Immediate corticosteroid therapy and rituximab to prevent generalization in ocular myasthenia gravis: a PROBE-type multicenter, open-label, randomized controlled trial

Prior treatment

• Alternative diagnosis to ocular involvement (pupillary abnormality other than that resulting from previous local disease or surgery abduction myopathy due to dysthyroid ophthalmopathy or dysimmune orbitopathy)
• Vaccination with live attenuated vaccine required during study and up to 6 months after rituximab discontinuation
• Onset of ocular symptoms more than one year prior to diagnosis
• Hyperuricemia on xanthine oxidase inhibitors (allopurinol and febuxostat)

Other illness

• Risk of urinary retention due to urethro-prostatic disorders
• Persons deprived of their liberty by judicial or administrative administrative decision, persons under psychiatric care by virtue of articles L.3212-1 and L.3213-1 and persons admitted to a health or social establishment for purposes purposes other than research (L.1121-6)
• History of immunosuppressive treatment or current immunosuppressive therapy for the management of a chronic pathology
• Hypersensitivity to paracetamol
• Hypersensitivity to rituximab or murine proteins
• Hypersensitivity to prednisone and/or methylprednisone
• Hypersensitivity to aziathioprine or 6-mercaptopurine
• Hypersensitivity to dexchlorpheniramine
• Any infectious condition (including hepatitis b)
• Severe heart failure (New York Heart Association (NYHA) Class IV) or severe uncontrolled heart disease
• Severe liver failure

Age

• Women of childbearing age* who do not wish to use effective contraception (effective contraception includes oral contraception, intrauterine devices and other forms of contraception with a failure rate <1%) during their participation and at least 12 months after the last dose (oral commitment by the patient recorded in the file by the investigator)

Other

• Thymoma
• Risk of angle-closure glaucoma
• Pregnant or breast-feeding women
• Adults under legal protection (L.1121-8)
• Patients with severe immune deficiency
• Psychotic state not yet controlled by treatment

• Patients over 18 years old
• Diagnosis of ocular myasthenia within the last 6 months, defined : either by a typical clinical examination objectified by an expert clinician: ptosis and/or binocular diplopia, with a variable and fluctuating character (either spontaneous or provoked by effort or rest) ; or by positive anti-AChR antibodies or the presence of a decrement on repetitive nerve stimulation or a positive edrophonium test
• Myasthenic symptoms limited to ocular and/or orbicular muscles muscles (no non-ocular symptoms on MMS, MGC and MG-ADL).
• Myasthenic symptoms for at least one month (to rule out generalized myasthenia at the outset)
• Immunosuppressive therapy-naive management of ocular myasthenia gravis
• Having received information about the study and having signed a consent to participate in the study
• Affiliated to a social security system