Intravenous Immunoglobulin and Plasma Exchange in Myasthenia Gravis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

87 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-03-31

Study Completion Date

2010-07-31

Brief Summary

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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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Detailed Description

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Conditions

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Myasthenia Gravid

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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IVIG

Intravenous Immunoglobulin, 2G/Kg, infused over 2 days in the Medical Day Unit of the University Health Network

Group Type ACTIVE_COMPARATOR

IVIG

Intervention Type BIOLOGICAL

Intravenous immunoglobulin

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.

Group Type EXPERIMENTAL

PLEX

Intervention Type PROCEDURE

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

Interventions

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IVIG

Intravenous immunoglobulin

Intervention Type BIOLOGICAL

PLEX

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

Intervention Type PROCEDURE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No