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NCT Number: NCT01179893

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.

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Key information

Conditions

Myasthenia Gravid Autoimmune Diseases Autoimmune Diseases of the Nervous System Immune System Diseases Myasthenia Gravis Neoplasms Neoplasms by Site Nervous System Diseases Nervous System Neoplasms Neurodegenerative Diseases Neuromuscular Diseases Neuromuscular Junction Diseases Paraneoplastic Syndromes Paraneoplastic Syndromes, Nervous System

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

University Health Network

Toronto, Ontario, M5G 2C4, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

IVIG

Biological

Intravenous immunoglobulin

PLEX

Procedure

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

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

University Health Network, Toronto

Other

Collaborators

  • Grifols Therapeutics LLC

Registry information

Official study title

A Randomized Trial of Plasma Exchange vs. IVIG in the Treatment of Myasthenia Gravis

Important dates

Study start
2007
Primary completion
2010
Study completion
2010
First posted
Aug 11, 2010
Registry last updated
Aug 11, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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