Phase
Condition
Neuropathy
Polymyositis (Inflammatory Muscle Disease)
Sarcopenia
Treatment
subcutaneous immunoglobulin (SCIG)
intravenous immunoglobulin + subcutaneous immunoglobulin (SCIG)
Clinical Study ID
Ages 18-100 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Patients over age 18
Patients with a confirmed diagnosis of myasthenia gravis based on clinical criteriaincluding fatiguable weakness and supported by either serological (acetylcholinereceptor, muscle specific kinase or anti-low-density lipoprotein receptor- relatedprotein 4 antibodies or electrophysiological testing (repetitive nerve stimulationof single fiber electromyography)
Myasthenia Gravis Federation of America class II-IV
Moderate to severe myasthenia gravis as defined by a quantitative myasthenia gravisscore >10 or generalized myasthenia gravis impairment index score > 11
Patient able to give consent and is able and willing to complete all studyprocedures and activities
Exclusion
Exclusion Criteria:
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 pastmonth prior to study entry
Patients will previous known allergy or severe adverse reaction to intravenous orsubcutaneous immunoglobulin
Evidence of renal insufficiency (Cr>1.5 x elevated) or liver disease (transaminases > 2.5 x elevation) at screening.
Study Design
Study Description
Connect with a study center
University Health Network
Toronto, Ontario M5G 2C4
CanadaSite Not Available
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