Status:
TERMINATED
Subcutaneous Ig Maintenance Therapy for Myasthenia Gravis
Lead Sponsor:
St. Louis University
Collaborating Sponsors:
CSL Behring
Conditions:
Myasthenia Gravis
Eligibility:
All Genders
18-80 years
Phase:
PHASE1
Brief 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 b...
Detailed Description
The study is a pilot study to ascertain the feasibility and tolerability of subcutaneous immunoglobulin (SCIG or IGSC) as a maintenance therapy for patients with non-thymomatous MG patients (MGFA clas...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
October 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2017
Estimated Enrollment :
4 Patients enrolled
Trial Details
Trial ID
NCT01828294
Start Date
October 1 2011
End Date
December 1 2017
Last Update
April 3 2019
Active Locations (2)
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1
George Washington University
Washington D.C., District of Columbia, United States, 20037
2
Saint Louis University
St Louis, Missouri, United States, 63110