drugset / Trial / NCT00965653

A Study of Subcutaneously Administered Tocilizumab in Patients With Rheumatoid Arthritis

NCT00965653

Phase 1 Completed 29 enrolled Hoffmann-La Roche
RandomizedParallel-groupOpen-labelTreatment

Summary

This open-label randomized 2arm study will investigate the pharmacokinetics, pharmacodynamics, efficacy and safety of subcutaneously administered tocilizumab in patients with rheumatoid arthritis who have shown an inadequate response to methotrexate. Patients will be randomized to receive tocilizumab 162 mg sc either weekly or every other week, in combination with methotrexate, for 12 weeks. Assessments will be made at regular intervals during treatment and on the 3 weeks of follow-up.Target sample size is \< 50 individuals.

Timeline

Start
2009-08
Primary completion
Completion
2011-07

Drugs

EvaluationDrugModalityDoseRoute
Comparator Tocilizumab Monoclonal antibody 162 mg Subcutaneous
Background Methotrexate Small molecule 7.5 mg
Background Methotrexate Small molecule 25 mg
Background folic acid Other / unclassified 5 mg

Indications