Clinical trial · Interventional
Subcutaneous Ig Maintenance Therapy for Myasthenia Gravis
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Study stopped by sponsor due to difficulty enrolling at site
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Myasthenia Gravis | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Subcutaneous immunoglobulins | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- Study Population
- description
- Study population will include patients (18-80 years old) with non-thymomatous myasthenia gravis MGFA Class II-IV receiving a minimum of 30mg of Prednisone daily and no other immunosuppression and no more 240 mgs per day of Cholinesterase inhibitor. Patients will receive Subcutaneous immunoglobulins weekly for 6 months.
- interventionNames
- Drug: Subcutaneous immunoglobulins
Primary outcomes (1)
- measure
- To monitor number of participants completing the study for the six months period
- timeFrame
- Baseline to 6 months
- description
- 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.
Secondary outcomes (7)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available