OCTAGON: A Phase 4, Single Arm Study to Investigate Oral Corticosteroid Tapering in Adult Patients With Generalized Myasthenia Gravis Treated With Ravulizumab
Alexion Pharmaceuticals, Inc.
Summary
This is a prospective, multicenter single arm study designed to evaluate the effectiveness and safety of a predefined oral corticosteroids (OCS) tapering schedule to reduce OCS use in adult participants with acetylcholine receptor positive (AChR+) generalized myasthenia gravis (gMG) being treated with intravenous ravulizumab.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Aged greater than 18 years and male or female * Clinical diagnosis of gMG * Receiving ravulizumab treatment prior to enrollment * Receipt of OCS therapy equivalent to a daily dose ≥ 7.5 mg of prednisone/prednisolone for ≥ 4 continuous weeks directly preceding enrollment * A participant of childbearing potential must have a negative highly sensitive pregnancy test (serum or urine, as required by local regulations) taken at Screening before OCS tapering begins. * Willing to sign informed consent Exclusion Criteria: * Concurrent participation in an interventional clinical…
Interventions
- ProcedureOral Corticosteroid Tapering Schedule
During the tapering period, participant will follow an Oral Corticosteroid tapering schedule as applicable to the participant. The oral corticosteroid (prednisone/prednisolone) is provided as per standard medical care.
- DrugRavulizumab
Patients being treated with intravenous ravulizumab as part of their standard medical care.
- DrugPrednisone/Prednisolone
Participants will continue with or be switched to prednisone/prednisolone as per standard medical care.
Locations (12)
- Research SiteChicago, Illinois
- Research SiteSchaumburg, Illinois
- Research SiteNeptune City, New Jersey
- Research SiteRaleigh, North Carolina
- Research SiteKnoxville, Tennessee
- Research SiteBochum