E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Generalized Myasthenia gravis with positive antibodies against Acetylcholine-receptors (ICD10GM2006 G70.0) |
|
MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | Yes |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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. |
|
E.2.2 | Secondary objectives of the trial |
Secondary objectives are to find out changes in clinical status, medication, and success of vaccination in the verum and placebo group. |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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 |
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E.4 | Principal 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 |
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E.5 End points |
E.5.1 | Primary end point(s) |
Changes in Acetylcholine-receptor antibody titres from baseline (percent, %) over a period of 12 weeks after vaccination with Mutagrip |
|
E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
| |
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 3 |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |