Rheumatoid Arthritis Clinical Trial
Official title:
A Randomized, Controlled Study of Sarilumab and Methotrexate (MTX) Versus Etanercept and MTX in Patients With Rheumatoid Arthritis (RA) and an Inadequate Response to 4 Months of Treatment With Adalimumab and MTX
Primary Objective:
To demonstrate the treatment effect of sarilumab and methotrexate (MTX) compared to
etanercept and methotrexate (MTX) in patients with rheumatoid arthritis (RA) and an
inadequate response to adalimumab and methotrexate by evaluation of the Disease Activity
Score for 28 joints (DAS28).
Secondary Objectives:
To assess the signs and symptoms of rheumatoid arthritis (RA) in patients taking sarilumab
in combination with methotrexate (MTX).
To assess the quality of life of patients with rheumatoid arthritis (RA) taking sarilumab in
combination with methotrexate (MTX).
To assess the safety and tolerability of sarilumab in combination with methotrexate (MTX) in
patients with rheumatoid arthritis (RA).
The maximum study duration per patient enrolled in the Main study is 54 weeks broken down as
follows:
- screening/run-in up to a maximum of 24 weeks
- treatment up to a maximum of 24 weeks
- follow-up of 6 weeks after treatment discontinuation.
The maximum study duration per patient enrolled in the Sub-study is 58 weeks broken down as
follows:
- treatment up to a maximum of 52 weeks
- follow-up of 6 weeks after treatment discontinuation.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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