Intravenous Immunoglobulin and Plasma Exchange in Myasthenia Gravis
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|ClinicalTrials.gov Identifier: NCT01179893|
Recruitment Status : Completed
First Posted : August 11, 2010
Last Update Posted : August 11, 2010
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.
|Condition or disease||Intervention/treatment||Phase|
|Myasthenia Gravid||Biological: IVIG Procedure: PLEX||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||87 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Investigator, Outcomes Assessor)|
|Official Title:||A Randomized Trial of Plasma Exchange vs. IVIG in the Treatment of Myasthenia Gravis|
|Study Start Date :||March 2007|
|Actual Primary Completion Date :||July 2010|
|Actual Study Completion Date :||July 2010|
Active Comparator: IVIG
Intravenous Immunoglobulin, 2G/Kg, infused over 2 days in the Medical Day Unit of the University Health Network
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.
Plasma exchange: removal of pathogenic antibodies and constituents and replacement with albumin.
- Change in Quantitative Myasthenia Gravis Score (QMGS) from baseline to day 14 after treatment [ Time Frame: QMGS at day 14, and patients followed to day 60 ]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 Score change at days 21 and 28 from start of treatment. [ Time Frame: 28 days ]Change in QMGS with time to see if effect ad day 14 is sustained.
- Post intervention status [ Time Frame: Day 14, 21 and 28 ]Categorical scale of improvement, worsening, or no change for myasthenia gravis.
- Single fiber electromyography: jitter, percent abnormal pair, percent blocking [ Time Frame: Days 14 and 28 compared to baseline ]Electrophysiological assessment of neuromuscular transmission.
- Repetitive Nerve stimulation studies [ Time Frame: Days 14 and 28 ]Assessment of decrement
- Acetylcholine Receptor Antibody titers [ Time Frame: Day 28 (if positive at baseline) ]Laboratory assay of pathogenic antibody
- AntiMUSK antibody [ Time Frame: Day 28 (if positive at baseline) ]Laboratory measure of pathogenic antibody
- Need for ICU admission, ventilation, intubation [ Time Frame: 60 days ]Myasthenic deterioration and crisis
- Hospitalization [ Time Frame: 60 days ]Myasthenic deterioration and crisis
- Need for additional myasthenic treatment [ Time Frame: Day 60 ]Myasthenic deterioration or crisis
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01179893
|University Health Network|
|Toronto, Ontario, Canada, M5G 2C4|
|Principal Investigator:||Vera Bril, BSc, MD, FRCPC||University Health Network, Toronto|
|Principal Investigator:||David Barth, MD||University Heatlh Network|