Rheumatoid Arthritis Modified Sharp Scoring

Challenge

Structural progression in rheumatoid arthritis is measured in small increments of erosion and joint space narrowing, and detecting change over 52 weeks demands a scoring methodology of exceptional repeatability. Modified total Sharp scoring is labor-intensive and interpretive, and without rigorous central control, reader drift and inter-reader variability can easily exceed the magnitude of the treatment effect the trial seeks to demonstrate. The sponsor needed central assessment disciplined enough to report the smallest detectable change with confidence.

Our Solution

Intrinsic Imaging assigned two blinded musculoskeletal radiologists to independently score paired hand and foot radiographs, with timepoint order randomized to prevent chronological bias from influencing scoring. A detailed scoring charter governed every assessment, and formal adjudication resolved any large discordance between readers. Reader performance was monitored throughout the study to confirm that scoring precision remained stable across the full 52-week follow-up.

Results

• Smallest detectable change reported per protocol
• Consistent scoring across readers
• Central imaging data supported the structural endpoint