The aim of this study is to evaluate the efficacy and safety of I10E (LFB 10% ready-to-use liquid human intravenous immunoglobulin) compared to Kiovig® for the maintenance treatment of MMN in a randomized, double-blind, active comparator-controlled, cross-over trial.
Who can participate
Age range18 Years – 80 Years
SexALL
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Inclusion criteria
âś“. Male or female patient aged 18 to 80 years.
âś“. Written informed consent obtained prior to any study-related procedures.
âś“. Diagnosis of definite or probable MMN according to the EFNS/PNS Guideline 2010, First revision made by neuromuscular disease specialists with specific electrodiagnostic expertise.
✓. Patients treated with a stable maintenance dose within 15% of any brand of IVIg (Kiovig® excluded) at 1 g/kg for 1-3 days up to 2 g/Kg for 2-5 days every 4 to 8 weeks (+/- 7 days), according to the EFNS/PNS Guideline 2010, First revision for at least 3 months prior to enrolment.
âś“. Covered by national health care insurance system if required by local regulations.
Exclusion criteria
âś•. Upper motor neuron, bulbar, cranial nerve or significant sensory deficit.
âś•. CSF protein \>100 mg/dL (if available and done as part of a previous evaluation).
✕. Any other ongoing disease that may cause neuropathy, such as toxin exposure, dietary difficency, uncontrolled diabetes, hyperthyroidism, cancer, systemic lupus erythematosus or other connective diseases, infection with HIV, hepatitis B virus (HBV), or hepatitis C (HCV), Lyme disease, multiple myeloma, Waldenström's macroglobulinemia, amyloid, and hereditary neuropathy.
âś•. BMI \>= 40 kg/m2.
âś•. Known hypersensitivity to the active substance or to any of the excipients of I10E (glycine and polysorbate 80) or Kiovig(glycine).
What they're measuring
1
Change between I10E and Kiovig® in the original MMRC 10 sum score described by Cats 2008
Timeframe: at 6 months and 1 year
Trial details
NCT IDNCT01951924
SponsorLaboratoire français de Fractionnement et de Biotechnologies
âś•. Patient who have been treated with Kiovig shall not have received Kiovig during the last 6 months prior to enrolment.
âś•. History of IgA deficiency, except if the absence of anti-IgA antibodies is documented.
âś•. Protein-losing enteropathy characterised by serum protein levels \<60 g/l and serum albumin levels \<30 g/l or nephrotic syndrome characterised by proteinuria \>=3.5 g/24 hours, serum protein levels \<60 g/l and serum albumin levels \<30 g/l.