Intravenous Immunoglobulin and Plasma Exchange in Myasthenia Gravis

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT01179893
• Date of registration: 09/08/2010
• Prospective Registration: No
• Primary sponsor: University Health Network, Toronto
• Public title: Intravenous Immunoglobulin and Plasma Exchange in Myasthenia Gravis
• Scientific title: A Randomized Trial of Plasma Exchange vs. IVIG in the Treatment of Myasthenia Gravis
• Date of first enrolment: March 2007
• Target sample size: 87
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT01179893
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Investigator, Outcomes Assessor), Primary Purpose: Treatment
• Phase: Phase 4

Countries of recruitment

Canada

Contacts

• Name: Vera Bril, BSc, MD, FRCPC
• Affiliation: University Health Network, Toronto

• Name: David Barth, MD
• Affiliation: University Heatlh Network

Key inclusion & exclusion criteria

Inclusion Criteria:

- >18 years old

- diagnosis of moderate-severe MG (defined as a Quantitative Myasthenia Gravis Score
QMGS >10.5)

- worsening weakness requiring a change in therapy judged by a neuromuscular expert

Exclusion Criteria:

- Worsening weakness secondary to concurrent medications (e.g. Aminoglycosides)

- Worsening weakness secondary to infection

- Change in corticosteroid dosage in the 2 weeks prior to screening

- Other disorders causing weakness or fatigue

- Known absolute IgA deficiency (risk of anaphylactic reaction to IVIG)

- History of anaphylaxis or severe systemic response to IVIG or albumin

- Pregnancy or breastfeeding

- Active renal failure precluding volume of IVIG (risk of volume overload with IVIG) as
judged by the investigators

- Clinically significant cardiac disease precluding IVIG volume as judged by the
investigators

- Known hyperviscosity or hypercoaguable state (risk of stroke with IVIG)

- Known coagulopathy with bleeding

- On another current study medication or protocol within 4 weeks of screening

- Patients with known refractory status to either IVIG or PLEX

- Poorly controlled or severe hypertension (exacerbation by IVIG)

- Patient refuses treatment with either IVIG or PLEX

- Patient refuses follow-up with electrophysiological studies

- Patient unable or unwilling to give informed consent



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Myasthenia Gravid

Intervention(s)

Biological: IVIG

Procedure: PLEX

Primary Outcome(s)

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]

Secondary Outcome(s)

Need for ICU admission, ventilation, intubation [Time Frame: 60 days]

QMGS Score change at days 21 and 28 from start of treatment. [Time Frame: 28 days]

Acetylcholine Receptor Antibody titers [Time Frame: Day 28 (if positive at baseline)]

Need for additional myasthenic treatment [Time Frame: Day 60]

Single fiber electromyography: jitter, percent abnormal pair, percent blocking [Time Frame: Days 14 and 28 compared to baseline]

Hospitalization [Time Frame: 60 days]

Post intervention status [Time Frame: Day 14, 21 and 28]

Repetitive Nerve stimulation studies [Time Frame: Days 14 and 28]

AntiMUSK antibody [Time Frame: Day 28 (if positive at baseline)]

Secondary ID(s)

07-0280-B

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Grifols Therapeutics Inc.