Clinical trial · Interventional
Intravenous Immunoglobulin and Plasma Exchange in Myasthenia Gravis
A Randomized Trial of Plasma Exchange vs. IVIG in the Treatment of Myasthenia Gravis
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Myasthenia Gravid | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| IVIG | Biological | — | UNRESOLVED |
| PLEX | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- IVIG
- description
- Intravenous Immunoglobulin, 2G/Kg, infused over 2 days in the Medical Day Unit of the University Health Network
- interventionNames
- Biological: IVIG
- type
- EXPERIMENTAL
- label
- PLEX
- description
- 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.
- interventionNames
- Procedure: PLEX
Primary outcomes (1)
- measure
- Change in Quantitative Myasthenia Gravis Score (QMGS) from baseline to day 14 after treatment
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (1)
- BACKGROUNDZinman L, Ng E, Bril V. IV immunoglobulin in patients with myasthenia gravis: a randomized controlled trial. Neurology. 2007 Mar 13;68(11):837-41. doi: 10.1212/01.wnl.0000256698.69121.45. PMID 17353471