Subcutaneous Ig Maintenance Therapy for Myasthenia Gravis

Stopped early · Phase 1

Conditions studied: Myasthenia Gravis

In brief

The study is being done with patients with Myasthenia Gravis (MG), age 18-80 years, positive acetylcholine receptor antibody, receiving greater than 30mg of prednisone daily. Patients may or may not be receiving anticholinesterase agents. A common treatment for patients with this disease includes the administration of intravenous immunoglobulin (IVIG), which is a plasma protein that is given to help maintain adequate antibody levels to prevent infections and decrease the symptoms of the disease of Myasthenia Gravis. This study is being done to test if giving this medication in a subcutaneous form (into the fat of the abdomen, legs and thighs) will be better tolerated for patients with Myasthenia Gravis.

Key facts

Study ID

NCT01828294

Run by

St. Louis University

People needed

4

Starts

2011-10-01

Expected to finish

2017-12-01

Last updated by the study team

2019-04-03

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• AChR Ab positive myasthenia gravis (acetylcholine receptor antibody).
• Age 18-80 years.
• MGFA Classification II-IV (The scale used to determine the severity of symptoms of MG).
• Receiving > or equal 30mg of Prednisone per day.
• No new MG-specific treatments in prior 3 months.
• Willingness to participate in study protocol.
• QMG > 10 (quantitative myasthenia gravis score: the sum of grades given for symptoms of MG).
• Treatment with any immunomodulator > than or equal to 3 months prior to trial initiation.

You may not qualify if…

• IgA deficiency (a major class of immunoglobulins found in serum and external body secretions such as saliva, tears, and sweat as well as in the gastrointestinal, respiratory, and genitourinary tracts).
• Previous thromboembolic events, including deep vein thrombosis, stroke and myocardial infarction
• MGFA Class I, IV (if patient requires hospitalization) or V
• History of thymoma
• Thymectomy in previous year or planning to undergo thymectomy in next six months
• Pregnancy or lactation; unwillingness to avoid pregnancy
• Serious concurrent medical, neurological or psychiatric condition that would interfere with IGSC administration or subsequent clinical assessments
• Unwillingness or incapacity to participate, agree to necessary follow-up visits, or give written and informed consent
• Patients who have had an anaphylactic or severe systemic reaction to the administration of human immune globulin or to components of Hizentra, such as polysorbate 80, or patients with hyperprolinemia because it contains the stabilizer L-proline
• Cholinesterase inhibitor no more than 240 mg/day
• Body weight greater than 120 kg.

Where it is running

• George Washington University — Washington D.C., District of Columbia, United States
• Saint Louis University — St Louis, Missouri, United States

Full record on ClinicalTrials.gov

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