Subcutaneous Ig Maintenance Therapy for Myasthenia Gravis

• Status: Terminated
• Trial end date: 2017-12-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: St. Louis University
• Collaborator: CSL Behring
• Treatments: Antibodies; Immunoglobulins; Immunoglobulins, Intravenous

Criteria

Inclusion Criteria:

1. AChR Ab positive myasthenia gravis (acetylcholine receptor antibody).

2. Age 18-80 years.

3. MGFA Classification II-IV (The scale used to determine the severity of symptoms of MG).

4. Receiving > or equal 30mg of Prednisone per day.

5. No new MG-specific treatments in prior 3 months.

6. Willingness to participate in study protocol.

7. QMG > 10 (quantitative myasthenia gravis score: the sum of grades given for symptoms of MG).

8. Treatment with any immunomodulator > than or equal to 3 months prior to trial initiation.

Exclusion Criteria:

1. 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).

2. Previous thromboembolic events, including deep vein thrombosis, stroke and myocardial infarction

3. MGFA Class I, IV (if patient requires hospitalization) or V

4. History of thymoma

5. Thymectomy in previous year or planning to undergo thymectomy in next six months

6. Pregnancy or lactation; unwillingness to avoid pregnancy

7. Serious concurrent medical, neurological or psychiatric condition that would interfere with IGSC administration or subsequent clinical assessments

8. Unwillingness or incapacity to participate, agree to necessary follow-up visits, or give written and informed consent

9. 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

10. Cholinesterase inhibitor no more than 240 mg/day

11. Body weight greater than 120 kg.