This is a prospective open-label, randomized, parallel arm clinical trial.
The primary objective of the study is to evaluate the safety and efficacy of Cuvitru 20%
subcutaneous immunoglobulin in patients with myasthenia gravis (MG). The secondary objective
is to evaluate patient preferences and effects on quality of life when treating MG patients
with SCIG. Exploratory objectives are to compare de novo administration starting SCIG
directly with those starting with a loading dose of IVIG followed by SCIG administration.
Patients over age 18 with moderate to severe MG with MGFA Class II-IV without
contraindications to immunoglobulin will be considered for the study.
All patients will be eligible to enter either arm of the study, Arm 1: 10% Gammagard IVIG
followed by 20% Cuvitry SCIG and Arm 2: Cuvitru 20% SCIG alone.
Phase:
Phase 2
Details
Lead Sponsor:
University Health Network, Toronto
Treatments:
Antibodies gamma-Globulins Immunoglobulin G Immunoglobulins Immunoglobulins, Intravenous Rho(D) Immune Globulin