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Sanofi and Regeneron Pharmaceuticals have announced patient enrolment in two Phase III trials, Compare and Ascertain, to assess sarilumab as a treatment for rheumatoid arthritis (RA).

Sarilumab, the first fully human monoclonal antibody directed against the IL-6 receptor, is delivered by subcutaneous injection every other week.

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Regeneron Laboratories president and Regeneron chief scientific officer Dr George Yancopoulos said; "The Compare trial will explore whether these patients would be better served by switching to a different mechanism of action, IL-6 inhibition, rather than administering another TNF-alpha inhibitor."

The trials are part of the Saril-RA clinical development programme, which is focused on adult populations with moderate-to-severe rheumatoid arthritis (RA) who inadequately respond to either methotrexate (MTX) or tumour necrosis factor alpha (TNF-alpha) inhibitor therapy.

"Sarilumab, the first fully human monoclonal antibody directed against the IL-6 receptor, is delivered by subcutaneous injection every other week."

The clinical development programme will enrol approximately 2,600 patients across five trials.

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The safety and efficacy of sarilumab in reducing the signs and symptoms of RA as well as inhibiting disease progression in a broad range of patients is the primary objective of the overall Phase III programme.

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The multi-centre, randomised Ascertain trial will evaluate the safety and tolerability of sarilumab and tocilizumab, both in combination with MTX.

The double-blind, active-control Compare trial will assess the safety and efficacy of sarilumab plus MTX, compared to etanercept (a TNF-alpha inhibitor) plus MTX.

The primary endpoint of the Ascertain study is safety, while change in Disease Activity Score 28 based on C-reactive protein (DAS28-CRP) at 24 weeks is the primary endpoint of Compare trial.