drugset / Trial / NCT00619905

Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ACZ885 in Patients With Rheumatoid Arthritis With Ongoing Treatment With Methotrexate

NCT00619905

Phase 1/2 Completed 53 enrolled Novartis
RandomizedParallel-groupDouble-blindTreatment

Summary

This study assessed the long-term safety and tolerability of ACZ885 in patients with rheumatoid arthritis, as well as long-term efficacy, long-term preservation and/or improvement of joint structure and bone mineral density, and long term maintenance of health-related quality of life.

Timeline

Start
2003-12
Primary completion
2005-08
Completion
2005-08

Drugs

EvaluationDrugModalityDoseRoute
Comparator Canakinumab Monoclonal antibody 0.3 mg/kg Intravenous
Comparator Canakinumab Monoclonal antibody 1 mg/kg Intravenous
Comparator Canakinumab Monoclonal antibody 3 mg/kg Intravenous
Comparator Canakinumab Monoclonal antibody 10 mg/kg Intravenous

Indications