To Evaluate Sarilumab - SAR153191 (REGN88) - Auto-injector Device In Patients With Rheumatoid Arthritis



Status:Completed
Conditions:Arthritis, Rheumatoid Arthritis
Therapuetic Areas:Rheumatology
Healthy:No
Age Range:18 - Any
Updated:4/21/2016
Start Date:March 2014
End Date:March 2016

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A Multicenter, Randomized, Open-Label, Parallel-Group Usability Study Of The Sarilumab Auto-Injector Device And A Prefilled Syringe In Patients With Moderate To Severe Active Rheumatoid Arthritis Who Are Candidates For Anti-IL6R Therapy

Primary Objective:

To collect real-use data of the sarilumab auto-injector used by rheumatoid arthritis (RA)
patients.

Secondary Objective:

To compare the pharmacokinetic (PK) exposure of sarilumab administered by AID versus
prefilled syringes (PFS).

Total study duration up to 74 weeks: screening up to 4 weeks, AID assessment phase 12 weeks,
extension phase 52 weeks, post-treatment follow-up of 6 weeks.

For patients not entering the extension phase, total study duration up to 22 weeks
(screening, AID assessment phase and follow-up).

Inclusion criteria:

- Diagnosis of rheumatoid arthritis (RA), ≥3 months disease duration

- Patient willing and able to self-inject

- Continuous treatment with 1 or a combination of nonbiologic DMARDs (except
leflunomide in combination with methotrexate)

- Moderate-to-severely active RA

Exclusion criteria:

- Patients<18 years

- Prior treatment with anti-interleukin 6 (IL-6) or IL-6 receptor (IL-6R) antagonists

- Treatment with tumor necrosis factor (TNF) antagonists

- Treatment with RA-directed biologic agents other than with a TNF-α antagonist
mechanism as follows: Anakinra, Abatacept, Rituximab or other cell-depleting agent

- Prior treatment with a Janus kinase inhibitor

The above information is not intended to contain all considerations relevant to a
patient's potential participation in a clinical trial.
We found this trial at
32
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Duncansville, Pennsylvania 16635
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North Charleston, South Carolina 29406
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Tupelo, MS
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