A Multi-Center, Single-Blind, Randomized Study Comparing Thymectomy to No Thymectomy in Non-Thymomatous Myasthenia Gravis (MG) Patients Receiving Prednisone

Phase 3

Completed

Conditions: myasthenia
myasthenia gravis
10003816
10028302

Registration Number: NL-OMON30649

Lead Sponsor: ational Institute of Health

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 5

Inclusion Criteria

Male and female MG patients aged 18 to 60 years inclusive (thymectomy is not regularly performed in non-thymomatous MG patients > 60 years of age).
Onset of generalized MG within the last 3 years.
Positive serum anti-acetylcholine receptor binding antibodies (AChR Ab <=/> 1.0 nmol/L).
MGFA class II-IV at entry, using the MG Foundation of America (MGFA) classification, while receiving optimal anti-cholinesterase treatment with or without oral prednisone.

Exclusion Criteria

Ocular MG without generalized weakness (MGFA Class I) or minimal weakness that would not require the use of corticosteroids.
Myasthenic weakness requiring intubation (MGFA class V) in the prior month.
Immunosuppressive therapy other than corticosteroids in the preceding year.
Medically unfit for thymectomy.
Chest computertomogreaphy evidence for thymoma.
Pregnancy or lactation; contraindications to the use of corticosteroids; unwillingness to practice effective contraception.
A serious concurrent medical, neurological or psychiatric condition.
Current daily dose of prednisone of more than 50 mg.
Participation in another experimental clinical trial.
History of alcohol or drug abuse.
Unwillingness or inability to comply with the requirements of the protocol.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary objective is to determine in the non-thymomatous MG patient<br /><br>population studied wether ETTX combined with prednisone therapy should be<br /><br>preferred to prednisone therapy alone.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>The secondary objectives are (i) to determine the efficacy of the therapies by<br /><br>documenting their effects on myasthenic weakness and (ii) to determine their<br /><br>safety by documenting total exposure to prednisone and by reecording the Trial<br /><br>Specific Adverse Events (TSAEs) and Adverse Symptoms (TSASs). Importantly, we<br /><br>shall also investigate wether outcomes vary between different subgroups by the<br /><br>following planned sub-group analyses:<br /><br>-use of corticosteroids vs. none prior to entering the study<br /><br>-male versus female<br /><br>-age < 40 years and age > 40 years at disease onset</p><br>