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TOSCARA Study: A Study of Subcutaneous RoActemra/Actemra (Tocilizumab) in Patients With Active Rheumatoid Arthritis Naïve to RoActemra/Actemra Treatment

Rheumatoid Arthritis Clinical Trial

Official title:
An Open-label, Single Arm Study to Evaluate the Efficacy and Safety and Tolerability of Tocilizumab (TCZ) Subcutaneous in TCZ-naïve Patients With Active Rheumatoid Arthritis

Clinical Trial Summary

This open-label, single-arm study will evaluate the efficacy and safety of subcutaneously administered RoActemra/Actemra (tocilizumab) in monotherapy and/or in combination with methotrexate and other non-biologic DMARDs in patients with active rheumatoid arthritis who are naïve to RoActemra/Actemra. Patients will receive RoActemra/Actemra 162 mg subcutaneously weekly for 24 weeks. Patients who complete the core study achieving at least a moderate EULAR response at Week 24 may enter the extension phase and receive RoActemra/Actemra for a further 28 weeks at the most.

Clinical Trial Description

n/a

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02031471
Study type Interventional
Source Hoffmann-La Roche
Contact
Status Completed
Phase Phase 3
Start date February 2014
Completion date September 2015
View Details
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