The effect of tetanus revaccination in patients with myasthenia gravis

Completed

Conditions: 10003816
10029317
lambert-eaton myasthenic syndrome
LEMS
myasthenia
myasthenia gravis

Registration Number: NL-OMON41984

Lead Sponsor: eurologie

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 80

Inclusion Criteria

Adult patients with myasthenia gravis or lambert eaton myasthenic syndrome based on
a) clinical signs or symptoms suggestive of myasthenia gravis or lambert eaton (for example, slowly progressive fluctuating muscle weakness in specific muscle groups); and a positive serologic test for acetylcholine recepter (AChR) antibodies or muscle specific receptor tyrosine kinase antibodies (MuSK) or voltage-gated calcium channel antibodies (VGCC).
b) patients with prednisone dose lower than 30mg and stable (dose +/-5mg) during the 3 months before participation; other immunosuppressive should be stable/unchanged. ;2. Males and females aged between 18 years and 65 years at the time of the injection.

Exclusion Criteria

1. Received no previous tetanus vaccination in the childhood age or received a revaccination in de past year.
2. Myasthenic crisis in the last 3 months.
3. Presence of a thymoma or a planned thymectomy during the study period or within 12 months prior to the first dose of the tetanus toxoid booster immunization.
4. History or evidence of intravenous immunoglobulines or plasmapheresis within 3 months prior to the tetanus toxoid booster immunization.
5. Received a influenza vaccination 1 month before the tetanus revaccination.
6. The patient is unable to fill out the study questionnaires or be interviewed in Dutch, or is unable to
7. The investigator can exclude patients for this trial which are deemed not suitable for any reason.
8. Use of vitamin K antagonist or the new oral coagulantia (NOACS)

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Raise in total tetanus specific tetanus serum IgG titer in patients with AChR<br /><br>MG, MuSK MG, or LEMS. A change in QMG composite score and MG ADL at 1 month<br /><br>after revacinnation . </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary endpoints are a change in the QMG, or QMG composite score and/or a<br /><br>changes in MG-ADL at 3 months after revaccination and a change in autoimmune<br /><br>antibody titers against AChR, MuSK or VGCC at 1 month after revaccination.</p><br>