drugset / Trial / NCT00580840

Dosing Flexibility Study in Patients With Rheumatoid Arthritis

NCT00580840

Phase 4 Completed 333 enrolled UCB Pharma
RandomizedParallel-groupDouble-blindTreatment

Summary

During the run-in period, CZP will be administered at 400 mg (2 injections) at Wks 0, 2, and 4 and 200 mg with placebo (1 injection placebo, 1 injection CZP) at Wks 6, 8, 10, 12, 14 and 16. At Wk 18 patients will be grouped as responders or non-responders based on results of the ACR20 at Week 16.

Timeline

Start
2007-12
Primary completion
2010-12
Completion
2011-03

Drugs

EvaluationDrugModalityDoseRoute
Subject Certolizumab Pegol Protein / enzyme biologic 200 mg
Subject Certolizumab Pegol Protein / enzyme biologic 400 mg

Indications