Summary
This analysis of two large multiple sclerosis trials (OPERA I/II and ENSEMBLE) evaluated the utility of composite progression independent of relapse activity (cPIRA) as a clinical trial endpoint. The study found that cPIRA events were largely independent of MRI activity in ocrelizumab-treated patients and occurred despite low serum neurofilament levels, and that cPIRA independently predicted subsequent disability worsening on multiple measures. The authors conclude cPIRA is a clinically relevant and sensitive endpoint for MS trials.
Regional applicability
This is an international multi-centre trial analysis (primarily European and North American sites) examining methodology for multiple sclerosis drug trials. The findings on endpoint validation are directly applicable to United Kingdom-based MS clinical research and trial design, though they do not address United Kingdom-specific clinical practice or policy.
Key measures
Expanded Disability Status Scale (EDSS) worsening, 9-Hole Peg Test, Timed 25-Foot Walk Test, MRI lesion activity, serum neurofilament light (sNfL), Symbol Digit Modalities Test, Multiple Sclerosis Impact Scale-29
Outcomes reported
The study evaluated composite progression independent of relapse activity (cPIRA) as a clinical trial endpoint in relapsing multiple sclerosis, measuring its characteristics, relationship to biomarkers, sustainability, and predictive value for future disability worsening.
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