Measurement of the Structural Efficacy in Active RA Patients Treated With Sarilumab in Combination With MTX and Naive to Biologics
Last updated on July 2021Recruitment
- Recruitment Status
- Active, not recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Rheumatoid Arthritis
- Type
- Interventional
- Phase
- Phase 3
- Design
- Allocation: N/AIntervention Model: Single Group AssignmentMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
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 (t...
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.
Tracking Information
- NCT #
- NCT03535402
- Collaborators
- Not Provided
- Investigators
- Not Provided
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