A Study of the Effects of RoActemra/Actemra on Vaccination in Patients With Rheumatoid Arthritis on Background Methotrexate (VISARA)

Phase 4 Completed 91 enrolled Genentech, Inc.

RandomizedParallel-groupOpen-labelTreatment

Summary

This randomized, parallel-group, open-label study will evaluate the effect of Actemra (tocilizumab) on vaccination in patients with active rheumatoid arthritis who have an inadequate response to methotrexate and who have had an inadequate clinical response or were intolerant to treatment with one or more anti-tumor necrosis factor (anti-TNF) therapies.

Timeline

Start: 2010-09
Primary completion: 2011-12
Completion: 2012-06

Publications

Results Bingham CO 3rd, Rizzo W, Kivitz A, Hassanali A, Upmanyu R, Klearman M. Humoral immune response to vaccines in patients with rheumatoid arthritis treated with tocilizumab: results of a randomised controlled trial (VISARA). Ann Rheum Dis. 2015 May;74(5):818-22. doi: 10.1136/annrheumdis-2013-204427. Epub 2014 Jan 21.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	23-valent pneumococcal polysaccharide vaccine	Vaccine	—	Intramuscular
Subject	Tetanus Toxoid Adsorbed Vaccine	Vaccine	—	Intramuscular
Subject	Tocilizumab	Monoclonal antibody	8 mg/kg	Intravenous
Background	Methotrexate	Small molecule	7.5 mg	Oral
Background	Methotrexate	Small molecule	25 mg	Oral

A Study of the Effects of RoActemra/Actemra on Vaccination in Patients With Rheumatoid Arthritis on Background Methotrexate (VISARA)

Summary

Timeline

Publications

Drugs

Indications