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

Trial details

Who runs it

Hopital Fondation Adolphe De Rothschild

Trial code

EU 2023-506656-24-00

Record updated

2025. június 6.

Original description

To evaluate, in patients with ocular-onset myasthenia gravis, the effect of a standardized proactive strategy combining immediate treatment with corticosteroids at the time of diagnosis and the addition of rituximab in the event of recurrence of ocular symptoms during corticosteroid taper, on generalization at 2 years.Read full original descriptionShow less

To evaluate, in patients with ocular-onset myasthenia gravis, the effect of a standardized proactive strategy combining immediate treatment with corticosteroids at the time of diagnosis and the addition of rituximab in the event of recurrence of ocular symptoms during corticosteroid taper, on generalization at 2 years.

Inclusion: 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.

Exclusion: 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); 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; 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); 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.

EU CTIS 2023-506656-24-00