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 |
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).
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).
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
sites
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