiving Certolizumab Pegol
Non-randomizedParallel-groupOpen-labelTreatment
Summary
The purpose of this study is to evaluate the long-term safety and tolerability of certolizumab pegol (CZP) treatment in children and adolescents with moderately to severely active Crohn's disease. Secondarily, to assess the long-term efficacy, pharmacokinetics (PK), and immunogenicity of CZP treatment in children and adolescents with moderately to severely active Crohn's disease.
Timeline
- Start
- 2010-08
- Primary completion
- 2017-11-27
- Completion
- 2017-11-27
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Certolizumab Pegol | Protein / enzyme biologic | 100 mg | Subcutaneous |
| Subject | Certolizumab Pegol | Protein / enzyme biologic | 200 mg | Subcutaneous |
| Subject | Certolizumab Pegol | Protein / enzyme biologic | 400 mg | Subcutaneous |