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To Evaluate the Immunogenicity and Safety of Sarilumab Administered as Monotherapy in Patients With Rheumatoid Arthritis (RA) — SARIL-RA-ONE  

Rheumatoid Arthritis Clinical Trial

Official title:
An Open-label, Randomized, Parallel Group Study Assessing the Immunogenicity and Safety of Sarilumab Administered as Monotherapy in Patients With Active Rheumatoid Arthritis

Clinical Trial Summary

Primary Objective:

To evaluate the immunogenicity of sarilumab administered as monotherapy.

Secondary Objectives:

- To evaluate the other safety aspects of sarilumab administered as monotherapy.

- To assess the exposure of sarilumab administered as monotherapy.

Clinical Trial Description

Total study duration is up to 34 weeks: Up to 4-week screening period, 24-week open-label treatment phase, 6-week post-treatment observation. After completion of the treatment phase of this study, patients are eligible to enter a long term safety study (LTS11210 - SARIL-RA-EXTEND) for continuous treatment with sarilumab (SAR153191 [REGN88]). ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02121210
Study type Interventional
Source Sanofi
Contact
Status Completed
Phase Phase 3
Start date June 2014
Completion date May 2015
View Details
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