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| Name | Class |
|---|---|
| Grifols Therapeutics LLC | INDUSTRY |
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Immunomodulation is effective in treating patients with myasthenia gravis (MG), but prior studies have not adequately defined if plasma exchange (PLEX) in superior to intravenous immunoglobulin (IVIG) in the treatment of myasthenia gravis. This study aimed to determine if PLEX was superior to IVIG in the treatment of patients with myasthenia gravis.
Patients with MG requiring immunomodulation are randomized to IVIG or PLEX and treated with a full course of immunomodulation. The quantitative myasthenia gravis score (QMGS) will be evaluated as the primary efficacy parameter at day 14 to determine if PLEX is superior to IVIG.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IVIG | Active Comparator | Intravenous Immunoglobulin, 2G/Kg, infused over 2 days in the Medical Day Unit of the University Health Network |
|
| PLEX | Experimental | Patients received one plasma volume plasma exchanges with 5% albumin replacement fluid. Five plasma exchange procedures occurred every second day with breaks over the weekend allowed. Patients treated in the apheresis units at the University Health Network. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IVIG | Biological | Intravenous immunoglobulin |
| |
| PLEX |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Quantitative Myasthenia Gravis Score (QMGS) from baseline to day 14 after treatment | QMGS is a validated clinical measure of myasthenia gravis ranging from 0 points (no myasthenic weakness) to a maximum of 39 points, with a defined change of 3.4 units required for clinical significance. | QMGS at day 14, and patients followed to day 60 |
| Measure | Description | Time Frame |
|---|---|---|
| QMGS Score change at days 21 and 28 from start of treatment. | Change in QMGS with time to see if effect ad day 14 is sustained. | 28 days |
| Post intervention status | Categorical scale of improvement, worsening, or no change for myasthenia gravis. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Vera Bril, BSc, MD, FRCPC | University Health Network, Toronto | Principal Investigator |
| David Barth, MD | University Heatlh Network | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Health Network | Toronto | Ontario | M5G 2C4 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17353471 | Background | Zinman L, Ng E, Bril V. IV immunoglobulin in patients with myasthenia gravis: a randomized controlled trial. Neurology. 2007 Mar 13;68(11):837-41. doi: 10.1212/01.wnl.0000256698.69121.45. |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | May 15, 2018 | |
| Reset | Dec 13, 2018 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| May 15, 2018 | Dec 13, 2018 |
| ID | Term |
|---|---|
| D009157 | Myasthenia Gravis |
| ID | Term |
|---|---|
| D020361 | Paraneoplastic Syndromes, Nervous System |
| D009423 | Nervous System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D016756 | Immunoglobulins, Intravenous |
| ID | Term |
|---|---|
| D007074 | Immunoglobulin G |
| D007132 | Immunoglobulin Isotypes |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
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| Procedure |
Plasma exchange: removal of pathogenic antibodies and constituents and replacement with albumin. |
|
| Day 14, 21 and 28 |
| Single fiber electromyography: jitter, percent abnormal pair, percent blocking | Electrophysiological assessment of neuromuscular transmission. | Days 14 and 28 compared to baseline |
| Repetitive Nerve stimulation studies | Assessment of decrement | Days 14 and 28 |
| Acetylcholine Receptor Antibody titers | Laboratory assay of pathogenic antibody | Day 28 (if positive at baseline) |
| AntiMUSK antibody | Laboratory measure of pathogenic antibody | Day 28 (if positive at baseline) |
| Need for ICU admission, ventilation, intubation | Myasthenic deterioration and crisis | 60 days |
| Hospitalization | Myasthenic deterioration and crisis | 60 days |
| Need for additional myasthenic treatment | Myasthenic deterioration or crisis | Day 60 |
| D010257 | Paraneoplastic Syndromes |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D019636 | Neurodegenerative Diseases |
| D020511 | Neuromuscular Junction Diseases |
| D009468 | Neuromuscular Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D007162 |
| Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |