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

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

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON30649

Enrollment

Registered

2007-08-08

Start date

2008-09-16

Completion date

Unknown

Last updated

2024-05-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

myasthenia myasthenia gravis

Interventions

Study participants will be randomized either to undergo the surgical procedure ETTX and receive prednisone treatment, or to receive prednisone treatment alone without surgery. Participants will be f

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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

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.

Design outcomes

Primary

Measure	Time frame
The primary objective is to determine in the non-thymomatous MG patient population studied wether ETTX combined with prednisone therapy should be preferred to prednisone therapy alone.	—

Secondary

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

Measure

Time frame

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

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Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)