Intravenous Immunoglobulin and Plasma Exchange in Myasthenia Gravis
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||A Randomized Trial of Plasma Exchange vs. IVIG in the Treatment of Myasthenia Gravis|
- 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 ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]Change in QMGS with time to see if effect ad day 14 is sustained.
- Post intervention status [ Time Frame: Day 14, 21 and 28 ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]Electrophysiological assessment of neuromuscular transmission.
- Repetitive Nerve stimulation studies [ Time Frame: Days 14 and 28 ] [ Designated as safety issue: No ]Assessment of decrement
- Acetylcholine Receptor Antibody titers [ Time Frame: Day 28 (if positive at baseline) ] [ Designated as safety issue: No ]Laboratory assay of pathogenic antibody
- AntiMUSK antibody [ Time Frame: Day 28 (if positive at baseline) ] [ Designated as safety issue: No ]Laboratory measure of pathogenic antibody
- Need for ICU admission, ventilation, intubation [ Time Frame: 60 days ] [ Designated as safety issue: Yes ]Myasthenic deterioration and crisis
- Hospitalization [ Time Frame: 60 days ] [ Designated as safety issue: Yes ]Myasthenic deterioration and crisis
- Need for additional myasthenic treatment [ Time Frame: Day 60 ] [ Designated as safety issue: Yes ]Myasthenic deterioration or crisis
|Study Start Date:||March 2007|
|Study Completion Date:||July 2010|
|Primary Completion Date:||July 2010 (Final data collection date for primary outcome measure)|
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.
|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|