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Study identifier: NCT06342544 Synced from ClinicalTrials.gov · July 29, 2026
● Recruiting

Immediate Corticosteroid Therapy and Rituximab to Prevent Generalization in Ocular Myasthenia: a PROBE Multicenter Open-label Randomized Controlled Trial.

Condition: Ocular Myasthenia Gravis  ·  Sponsor: Fondation Ophtalmologique Adolphe de Rothschild

PhasePhase 3
Planned participants128
Who can joinAll sexes, 18 Years to no upper limit
Healthy volunteersNo

About this study

Myasthenia is an autoimmune disease causing dysfunction of the neuromuscular junction, resulting in fluctuating and variable muscle weakness. In the initial phase of the disease, 70% of patients present with ocular onset myasthenia (OMG), i.e. weakness limited to the oculomotor muscles. Generalization to skeletal, bulbar and axial muscles occurs in 20-40% of cases, with a higher frequency in the first and second years, respectively 46% and 60% of generalizations. This reflects the maturation of the autoimmune response in the early years of the disease, and represents a therapeutic window of opportunity to modify the course of the disease. Generalization is a critical event, putting the patient at risk of admission to an intensive care unit and necessitating the use of long-term immunosuppressants. There is currently no validated strategy for preventing generalization. On the one hand, a preventive role for corticosteroid therapy in ocular-onset myasthenia has been observed in some studies, but not confirmed by others. These contradictory results may be explained by the bias of retrospective observational studies and the use of different corticosteroid administration regimens. On the other hand, recent data on the use of low-dose Rituximab in the early phase of the disease shows greater efficacy than later use, enabling prolonged remission of the disease with a very good tolerability profile. We propose to compare in a randomized controlled trial the usual practice with a…

This description comes directly from the study's public registry record.

Talk to the study team

Antoine Gueguen  ·  +33148036852  ·  agueguen@for.paris

Always discuss trial participation with your own doctor first.

Locations (11)

Centre Hospitalier Universitaire De BordeauxBordeaux, FranceRecruiting
Hôpital Raymond PointcarreGarches, FranceNot Yet Recruiting
Centre Hospitalier Universitaire De LilleLille, FranceRecruiting
Hospices Civils De LyonLyon, FranceRecruiting
Centre Hospitalier Universitaire De NiceNice, FranceRecruiting
CHNOParis, FranceActive Not Recruiting
Hôpital de la Pitié-SalpêtrièreParis, FranceNot Yet Recruiting
Centre Hospitalier Sainte AnneParis, FranceActive Not Recruiting
Fondation Adolphe de RothschildParis, FranceRecruiting
Les Hopitaux Universitaires De StrasbourgStrasbourg, FranceRecruiting
Centre Hospitalier Universitaire De ToulouseToulouse, FranceActive Not Recruiting

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Source record: clinicaltrials.gov/study/NCT06342544