The purpose of the study is to evaluate clinical efficacy of rozanolixizumab as a treatment for subjects with chronic inflammatory demyelinating polyradiculoneuropathy (CIDP).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
34
Subjects will receive rozanolixizumab in a specified sequence during the treatment period.
Subjects will receive placebo in a specified sequence during the treatment period.
Cidp01 902
Phoenix, Arizona, United States
Cidp01 905
Los Angeles, California, United States
Change From Baseline to Week 13 (Day 85) in Inflammatory Rasch-built Overall Disability Scale (iRODS) Score
iRODS is a linearly weighted patient-reported outcome measure (questionnaire) that captures activity and social participation limitations in participants with chronic inflammatory demyelinating polyradiculoneuropathy. Questionnaire consisted of 24 items (including eating, taking a shower, walking a flight of stairs, standing for hours, etc.) and assesses a participant's ability to perform daily and social activities. Participants had 3 response options: 0=impossible to perform; 1=performed with difficulty; 2=easily performed, performed without difficulty. Raw sum scores of iRODS (range 0 to 48, where 0=worse and 48=best) were translated to log odds units (logits) scale, placing participant' estimates on same logit scale, which had a score range of -6.95 (most severe activity and social participation restrictions) to 8.11 (no activity and social participation limitations). A positive change is associated with a better outcome of less disease activity and more social activity.
Time frame: From Baseline up to Week 13 (Day 85)
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Cidp01 901
Tampa, Florida, United States
Cidp01 907
Augusta, Georgia, United States
Cidp01 911
Lexington, Kentucky, United States
Cidp01 903
Charlotte, North Carolina, United States
Cidp01 912
Durham, North Carolina, United States
Cidp01 101
Ghent, Belgium
Cidp01 102
Leuven, Belgium
Cidp01 103
Liège, Belgium
...and 12 more locations