OCTAGON: A Phase 4, Single Arm Study to Investigate Oral Corticosteroid Tapering in Adult Patients With Generalized Myasthenia Gravis Treated With Ravulizumab
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.
Arms & 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.
Outcome measures
Primary
Proportion of Adult Participants With gMG Who Either: Discontinue Oral Corticosteroids (OCS) or Reduce Their Daily OCS Dosage ≤ 5 mg/day and Maintain this Status for ≥ 4 Weeks Without Clinical Deterioration of gMG
Time frame: Up to approximately 32 weeks
Secondary
Proportion of Adult Participants with gMG Who Discontinue OCS (0 mg/day), Sustained ≥ 4 Weeks Without Clinical Deterioration of gMG
Time frame: Up to approximately 32 weeks
Percentage Change From Daily OCS Dose (mg/day) at Baseline
Time frame: Baseline, Up to approximately 32 weeks
Change from Baseline in the Myasthenia Gravis Quality of Life-15 Revised (MG-QoL-15r) Score in Adult Participants with gMG
Time frame: Baseline, Up to approximately 32 weeks
Change from Baseline in the Myasthenia Gravis-Activities of Daily Living (MG-ADL) Total Score in Adult Participants with gMG
Time frame: Baseline, Up to approximately 32 weeks
Cumulative Worsening Score per the Glucocorticoid Toxicity Index - Metabolic Domains (GTI-MD) in Adult Participants with gMG
Time frame: Baseline up to approximately 32 weeks
Aggregate Improvement Score per the GTI-MD in Adult Participants with gMG
Time frame: Baseline up to approximately 32 weeks
Eligibility criteria
Study locations (5)
Research Site
Chicago, Illinois, 60637
Research Site
Schaumburg, Illinois, 60173
Research Site
Neptune City, New Jersey, 07753
Research Site
Raleigh, North Carolina, 27607
Research Site
Knoxville, Tennessee, 37920