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Clinical Trial Summary

This is a single site study to determine the structural efficacy of sarilumab when administered to biologic naive patients with active rheumatoid arthritis


Clinical Trial Description

This is a single site Phase III 48-week open-label study to evaluate the structural response of sarilumab 200 mg SC injection administered to active RA patients. Active RA is defined as having a Clinical Disease Activity Index (CDAI) >10.0. All patients will have had an inadequate response to MTX (treated with 12.5-20 mg/wk. for at least 3 months) and have had no prior exposure to biologic medications for RA. The MTX will be continued throughout the trial allowing for dose reduction at the Primary Investigator's discretion due to safety. There will be a total of twenty (20) patients enrolled into the trial. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03535402
Study type Interventional
Source Gaylis, Norman B., M.D.
Contact
Status Active, not recruiting
Phase Phase 3
Start date June 1, 2018
Completion date December 30, 2020

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