Arthritis Clinical Trials

Primary Objectives:

Part A: to demonstrate that SAR153191 (REGN88) on top of Methotrexate (MTX) is effective on reduction of signs and symptoms of rheumatoid arthritis at 12 weeks.

Part B: to demonstrate that SAR153191 (REGN88) on top of MTX is effective on reduction of signs and symptoms of rheumatoid arthritis at 24 weeks.

Secondary Objectives:

Part B:

To demonstrate that SAR153191 (REGN88) on top of MTX is effective on:

• inhibition of progression of structural damage at 52 weeks,
• improvement in physical function at 52 weeks,
• induction of a major clinical response at 52 weeks.

To assess the safety of SAR153191 (REGN88) on top of MTX.

To document the pharmacokinetic profile of SAR153191 (REGN88) on top of MTX in patients with active rheumatoid arthritis who are inadequate responders to MTX therapy.