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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
75
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.
Patients being treated with intravenous ravulizumab as part of their standard medical care.
Participants will continue with or be switched to prednisone/prednisolone as per standard medical care.
Research Site
Chicago, Illinois, United States
Research Site
Schaumburg, Illinois, United States
Research Site
Neptune City, New Jersey, United States
Research Site
Raleigh, North Carolina, United States
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
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
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Research Site
Knoxville, Tennessee, United States
Research Site
Bochum, Germany
Research Site
Napoli, Italy
Research Site
Rome, Italy
Research Site
Ibaraki, Japan
Research Site
Kitakyushu-shi, Japan
...and 1 more locations