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Intravenous Immunoglobulin and Plasma Exchange in Myasthenia Gravis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01179893
Recruitment Status : Completed
First Posted : August 11, 2010
Last Update Posted : August 11, 2010
Grifols Therapeutics LLC
Information provided by:
University Health Network, Toronto

Brief Summary:

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 87 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Active Comparator: IVIG
Intravenous Immunoglobulin, 2G/Kg, infused over 2 days in the Medical Day Unit of the University Health Network
Biological: IVIG
Intravenous immunoglobulin

Experimental: PLEX
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.
Procedure: PLEX
Plasma exchange: removal of pathogenic antibodies and constituents and replacement with albumin.

Primary Outcome Measures :
  1. 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.

Secondary Outcome Measures :
  1. 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.

  2. Post intervention status [ Time Frame: Day 14, 21 and 28 ]
    Categorical scale of improvement, worsening, or no change for myasthenia gravis.

  3. Single fiber electromyography: jitter, percent abnormal pair, percent blocking [ Time Frame: Days 14 and 28 compared to baseline ]
    Electrophysiological assessment of neuromuscular transmission.

  4. Repetitive Nerve stimulation studies [ Time Frame: Days 14 and 28 ]
    Assessment of decrement

  5. Acetylcholine Receptor Antibody titers [ Time Frame: Day 28 (if positive at baseline) ]
    Laboratory assay of pathogenic antibody

  6. AntiMUSK antibody [ Time Frame: Day 28 (if positive at baseline) ]
    Laboratory measure of pathogenic antibody

  7. Need for ICU admission, ventilation, intubation [ Time Frame: 60 days ]
    Myasthenic deterioration and crisis

  8. Hospitalization [ Time Frame: 60 days ]
    Myasthenic deterioration and crisis

  9. Need for additional myasthenic treatment [ Time Frame: Day 60 ]
    Myasthenic deterioration or crisis

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

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 identifier (NCT number): NCT01179893

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Canada, Ontario
University Health Network
Toronto, Ontario, Canada, M5G 2C4
Sponsors and Collaborators
University Health Network, Toronto
Grifols Therapeutics LLC
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Principal Investigator: Vera Bril, BSc, MD, FRCPC University Health Network, Toronto
Principal Investigator: David Barth, MD University Heatlh Network
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Responsible Party: Vera Bril, University Health Network Identifier: NCT01179893    
Other Study ID Numbers: 07-0280-B
First Posted: August 11, 2010    Key Record Dates
Last Update Posted: August 11, 2010
Last Verified: August 2010
Keywords provided by University Health Network, Toronto:
Myasthenia Gravis
Additional relevant MeSH terms:
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Muscle Weakness
Myasthenia Gravis
Muscular Diseases
Musculoskeletal Diseases
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Pathologic Processes
Autoimmune Diseases of the Nervous System
Neuromuscular Junction Diseases
Neuromuscular Diseases
Autoimmune Diseases
Immune System Diseases