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OPTIMISE
Identification of Clinical, Biological, Cellular and Genetic Markers of Favorable Response Complement Inhibitors Therapy in Patients With Generalized Myasthenia Gravis
Sponsor study identifier
observational
50
1 country
1
Study Start
June 5, 2024
Actual (reported)Primary Completion
June 1, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
June 1, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Myasthenia gravis is an autoimmune neurological disease caused by autoantibodies primarily directed against components of the postsynaptic membrane of the neuromuscular junction. Approximately 85% of patients have antibodies directed against the acetylcholine receptor (anti-AChR). Anti-AChR antibodies act through three distinct mechanisms:
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
June 1, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
June 3, 2024
Actual (reported)June 5, 2024
Actual (reported)June 12, 2024
Actual (reported)June 1, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
June 1, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Identification of Clinical Markers of Favorable Response to Complement Inhibitors Therapy in Patients With Generalized Myasthenia Gravis
\- Analyze the clinical status of patients comparing the results of MG-ADL and QMG clinical scales pre/post complement inhibitors therapy.
24 months
Identification of Biological and Cellular Markers of Favorable Response to Complement Inhibitors Therapy in Patients With Generalized Myasthenia Gravis
Analyze the differences between complement proteins pre/post therapy with complement inhibitor drugs.
24 months
Identification of Biological and Cellular Markers of Favorable Response to Complement Inhibitors Therapy in Patients With Generalized Myasthenia Gravis
Measure the levels of proteins involved in the pathogenesis of the disease.
24 months
Identification of Genetic Markers of Favorable Response to Complement Inhibitors Therapy in Patients With Generalized Myasthenia Gravis
Investigate the presence of polymorphisms in the gene encoding the complement protein C5 in patients refractory to therapy with complement inhibitors.
24 months
Predictive algorithm of favorable response
24 months
Patients with generalized Myasthenia Gravis positive for anti-AChR antibodies undergoing therapy with complement inhibitor drugs
Fondazione Policlinico Universitario A. Gemelli IRCCS
Roma, 00168, Italy
Raffaele Iorio
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
First Submitted
June 3, 2024
First Posted
June 12, 2024
Study Start
June 5, 2024
Actual (reported)Primary Completion
June 1, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Contact the study team to confirm eligibility.
Study Completion
June 1, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
August 1, 2025
Record last verified: 2025-07
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Source: ClinicalTrials.gov.
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