Chronic inflammatory demyelinating polyneuropathy (CIDP) is a treatable form of peripheral neuropathy with suspected autoimmune cause. The current first-line treatment is IVIG (immune globulin), which is infused in a set regimen that requires 4-5 hours in a hospital day unit, taking up resources such as nursing time and hospital space. Chronic treatment is required in most cases.
The proposed trial will be an exploratory, open-label, single-centre, phase IIIb safety, tolerability and efficacy study, wherein each patient acts as their own control. The primary outcome measure is safety and tolerability of panzyga in patients with active CIDP at standard and high infusion rates as measured by: * Occurrence of all adverse events with focus on adverse drug reactions (ADRs) * The secondary outcomes include: Patients' treatment satisfaction, proportion of patients successfully achieving higher infusion rates, health utilities associated with treatment, proportion of responders to treatment based on change in clinical scores, grip strength, and quality of life measures. The total sample size is 25-30 patients, based on a difference of 30% in adverse events rates between the standard infusion rate and the maximum rate tolerated by each patient.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
30
standard Immune lobulin 10% intravenous solution infusion at standard and high infusion rates.
UHNToronto
Toronto, Ontario, Canada
Occurrence of all adverse events with focus on adverse drug reactions (ADRs)
adverse drug reactions
Time frame: 2 years
treatment satisfaction
completion of questionnaire
Time frame: 2 years
proportion of patients successfully achieving higher infusion rates
descriptive analysis of number of patients
Time frame: 2 years
health utilities
completion of questionnaire
Time frame: 2 years
proportion of responders to treatment based on change in clinical scores
completion of scale
Time frame: 2 years
grip strength
measurements in kPa
Time frame: 2 years
quality of life measures
completion of scale
Time frame: 2 years
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