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Immediate corticosteroid therapy and rituximab to prevent generalization in ocular myasthenia gravis: a PROBE-type multicenter, open-label, randomized controlled trial
EU CTIS ID: 2023-506656-24-00
What this study is testing
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.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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
You likely can't join if
- Thymoma
- Risk of angle-closure glaucoma
- Risk of urinary retention due to urethro-prostatic disorders
- 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
- 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)
See the full eligibility criteria
- 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
- Thymoma
- Risk of angle-closure glaucoma
- Risk of urinary retention due to urethro-prostatic disorders
- 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
- 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)
- Pregnant or breast-feeding women
- 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)
- Adults under legal protection (L.1121-8)
- History of immunosuppressive treatment or current immunosuppressive therapy for the management of a chronic pathology
- Onset of ocular symptoms more than one year prior to diagnosis
- 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)
- Patients with severe immune deficiency
- Severe heart failure (New York Heart Association (NYHA) Class IV) or severe uncontrolled heart disease
- Severe liver failure
- Psychotic state not yet controlled by treatment
- Hyperuricemia on xanthine oxidase inhibitors (allopurinol and febuxostat)
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.