Immune system diseases.
Conditions
Brief summary
Number of participants having any adverse events (AEs), serious adverse events (SAEs), adverse events leading to treatment discontinuation, adverse events of special interest (AESIs), and potentially clinically significant abnormalities (PCSAs) in safety laboratory tests, electrocardiograms (ECGs), and vital signs during the study period.
Detailed description
Percentage of participants relapse-free since the first dose of riliprubart in the parent study (PDY16744, EFC17236, or EFC18156)., Percentage of participants experiencing improvement from baseline., Change from baseline in adjusted Inflammatory Neuropathy Cause and Treatment (INCAT) disability score over time., Change from baseline in Inflammatory Rasch-built Overall Disability Scale (I-RODS) over time., Change from baseline in grip strength (kilopascals; dominant hand) over time., Change from baseline in Medical Research Council-Sum Score (MRC-SS) for muscle strength over time.
Interventions
Sponsors
Eligibility
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of participants having any adverse events (AEs), serious adverse events (SAEs), adverse events leading to treatment discontinuation, adverse events of special interest (AESIs), and potentially clinically significant abnormalities (PCSAs) in safety laboratory tests, electrocardiograms (ECGs), and vital signs during the study period. | — |
Secondary
| Measure | Time frame |
|---|---|
| Percentage of participants relapse-free since the first dose of riliprubart in the parent study (PDY16744, EFC17236, or EFC18156)., Percentage of participants experiencing improvement from baseline., Change from baseline in adjusted Inflammatory Neuropathy Cause and Treatment (INCAT) disability score over time., Change from baseline in Inflammatory Rasch-built Overall Disability Scale (I-RODS) over time., Change from baseline in grip strength (kilopascals; dominant hand) over time., Change from baseline in Medical Research Council-Sum Score (MRC-SS) for muscle strength over time. | — |
Countries
Belgium, Bulgaria, Czechia, Denmark, France, Germany, Greece, Hungary, Italy, Netherlands, Poland, Portugal, Spain, Sweden