Extension Study of ECU-MG-301 to Evaluate Safety and Efficacy of Eculizumab in Refractory Generalized Myasthenia Gravis
Refractory Generalized Myasthenia Gravis
About this trial
This is an interventional treatment trial for Refractory Generalized Myasthenia Gravis focused on measuring gMG, Myasthenia Gravis, safety, efficacy
Eligibility Criteria
Inclusion Criteria:
- Participant has completed Study ECU-MG-301.
- Participant has given written informed consent.
- Participant was willing and able to comply with the protocol requirements for the duration of the study.
- Female participant of childbearing potential must have had a negative pregnancy test (serum human chorionic gonadotropin). All participants were required to practice an effective, reliable, and medically approved contraceptive regimen during the study and for up to 5 months following discontinuation of treatment.
Exclusion Criteria:
- Participants who withdrew from Study ECU-MG-301 as a result of an adverse event related to study drug.
- Female participants who were pregnant, breastfeeding, or intended to conceive during the course of the study.
- Unresolved meningococcal infection
- Hypersensitivity to murine proteins or to one of the excipients of eculizumab
- Any medical condition or circumstances that, in the opinion of the investigator, might have interfered with the participant's participation in the study, posed any added risk for the participant, or confounded the assessment of the participants.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Experimental
Experimental
Eculizumab/Eculizumab
Placebo/Eculizumab
Blind Induction Phase: Participants who had received blinded treatment with eculizumab in Study ECU-MG-301 were administered eculizumab (4 vials/1200 milligrams [mg]) on Day 1 and Week 2 and placebo (4 vials/0 mg) at Weeks 1 and 3. Open-Label Maintenance Phase: Participants received open-label eculizumab (4 vials/1200 mg) every 2 weeks starting at Week 4 and continued throughout the study. Eculizumab 1200 mg was administered for up to 4 years in this extension study.
Blind Induction Phase: Participants who had received blinded treatment with placebo in Study ECU-MG-301 were administered eculizumab/placebo (3 vials/900 mg, plus 1 vial/0 mg, respectively) on Day 1 and Weeks 1 through 3. Open-Label Maintenance Phase: Participants received open-label eculizumab (4 vials/1200 mg) every 2 weeks starting at Week 4 and continued throughout the study. Eculizumab 1200 mg was administered for up to 4 years in this extension study.