A Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Immune Globulin (Human), 10% Caprylate/Chromatography Purified (IGIV-C) as a Corticosteroid Sparing Agent in Corticosteroid Dependent Patients with Generalized Myasthenia Gravis
Efficacy and Safety of IGIV-C in Corticosteroid Dependent Patients With Generalized Myasthenia Gravis
Sponsor: Grifols Therapeutics, Inc.
Enrolling: Male and Female Patients
Clinic Visits: 22
IRB Number: AAAP9814
U.S. Govt. ID: NCT02473965
Contact: Arreum Kim: 2123056035 / ak3905@cumc.columbia.edu
Additional Study Information: This study is designed to test how well an intravenous human immunoglobulin concentrate, IGIV-C (compared with placebo) improves the ability to taper participant's dose of corticosteroids without causing significant increase in your muscle weakness and worsening MG symptoms. A placebo is a medication that looks like the study medication but has no active ingredient. Immunoglobulin is an antibody produced by white blood cells that is used by the immune system (body protection system) to identify and neutralize foreign objects (such as viruses, bacteria, antibodies, etc). In MG treatment, human immunoglobulins are used to potentially affect the function or production of the abnormal antibodies occurring in MG patients. This study will be used to analyze the effectiveness of IGIV-C (versus placebo) in allowing corticosteroid doses to be tapered to the lowest dose possible without significant worsening of MG symptoms or weakness.
This study is closed
Thomas Brannagan, MD
Do You Qualify?
Anti-AChR antibody positive? Yes No
On corticosteroids for a minimum period of at least three months and on a stable CS dose of 15 mg/day and 60 mg/day? Yes No
Thymectomy within the preceding six months prior to Screening? Yes No
Rituximab, belimumab, eculizumab or any monoclonal antibody used for immunomodulation within the past 12 months? Yes No
Immune globulin treatment given by IV, subcutaneous, or intramuscular route within the last 3 months? Yes No
You may be eligible for this study

Place Holder

For more information, please contact:
Arreum Kim