Generalized Myasthenia gravis with positive antibodies against Acetylcholine-receptors (ICD10GM2006 G70.0)
Conditions
Interventions
Trade Name: Mutagrip
Product Name: Mutagrip
Pharmaceutical Form: Suspension for injection
Pharmaceutical form of the placebo: Solution for injection
Route of administration of the placebo: Intramuscul
Sponsors
Philipps-University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: written informed consent age 18-80 diagnosis of a generalized Myasthenia gravis (ICD10GM2006: G70.0) positive Acetylcholine receptor antibodies stable clinical course for at least 4 weeks before inclusion in the study Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: contraindication for Mutagrip according to the "Fachinformation" any vaccination in the last 9 months prior to study entry serious or acute heart disease (e. g. uncontrolled cardiac dysrhythmias, angina pectoris, cardiomyopathy, congestive heart failure) known allergy to chicken proteins, neomycine, formaldehyde, Octoxinol 9) current infection or current pyrexia pregnancy history of cancer severe adverse event in earlier vaccination current participation in another clinical trail
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Influenza vaccination is often requested by patients suffering from autoimmune diseases, but evidence for its influence on disease activity is still sparse. Myasthenia gravis (MG) is an autoimmune and antibody-mediated neurological disease. Autoantibody-blockade of the nicotinergic acetylcholine receptor at the neuromuscular junction leads to fluctuating weakness, especially after muscule work. Evidence for a direct impact of influenca vaccination on disease activity is still sparse, but a continous matter of discussion. Concerning this issue, no data are available from prospective, randomized, controlled trials so far. The main objective of the trial is to compare for acetylcholine receptor antibody changes after influenza vaccination in MG patients with the plecebo group. ;Secondary Objective: Secondary objectives are to find out changes in clinical status, medication, and success of vaccination in the verum and placebo group.;Primary end point(s): Changes in Acetylcholine-receptor antibody titres from baseline (percent, %) over a period of 12 weeks after vaccination with Mutagrip | — |
Countries
Germany
Outcome results
None listed