Rheumatoid Arthritis Clinical Trial
Official title:
A Randomized, Double-blind, Placebo-controlled, Multicenter, Two-part, Dose Ranging and Confirmatory Study With an Operationally Seamless Design, Evaluating Efficacy and Safety of SAR153191 on Top of Methotrexate (MTX) in Patients With Active Rheumatoid Arthritis Who Are Inadequate Responders to MTX Therapy
Primary Objectives:
Part A (dose ranging study):
To demonstrate that sarilumab (SAR153191/REGN88) on top of MTX was effective on reduction of
signs and symptoms of rheumatoid arthritis at 12 weeks.
Part B (pivotal study):
To demonstrate that sarilumab added to MTX was effective in:
- reduction of signs and symptoms of rheumatoid arthritis at 24 weeks
- inhibition of progression of structural damage at 52 weeks
- improvement in physical function at 16 weeks
Secondary Objectives:
Part B:
To demonstrate that sarilumab added to MTX was effective in induction of a major clinical
response at 52 weeks
To assess the safety of sarilumab added to MTX
To document the pharmacokinetic profile of sarilumab added to MTX in participants with
active rheumatoid arthritis who were inadequate responders to MTX therapy.
The total study duration for a participant was 16-22 weeks (Part A) and 56-62 weeks (Part B)
broken down as follows:
- Screening: Up to 4 weeks
- Treatment: 12 weeks (Part A) and 52 weeks (Part B)*
- Follow-up: 6 weeks (for participants who would not continue in the long-term extension
study).
'*' Participants successfully completing their treatment period would be offered the
opportunity to enter the long term extension study LTS11210 (SARIL-RA-EXTEND) (NCT01146652).
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