An Evaluation of Sarilumab Plus Methotrexate Compared to Etanercept Plus Methotrexate in RA Patients Not Responding to Adalimumab Plus Methotrexate

Conditions

• Rheumatoid Arthritis

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Sarilumab — DRUG
  Pharmaceutical form: Solution for injection in pre-filled syringe; Route of administration: Subcutaneous
• Etanercept — DRUG
  Pharmaceutical form: Solution for injection in pre-filled syringe; Route of administration: Subcutaneous
• Methotrexate — DRUG
  Dispensed according to local practice.
• Placebo (for sarilumab) — DRUG
• Placebo (for etanercept) — DRUG
• Adalimumab — DRUG
  Pharmaceutical form: Solution for injection in pre-filled syringe; Route of administration: Subcutaneous

Study Details

Primary Objective: To demonstrate the treatment effect of sarilumab and methotrexate (MTX) compared to etanercept and MTX in participants with rheumatoid arthritis (RA) and an inadequate response to adalimumab and MTX by evaluation of the Disease Activity Score for 28 joints (DAS28). Secondary Objectives: To assess the signs and symptoms of RA in participants taking sarilumab in combination with MTX. To assess the quality of life of participants with RA taking sarilumab in combination with MTX. To assess the safety and tolerability of sarilumab in combination with MTX in participants with RA.

Key Dates

Start date

Apr 30, 2013

Status verified

Jun 2017

Primary completion

Jan 31, 2015

Completion

Jan 31, 2015

Study Design

Enrollment

776 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Adalimumab Open Label run-in
  Adalimumab 40 mg every 2 weeks (Q2W) for 16 weeks added to stable dose of MTX.
• Active Comparator: Etanercept + MTX (Randomized)
  Etanercept 50 mg in combination with Placebo for sarilumab Q2W and etanercept 50 mg on alternating weeks for 24 weeks added to stable dose of MTX.
• Experimental: Sarilumab 150 mg + MTX (Randomized)
  Sarilumab 150 mg in combination with placebo for etanercept Q2W and placebo for etanercept on alternating weeks for 24 weeks added to stable dose of MTX.
• Experimental: Sarilumab 200 mg + MTX (Randomized)
  Sarilumab 200 mg in combination with placebo for etanercept Q2W and placebo for etanercept on alternating weeks for 24 weeks added to stable dose of MTX.
• Experimental: Sarilumab 150 mg + MTX Open Label Sub-study
  Sarilumab 150 mg Q2W for 52 weeks added to stable dose of MTX.

Primary Outcome Measure

Change From Baseline in Disease Activity Score for 28 Joints - C-Reactive Protein (DAS28-CRP) Score at Week 24 [ Time Frame: Baseline, Week 24 ]

Locations (30)

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