drugset / Trial / NCT00329420

Maintenance Study Including Re-induction Therapy for Patients Who Did Not Show a Clinical Effect in Study C87037 (NCT00291668)

NCT00329420

Phase 2 Completed 46 enrolled UCB Pharma
Non-randomizedSingle-groupOpen-labelTreatment

Summary

This 26-week extension study evaluates the efficacy and safety of certolizumab pegol administered subcutaneously every 4 weeks (dosed at Weeks 16, 20, 24, 28 and 32) in subjects with active Crohn's disease who had no clinical response at Week 6 to induction therapy in the 6-week double-blind main study, C87037 (NCT00291668), but subsequently showed clinical response at Week 14 to repeated induction therapy (dosed at Weeks 8, 10 and 12) in this extension study.

Timeline

Start
2006-05
Primary completion
2008-05
Completion
2008-05

Drugs

EvaluationDrugModalityDoseRoute
Subject Certolizumab Pegol Protein / enzyme biologic 400 mg Subcutaneous

Indications