Myasthenia Gravis Clinical Trial
— SIMMOfficial title:
Subcutaneous Ig Maintenance Therapy for Myasthenia Gravis
NCT number | NCT01828294 |
Other study ID # | 17005 |
Secondary ID | |
Status | Terminated |
Phase | Phase 1 |
First received | |
Last updated | |
Start date | October 2011 |
Est. completion date | December 2017 |
Verified date | April 2019 |
Source | St. Louis University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Terminated |
Enrollment | 4 |
Est. completion date | December 2017 |
Est. primary completion date | December 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
United States | Saint Louis University | Saint Louis | Missouri |
United States | George Washington University | Washington | District of Columbia |
Lead Sponsor | Collaborator |
---|---|
St. Louis University | CSL Behring |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | To monitor number of participants completing the study for the six months period | To evaluate feasibility and tolerability of IGSC as a maintenance treatment of generalized MG as measured by treatment adherence and adverse events experienced by the patient. Patients will be asked if they have experienced any of the most commonly known side effects of Hizentra. A case report form detailing any adverse events will be included with every study visit and reviewed with the patient at each visit. | Baseline to 6 months | |
Secondary | To monitor number of adverse events in participants | •To evaluate safety IGSC for treatment of generalized MG as measured by adverse events experienced by each patient and reviewed monthly by the principal investigator. | Baseline to 6 months | |
Secondary | Number of participants able to decrease prednisone dose below 30 mgs | • To evaluate the potential steroid-sparing effect of IGSC treatment as measured by the total dose of prednisone required by each patient over the six month period. | Baseline to 6 months | |
Secondary | To monitor effect on manual muscle testing | • To evaluate the effect of IGSC treatment on symptoms associated with MG as measured by the QMG and MG-ADL. | Baseline to 6 months | |
Secondary | To measure changes on SF-36 quality of life measurement tool before and after completion of study | • To evaluate Quality of Life with IGSC treatment for MG as measured by the SF-36. | Baseline to 6 months | |
Secondary | To measure and correlate levels of serum IgG with clinical response of the participants | • To evaluate pharmacokinetics (IgG) levels associated with IGSC treatment for MG as measured by the monthly blood draws. | Baseline to 6 months | |
Secondary | To monitor minimal manifestation of Myasthenia Gravis | To evaluate the effect of IGSC treatment on symptoms associated with MG | Baseline to 6 months | |
Secondary | To monitor effect on Quantitative Myasthenia Gravis Score | To evaluate the effect of IGSC treatment on the Quantitative Myasthenia Score. Data collected will be qualitative and quantitative, and scores will be compared over time. Data will be captured on case report forms, and entered into an SPSS database. Dr. Gary Cutter, who is serving as a statistician for this study, will review the data monthly for safety, and a report will be sent to Dr. Hayat. | Baseline to 6 months |
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