Subcutaneous Ig Maintenance Therapy for Myasthenia Gravis

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT01828294
• Date of registration: 01/11/2011
• Prospective Registration: No
• Primary sponsor: St. Louis University
• Public title: Subcutaneous Ig Maintenance Therapy for Myasthenia Gravis SIMM
• Scientific title: Subcutaneous Ig Maintenance Therapy for Myasthenia Gravis
• Date of first enrolment: October 2011
• Target sample size: 4
• Recruitment status: Terminated
• URL: https://clinicaltrials.gov/show/NCT01828294
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 1

Countries of recruitment

United States

Contacts

• Name: Ghazala Hayat, M.D.
• Affiliation: St. Louis University

• Name: Jafar Kafaie, M.D.
• Affiliation: St. Louis University

Key inclusion & exclusion criteria

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.



Age minimum: 18 Years
Age maximum: 80 Years
Gender: All

Health Condition(s) or Problem(s) studied

Myasthenia Gravis

Intervention(s)

Drug: Subcutaneous immunoglobulins

Primary Outcome(s)

To monitor number of participants completing the study for the six months period [Time Frame: Baseline to 6 months]

Secondary Outcome(s)

To monitor number of adverse events in participants [Time Frame: Baseline to 6 months]

To measure and correlate levels of serum IgG with clinical response of the participants [Time Frame: Baseline to 6 months]

To monitor effect on manual muscle testing [Time Frame: Baseline to 6 months]

To monitor effect on Quantitative Myasthenia Gravis Score [Time Frame: Baseline to 6 months]

Number of participants able to decrease prednisone dose below 30 mgs [Time Frame: Baseline to 6 months]

To measure changes on SF-36 quality of life measurement tool before and after completion of study [Time Frame: Baseline to 6 months]

To monitor minimal manifestation of Myasthenia Gravis [Time Frame: Baseline to 6 months]

Secondary ID(s)

17005

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

CSL Behring