NCT04728425CompletedPhase 2
Subcutaneous Immunoglobulin for Myasthenia Gravis
Efficacy and Safety of Subcutaneous Immunoglobulin in Patients With Myasthenia Gravis
Source: ClinicalTrials.gov · Last updated 27 Apr 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 30 (actual)
- First submitted
- 14 Jul 2020
- Start date
- Aug 2020
- Primary completion date
- Jun 2023
- Lead sponsor
- University Health Network, Toronto
- Diseases
- Myasthenia gravis
- NCT number
- NCT04728425
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 30
- From Aug 2020 to the primary completion date, Jun 2023
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients receiving another biologic agent such as rituximab, belimubab, cyclophosphamide and eculizumab in the past 6 months prior to study entry
- 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
Lab values
- Evidence of renal insufficiency (Cr\>1.5 x elevated) or liver disease (transaminases \> 2.5 x elevation) at screening.
Other
- 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
- No IVIG or subcutaneous immunoglobulin within the past month
Who the study is looking for
- 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
Age in the registry: 18 years to 100 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University Health Network Coordinator of this site? Confirm its status | Toronto | Canada | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.