Generalized Myasthenia Gravis
Conditions
Brief summary
Change from Baseline in Myasthenia Gravis - Activities of Daily Living (MG-ADL) Scale Score at Week 24 During the Double-Blind Placebo Controlled (DBPC) Period.
Detailed description
Change from Baseline in Quantitative Myasthenia Gravis (QMG) Scale Score at Week 24 during the Double-Blind Placebo Controlled (DBPC) Period., Percentage of MG-ADL Responders at Week 24 during the Double-Blind Placebo Controlled (DBPC) Period., Change from Baseline in Myasthenia Gravis Composite (MGC) Scale Score at Week 24 during the Double-Blind Placebo Controlled (DBPC) Period., Percentage of Quantitative Myasthenia Gravis (QMG) Scale Responders at Week 24 during the Double-Blind Placebo Controlled (DBPC) Period., Change from Baseline in the Revised Myasthenia Gravis Quality of Life – 15 Scale (MG-Qol15r) Score at Week 24 during the Double-Blind Placebo Controlled (DBPC) Period., Time From Initial Cladribine Full Dose Treatment to First Retreatment of Rescue Treatment up to end of Study., Number of Participants With Adverse Events (AEs) and Adverse Events of Special Interest (AESIs)., Number of participants with Adverse Events (AEs) by Severity as per National Cancer Institute Common Terminology Criteria for Adverse Events, version 5.0., Number of Participants with Abnormal Laboratory Variables including Absolute Lymphocyte Count and Vital Signs., Pharmacokinetic (PK) Plasma Concentrations of Cladribine.
Interventions
Sponsors
Eligibility
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from Baseline in Myasthenia Gravis - Activities of Daily Living (MG-ADL) Scale Score at Week 24 During the Double-Blind Placebo Controlled (DBPC) Period. | — |
Secondary
| Measure | Time frame |
|---|---|
| Change from Baseline in Quantitative Myasthenia Gravis (QMG) Scale Score at Week 24 during the Double-Blind Placebo Controlled (DBPC) Period., Percentage of MG-ADL Responders at Week 24 during the Double-Blind Placebo Controlled (DBPC) Period., Change from Baseline in Myasthenia Gravis Composite (MGC) Scale Score at Week 24 during the Double-Blind Placebo Controlled (DBPC) Period., Percentage of Quantitative Myasthenia Gravis (QMG) Scale Responders at Week 24 during the Double-Blind Placebo Controlled (DBPC) Period., Change from Baseline in the Revised Myasthenia Gravis Quality of Life – 15 Scale (MG-Qol15r) Score at Week 24 during the Double-Blind Placebo Controlled (DBPC) Period., Time From Initial Cladribine Full Dose Treatment to First Retreatment of Rescue Treatment up to end of Study., Number of Participants With Adverse Events (AEs) and Adverse Events of Special Interest (AESIs)., Number of participants with Adverse Events (AEs) by Severity as per National Cancer Institute Commo | — |
Countries
Belgium, Bulgaria, Czechia, France, Germany, Greece, Hungary, Italy, Poland, Romania, Spain, Sweden