drugset / Trial / NCT01645280

A Study of the Effectiveness and Safety of Ustekinumab (STELARA) and CNTO 1959 Administered Under the Skin of Patients With Active Rheumatoid Arthritis, Despite Existing Methotrexate Therapy

NCT01645280

Phase 2 Completed 274 enrolled Janssen Research & Development, LLC
RandomizedParallel-groupTriple-blindTreatment

Summary

The purpose of this study is to evaluate the efficacy of ustekinumab and CNTO 1959 in reducing the signs and symptoms of disease in patients with active rheumatoid arthritis (RA) despite concomitant methotrexate (MTX) therapy and to evaluate the safety of ustekinumab and CNTO 1959 in this population.

Timeline

Start
2012-08
Primary completion
2013-12
Completion
2014-05

Drugs

EvaluationDrugModalityDoseRoute
Subject Guselkumab Monoclonal antibody 50 mg Subcutaneous
Subject Guselkumab Monoclonal antibody 200 mg Subcutaneous
Subject Ustekinumab Monoclonal antibody 90 mg Subcutaneous
Comparator Methotrexate Small molecule

Indications