Open Label Study of Subcutaneous Immunoglobulin (SCIg) in Myasthenia Gravis
The purpose of this study is to determine whether Hizentra is a safe and effective treatment for people with myasthenia gravis (MG).
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Open Label Study of Subcutaneous Immunoglobulin (SCIg) in Myasthenia Gravis|
- Change in MG severity [ Time Frame: Change from Baseline to Week 12 ] [ Designated as safety issue: Yes ]Change will be measured using the Quantitative Myasthenia Gravis (QMG) Score for Disease severity. The QMG is a validated clinical composite scale.
- Efficacy of SCIg in MG [ Time Frame: Change from Baseline to Week 12 ] [ Designated as safety issue: No ]Composite measure of scores from measurement scales including Myasthenia Gravis-specific Activities of Daily Living scale (MG-ADL), MG Quality of Life (QOL)-15, MG composite score, and Treatment Satisfaction Questionnaire for Medication (TSQM)
- Safety and tolerability of SCIg in people with MG [ Time Frame: Change from Week -12 to Week 12 ] [ Designated as safety issue: No ]Measure safety profile between intravenous and subcutaneous treatment phases as measured by changes in routine safety laboratory tests. Lab tests used to determine outcome include CBC, differential and comprehensive chemistry profile.
- Number of Participants with Serious and Non-Serious Adverse Events [ Time Frame: Up to 16 Weeks ] [ Designated as safety issue: Yes ]Safety of SCIg in MG patients measured according to adverse event experienced by trial participants
- Effect of SCIg on IgG antibody levels [ Time Frame: Change from Week -12 to Week 12 ] [ Designated as safety issue: No ]Measure IgG level between intravenous and subcutaneous study phases
|Study Start Date:||January 2015|
|Estimated Study Completion Date:||May 2017|
|Estimated Primary Completion Date:||May 2017 (Final data collection date for primary outcome measure)|
Hizentra is a subcutaneous (under the skin) immunoglobin (SCIg). Participants will receive weekly Hizentra. Dose and rate depend on the visit and how each participant tolerates the drug. Max flow rate not to exceed 100 mL per hour.
Drug: HIZENTRA ®
Other Name: Immune Globulin Subcutaneous (Human), 20% Liquid
Myasthenia gravis (MG) is a rare autoimmune disorder which causes the muscles to become weak because the immune system attacks the connection between the nerves and the muscles.
Hizentra is a subcutaneous (under the skin) immunoglobin (SCIg). An immunoglobin is a blood protein. Hizentra is being studied for the treatment of patients with MG. Hizentra is administered by an injection into the skin through a portable infusion pump, which may be easier for patients to administer than the current treatments.
Participants will be asked to complete 9 clinic visits and 3 telephone calls. It could take up to 30 weeks to complete all study visits.
Please refer to this study by its ClinicalTrials.gov identifier: NCT02100969
|Contact: Gabrielle Rico||(913) firstname.lastname@example.org|
|United States, Kansas|
|University of Kansas Medical Center||Recruiting|
|Kansas City, Kansas, United States, 66160|
|Principal Investigator:||Mazen M Dimachkie, MD||University of Kansas|