Measurement of the Structural Efficacy in Active RA Patients Treated With Sarilumab in Combination With MTX and Naive to Biologics

Rheumatoid Arthritis Clinical Trial

Official title: Measurement of the Structural Efficacy in Active Rheumatoid Arthritis (RA) Patients Treated With Sarilumab in Combination With Methotrexate (MTX) and Naive to Biologics as Measured by Low-field MRI Using a Modified OMERACT-RAMRIS Score.

Status Active, not recruiting

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. ;

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

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