Status:
COMPLETED
Subcutaneous Immunoglobulin for Myasthenia Gravis
Lead Sponsor:
University Health Network, Toronto
Conditions:
Myasthenia Gravis
Eligibility:
All Genders
18-100 years
Phase:
PHASE2
Brief Summary
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 pati...
Detailed Description
Myasthenia gravis (MG) is an autoimmune neuromuscular condition which can cause fatigable weakness of skeletal muscles including bulbar, ocular, limb, axial and respiratory muscles. Symptoms range fro...
Eligibility Criteria
Inclusion
- Patients over age 18
- Patients with a confirmed diagnosis of myasthenia gravis based on clinical criteria including fatiguable weakness and supported by either serological (acetylcholine receptor, muscle specific kinase or anti-low-density lipoprotein receptor- related protein 4 antibodies or electrophysiological testing (repetitive nerve stimulation of single fiber electromyography)
- Myasthenia Gravis Federation of America class II-IV
- Moderate to severe myasthenia gravis as defined by a quantitative myasthenia gravis score \>10 or generalized myasthenia gravis impairment index score \> 11
- Patient able to give consent and is able and willing to complete all study procedures and activities
Exclusion
- Patients who are pregnant or breastfeeding
- Patients not able to complete the study procedures or with an alternate diagnosis
- Patients with recent thymectomy in the past 6 months
- Patients receiving another biologic agent such as rituximab, belimubab, cyclophosphamide and eculizumab in the past 6 months prior to study entry
- No IVIG or subcutaneous immunoglobulin within the past month
- Patients on prednisone who have had alterations in prednisone dose over the past month prior to study entry
- Patients will previous known allergy or severe adverse reaction to intravenous or subcutaneous immunoglobulin
- Evidence of renal insufficiency (Cr\>1.5 x elevated) or liver disease (transaminases \> 2.5 x elevation) at screening.
Key Trial Info
Start Date :
August 28 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 30 2023
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT04728425
Start Date
August 28 2020
End Date
December 30 2023
Last Update
April 27 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
University Health Network
Toronto, Ontario, Canada, M5G 2C4