NCT01163747

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

A Randomized, Parallel-group, Open-label, Multicenter Study to Evaluate the Effects of Tocilizumab on Vaccination in Subjects With Active Rheumatoid Arthritis Receiving Background Methotrexate

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 91 (actual)
• Sponsor: Genentech, Inc. · Industry
• Sex: All
• Age: 18 Years – 64 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Rheumatoid Arthritis

Interventions

Type	Name	Description
BIOLOGICAL	tocilizumab	Intravenous repeating dose
DRUG	methotrexate	A stable dose of between 7.5 and 25 mg/week, oral or parenteral.
BIOLOGICAL	23-Valent Pneumococcal Polysaccharide Vaccine	Intramuscular or subcutaneous injection
BIOLOGICAL	Tetanus Toxoid Adsorbed Vaccine	Intramuscular injection

Timeline

• Start date: 2010-09-01
• Primary completion: 2011-12-01
• Completion: 2012-06-01
• First posted: 2010-07-16
• Last updated: 2012-12-07
• Results posted: 2012-12-07

Locations

47 sites across 1 country: United States