Overview

RA-PRO PRAGMATIC TRIAL

Status:
Recruiting
Trial end date:
2025-12-31
Target enrollment:
Participant gender:
Summary
The 2015 ACR RA treatment guideline, based on widely acknowledged low to moderate quality evidence, recommends adding TNFi-biologic, non-TNFi biologic or a tsDMARD to MTX in MTX-IR patients with active RA.24 In practice, most patients receive a TNFi-biologic first. This is not based on solid evidence, but on arbitrary algorithms often proposed by health insurance plans, physician experience (first TNFi launched 22 yrs ago vs. first tsDMARD 8 yrs ago). This study will fill a critical knowledge gap by generating CER data for important PROs between these treatment options, adding TNFi-biologic or a tsDMARD to MTX in MTX-IR patients.
Phase:
Phase 2
Details
Lead Sponsor:
University of Alabama at Birmingham
Collaborator:
Patient-Centered Outcomes Research Institute