Intravenous Immune Globulin Treatment Compared to Placebo in Patients With Myasthenia Gravis

Study Overview
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Brief Summary
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This study is a double-blind, placebo-controlled, randomized clinical trial to determine whether IVIG is effective in improving motor scores in patients with myasthenia gravis and worsening weakness.

Detailed Description
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Patients aged 18 years or older with a diagnosis of myasthenia gravis (MG) and worsening weakness were enrolled in the study after providing informed consent. Fifty-two patients were recruited to the study, but one withdrew consent prior to starting so that 51 patients were recruited. Baseline clinical assessments using the Quantitative MG Score for Disease Severity (QMGS) were repeated at 2 and 4 weeks after treatment with IVIG or saline infusion. The Post-Intervention Status was assessed at 2 and 4 weeks after treatment. The treatment was randomized and double-masked. Electrophysiological and immunological tests were done at baseline and after 2 weeks. Baseline characteristics were compared by the Student's t test for continuous variables or Chi-square test for categorical variables. An analysis of covariance was performed for the primary outcome measure, the change in QMGS.

Official Title
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IVIG Treatment Compared to Placebo in Patients With Myasthenia Gravis: A Randomized Clinical Trial

Conditions
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Myasthenia Gravis

Intervention / Treatment
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* Drug: Intravenous ImmuneGlobulin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: age > or equal to 18 years old with a confirmed diagnosis of myasthenia gravis and worsening weakness Exclusion Criteria: age <18; severe myasthenia gravis requiring intensive care admission; change in immunosuppresive medication in previous 3 months; patients with severe bulbar weakness at risk for aspiration and respiratory failure; patients with other serious underlying medical conditions (renal failure, congestive heart failure); unwilling to provide informed consent.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Intravenous ImmuneGlobulin|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in the Myasthenia Gravis Foundation of America (MGFA) Quantitative MG Score for Disease Severity |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| MGFA Post Intervention Status Scale, changes in single fiber eletromyography and repetitive nerve stimulation studies, changes in antiacetylcholine receptor antibody titers |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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myasthenia gravis, immunoglobulin, intravenous immunoglobulin, treatment