Assessment of Structural Benefits of Injectable Abatacept as Measured by MRI in RA Patients Who Have Failed Prior Anti-Tumor Necrosis (TNF) Therapy and Correlated With Clinical Outcomes
Results in the literature suggest the structural benefits of intravenous (IV) abatacept as
measured by high and low field MRI and X-ray in patients with rheumatoid arthritis who have
previously failed clinical treatment with TNF agents. This study attempts to measure the
structural benefits of SC abatacept in a similar cohort of patients while at the same time
comparing the structural findings with clinical outcome measurements as collected at
corresponding time points with an automated patient and physician disease activity scoring
system of 28 joints (DAS28).
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
The primary objective is to evaluate the change from baseline in bone edema/osteitis using low-field MRI in rheumatoid arthritis patients who are using weekly SC abatacept in combination with methotrexate over a 12-month period.
MRIs will be performed at Baseline, Weeks 12, 24, 48
Norman B Gaylis, MD
Arthritis & Rheumatic Disease Specialties Research
United States: Food and Drug Administration
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